[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-lung-non-small-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-lung-non-small-cell-carcinoma":432},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,46,117,138,163,184,206,227,246,293,332,352,372,390,412],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100601865",false,"NCT07116057","MOv19-BBz CAR T Cells in FRa+ Cancers","Phase I Clinical Trial of Autologous Folate Receptor-Alpha Redirected T Cells in Patients With FRa+ Cancers","Inclusion Criteria:\n\n1. Signed informed consent form\n2. Documentation of tumor FRa expression by IHC at the Hospital of the University of Pennsylvania (≥ 10% of tumor cells). Subjects must have archived tumor tissue available.\n3. Disease-specific criteria:\n\n   a. NSCLC Patients: i. Metastatic or recurrent lung adenocarcinoma with cytologically or pathologically confirmed malignant pleural effusion.\n\n   ii. Failure of at least one prior line of standard of care therapy for advanced stage disease.\n4. Patients must have evidence of active disease as defined by RECIST 1.1 criteria\n5. Patients with asymptomatic CNS metastases that have been treated (and are off steroids for the treatment of CNS disease) are allowed. They must meet the following criteria\n\n   1. No concurrent treatment for the CNS disease\n   2. No progression of CNS metastasis on MRI at screening\n   3. No evidence of leptomeningeal disease or cord compression\n6. Adequate organ function defined as:\n\n   1. Serum creatinine ≤ 1.5 mg\u002Fdl or creatinine clearance ≥ 30 cc\u002Fmin; Patient must not be on dialysis\n   2. ALT\u002FAST ≤ 3x upper limit of normal range\n   3. Serum total bilirubin ≤ 1.5 mg\u002Fdl, unless the subject has Gilbert's syndrome (if so, serum total bilirubin must be ≤ 3.0 mg\u002Fdl)\n   4. Must have a minimum level of pulmonary reserve defined as \\\u003C Grade 1 dyspnea and pulse oxygen \\> 92% on room air\n   5. Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO or MUGA\n7. Male or female age ≥ 18 years\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status that is either 0 or 1\n9. Subjects must be a possible clinical candidate for standard of care treatment with a commercial checkpoint inhibitor, as per physician-investigator assessment.\n\nExclusion Criteria:\n\n1. Any clinically significant pleural effusion that cannot be drained with standard approaches.\n2. Patients with significant lung disease as follows:\n\n   1. Patients with radiographic evidence of greater than lobar lymphangitic pulmonary involvement, greater than lobar bronchial wall thickening suggestive of peribronchial lymphatic disease extension, and\u002For evidence of extensive bilateral parenchymal metastatic burden.Note: \"Greater than lobar\" = \"in more than 1 lobe\".\n   2. Patients with radiographic and\u002For clinical evidence of active radiation pneumonitis.\n   3. Patients with radiographic evidence of underlying interstitial lung disease, including evidence of unresolved drug toxicity from any agent (e.g. chemotherapy, targeted agents, amiodarone, nitrofurantoin, etc.).\n   4. Patients with radiographic evidence of significant pleural effusion that is not readily amenable to minimally invasive drainage.\n3. Active hepatitis B or hepatitis C infection\n4. Any other active, uncontrolled infection\n5. Class III\u002FIV cardiovascular disability according to the New York Heart Association Classification\n6. Active invasive cancer, other than the proposed cancer included in this protocol, within 2 years prior to eligibility confirmation by a physician-investigator. \\[Note: non-invasive cancers treated with curative intent (e.g., non-melanoma skin cancer) may still be eligible\\].\n7. Dependence on systemic steroids or immunosuppressant medications.\n8. Pregnant or nursing (lactating) patients. Participants of reproductive potential must agree to use acceptable birth control methods\n9. Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone daily. Patients with autoimmune neurologic diseases (such as MS) will be excluded.\n10. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)","ALL","18 Years",{"count":18,"type":19},10,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","This is a Phase I open-label clinical trial to assess the safety, feasibility, and preliminary efficacy of intrapleural administration of MOv19-BBz CAR T cells in patients with FRa+ cancers. This study will be initiated in patients with metastatic or recurrent non-small cell lung cancer (NSCLC) only. Subjects will receive a single dose of MOv19-BBz CAR T cells via intrapleural infusion following lymphodepleting chemotherapy. Subjects without an existing intra-pleural catheter will have a temporary pleural catheter placed for the study. Subjects may initiate treatment with commercial checkpoint inhibitors per routine care beginning at least 28 days after receiving MOv19-BBz CAR T cells.",[25,26],"Metastatic Non Small Cell Lung Cancer","Recurrent Lung Non-Small Cell Carcinoma",[28,29,30,31,32],"NSCLC","CAR T cells","FRa+","lung cancer","lung adenocarcinoma","RECRUITING","2026-06-16",{"date":36,"type":37},"2026-06-18","ACTUAL",{"date":39,"type":37},"2025-10-07",{"date":41,"type":19},"2040-10",{"name":43,"class":44},"University of Pennsylvania","OTHER",1,{"id":47,"slug":4,"hasResults":10,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":20,"phases":54,"briefSummary":56,"conditions":57,"keywords":88,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100499720","NCT05786924","Phase 1\u002F2 Trial of S241656 in Selected RAS\u002FMAPK Mutation- Positive Malignancies","A Phase 1\u002F2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With KRAS, BRAF and Other Selected RAS\u002FMAPK Mutation-Positive Malignancies","Key Inclusion Criteria:\n\n* Life expectancy of ≥ 12 weeks in the opinion of the investigator.\n* Histologically or cytologically confirmed recurrent locally advanced (unresectable) or metastatic solid tumors with documented RAS or RAF mutations or alterations.\n* Adequate bone marrow and organ function.\n* Recovered from toxicity to prior anti-cancer therapy.\n\nPart 1 Dose Escalation cohort ONLY:\n\n* Part 1A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C, HRAS, NRAS, BRAF or CRAF (RAF1) mutations or alterations\n* Part 1B: Advanced\u002Fmetastatic GI tumors (e.g., PDAC, CRC, and BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1C: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1D: Colorectal adenocarcinoma with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1E: Other advanced\u002Fmetastatic non-GI, non-NSCLC solid tumors with KRAS, HRAS, NRAS, BRAF, CRAF (RAF1) mutations or alterations\n\nPart 2 Dose Optimization and Expansion cohorts ONLY:\n\n* Part 2A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations and\u002For BRAF mutations\n* Part 2A1: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations\n* Part 2A2: Advanced\u002Fmetastatic NSCLC with BRAF mutations\n* Part 2A3: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C or BRAF mutations or alterations and active CNS metastatic disease\n* Part 2A4: Advanced\u002Fmetastatic NSCLC with a KRAS G12C mutation\n* Part 2B1: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B2: Advanced\u002Fmetastatic CRC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B3: Advanced\u002Fmetastatic BTC (adenocarcinoma) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n\nKey Exclusion Criteria:\n\n* Cancer that has a known MEK1\u002F2 mutation.\n* Known allergy\u002Fhypersensitivity to excipients of S241656 or to any of the registered IMPs administered in combination.\n* Any contra-indication, to use of any of the combination chemotherapy or anti-EGFR therapy partners administered as part of this trial.\n* Major surgery within 4 weeks of study entry or planned during study.\n* Ongoing anticancer therapy.\n* Ongoing radiation therapy.\n* Uncontrolled or active clinically relevant bacterial, fungal, or specific viral infection requiring systemic therapy.\n* Clinically significant cardiovascular disease.\n* Symptomatic spinal cord compression.\n* Evidence of active malignancy (other than study-specific malignancies) requiring systemic therapy within the next 2 years.\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.\n* Females who are pregnant or breastfeeding.\n* Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.\n* Prior use of experimental agents that target the KRAS\u002FBRAF\u002FMEK\u002FERK pathway.",{"count":53,"type":19},554,[22,55],"PHASE2","BDTX-4933-101 is a first-in-human, open-label, Phase 1\u002F2 dose escalation, dose optimization and expansion study designed to evaluate the safety and tolerability of S241656 as monotherapy and in combination with other anti-cancer therapies in participants with selected advanced malignancies. The study population for the Dose Escalation part of the study comprises adults with recurrent advanced\u002Fmetastatic non-small cell lung cancer (NSCLC), Gastrointestinal (GI) cancers, and other solid tumors harboring KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (Rapidly Accelerated Fibrosarcoma (RAF1)) mutations or alterations. A dose optimization part in adults with NSCLC may follow the dose escalation phase if the sponsor, in consultation with the safety review committee, decides it is necessary to further characterize the optimal dose. However, the study may also proceed directly to the expansion phase. The study population for the Dose Expansion part of the study comprises adults with advanced\u002Fmetastatic NSCLC with KRAS and\u002For BRAF mutations, and with Pancreatic Ductal AdenoCarcinoma (PDAC), ColoRectal Cancer (CRC), and Biliary Tract Cancer (BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations and alterations. All patients will self-administer S241656 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.",[58,59,60,61,62,63,64,65,66,67,68,26,28,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87],"Non-small Cell Lung Cancer","Histiocytic Neoplasm","Histiocytosis","BRAF Gene Mutation","BRAF V600E","BRAF V600 Mutation","BRAF Mutation-Related Tumors","BRAF","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Lung Cancer","Recurrent Lung Cancer","Solid Tumor","Solid Carcinoma","KRAS G12D","KRAS G12V","KRAS Mutation-Related Tumors","NRAS Gene Mutation","Thyroid Cancer","Thyroid Carcinoma","Colorectal Cancer","Colorectal Carcinoma","Recurrent Histiocytic and Dendritic Cell Neoplasm","Brain Metastases","Recurrent NSCLC","KRAS G13C","Acquired Resistance to KRAS G12C Inhibitor","KRAS G12A","KRAS G12F","KRAS G12R","KRAS G13D",[89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107],"BRAF Class I","BRAF Class II","BRAF Class III","KRAS","Intolerant histiocytic neoplasm","BDTX-4933","Phase 1","dose escalation","dose expansion","MAPK","mitogen-activated protein kinase","RAS","RAF","Upstream oncogenic alterations","RAF inhibitor","intracranial disease","CRAF","NRAS","RAF fusions",{"date":109,"type":37},"2026-06-17",{"date":111,"type":37},"2023-04-18",{"date":113,"type":19},"2028-06",{"name":115,"class":44},"Institut de Recherches Internationales Servier",27,{"id":118,"slug":4,"hasResults":10,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":20,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":45},"100483114","NCT05570825","SX-682 With Pembrolizumab for the Treatment of Metastatic or Recurrent Stage IIIC or IV Non-Small Cell Lung Cancer","A Phase 2 Trial of SX-682 and Pembrolizumab in Patients With Treatment Naive Stage IV or Recurrent Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Subjects aged 18 years and older\n* Pathologically or cytologically confirmed non-small cell lung cancer with no known oncogenic EGFR mutation, ALK rearrangement, ROS1 rearrangement or RET rearrangement\n* Tumoral PD-L1 expression \\>=1% by any Clinical Laboratory Improvement Act (CLIA)-certified assay\n* Metastatic or recurrent non-small cell lung cancer (NSCLC). Stage IIIC per 8th edition TNM stage classification is allowed if not amenable to curative surgery or radiation per investigator judgment\n* At least one site of measurable disease as determined by the Investigator, using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. Subjects must have ECOG PS 0 or 1 at the time of informed consent and at the time of treatment initiation\n* Must be willing to provide pre-treatment archived specimen or undergo a biopsy procedure if archived specimen is not available\n* Must be willing to provide an on-treatment biopsy, if deemed safe by the treating physician\n* Platelet count \\>= 100,000\u002FuL\n* Absolute neutrophil count \\>= 1,500\u002FuL\n* Hemoglobin \\>= 8g\u002FdL\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 times upper limit of normal\n* Creatinine =\\\u003C 2.0 mg\u002FdL\n* Women of child-bearing potential and sexually active men must agree to use adequate contraception (hormonal or barrier method) prior to treatment initiation, during treatment and for three months after completing treatment\n* Negative beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential. Pregnant or breast feeding women are not eligible\n* Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment\n\nExclusion Criteria:\n\n* Participants must not have received prior chemotherapy or immune checkpoint inhibitor or immune-modulatory therapy (e.g. anti-PD\\[L\\]1, anti-CTLA4, anti-TIM3, anti-GITR, anti-TIGIT, anti-LAG3), for metastatic or recurrent NSCLC, with the following exceptions:\n\n  * Participants may have received prior chemotherapy, immune checkpoint inhibitor, and\u002For immune modulatory therapy in the curative setting if the last dose of treatment was more than (\\>) 24 weeks prior to consenting\n  * For patients with NSCLC harboring an oncogenic alteration other than listed may have received prior small molecule inhibitor therapy (e.g. MET inhibitor for MET exon 14 mutated NSCLC). A wash-out period of at least 5 half-lives is required prior to start of study treatment\n* Presence of other active cancers within the last 2 years. Patients with any prior early stage cancer who have received definitive local treatment at least 2 years previously and no evidence of recurrence are eligible. All patients with previously treated in situ carcinoma are eligible, as patients with history of non-melanoma skin cancer\n* Symptomatic central nervous system (CNS) metastases; participants with known brain metastasis must be asymptomatic with no steroids or escalating doses of antiepileptics within 7 days prior to start of study treatment\n\n  * Patients with untreated CNS metastases may be enrolled as long as they meet the above criteria. Patients with bulky CNS metastases should consider receiving radiation prior to study entry per investigator judgment\n* Participants with spinal cord compression must have received local treatment and must have been symptomatically stable with no use of steroids for at least 7 days prior to start of study treatment\n* Participants must not have an active autoimmune disease that has required immune modulating treatment within (\\\u003C) 365 days prior to consenting (i.e., disease modifying agents, corticosteroids). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed\n* Inability to discontinue systemic corticosteroid therapy; systemic steroids must be tapered off 7 days prior to first dose of SX-682\n* Known history of primary immunodeficiency\n* History of organ transplant that requires use of immunosuppressives\n* Current symptomatic pneumonitis and any past history of immune checkpoint inhibitor related pneumonitis regardless of steroid treatment history\n* History of non-infectious pneumonitis (e.g. radiation pneumonitis) that required steroids within 3 months of start of study treatment\n* Radiotherapy within 7 days of start of study treatment\n* Major surgery within 21 days of start of study treatment. Minor surgery within 2 weeks of start of study treatment. Placement of vascular access device and biopsies are not considered major or minor surgery and are allowed\n* Electrocardiogram (EKG) demonstrating a corrected QT (QTc) interval \\> 480 msec on three consecutive EKGs or patients with congenital long QT syndrome\n* Severe lung disease (e.g. chronic obstructive pulmonary disease \\[COPD\\]) who cannot stop steroids 7 days prior to start of study treatment\n* Serious cerebrovascular and cardiac disease defined as:\n\n  * Active unstable angina pectoris\n  * Congestive heart failure NYHA (New York Heart Association) \\> grade 3\n  * Acute myocardial infarction within 3 months of consenting\n  * Stroke or transient ischemic attack within 3 months of consenting\n* Known active chronic infections: Active hepatitis B, hepatitis C and tuberculosis. Testing is not required for assessment of eligibility. Active infection requiring IV antibiotics within 7 days of study treatment initiation\n\n  * Hepatitis C virus (HCV) infection: Patients with known history of HCV infection are eligible if HCV viral load is below the limit of quantification per local assay\n  * Hepatitis B virus (HBV) infection: Patients with known history of HBV infection are eligible if HBV viral load is below the limit of quantification and negative hepatitis B virus surface antigen (HBsAg) per local assay\n* Known uncontrolled HIV (human immunodeficiency virus) infection\n\n  * Participants with known HIV infection are allowed if they are receiving anti-retroviral therapy, have CD4+ T-cell count \\>= 350 cells\u002FuL within 6 months prior to study treatment initiation and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection\n* Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study\n* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent",{"count":124,"type":19},30,[55],"This phase II trial tests whether CXCR1\u002F2 inhibitor SX-682 (SX-682) with pembrolizumab works to treat patients with stage IIIC or IV non-small cell lung cancer that has spread to other parts of the body (metastatic) or that has come back (recurrent). SX-682 is a drug that binds to receptors on some types of immune and cancer cells, inhibiting signaling pathways, reducing inflammation, and allowing other types of immune cells to kill and eliminate cancer cells. Pembrolizumab is a monoclonal antibody that binds to a receptor called PD-1 that is found on the surface of T-cells (a type of immune cell), activating an immune response against tumor cells. Giving SX-682 in combination with pembrolizumab may be more effective at treating patients with metastatic or recurrent non-small cell lung cancer than giving these treatments alone.",[66,26,128,129],"Stage IIIC Lung Cancer AJCC v8","Stage IV Lung Cancer AJCC v8","2026-06-15",{"date":109,"type":37},{"date":133,"type":37},"2023-04-06",{"date":135,"type":19},"2028-07-01",{"name":137,"class":44},"University of Washington",{"id":139,"slug":4,"hasResults":10,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":20,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":162},"100300444","NCT03191149","Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change","Phase II Study of Osimertinib (AZD9291) in Advanced NSCLC Patients With Exon 20 Insertion Mutations in EGFR","Inclusion Criteria:\n\n* Participants must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC)\n* Participants must have advanced disease - either stage IV disease, stage IIIB disease not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease. All staging is via the American Joint Committee on Cancer (AJCC)\u002FInternational Association for the Study of Lung Cancer (IASLC) 7th edition staging criteria\n* An EGFR exon 20 insertion mutation must be detected in the tumor tissue. Patients may be enrolled in the study based on an exon 20 insertion EGFR mutation detected by any Clinical Laboratory Improvement Act (CLIA)-certified tissue assay\n\n  * NOTE: Testing results are to be submitted via Medidata Rave and the study chair or delegate will review the reports\n* Patients must have measurable disease; baseline measurements and ALL sites of disease must be obtained within 4 weeks to registration\n* Patients must have previously received at least one line of therapy for their advanced lung cancer; there are no restrictions on the maximum number of prior therapies allowed\n* Participants must not have previously received osimertinib\n* Participants must have not previously received therapies targeting PDL1, PD1 or CTLA4 within 6 months (180 days) prior to registration\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 1\n* Hemoglobin \\>= 9.0 g\u002FL (within 4 weeks before registration)\n* Leukocytes\u002Fwhite blood cells \\>= 3,000\u002FmcL (within 4 weeks before registration)\n* Absolute neutrophil count \\>= 1,500\u002FmcL (within 4 weeks before registration)\n* Platelets \\>= 100,000\u002FmcL (within 4 weeks before registration)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) if no liver metastases or =\\\u003C 3 times ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases (within 4 weeks before registration)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x institutional upper limit of normal; for patients with known hepatic metastases AST and\u002For ALT =\\\u003C 5 x ULN (within 4 weeks before registration)\n* Creatinine =\\\u003C 1.5 x institutional upper limit of normal (within 4 weeks before registration)\n* Participants may not have clinically active or symptomatic interstitial lung disease or interstitial pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention), or a history of clinically significant interstitial lung disease or radiation pneumonitis\n* Participants may not have had radiation to the lung fields within four weeks (28 days) of starting treatment. For patients receiving palliative radiation to thoracic vertebrae, ribs or other sites where the radiation field includes the lungs, radiation must be completed at least two weeks before starting treatment. For all palliative radiation to all other sites, at least 7 days must have elapsed prior to starting treatment. At least six months (180 days) must have elapsed prior to starting treatment for radiation given with curative intent. Palliative radiotherapy to control symptoms (including gamma knife technique) is permitted. For stereotactic radiosurgery (SRS) to central nervous system (CNS) lesions, osimertinib can be held on the day of radiation only. For palliative radiotherapy (RT) to other sites of disease outside of the thorax osimertinib (osi) should be held for a minimum of 3 days before radiation and 3 days after RT is completed, but the duration of washout can be adjusted at the investigator's discretion with the approval of the study principal investigator (PI). For thoracic radiation, a 7-10 day washout period before the procedure and one week period after procedure before restarting osimertinib is advised to minimize the risk of pneumonitis. All radiotherapy related toxicities should be managed and ideally resolved before restarting osimertinib. Investigators should consider the radiotherapy when assessing causality if there are any localized adverse events (AEs) following the procedure\n* Participants may not have clinically symptomatic brain metastases, leptomeningeal disease, or spinal cord compression. Patients may be on a stable dose of corticosteroids to control brain metastases if they have been on a stable dose for two weeks (14 days) prior to study treatment and are clinically asymptomatic\n* Patients must have an ECHO or a nuclear study (MUGA or first pass) within 4 weeks (28 days) prior to registration to treatment and must not have a left ventricular ejection fraction (LVEF) \\\u003C institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be \\>= 50% for the patient to be eligible\n* Participants may not have any of the following cardiac criteria:\n\n  * Mean resting corrected QT interval (QTc) \\>= 470 msec obtained from 3 electrocardiograms (ECGs) using the screening clinic ECG machine-derived QTc value\n  * No history of QT prolongation associated with other medications that required discontinuation of that medication\n  * Patient must not be receiving any concomitant medications that are known to be associated with Torsades de Pointes\n  * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third degree heart block, second degree heart block, any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: serum\u002Fplasma potassium \\\u003C LLN; serum\u002Fplasma magnesium \\\u003C LLN; serum\u002Fplasma calcium \\\u003C LLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval\n  * Symptomatic heart failure - New York Heart Association (NYHA) grade II-IV\n* Participants may not have a second, clinically active, cancer. Patients with second cancers which have been treated with curative intent and\u002For are currently inactive are allowed\n* Participants may not be receiving any other investigational agents. Patients previously treated with investigational agents must complete a washout period of at least two weeks or five half-lives, whichever is longer, before starting treatment\n* Participants may not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patients must have no history of hypersensitivity active or inactive excipients of osimertinib (AZD9291) or drugs with a similar chemical structure or class to osimertinib (AZD9291)\n* Patients must not currently be receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 week prior). All patients must try to avoid concomitant use of any medications, herbal supplements and\u002For ingestion of foods with known inducer effects on CYP3A4\n* If medically feasible, patients taking regular medication, with the exception of potent inducers of CYP3A4, should be maintained on it throughout the study period. Patients taking concomitant medications whose disposition is dependent upon breast cancer resistance protein (BCRP) or P-glycoprotein (Pgp) and which have a narrow therapeutic index should be closely monitored for signs of changed tolerability as a result of increased exposure of the concomitant medication whilst receiving osimertinib (AZD9291)\n\n  * NOTE: Use of St John's wort is a contra-indication for osimertinib (AZD9291) use\n* If applicable, it is recommended that the starting and maintenance dose of rosuvastatin (due to BCRP inhibition by AZD9291 \\[osimertinib\\]) should be as low as possible and should be guided by the statin label. Monitoring of low-density lipoprotein (LDL) cholesterol levels is advised. If the subject experiences any potentially relevant adverse events suggestive of muscle toxicity including unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, the statin should be stopped, creatine kinase (CK) levels should be checked, and any appropriate further management should be taken\n* Subjects taking warfarin should be monitored regularly for changes in prothrombin time or international normalized ratio (INR)\n* No unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2, prior platinum-therapy-related neuropathy\n* Patients with refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib (AZD9291) are ineligible\n* Women must not be pregnant or breast-feeding because osimertinib (AZD9291) has been shown to cause fetal harm in animal models. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Women of childbearing potential (WOCBP) and sexually active males must use an accepted and effective method of contraception while receiving protocol treatment or abstain from sexual intercourse for the duration of their participation in the study. WOCBP must use birth control for two weeks prior to the start of the treatment and continue for 6 weeks after the last dose of the study drug. Sexually active male patients must use effective contraception from day 1 of treatment and continue for 4 months after the last dose of the study drug\n* Other anticancer agents and investigational agents should not be given while the subject is on study treatment\n* Supportive care and other medications that are considered necessary for the subject's wellbeing may be given at the discretion of the investigator\n* A guidance regarding potential interactions with concomitant medications is provided",{"count":145,"type":19},46,[55],"This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back after a period of improvement (recurrent). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.",[149,26,150,151],"Advanced Lung Non-Small Cell Carcinoma","Stage IIIB Lung Non-Small Cell Cancer AJCC v7","Stage IV Lung Non-Small Cell Cancer AJCC v7","2026-06-10",{"date":154,"type":37},"2026-06-11",{"date":156,"type":37},"2018-04-25",{"date":158,"type":19},"2027-06-30",{"name":160,"class":161},"National Cancer Institute (NCI)","NIH",345,{"id":164,"slug":4,"hasResults":10,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":20,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":45},"100617724","NCT07322341","SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer","A Phase 2 Trial of SX-682 and Atezolizumab in Patients With Advanced NSCLC Who Progressed on Prior Chemotherapy and Immune Checkpoint Inhibitor (ICI) Therapy","Inclusion Criteria:\n\n* Age 18 years and older\n* Ability to understand and willingness to sign a written informed consent document\n* Pathologically or cytologically confirmed non-small cell lung cancer with no known oncogenic EGFR mutation, ALK fusion, ROS1 fusion or RET fusions.\n\n  * For participants with NSCLC harboring an oncogenic alteration other than the above must have received prior targeted therapy (e.g. small molecule inhibitor therapy or antibody drug conjugates). A wash-out of at least 5 half-lives is required prior to start of study treatment\n* Metastatic or recurrent NSCLC. Stage 3C per 8th edition TNM stage classification is allowed if not amenable to curative surgery or radiation per investigator judgment\n* Participants must have received and progressed on at least 6 weeks of treatment with prior anti-PD-1 or anti-PD-L1 therapy for advanced disease. Also, participants must have received prior platinum doublet chemotherapy. Anti-PD1\u002FPD-L1 therapy may have been received concurrently with chemotherapy or as sequential therapy (e.g. anti-PD1 followed by chemotherapy).\n\n  * For participants who received neoadjuvant, adjuvant and\u002For consolidation anti-PD-1 or anti-PD-L1 therapy for stage 1 - 3 NSCLC: If they experienced disease progression ≤ 365 days from initiation of anti-PD-1 or anti-PD-L1 therapy, this counts as the allowed anti-PD-1 or anti-PD-L1 therapy for advanced disease.\n  * For participants who experienced disease progression more than 365 days from initiation of anti-PD-1 or anti-PD-L1 therapy for advanced disease, this is not considered anti-PD-1 or anti-PD-L1 therapy for advanced disease. These patients must have received anti-PD-1 or anti-PD-L1 therapy for stage 4 or recurrent disease\n* Participants must have a minimum of 28 days after the last dose, or 5 half-lives of washout period (whichever is shorter) from last dose of most recent systemic therapy prior to initiation of study treatment, including investigational agents\n* Participants must have at least one site of measurable disease as determined by the investigator, using RECIST v 1.1 criteria documented within 28 days prior to study treatment initiation\n* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 at the time of informed consent and at the time of treatment initiation\n* Participants must be willing to provide pre-treatment archived specimen (taken within a year of trial entry) or undergo a biopsy procedure if archived specimen is not available.\n\n  * If biopsy is not deemed safe, it may be waived after discussion with principal investigator (PI)\n* Participants must be willing to provide an on-treatment biopsy, to be obtained at 6 - 9 weeks, if deemed safe by the treating physician\n* Platelet count \\> 100,000\u002FμL\n* Absolute neutrophil count \\> 1,500\u002FμL\n* Hemoglobin \\> 9.0 g\u002FdL. Participants may be transfused to meet this criterion\n* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) \\\u003C 2.5 times upper limit of normal\n* Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) with the following exception: Patients with known Gilbert disease: serum bilirubin ≥ 3 x ULN\n* Creatinine clearance ≥ 30 mL\u002Fmin\n* For patients not receiving therapeutic anticoagulation: International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN\n* For patients receiving therapeutic anticoagulation: stable anticoagulant regimen\n* Participants of child-bearing potential and sexually active men must agree to use adequate contraception (hormonal methods must be supplemented by barrier method) prior to treatment initiation, during treatment, and for 5 months after the last dose of atezolizumab\n* Negative beta human chorionic gonadotropin (β-hCG) pregnancy test result within 14 days prior to initiation of study treatment for participants of childbearing potential. Pregnant or breast-feeding women or intention of becoming pregnant during study treatment or within 5 months of last dose of atezolizumab are not eligible\n\nExclusion Criteria:\n\n* Presence of other active cancers within the last 2 years. Participants with another cancer who have received definitive therapy at least 2 years previously and no evidence of recurrence are eligible. All participants with previously treated in situ carcinoma are eligible, as are participants with history of non-melanoma skin cancer\n* Symptomatic central nervous system (CNS) metastases; participants with known brain metastasis must be asymptomatic with no ongoing requirement for steroids within 7 days prior to start of study treatment, no history of intracranial hemorrhage or spinal cord hemorrhage. If the patient is receiving anti-convulsant therapy, the dose is considered stable\n\n  * Participants with untreated CNS metastases may be enrolled as long as they meet the above criteria. Participants with bulky CNS metastases should consider receiving radiation prior to study entry per investigator judgment\n* Participants with spinal cord compression must have received local treatment and must have been symptomatically stable with no use of steroids for at least 7 days prior to start of study treatment\n* Participants must not have an active autoimmune disease that has required immune modulating treatment within 1 year prior to consenting (i.e., disease modifying agents, long term corticosteroids). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed. Short-term steroid therapy (≤ 2 weeks) is allowed\n* Inability to discontinue corticosteroid therapy; steroids must be tapered off 7 days prior to first dose of SX-682. Limited steroid use for allergic reactions is acceptable\n* Known history of primary immunodeficiency\n* History of organ transplant or prior allogenic stem cell transplantation that requires use of immunosuppressives\n* Current symptomatic pneumonitis and any past history of immune checkpoint inhibitor related pneumonitis regardless of steroid treatment history\n* Prior history of grade 3 or higher immune checkpoint inhibitor (ICI)-induced immune-related adverse event (AE) (immune related adverse event \\[irAE\\]) except endocrine irAEs that are resolved or managed with replacement therapy\n* Radiotherapy within 7 days of start of study treatment\n* Major surgery within 21 days of start of study treatment. Minor surgery within 2 weeks of start of study treatment.\n\n  * Placement of vascular access device and biopsies are not considered major or minor surgery and are allowed\n* Electrocardiogram (ECG) demonstrating a Fridericia's corrected QT interval (QTcF) interval \\> 480 msec or patients with congenital long QT syndrome\n* Severe lung disease (e.g. chronic obstructive pulmonary disease \\[COPD\\]) who cannot stop steroids 7 days prior to start of study treatment\n* Serious cerebrovascular and cardiac disease defined as:\n\n  * Active unstable angina pectoris\n  * Congestive heart failure New York Heart Association (NYHA) \\> grade 3\n  * Acute myocardial infarction within 3 months of consenting\n  * Stroke or transient ischemic attack within 3 months of consenting\n* Known active chronic infections: Active hepatitis B, hepatitis C and tuberculosis. Testing is not required for assessment of eligibility per investigator judgment. Active infection requiring IV antibiotics within 7 days of study treatment initiation.\n\n  * Hepatitis C virus (HCV) infection: Patients with known history of HCV infection are eligible if HCV viral load is below the limit of quantification per local assay per investigator judgment.\n  * Hepatitis B virus (HBV) infection: Patients with known history of HBV infection are eligible if HBV viral load is below the limit of quantification and negative hepatitis B surface antigen (HBsAg) per local assay per investigator judgment\n* Known uncontrolled HIV (human immunodeficiency virus) infection\n\n  * Participants with known HIV infection are allowed if they are receiving anti-retroviral therapy, have CD4+ T-cell count \\> 350 cells\u002FµL within 6 months prior to study treatment initiation and no history of AIDS- defining opportunistic infection\n* Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study\n* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab\n* History of leptomeningeal disease\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment, or 5 half-lives of washout period (whichever is shorter) from last dose of most recent systemic therapy\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Known allergy or hypersensitivity to any component of the atezolizumab formulation",{"count":170,"type":19},32,[55],"This phase II trial tests how well SX-682 and atezolizumab works for the treatment of non-small cell lung cancer (NSCLC) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic), and has come back after a period of improvement (recurrent). SX-682 blocks proteins that may be able to stimulate the immune system to kill and eliminate tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving SX-682 and atezolizumab may be effective for the treatment of advanced or metastatic, recurrent NSCLC.",[149,66,26,174,129],"Stage III Lung Cancer AJCC v8","NOT_YET_RECRUITING","2026-06-04",{"date":178,"type":37},"2026-06-08",{"date":180,"type":19},"2026-09-01",{"date":182,"type":19},"2031-11-01",{"name":137,"class":44},{"id":185,"slug":4,"hasResults":10,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":20,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":205},"100488627","NCT05642572","Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial)","A Randomized Phase II Study of INC280 (Capmatinib) Plus Osimertinib With or Without Ramucirumab in Participants With EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)","Inclusion Criteria:\n\n* Patients must meet all SCREENING\u002FPRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II\u002FIII Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)\n* Participants must have been assigned to S1900G by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900G is determined by the LUNGMAP protocol\n* Participants must have documentation of NSCLC with a sensitizing EGFR mutation and have radiologically or clinically progressed (in the opinion of the treating physician) on osimertinib, alone or in combination with other agent(s), as their most recent line of therapy. Any number of prior lines of therapy is allowed\n* Participants must have a MET amplification determined by tissue-based or blood-based (circulating tumor DNA \\[ctDNA\\]) next generation sequencing (NGS) assay. MET amplifications may have been determined based on tissue submitted for testing by Foundation Medicine Inc (FMI) through the LUNGMAP screening protocol or using test results completed outside of the study. Tissue or blood must be obtained after disease progression on osimertinib (alone or in combination with another agent\\[s\\]). The testing must be done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)\u002FIndependent Ethics Committee (IEC), College of American Pathologists (CAP), or similar certification\n\n  * Note: Participants previously tested for and determined to have MET amplified NSCLC, at the time of progression on osimertinib, outside of LUNGMAP, must also submit tissue for central FMI testing on the LUNGMAP screening protocol, if available\n* Participants must have either measurable disease or non-measurable disease documented by CT or MRI. The CT from a combined PET\u002FCT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to sub-study randomization. Non-measurable disease must be assessed within 42 days prior to sub-study randomization. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to sub-study randomization to be considered measurable\n* Participants must have a CT with contrast or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study randomization\n* Participants with symptomatic CNS metastasis (brain metastases or leptomeningeal disease) must be neurologically stable and have a stable or decreasing corticosteroid requirement for at least 5 days before sub-study randomization\n* Participants must have recovered (=\\\u003C grade 1) from any side effects of prior therapy, except for alopecia and vitiligo\n* Participants must be able to swallow tablets whole\n* Absolute neutrophil count \\>= 1.5 x 10\\^3\u002FuL (within 28 days prior to sub-study randomization)\n* Hemoglobin \\\u003C 9.0 g\u002FdL (within 28 days prior to sub-study randomization)\n* Platelets \\>= 100 x 10\\^3\u002FuL (within 28 days prior to sub-study randomization)\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to sub-study randomization). Participants with history of Gilbert's disease must have total bilirubin =\\\u003C 5 x institutional ULN\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x institutional ULN. Participants with history of liver metastasis must have AST =\\\u003C 5 x ULN (within 28 days prior to sub-study randomization)\n* Participants must have a serum creatinine =\\\u003C the IULN OR calculated creatinine clearance \\>= 50 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to sub-study randomization\n* Participants' most recent Zubrod performance status must be 0-1 and be documented within 28 days prior to sub-study randomization\n* Participants must have an electrocardiogram (ECG) performed, with a Fridericia's Correction Formula (QTcF) =\\\u003C 470 msec, within 28 days prior to sub-study randomization. It is suggested that a local cardiologist review the QTcF intervals\n* Participants must have a completed medical history and physical exam within 28 days prior to sub-study randomization\n* Participants must have a urinalysis performed 28 days prior to sub-study randomization. Participant must have a urinary protein =\\\u003C 1+ on dipstick or routine urinalysis (UA). Random analysis of urine protein with a normal value is sufficient. If urine dipstick or routine analysis indicated proteinuria \\>= 2+, then a 24-hour urine is to be collected and demonstrate \\\u003C 2000 mg of protein in 24 hours to allow participation in the study\n* Participants must have an International Normalized Ratio (INR) =\\\u003C 1.5 seconds above the institutional upper limit of normal (IULN) (unless receiving anticoagulation therapy) documented within 28 days to sub-study randomization. Participants must have a partial thromboplastin time (PTT) =\\\u003C 5 seconds above the 'institutional upper limit of normal (IULN) (unless receiving anticoagulation therapy) documented within 28 days prior to sub-study randomization\n* Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy at randomization and have undetectable viral load within 6 months prior to sub-study randomization\n* Participants must have asymptomatic serum amylase =\\\u003C 2 x ULN and serum lipase =\\\u003C ULN obtained within 28 days prior to sub-study randomization. Asymptomatic is defined as having no signs and\u002F or symptoms suggesting pancreatitis or pancreatic injury (e.g. elevated P. amylase, abnormal imaging findings of pancreas, etc.)\n* Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)\n* Participants must also be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System\n* Note: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n* Participants with impaired decision-making capacity must not have a neurological or psychological condition that precludes their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator). For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n\nExclusion Criteria:\n\n* Participants must not have received an anti-VEGF or VEGFR inhibitor or MET inhibitor\n* Participants must not have received any anti-cancer drug (investigational or standard of care drug, except osimertinib) within 21 days prior to sub-study randomization\n\n  * Note: osimertinib may continue up to the day prior to study treatment initiation\n* Participants must not have received any radiation therapy within 14 days prior to sub-study randomization\n* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study\n* Participants must not have had a major surgery within 14 days prior to sub-study randomization. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator\n* Participants must not have received a live attenuated vaccination within 28 days prior to sub-study randomization. All COVID-19 vaccines that have received Food and Drug Administration (FDA) approval or FDA emergency use authorization are acceptable\n* Participants must not have received strong inducers of CYP3A4 (including herbal supplements such as St. John's Wort); CYP3A4 inhibitors; CYP1A2 substrates; P-gp and BCRP substrates; sensitive substrates of MATE1 and MATE2K; or drugs that are known to prolong QT interval within 7 days prior to sub-study registration and must not be planning to use any of these throughout protocol treatment\n* Participants must not have uncontrolled blood pressure and hypertension within 28 days prior to sub-study randomization\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or breastfeeding (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen",{"count":191,"type":19},66,[55],"This phase II Lung-MAP treatment trial test the combination of targeted drugs (capmatinib, osimertinib, and\u002For ramucirumab) in treating patients with non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that has EGFR and MET gene changes. Capmatinib and osimertinib are in a class of medications called kinase inhibitors. They work by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving capmatinib, osimertinib, and\u002For ramucirumab and targeting abnormal gene changes in tumor cells may be effective in shrinking or stabilizing advanced non-small cell lung cancer.",[26,129],"2026-06-01",{"date":197,"type":37},"2026-06-03",{"date":199,"type":37},"2023-05-05",{"date":201,"type":19},"2028-06-30",{"name":203,"class":204},"SWOG Cancer Research Network","NETWORK",454,{"id":207,"slug":4,"hasResults":10,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":20,"phases":214,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},"100563470","NCT06616584","Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial)","A Randomized Phase II\u002FIII Study of Docetaxel and Ramucirumab With or Without Cemiplimab for Participants Previously Treated With Platinum-Based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)","Inclusion Criteria:\n\n* Participants must have been assigned to S1800E by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1800E is determined by the LUNGMAP protocol\n* Participants must have measurable or non-measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)\u002FCT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to randomization. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to randomization. All disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration\n* Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to randomization\n* Participants must have received exactly one anti-PD-1 or anti-PD-L1 therapy for advanced disease (stage IV or recurrent disease, or stage I-III disease in certain circumstances outlined below). Anti-PD-1 or anti-PD-L1 therapy may have been given alone or in combination with other therapy. For participants who received neoadjuvant, adjuvant, and\u002For consolidation anti-PD-1 or anti-PD-L1 therapy for stage I-III disease:\n\n  * If they experienced disease progression within (≤) 365 days from initiation (cycle 1 day 1) or anti-PD-1 or anti-PD-L1 therapy, this counts as the single allowed anti-PD-1 or anti-PD-L1 therapy for advanced disease\n  * If they experienced disease progression more than (\\>) 365 days from initiation (cycle 1 day 1) or anti-PD-1 or anti-PD-L1 therapy, this is not considered anti-PD-1 or anti-PD-L1 therapy for advance disease. These participants must have received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease\n* Participants must have experienced disease progression (in the opinion of the treating investigator) more than (\\>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or anti-PD-L1 therapy\n* Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease must have had a best response of stable disease, partial response or complete response (in the opinion of the treating investigator) on the anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease\n* Participants must have received platinum-based chemotherapy and experienced disease progression (in the opinion of the treating investigator) during or after this regimen\n* Participants with a known sensitizing molecular alteration for which a Food and Drug Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, KRAS, HER2, and MET sensitizing mutations), must have previously received at least one of the approved therapy(s). Prior targeted therapy for participants with targetable alterations is allowed if all other eligibility criteria are also met\n* Participants must have recovered (≤ grade 1) from any side effects from the most recent anti-cancer treatment prior to randomization\n* Participants must not have received prior therapy with docetaxel for this disease\n* Participants must not have received any palliative radiation therapy within 14 days (or palliative bone radiation therapy within 7 days) prior to randomization\n* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, or biologic therapy for cancer treatment while receiving treatment on this study\n* Participants must not have undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization. Participants must not have postoperative bleeding complications or wound complications from a surgical procedure performed within 2 months prior to randomization. The participant must not have elective or planned major surgery to be performed during the course of this study\n* Absolute neutrophil count ≥ 1.5 x 10\\^3\u002FuL (within 28 days prior to randomization)\n* Hemoglobin ≥ 9.0 g\u002FdL (within 28 days prior to randomization)\n* Platelets ≥ 100 x 10\\^3\u002FuL (within 28 days prior to randomization)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to randomization) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to randomization). Participants with history of liver metastasis must have AST and ALT ≤ 5 x ULN\n* Participants must have a creatinine ≤ the institutional (I)ULN or calculated creatinine clearance ≥ 50 mL\u002Fmin using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to randomization\n* Participants must have a urinary protein test performed within 28 days prior to randomization\n* Participants' most recent Zubrod\u002FEastern Cooperative Oncology Group (ECOG) performance status must be 0-1 and be documented within 28 days prior to randomization\n* Participants must have a completed medical history and physical exam within 28 days prior to randomization\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated by the treating investigator\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated by the treating investigator\n* Participants with known human immunodeficiency virus (HIV) infection are eligible, provided they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to randomization\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not have an active autoimmune disease that has required systemic treatment within 730 days prior to randomization (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed\n* Participants must not have any history of primary immunodeficiency\n* Participants must be able to safely receive study therapy and must not have experienced the following:\n\n  * Any grade 3 or worse immune-mediated adverse event. Exception: asymptomatic nonbullous\u002Fnonexfoliative rash\n  * Any unresolved grade 2 immune-mediated adverse event\n  * Any toxicity that led to permanent discontinuation of prior anti-PD-1\u002FPD-L1 immunotherapy\n  * Exception to the above: Toxicities of any grade that requires replacement therapy and has stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed\n* Participants must not have any history of organ transplant that requires use of immunosuppressives\n* Participants must not have received a live or live attenuated vaccine within 28 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster, yellow fever rabies, Bacillus Calmette-Guerin (BCG) and typhoid vaccine. Seasonal influenza vaccines and COVID-19 vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated and are not allowed\n* Participants must not have clinical signs or symptoms of active tuberculosis infection\n* Participants must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis\u002Finterstitial lung disease\n* Participants must not have had a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization\n* Participants must not have a history of gastrointestinal perforation or fistula within 6 months prior to randomization\n* Participants must not have grade 3-4 gastrointestinal bleeding (defined by National Cancer Institute \\[NCI\\] Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\]5) within 3 months prior to randomization. No history of gastrointestinal (GI) bleed within 3 months prior to randomization\n* Participants must not have any grade III\u002FIV cardiac disease as defined by the New York Heart Association criteria (i.e., participants with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months prior to randomization, or serious uncontrolled cardiac arrhythmia\n* Participants must not have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to randomization\n* Participants must not have gross hemoptysis within two months prior to randomization (defined as bright red blood or ≥ 1\u002F2 teaspoon) or with radiographic evidence of intratumor cavitation or has radiologically documented evidence of major blood vessel invasion or encasement by cancer\n* Participants must not have been diagnosed with venous thrombosis within 3 months prior to randomization. Participants with venous thrombosis diagnosed more than 3 months prior to randomization must be on stable doses of anticoagulants\n* Participants must not have cirrhosis at a level of Child-Pugh B (or worse) AND a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis, OR any degree of cirrhosis\n* Participants must not be pregnant or breastfeeding (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)\n* Participants must be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG specimen tracking system\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. NOTE: Participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations",{"count":213,"type":19},378,[55,215],"PHASE3","This phase II\u002FIII Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab alone in treating patients with non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Cemiplimab is a monoclonal antibody that stimulates the immune system by blocking the PD-1 pathway. Tumors use the PD-1 pathway to escape attacks from the immune system. By blocking the PD-1 pathway, cemiplimab may help the immune system recognize and attack tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Adding cemiplimab to usual treatment, docetaxel and ramucirumab, may kill more tumor cells compared to docetaxel and ramucirumab alone in treating patients with stage IV or recurrent non-small cell lung cancer.",[26,129],"2026-05-04",{"date":220,"type":37},"2026-05-05",{"date":222,"type":37},"2025-05-22",{"date":224,"type":19},"2028-12-31",{"name":203,"class":204},386,{"id":228,"slug":4,"hasResults":10,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":10,"sex":15,"minAge":233,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":20,"phases":236,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":245},"100518526","NCT06031688","Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial)","A Randomized Phase II Study of Tepotinib With or Without Ramucirumab in Participants With MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)","Inclusion Criteria:\n\n* Participants must have been assigned to S1900K by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900K is determined by the LUNGMAP protocol\n* Participants must have documentation of stage IV or recurrent NSCLC with a MET exon 14 skipping mutation determined by tissue-based or blood-based (circulating tumor DNA \\[ctDNA\\]) next generation sequencing (NGS) assay done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)\u002F International Electrotechnical Commission (IEC), College of American Pathologists (CAP), or similar certification. Documentation must either be:\n\n  * NGS test results from tissue submitted for LUNGMAP screening, or\n  * Submitted documentation in the LUNGMAP Rave Electronic Data Capture System of a MET exon 14 skipping mutation from a previously completed tissue or blood-based NGS test\n* Participants must have measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)\u002FCT may be used to document measurable disease ONLY if it is of diagnostic quality, otherwise, it may be used to document non-measurable disease only. Measurable disease must be assessed within 28 days prior to sub-study randomization. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study randomization. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to sub-study randomization to be considered measurable\n* Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study randomization\n* Participants must not have leptomeningeal disease, spinal cord compression or brain metastases unless:\n\n  * Metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 3 days following the stereotactic radiation and\u002For 14 days following whole brain radiation, and prior to sub-study randomization, AND\n  * Participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study randomization\n* Participants must not have other known actionable oncogenic alterations, such as (but not limited to) EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS1 gene rearrangement, RET gene rearrangement, NTRK rearrangement, HER2 mutation, KRAS activating mutations, and BRAF V600E mutation\n* Participants who have received at least one line of systemic treatment for stage IV or recurrent NSCLC must have progressed (in the opinion of the treating physician) following the most recent line of therapy. Participants who have not yet received systemic treatment for their stage IV or recurrent NSCLC are allowed\n* Participants may have received any number of lines of therapy for stage IV or recurrent NSCLC (including zero) and must be able to report prior treatment information\n* Participants must have recovered (=\\\u003C grade 1) from any side effects of prior therapy for NSCLC except alopecia and vitiligo\n* Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study randomization\n* Participants must not have received treatment with prior MET inhibitor therapies (e.g., crizotinib, tivantinib, savolitinib, tepotinib, cabozantinib, and foretinib).\n* Participants must not have received treatment with prior angiogenesis inhibitor therapies (including but not limited to bevacizumab and ramucirumab)\n* Participants must not have a history of interstitial lung disease that required steroid treatment\n* Participants must not have received any radiation therapy within 7 days prior to sub-study randomization with the exceptions of\n\n  * Stereotactic radiation to CNS metastases which must have been completed at least 3 days prior to sub-study randomization and\n  * Palliative radiotherapy to bone metastases which must have been completed at least 1 day prior to sub-study randomization\n* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study\n* Participants must not have had a major surgery within 14 days prior to sub-study randomization. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Absolute neutrophil count \\>= 1.5 x 10\\^3\u002FuL (within 28 days prior to sub-study randomization)\n* Hemoglobin \\>= 9.0 g\u002FdL (within 28 days prior to sub-study randomization)\n* Platelets \\>= 100 x 10\\^3\u002FuL (within 28 days prior to sub-study randomization)\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\\\u003C 5 x institutional ULN (within 28 days prior to sub-study randomization)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 × institutional ULN. Participants with history of liver metastasis must have AST and ALT =\\\u003C 5 x ULN (within 28 days prior to sub-study randomization)\n* Participants must have a serum creatinine =\\\u003C the institutional upper limit of normal (IULN) or calculated creatinine clearance \\>= 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to sub-study randomization\n* Participants must have a cystatin C test performed to obtain baseline value within 28 days prior to sub-study randomization\n* Participants' most recent Zubrod performance status must be 0-1 and be documented within 28 days prior to sub-study randomization\n* Participants must have a completed medical history and physical exam within 28 days prior to sub-study randomization\n* Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy and have undetectable viral load test on the most recent test results obtained within 6 months prior to sub-study randomization\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to sub-study randomization, if indicated by the treating investigator\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to sub-study randomization, if indicated by the treating investigator\n* Participants must not have cirrhosis at a level of Child-Pugh B (or worse) OR any degree of cirrhosis AND a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis\n* Participants must not have grade \\\u003C 0 of peripheral edema within 28 days prior to sub-study randomization\n* Participants must not have experienced any arterial thromboembolic events, including but not limited to transient ischemic attack or cerebrovascular accident within 6 months prior to sub-study randomization\n* Participants must not have uncontrolled blood pressure and hypertension within 28 days prior to sub-study randomization\n* Participants must not be pregnant or breastfeeding (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must also be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n\n  * NOTE: Participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations","18 Minutes",{"count":235,"type":19},56,[55],"This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a period of improvement (recurrent). Tepotinib is used in patients whose cancer has a mutated (changed) form of a gene called MET. It is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal MET protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving tepotinib with ramucirumab may lower the chance of the cancer from growing or spreading in patients with stage IV or recurrent non-small cell lung cancer.",[26,129],{"date":220,"type":37},{"date":241,"type":37},"2024-08-08",{"date":243,"type":19},"2028-05-31",{"name":203,"class":204},266,{"id":247,"slug":4,"hasResults":10,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":255,"phases":4,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":292},"100542959","NCT06349642","Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform","Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform","ELEPHAS-04","Inclusion Criteria:\n\nSubjects must meet one of the following criteria:\n\n* Subjects suspected of or diagnosed with the following Stage IV\u002Fmetastatic or recurrent malignancies:\n\n  * Lung: Non-small Cell Lung Cancer (NSCLC)\n  * Skin: Cutaneous Malignancy, excluding Uveal Melanoma\n  * Esophageal Cancer\n  * Cervical Cancer\n  * Endometrial Cancer\n  * Colon Cancer: Mismatch repair deficient (dMMR) CRC only\n  * All solid tumors with high tumor mutation burden (TMB)\n  * All solid tumors that are microsatellite instability high (MSI-H)\n  * All mismatch repair deficient (dMMR) solid tumors\n  * Liver Cancer\n  * Any solid tumor with measurable disease that is eligible for pure ICI therapy or that the clinician plans to treat with immune checkpoint inhibitor (ICI) therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate laboratory developed tests (LDTs) that, per clinician, render the patient eligible for ICI therapy, either frontline or a later line.\n\nOR\n\n* Subjects suspected of or diagnosed with the following Stage III per provider discretion or IV\u002Fmetastatic malignancies:\n\n  * Kidney: Clear Cell Renal Cell Carcinoma (ccRCC)\n  * Bladder: Urothelial Carcinoma (UC)\n  * Any solid tumor with measurable disease that is eligible for pure ICI therapy or that the clinician plans to treat with ICI therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate LDT tests that per clinician, render the patient eligible for ICI therapy, either frontline or a later line\n\nOR\n\n* Patients who will be receiving neoadjuvant CPI for the following resectable early-stage malignancies:\n\n  * Breast Cancer: Triple negative breast cancer (TNBC)\n  * Lung: Non-small cell lung cancer (NSCLC)\n\n    * NOTE: Patients with suspected NSCLC who would be eligible for neoadjuvant checkpoint inhibitor (CPI) are eligible to enroll per provider discretion\n  * Any solid tumor that is eligible for pure ICI therapy or that the clinician plans to treat with ICI therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate LDT tests that per clinician, render the patient eligible for ICI therapy, either frontline or a later line\n* LOCALLY ADVANCED\u002FMETASTATIC PATIENTS: Measurable disease as defined per protocol NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible.\n* NEOADJUVANT PATIENTS: Subjects must be eligible based on investigator discretion to receive approved CPI therapy.\n* Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy.\n* Subjects who are Stage I, II, or III and have progressed to metastatic cannot have received any anti-cancer treatment for at least 2 - 4 weeks (depending upon the washout period of prior anti-cancer treatment) prior to biopsy as per the agents used.\n* ECOG Performance Status (PS) 0, 1 or 2.\n* Negative pregnancy test done ≤7 days prior to enrollment, for persons of childbearing potential only\n* Female subjects must not be pregnant or breastfeeding and must use appropriate methods of contraception when applicable.\n* Subjects must be clinically able, at investigator discretion, and willing to undergo either:\n\n  * additional biopsy passes during their standard of care biopsy, OR\n  * a biopsy for research only, if applicable.\n  * NOTE: These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to biopsies per the clinician.\n* Subjects with a known secondary cancer diagnosis are eligible to participate if participation does not interfere with systemic anti-cancer standard of care treatment for suspected primary diagnosis.\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Pregnant women because this study involves a greater than minimal risk procedure (biopsy)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety for the biopsy\n* Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * ongoing or active infection\n  * psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Subjects who are enrolled or plan to be enrolled in a blinded cancer therapeutic treatment trial",{"count":254,"type":19},324,"OBSERVATIONAL","This study is being done to collect tissue samples to test how accurately a tumor response platform, Elephas, can predict clinical response across multiple types of immunotherapies, chemoimmunotherapy and tumor types.",[258,259,260,261,262,263,264,265,66,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,26,281,282],"Early Stage Triple-Negative Breast Carcinoma","Metastatic Bladder Urothelial Carcinoma","Metastatic Cervical Carcinoma","Metastatic Clear Cell Renal Cell Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Endometrial Carcinoma","Metastatic Esophageal Carcinoma","Metastatic Liver Carcinoma","Metastatic Malignant Skin Neoplasm","Metastatic Malignant Solid Neoplasm","Resectable Lung Non-Small Cell Carcinoma","Early Stage Lung Non-Small Cell Carcinoma","Resectable Malignant Solid Neoplasm","Resectable Triple-Negative Breast Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Cervical Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Recurrent Cervical Carcinoma","Recurrent Colorectal Carcinoma","Recurrent Endometrial Carcinoma","Recurrent Esophageal Carcinoma","Recurrent Liver Carcinoma","Recurrent Malignant Skin Neoplasm","Recurrent Malignant Solid Neoplasm","2026-03-11",{"date":285,"type":37},"2026-03-12",{"date":287,"type":37},"2024-04-24",{"date":289,"type":19},"2027-05",{"name":291,"class":44},"Mayo Clinic",3,{"id":294,"slug":4,"hasResults":10,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":20,"phases":301,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":45},"100446805","NCT05098210","Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma, Hormone Receptor Positive HER2 Negative Metastatic Refractory Breast Cancer or Stage III-IV Non-Small Cell Lung Cancer","PNV21-001: A Phase I Study of a Personalized Multi-Peptide Neo-Antigen Vaccine in Breast Cancer, PD1\u002FPD-L1 Inhibitor-Refractory Melanoma, and Pretreated Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Female and\u002For male patients age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* Patients must have at least 1 lesion (or aggregate lesions) to obtain tumor tissue for resection of \\>= 1 cm or \\>= 4 core biopsies acceptable. Amenable to image (CT, ultrasound \\[U\u002FS\\], or magnetic resonance imaging \\[MRI\\]) guided biopsy for tissue collection necessary for neoantigen identification. Either primary or metastatic sites are options for tissue collection\n* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria: Participants must have measurable disease, defined as at least one target lesion that can be measured in at least one dimension (longest diameter to be recorded) as \\>= 10 mm, unless lymph node in which case short axis must be \\>= 15 mm. Baseline imaging (for example diagnostic CT chest\u002Fabdomen\u002Fpelvis, PET CT scan and imaging of the affected extremity as appropriate), brain imaging (MRI or CT scan) must be obtained within 45 days of prior to start of first planned vaccine dose infusion. MRI can be substituted for CT in patients unable to have CT contrast\n* Serum creatine \\\u003C 1.5 mg\u002FdL or estimated glomerular filtration rate (eGFR) \\> 60 mL\u002Fmin\n* Total bilirubin (tBili) \\\u003C 1.5 x upper limit of normal (ULN) and an aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\\u003C 2.5 x ULN and \\\u003C 5 x ULN for subjects with documented liver metastasis. Patients with suspected Gilbert syndrome may be included if tBili \\> 3 but no other evidence of hepatic dysfunction\n* =\\\u003C grade 1 dyspnea and arterial oxygen saturation (SaO2) \\>= 92% on ambient air. If pulmonary function tests (PFTs) are performed based on the clinical judgement of the treating physician, patients with forced expiratory volume in 1 second (FEVI) \\>= 70% of predicted and carbon monoxide diffusing capability (DLCO) (corrected) of \\>= 60% of predicted will be eligible\n* Patients with active interstitial lung disease (ILD)\u002Fpneumonitis or a history of ILD\u002Fpneumonitis requiring treatment with systemic steroids will be excluded\n* Patients 60 years of age or older are required to have left ventricular ejection fraction (LVEF) evaluation performed within 60 days prior to enrollment. LVEF may be established with echocardiogram or MUGA scan, and left ejection fraction must be \\>= 50%. Cardiac evaluation for other patients is at the discretion of the treating physician\n* Subjects with a history of myocarditis or congestive heart failure (as defined by New York Heart Association functional classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction 6 months prior to study entry will be excluded\n* Absolute neutrophil count (ANC) \\> 1000 cells\u002Fmm\\^3\n* Hemoglobin \\>= 9 mg\u002FdL\n* Platelet count \\>= 50,000\u002FuL\n* Toxicity from prior therapy must be recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5 grade 2 or less\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures\n* Capable of understanding and providing a written informed consent\n* The effects of neoantigen vaccination on the developing human fetus are unknown. For this reason, patients who are having sex that can lead to pregnancy must agree to use adequate contraception (hormonal, barrier method of birth control, or abstinence) for the duration of study participation. Should a woman become pregnant while participating in the study, she should inform her study doctor immediately and will not receive any more study treatment\n* MELANOMA SPECIFIC: Tissue confirmation of melanoma: Histologically confirmed metastatic (recurrent or de novo stage IV) or unresectable locally advanced (stage IIIC or IIID) cutaneous, acral, conjunctival or mucosal melanoma, as defined by the American Joint Committee on Cancer (AJCC) v8.0. Confirmation of diagnosis must be or have been performed by internal pathology review of archival, initial or subsequent biopsy or other pathologic material at Fred Hutchinson Cancer Center (FHCC)\u002FUniversity of Washington Medical Center (UWMC)\n* MELANOMA SPECIFIC: Patients must have received stage specific standard of care therapy per National Comprehensive Cancer Network (NCCN) guidelines and have persistent\u002Frecurrent disease after at least one line of therapy prior to enrollment on the study\n* MELANOMA SPECIFIC: Known BRAF mutational status\n* MELANOMA SPECIFIC: History of detectable disease during\u002Fafter treatment with a PD-1 or PD-L1 inhibitor, as defined by the Society of Immunotherapy of Cancer's definition of primary or secondary resistance (Kluger and others \\[et al.\\], 2020):\n\n  * Drug exposure \\>= 6 weeks and best response progressive disease (PD) or stable disease (SD) \\\u003C 6 months or\n  * Drug exposure \\>= 6 months and best response complete response (CR), partial response (PR), or SD \\> 6 months\n* MELANOMA SPECIFIC: A confirmatory scan performed at least 4 weeks after disease persistence\u002Fprogression is required but this requirement can be waived if the judgement of the treating clinician is that the patient would be at risk of rapid or symptomatic progression in that interval. This confirmatory scan can occur during production of the vaccine after enrollment\n* BREAST CANCER SPECIFIC: Tissue confirmation of stage IV (recurrent or de novo metastatic) hormone receptor (HR) positive, HER2 negative breast cancer:\n\n  * Hormone receptor (HR) positive breast cancer as defined by either one, or both of the following criteria:\n\n    * Estrogen receptor (ER) positive disease defined as follows documented by a local laboratory: 1-100% positive stained cells based on de novo tumor biopsy\n    * Progesterone receptor (PR) positive disease defined as follows documented by a local laboratory: 1-100% positive stained cells based on de novo tumor biopsy\n  * Human epidermal growth factor receptor 2 (HER2) negative breast cancer (per American Society of Clinical Oncology \\[ASCO\\]\u002FCollege of American Pathologists \\[CAP\\] guideline update, 2018) as documented by a local laboratory with HER2-negativity defined as:\n\n    * Immunohistochemistry score 0\u002F1+ or 2+ and \u002F or\n    * Negative by in situ hybridization (fluorescence in situ hybridization \\[FISH\\]\u002Fchromogenic in situ hybridization \\[CISH\\]\u002Fsilver-enhanced in situ hybridization \\[SISH\\]) per ASCO\u002FCAP guideline update, 2018\n  * Confirmation of diagnosis must be or have been performed by internal pathology review of archival, initial or subsequent biopsy or other pathologic material at FHCC\u002FUWMC\n* BREAST CANCER SPECIFIC: Patients must have received at least one line of systemic therapy in the metastatic setting prior to enrollment on the study and have progressive\u002Fpersistent disease after\n* NON-SMALL CELL LUNG CANCER SPECIFIC: Tissue confirmation of stage III unresectable or stage IV (recurrent or de novo metastatic) non-small cell lung cancer (NSCLC):\n\n  * Genetic testing must have been performed for targetable driver mutations, including EGFR, ROS1, Alk, KRAS, BRAF\n  * Confirmation of diagnosis must be or have been performed by internal pathology review of archival, initial or subsequent biopsy or other pathologic material at FHCC\u002FUWMC\n* NON-SMALL CELL LUNG CANCER SPECIFIC: Patients must have received at least one line of systemic therapy in the metastatic or stage II or III setting including a PD-1 or PD-L1 inhibitor prior to enrollment on the study and have progressive or recurrent disease after\n* NON-SMALL CELL LUNG CANCER SPECIFIC: For patients who have received neoadjuvant, adjuvant, and\u002For consolidation anti-PD-1 or anti-PD-L1 for stage II or III disease, they must have experienced disease progression in less than or equal to 365 days from initiation (cycle 1 day 1) of anti-PD-1 or anti-PD-L1 therapy for this to count as the systemic therapy for advanced disease. Patients experiencing progression more than 365 days from initiation (cycle 1 day 1) of anti-PD-1 or anti-PD-L1 therapy will not be considered as having received one line of systemic therapy. These patients must have received an anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease\n\nExclusion Criteria:\n\n* Fertile male patients and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 5 months after the last dose of investigational product\n* Any history of an immune-related grade 4 adverse event attributed to prior cancer immunotherapy CIT (other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum amylase or lipase)\n* Any history of an immune-related grade 3 adverse event attributed to prior CIT that required permanent discontinuation of PD-1 inhibitor therapy\n* Immune-related adverse events related to prior CIT (other than endocrinopathy managed with replacement therapy or stable vitiligo) that have not resolved to baseline. Patients treated with corticosteroids for immune-related adverse events must demonstrate absence of related symptoms or signs for \\>= 4 weeks following discontinuation of corticosteroids\n* Uncontrolled tumor-related pain. Patients requiring narcotic pain medication must be on a stable regimen at study entry. Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should be treated \\> 4 weeks prior to enrollment. Patients should be recovered from the effects of radiation\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days. Indwelling drainage catheters (e.g., PleurX®) are allowed\n* Patients with known symptomatic brain metastases. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable for \\>= 1 months (confirmed by magnetic resonance imaging \\[MRI\\])\n* Patients with rapidly progressing disease, symptomatic visceral disease, or patients who are expected to have rapidly progressive disease over the course of several months despite bridging therapy approved by the protocol\n* Known primary immunodeficiencies, either cellular (e.g., DiGeorge syndrome, T-negative severe combined immunodeficiency \\[SCID\\]) or combined T- and B-cell immunodeficiencies (e.g., T- and B-negative SCID, Wiskott-Aldrich syndrome, ataxia telangiectasia, common variable immunodeficiency)\n* Prior allogeneic bone marrow transplantation or prior solid organ transplantation\n* Known positive test for HIV infection\n* Patients with active infection causing fever (temperature \\> 38.1 degrees Celsius \\[C\\]) or subjects with unexplained fever (temperature \\> 38.1 degrees C) may not receive the investigational product unless the fever is =\\\u003C 38.1 for 5 days prior to start\n* Active uncontrolled infection: individuals with a history of hepatitis C who have successfully completed antiviral therapy with an undetectable viral load, and those with hepatitis B who have, per standard practice, hepatitis well-controlled on medication (e.g., AST and ALT \\\u003C 5 x ULN) can be included\n* History of autoimmune disease that has not been controlled with treatment in the last 12 months, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis with the following exceptions: Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible. Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., no psoriatic arthritis) may be eligible\n* Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone \\> 10 mg\u002Fday or equivalent, cyclophosphamide, azathioprine, methotrexate, thalidomide, and TNF-alpha antagonists) within 2 weeks prior screening. The use of topical, eye drops, local injections, or inhaled corticosteroids (e.g. fluticasone for chronic obstructive pulmonary disease) is allowed. The use of oral mineralocorticoids (e.g. fludrocortisone for patients with orthostatic hypotension) is allowed. Physiologic doses of corticosteroids for adrenal insufficiency are allowed. Low dose corticosteroids for a short duration \\[5 mg once daily (QD) prednisone for 2 weeks\\] as symptomatic treatment and upon with discussion with the investigator is allowed. Note: Patients with adrenal insufficiency may take 10 mg of prednisone or equivalent daily\n* Subjects should have an international normalized ratio (INR) or activated partial thromboplastin time (aPTT) =\\\u003C 1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy should have a prothrombin time (PT) or partial thromboplastin time (PTT) within therapeutic range of intended use and no history of severe hemorrhage. Antiplatelet agents (eg, aspirin, clopidogrel, etc.) are not considered anticoagulants for the purposes of this study (i.e., they are allowed)\n* Other medical, social, or psychiatric factor that interferes with medical appropriateness and\u002For ability to comply with study, as determined by the principal investigator (PI)\n* Participants of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment. Childbearing potential is defined as women who have not been surgically sterilized and who are not post-menopausal (free of menses for at least 1 year)\n* Female patients who are lactating or intend to breastfeed during the duration of the study\n* Patients who have received a live vaccine within 30 days prior to enrollment\n* Patients with any underlying medical condition for which, in the investigator's opinion, participation would not be in the best interest of the participant (e.g.- compromises the health of the subject) or that could prevent, limit or confound protocol assessments\n* MELANOMA SPECIFIC: Uveal or choroidal melanoma. This entity is excluded due to the absence of abundant mutations\n* BREAST SPECIFIC: Patients with symptomatic disease including patients with symptomatic lung metastases, bone marrow replacement with associated cytopenia, or significant liver metastases with associated liver dysfunction\n* NON-SMALL CELL LUNG CANCER SPECIFIC: Activating mutations in EGFR or genetic alterations in ROS1 or Alk, as these mutations are associated with lower mutation burden and non-response to immune therapies",{"count":300,"type":19},25,[22],"This phase I trial studies the safety of personalized neo-antigen peptide vaccine in treating patients with stage IIIC-IV melanoma, hormone receptor positive HER2 negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or does not respond to treatment (refractory) or stage III-IV non-small cell lung cancer. Personalized neo-antigen peptide vaccine is a product that combines multiple patient specific neo-antigens. Given personalized neo-antigen peptide vaccine together with Th1 polarizing adjuvant poly ICLC may induce a polyclonal, poly-epitope, cytolytic T cell immunity against the patient's tumor.",[304,305,306,307,308,309,310,311,312,66,267,313,314,315,316,317,318,26,319,174,129,320,321,322,323],"Anatomic Stage IV Breast Cancer AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Locally Advanced Cutaneous Melanoma","Locally Advanced Mucosal Melanoma","Metastatic Acral Melanoma","Metastatic Conjunctival Melanoma","Metastatic Cutaneous Melanoma","Metastatic HER2-Negative Breast Carcinoma","Metastatic Hormone Receptor-Positive Breast Carcinoma","Metastatic Mucosal Melanoma","Pathologic Stage IIIC Cutaneous Melanoma AJCC v8","Pathologic Stage IIID Cutaneous Melanoma AJCC v8","Recurrent Cutaneous Melanoma","Recurrent HER2-Negative Breast Carcinoma","Recurrent Hormone Receptor-Positive Breast Carcinoma","Recurrent Mucosal Melanoma","Unresectable Acral Melanoma","Unresectable Cutaneous Melanoma","Unresectable Lung Non-Small Cell Carcinoma","Unresectable Mucosal Melanoma","2026-03-10",{"date":285,"type":37},{"date":327,"type":37},"2022-06-09",{"date":329,"type":19},"2028-11-01",{"name":331,"class":44},"Fred Hutchinson Cancer Center",{"id":333,"slug":4,"hasResults":10,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":20,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":45},"100563473","NCT06616623","Vismodegib and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer","A Phase Ib Study of Vismodegib and Atezolizumab in Patients With Advanced Non-Small Cell Lung Cancer (ML43922)","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed recurrent or metastatic non-small cell carcinoma of the lung of any histology without curative options\n* Measurable disease based on RECIST v1.1\n* Patients must have received standard of care chemotherapy and\u002For immunotherapy. No limits to prior lines of therapy. Prior PD-1 and\u002For PD-L1 directed therapies are permitted\n* Patients with adenocarcinoma and known actionable mutations with Food and Drug Administration (FDA) approved treatment options must have received all approved and standard of care treatment options (i.e. osimertinib for epidermal growth factor receptor (EGFR), alectinib for anaplastic lymphoma kinase (ALK), etc.). Mutational testing is not required for patients with squamous cell non-small cell lung carcinoma\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Absolute neutrophil count (ANC) ≥ 1,500 \u002FmcL without granulocyte colony-stimulating factor support\n* Platelet count ≥ 100,000 \u002FuL without transfusion\n* Hemoglobin ≥ 90 g\u002FL (9 g\u002FdL) patients may be transfused to meet this criterion\n* Measured or calculated creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60 mL\u002Fmin for subject with creatinine levels ≤ 1.5 x institutional upper limit of normal (ULN)\n* Serum total bilirubin ≤ 1.5 x ULN with the following exception:\n\n  * Patients with known Gilbert disease: serum bilirubin ≤ 3 x ULN\n* Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 x ULN with the following exceptions:\n\n  * Patients with documented liver metastases: AST and ALT ≤ 5 x ULN\n  * Both values must be in the specified range\n* Alkaline phosphatase (ALP) ≤ 2.5 x ULN with the following exceptions:\n\n  * Patients with documented liver or bone metastases: ALP ≤ 5 x ULN\n* Albumin ≥ 2.5 g\u002FdL\n* International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy\n\n  * As long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants\n* Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy\n\n  * As long as PT or PTT is within therapeutic range of intended use of anticoagulants\n* Anticipated life expectancy of ≥ 3 months\n* Willing to comply with study procedures\n* Female subject of childbearing potential will have a serum pregnancy test at screening. Urine pregnancy tests will be performed at specified subsequent visits. If a urine pregnancy test is positive, it must be confirmed by a serum pregnancy test\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:\n\n  * Women must remain abstinent or use contraceptive methods with a failure rate of \\< 1% per year during the treatment period and for 5 months after the final dose of atezolizumab and 24 months after the final dose of vismodegib. Women must refrain from donating eggs during this same period\n  * A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirement\n  * Examples of contraceptive methods with a failure rate of \\< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, for 5 months from last atezolizumab dose and 24 months after the final dose of vismodegib, as defined below:\n\n  * With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and, for 5 months from last atezolizumab dose and 24 months after the final dose of vismodegib to avoid exposing the embryo. Men must refrain from donating sperm during this same period\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of preventing drug exposure\n* Be willing and able to understand and sign the written informed consent document\n* Availability of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block. A recently obtained archival FFPE tumor tissue block (if an FFPE tissue block cannot be provided, 15 unstained slides (10 minimum) will be acceptable) from a primary or metastatic tumor resection or biopsy can be provided if it was obtained within 1 year of trial screening\n* Be willing to provide tissue from an on-treatment fine needle aspiration (FNA) or core biopsy of a tumor lesion. Subjects must consent to on-treatment biopsy prior to initiation of clinical trial, however subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may still continue on study\n* Negative HIV test at screening with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count \\> 200\u002FuL, and have an undetectable viral load\n* Negative total hepatitis B core antibody (HBcAb) test at screening. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening\n\n  * The HCV RNA test must be performed for patients who have a positive HCV antibody test\n\nExclusion Criteria:\n\n* Active autoimmune disease requiring treatment or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:\n\n  * Patients with a history of autoimmune-related hypothyroidism who are stable on thyroid-replacement hormone are eligible for the study\n  * Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study\n  * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n    * Rash must cover ≤ 10% of body surface area\n    * Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n    * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses \\> 10 mg prednisone or equivalent or other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment\n* Cirrhosis (Child-Pugh B or worse) or cirrhosis with history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis\n* Has symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with asymptomatic CNS lesions will be eligible if considered appropriate by the treating physician. Subjects with previously treated brain metastases may participate provided they have had a stable neurological status for at least 2 weeks after completion of definitive therapy\n\n  * Asymptomatic patients with treated CNS lesions are eligible, provided that all of the following criteria are met:\n\n    * Measurable disease, per RECIST v1.1, must be present outside the CNS\n    * The patient has no history of intracranial hemorrhage or spinal cord hemorrhage\n    * The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment\n    * The patient has no ongoing requirement for corticosteroids as therapy for CNS disease\n    * If the patient is receiving anti-convulsant therapy, the dose is considered stable\n* Pregnancy or breastfeeding or intention of becoming pregnant during study treatment or within 5 months for atezolizumab or within 24 months after the final dose of vismodegib.\n\n  * Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n* Known active tuberculosis (specific testing is only needed if clinically indicated)\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could impact patient safety\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study\n* Prior allogeneic stem cell or solid organ transplantation\n* Live, attenuated vaccines (e.g., FluMist®) are prohibited within 4 weeks prior to initiation of study treatment, during treatment with atezolizumab, and for 5 months after the last dose of atezolizumab\n* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Any patient who experience unacceptable toxicity on prior checkpoint inhibitor therapy:\n\n  * ≥ grade 3 adverse event (AE) related to checkpoint inhibitor\n  * ≥ grade 2 immune-related AE associated with checkpoint inhibitor\n  * CNS, ocular or cardiac AE of any grade related to checkpoint inhibitor\n\n    * NOTE: Patients with a prior endocrine AE are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic",{"count":339,"type":19},24,[22],"This phase Ib trial tests the safety, side effects, and best dose of the combination of vismodegib and atezolizumab in treating patients with non-small cell lung cancer (NSCLC) that has come back after a period of improvement (recurrent) or has spread from where it first started (primary site) to other places in the body (metastatic). Vismodegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving a combination of vismodegib and atezolizumab may be safe, tolerable and\u002For effective than either drug alone in treating patients with recurrent or metastatic NSCLC.",[66,26,129],"2026-02-24",{"date":345,"type":37},"2026-02-27",{"date":347,"type":37},"2024-12-31",{"date":349,"type":19},"2027-12-01",{"name":351,"class":44},"Dwight Owen",{"id":353,"slug":4,"hasResults":10,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":20,"phases":359,"briefSummary":360,"conditions":361,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":45},"100457262","NCT05234307","PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer","A Phase Ib Trial of PBF-1129 and Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Confirmed recurrent or metastatic non-small cell carcinoma of the lung of any histology without curative options\n* Measurable disease based on RECIST 1.1\n* Patients must have received standard of care chemotherapy and immunotherapy. No limits to prior lines of therapy. Prior PD-1 and\u002For PD-L1 directed therapies are required. Prior CTLA4 therapy is permitted. Patients may have received no more than 3 prior lines of therapy in the metastatic setting (excluding targeted therapies)\n* Patients with known actionable mutations with Food and Drug Administration (FDA)-approved treatment options must have received all approved and standard of care treatment options (ie osimertinib for EGFR, alectinib for ALK, etc)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Absolute neutrophil count (ANC) \\>= 1,500 \u002FmcL\n* Platelets \\>= 100,000 \u002F mcL\n* Serum creatinine OR measured or calculated creatinine clearance (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or creatinine clearance \\[CrCl\\]) =\\\u003C 1.5 X upper limit of normal (ULN) OR \\>= 60 mL\u002Fmin for subject with creatinine levels \\> 1.5 X institutional ULN\n* Serum total bilirubin =\\\u003C 1.5 X ULN OR direct bilirubin =\\\u003C ULN for subjects with total bilirubin levels \\> 1.5 ULN\n* AAspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 X ULN OR =\\\u003C 5 X ULN for subjects with liver metastases\n* Albumin \\>= 2.5 mg\u002FdL\n* International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) =\\\u003C 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants =\\\u003C 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n* Anticipated life expectancy of \\>= 3 months\n* Willing to comply with study procedures\n* Must be able to swallow pills\n* Female subjects of childbearing potential must be willing to use an adequate method of contraception\n* For female patients of childbearing potential, a negative serum pregnancy test within 7 days prior to first dose of protocol therapy is required\n* Be willing and able to understand and sign the written informed consent document\n* Availability of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block. A recently obtained archival FFPE tumor tissue block (if an FFPE tissue block cannot be provided, 15 unstained slides (10 minimum) will be acceptable) from a primary or metastatic tumor resection or biopsy can be provided if it was obtained within 1 year of trial screening. Patients with archival tissue that does not meet this criteria may still be eligible in the dose escalation cohort only upon approval from PI.\n* For patients in dose expansion cohort: Be willing to provide tissue from a pre-treatment and on-treatment fin needle aspirate (FNA) or core biopsy of a tumor lesion. Subjects must consent to pre-treatment and on-treatment biopsy prior to initiation of clinical trial, however subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may still continue on study\n* Be willing to provide peripheral blood samples for correlative studies\n\nExclusion Criteria:\n\n* Has active autoimmune disease, including myasthenic syndrome, which has required systemic treatment in the past 12 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided that disease is well controlled at baseline and requires only topical corticosteroids.\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at a dose \\> 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment\n* Known active chronic infections - human immunodeficiency virus (HIV)\u002Facquired immunodeficiency syndrome (AIDS), known active (ie with detectable polymerase chain reaction \\[PCR\\]) Hepatitis B or C\n* Cirrhosis (Child-Pugh B or worse) or cirrhosis with history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis\n* Symptomatic central nervous system (CNS) metastases. Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, on stable dose of steroids after cranial irradiation with maximum of 10 mg prednisone equivalent. Treatment (whole brain radiation therapy, focal radiation therapy, and stereotactic radiosurgery) must be completed at least 2 weeks prior to study entry, or after surgical resection performed at least 28 days prior to treatment initiation. Patients with asymptomatic lesions will be eligible if considered appropriate by the treating physician.\n* Pregnancy or breastfeeding\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n* Any of the following cardiac criteria:\n\n  * Mean resting corrected QT interval (corrected QT \\[QTc\\] using Fredericia's formula \\[QTcF\\]) \\> 470 msec (Fridericia's Criteria for Corrected QT interval \\[QTc\\] Calculation: Fridericia's formula QTcF = (QT\u002FRR0.33). RR is the time from the interval of 1 QRS complex to the next measured in seconds and is commonly calculated as (60\u002Fheart rate \\[HR\\])\n  * Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG) (e.g., complete left bundle branch block, third degree heart block, second degree heart block\n* Any patient who experience unacceptable toxicity on prior checkpoint inhibitor therapy:\n\n  * \\>= grade 3 adverse event (AE) related to checkpoint inhibitor with the exception of grade 3 pneumonitis that has resolved to grade 1 at time of study entry.\n  * Ongoing \\>= grade 2 immune-related AE associated with checkpoint inhibitor with the exception of endocrine toxicities as detailed below\n  * CNS, ocular or cardiac AE of any grade related to checkpoint inhibitor\n  * NOTE: Patients with a prior endocrine AE are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic",{"count":124,"type":19},[22],"This phase I trial studies the side effects and best dose of PBF-1129 in combination with nivolumab in treating patients with non-small cell lung cancer that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as PBF-1129 and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.",[66,26,129,362,363],"Stage IVA Lung Cancer AJCC v8","Stage IVB Lung Cancer AJCC v8","2026-02-04",{"date":366,"type":37},"2026-02-06",{"date":368,"type":37},"2022-11-21",{"date":370,"type":19},"2026-12-31",{"name":351,"class":44},{"id":373,"slug":4,"hasResults":10,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":20,"phases":380,"briefSummary":381,"conditions":382,"keywords":4,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":4},"100623201","NCT07393555","Treatment for Advanced Non-small Cell Lung Cancer With Actionable Genomic Alterations After Targeted Treatment and Chemotherapy (An Expanded Lung-MAP Treatment Trial)","A Randomized Phase II Study of Sacituzumab Govitecan Alone, Ivonescimab Alone, or Sacituzumab Govitecan and Ivonescimab in Participants With Previously-Treated Actionable Genomic Alteration Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)","Inclusion Criteria:\n\n* Participants must have been assigned to S1900N by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900N is determined by submission of documentation of NSCLC harboring an actionable genomic alteration (AGA) in the LUNGMAP protocol. AGA is defined in this protocol as an activating driver alteration with an approved targeted therapy for lung cancer in one of the following genes: ALK, EGFR, HER2 (ERBB2), MET, NTRK, RET, and ROS1.\n* Participants must have measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)\u002FCT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to randomization. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to randomization. All disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to randomization.\n* Participants must have a CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to randomization.\n* Participants with spinal cord compression or brain metastases must not have residual neurological dysfunction, unless no further recovery is expected, and the participant has been stable on weaning doses of corticosteroids (≤ 10 mg daily prednisone or equivalent) prior to randomization. Participants with spinal cord compression or brain metastases that require local treatment must have received local treatment to these metastases and remained clinically controlled and asymptomatic for at least 7 days following stereotactic radiation and\u002For 14 days following whole brain radiation, and prior to randomization.\n* Participants must not have leptomeningeal disease that requires CNS-specific treatment prior to randomization and must not be planning to receive the CNS-specific treatment while on study.\n* Participants must have progressed (in the opinion of the treating physician) during or following the most recent line of systemic therapy.\n* Participants must have previously received an appropriate targeted therapy for the lung cancer AGA (ALK, EGFR, HER2 (ERBB2), MET, NTRK, RET, and ROS1).\n* Participants must have previously received platinum-based chemotherapy for stage IV or recurrent disease.\n* Participants must have received no more than (\\\u003C=) 3 lines of prior cytotoxic therapy (including chemotherapy, antibody-drug conjugates) for NSCLC.\n* Participants must not have received prior TROP2-targeted antibody-drug conjugate or a systemic therapy containing sacituzumab govitecan\u002FSN-38.\n* Participants must not have received prior anti-PD-1 or anti-PD-L1 antibody therapy.\n* Participants must not have received any systemic lung cancer therapy (except orally administered drugs) within 21 days prior to randomization. Orally administered lung cancer therapies must not have been administered within 10 days prior to randomization.\n* Participants must have completed any prior radiation therapy within 7 days prior to randomization.\n* Participants must have recovered (≤ Grade 1) from any side effects of prior therapy (except for alopecia) prior to randomization.\n* Participants must not be planning to receive any concurrent systemic therapy (e.g. chemotherapy, immunotherapy, targeted therapy etc) for lung cancer treatment while receiving treatment on this study.\n* Participants' most recent Zubrod performance status must be 0-1 and be documented within 28 days prior to randomization.\n* Participants must have a complete medical history and physical exam within 28 days prior to randomization.\n* Absolute neutrophil count ≥ 1.5 x 10\\^3\u002FuL (within 28 days prior to randomization)\n* Hemoglobin \\>= 10.0 g\u002FdL (within 28 days prior to randomization)\n* Platelets ≥ 100 x 10\\^3\u002FuL (within 28 days prior to randomization)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to randomization). Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN.\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to randomization). Participants with history of liver metastasis must have AST and ALT ≤ 5 x ULN\n* Participants must have calculated creatinine clearance ≥ 50 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to randomization.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better.\n* Participants must not have experienced an arterial or venous thrombotic event or hemoptysis within 28 days prior to randomization.\n* Participants must not be planning to receive warfarin (or other coumadin derivatives) while receiving treatment on this study.\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen.\n* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization.\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization.\n* Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)\n* Participants must be offered the opportunity to participate in specimen banking",{"count":379,"type":19},117,[55],"This phase II Expanded Lung-MAP treatment trial compares how well sacituzumab govitecan alone, ivonescimab alone, or sacituzumab govitecan in combination with ivonescimab works in treating patients with non-small cell lung cancer (NSCLC) that has come back after a period of improvement (recurrent) or is stage IV and has a change in at least 1 of these genes: ALK, EGFR, HER2 (ERBB2), MET, NTRK, RET, and ROS1. This type of gene change is called an actionable genomic alteration (AGA), which means certain treatments can target the change to fight the cancer. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a toxic drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as TROP2 receptors, and delivers SN-38 to kill them. Ivonescimab is a bispecific antibody that can bind to two different antigens at the same time. It binds to programmed cell death protein 1 (PD1), a protein found on the surface of T cells (a type of white blood cell) and vascular endothelial growth factor (VEGF), a protein found on the surface of tumor cells. Ivonescimab may strengthen the immune system and interfere with the ability of tumor cells to grow and spread. Giving a combination of sacituzumab govitecan and ivonescimab work better than either drug alone, and sacituzumab govitecan alone, ivonescimab alone, or sacituzumab govitecan and ivonescimab together may work better than standard treatments at shrinking NSCLC with an AGA.",[26,129],"2026-01-30",{"date":366,"type":37},{"date":386,"type":19},"2026-08-07",{"date":388,"type":19},"2029-11",{"name":203,"class":204},{"id":391,"slug":4,"hasResults":10,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":20,"phases":398,"briefSummary":400,"conditions":401,"keywords":402,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":45},"100374167","NCT04151940","PET\u002FCT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer","An Interventional Study of PET\u002FCT Changes During Chemoimmunotherapy and Radiation Therapy for Patients With Metastatic NSCLC (PET Bright)","Inclusion Criteria:\n\n* Histologically-confirmed or cytologically-confirmed metastatic NSCLC in patients who have not received chemotherapy or immunotherapy for their advanced disease (stage IV or recurrent, using the American Joint Committee on Cancer \\[AJCC\\]\u002FUnion for International Cancer Control \\[UICC\\] 8th edition for staging)\n* Evidence of stage IV disease on imaging by CT, PET\u002FCT, or magnetic resonance imaging (MRI)\n* Plan to treat with a platinum doublet with a PD1 or PDL1 inhibitor\n* Adjuvant chemotherapy or concurrent chemoradiation for early stage disease does not count as prior therapy unless subject progressed within 6 months of completion of regimen.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, at treating physician's discretion\n* Subjects must be ≥ 18 years of age\n* Patients with known activating mutations in EGFR, BRAF or known translocation in ALK or ROS-1 are eligible provided they have progressed on or were intolerant to Food and Drug Administration (FDA) approved targeted therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2\n* Creatinine =\\\u003C 2 mg\u002FdL or creatinine clearance \\> 50 mL\u002Fmin\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 5x institutional upper limit of normal\n* Total bilirubin =\\\u003C 1.5 mg\u002FdL\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL (\\>= 1500 per mm\\^3)\n* Platelet count \\>= 100 x 10\\^9\u002FL (\\>=100,000 per mm\\^3)\n* Capability to understand and comply with the protocol requirements and signed informed consent documents\n\nExclusion Criteria:\n\n* Any known additional malignancy (with exception of non-melanoma skin cancer, in-situ breast cancer, low risk prostate cancer, or a malignancy diagnosed \\>= 3 years prior to the current NSCLC diagnosis and with no evidence of requiring active treatment)\n* Had prior treatment with an anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms\n* Has any serious or uncontrolled active infection that could create false positives on a PET\u002FCT scan, in the opinion of the treating investigator\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n* Has an active autoimmune disease currently requiring systemic treatment (e.g. disease modifying agents, corticosteroids or immunosuppressive drugs)\n\n  \\*\\*Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Has known, active, and symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n\n  * Patients with stable or previously treated brain metastases are eligible as long as they are not receiving more than 10 mg of prednisone, or equivalent, per day",{"count":397,"type":19},80,[399],"NA","This study investigates the changes in positron emission tomography (PET)\u002Fcomputed tomography (CT) imaging scans during chemoimmunotherapy and radiation therapy treatment in patients with stage IV non-small cell lung cancer. Analyzing changes in PET\u002FCT imaging scans may help doctors assess and predict patterns of cancer response to chemoimmunotherapy and radiation therapy.",[66,26,129],[403],"Lung","2026-01-12",{"date":406,"type":37},"2026-01-14",{"date":408,"type":37},"2019-09-26",{"date":410,"type":19},"2027-11-30",{"name":137,"class":44},{"id":413,"slug":4,"hasResults":10,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":20,"phases":420,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":45},"100521298","NCT06067776","Osimertinib, Cetuximab, and Tucatinib for the Treatment of EGFR-Mutant Stage IV or Recurrent Non-small Lung Cell Cancer","A Phase I Study of Osimertinib, Cetuximab, and Tucatinib in Advanced EGFR-Mutant NSCLC With Acquired Resistance to Osimertinib","Inclusion Criteria:\n\n* Participants with Stage IV or recurrent\u002Fmetastatic histologically confirmed non-small cell lung cancer (NSCLC).\n* NSCLC must harbor at least one of the following EGFR activating mutations: Exon 21 L858R, Exon 19 deletion, Exon 18 G719X, Exon 21 L861Q, Exon 20 S768I.\n* For patients in the dose escalation cohort, patients must have progressed on any prior EGFR-Tyrosine Kinase Inhibitor (TKI) and if T790M positive must have also progressed on osimertinib. Participants in the dose expansion cohort must have had progressive disease as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version (v)1.1 criteria on osimertinib as first-line therapy.\n* 4\\. Participants in the dose expansion cohort must be negative for clinically significant non-ERBB bypass tract resistance such as MET amplification, BRAF mutation, RAS-RAF-MAPK alteration, ALK fusion, RET fusion by a Clinical Laboratory Improvement Amendments (CLIA) (performed after progression on prior EGFR-TKI; if any questions please consult with the Principal Investigator). A defined subset of patients in the expansion cohort will have human epidermal growth factor receptor (HER2) aberrant signaling as putative resistance to osimertinib with overexpression\u002Famplification (or more rarely HER2 Exon 20 insertion mutation) as determined by IHC (3+ IHC) or FISH (HER2\u002FCEP17 \\> 2.2 or HER2 copy number \\> 6) or NGS for HER2 mutation.\n* Adequate archival tissue from a biopsy performed after progression of disease on previous osimertinib (or last EGFR-TKI for dose escalation cohort) or willingness to consent for a fresh tumor biopsy.\n* Participants must have measurable disease by RECIST 1.1, by positron emission tomography\u002Fcomputed tomography (PET\u002FCT) or CT imaging within 28 days prior to registration. The CT from a combined PET\u002FCT may be used only if it is of diagnostic quality.\n* Men and women \\>=18 years of age at the time of consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Life expectancy greater than 3 months.\n* Absolute neutrophil count \\>= 1.5 x 10\\^9\u002FL.\n* Platelets \\>= 100 x 10\\^9\u002FL.\n* Hemoglobin \\>= 9 g\u002FdL.\n* Serum albumin \\>= 2.5 g\u002FdL.\n* Bilirubin =\\\u003C 1.5 x the upper limit of normal (ULN).\n* Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate transaminase (AST) =\\\u003C 2.5 x ULN.\n* Potassium within institutional normal limits.\n* Magnesium within institutional normal limits.\n* Coagulation parameters of international normalized ratio (INR) \\\u003C 1.5 and partial thromboplastin time (PTT) \\\u003C 30 seconds.\n* Creatinine =\\\u003C 1.5 x ULN or calculated creatinine clearance \\>= 50 mL\u002Fmin (per the Cockcroft-Gault formula).\n* If brain metastases are present, they must be stable and asymptomatic. Participants on corticosteroids for brain metastases are excluded.\n* Left ventricular ejection fraction 50% or more on echocardiogram or multigated acquisition scan.\n* Individuals of child-bearing potential must test negative for pregnancy =\\\u003C 14 days prior to receiving first dose of study medication based on a serum pregnancy test and agree to use 2 methods of birth control or abstain from heterosexual activity during the study and for 6 months following the last dose of the study drug(s), whichever is longer; or be of non- childbearing potential. Non-childbearing potential is defined as (by other than medical reasons) \\* \\>= 45 years of age and has not had menses for greater than 2 years. \\* Amenorrheic for \\\u003C 2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation. \\*Post hysterectomy, oophorectomy or tubal ligation. Documented hysterectomy or oophorectomy must be confirmed (of the actual procedure or confirmed by an ultrasound). Tubal ligation must be confirmed (of the actual procedure) otherwise the participant must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 6 months after the last dose of study therapy.\n* Ability to swallow pills.\n* Ability to understand and willingness to sign an informed consent form.\n* Ability to adhere to the study visit schedule and protocol requirements.\n* Participants previously on osimertinib allowed to continue prior to initiating study.\n\nExclusion Criteria:\n\n* History of pneumonitis requiring steroids, including history of radiation-induced pneumonitis.\n* Known or suspected leptomeningeal disease as documented by the investigator. Stable asymptomatic brain metastases not requiring steroids is allowed; radiation for brain metastases is allowed as long as there is a two-week washout period prior to starting study treatment.\n* Have poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases notwithstanding central nervous system (CNS)-directed therapy.\n* The participant has a known allergy \u002F history of hypersensitivity reaction to any of the treatment components (including any ingredient or similar ingredient used in the product formulations) or red meat.\n* History of tick bite or any other contraindication to one of the administered treatments.\n* History of arterial or venous thromboembolism within 3 months prior to study enrollment. Participants with a history of venous thromboembolism beyond 3 months prior to study enrollment can be enrolled if they are appropriately treated with low molecular weight heparin or direct oral anti-coagulants.\n* History or evidence of current clinically relevant coronary artery disease \\>= Grade III by the Canadian Cardiovascular Society Angina Grading Scale or uncontrolled congestive heart failure of current \\> Class III as defined by the New York Heart Association.\n* The participant has experienced myocardial infarction within 6 months prior to study enrollment.\n* The participant has a history of clinically significant ventricular arrhythmia, cardiac arrest, or torsades de pointes.\n* The participant has high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency.\n* The participant has uncontrolled or poorly controlled hypertension (\\>180 mmHg systolic or \\> 130 mmHg diastolic.\n* Use of a strong cytochrome P450 CYP2C8 inhibitor within 5 half-lives of the inhibitor or use of a strong CYP3A4 or CYP2C8 inducer within 5 days prior to the first dose of study treatment.\n* The participant is pregnant or breast feeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment.\n* The participant has any ongoing or active clinically significant infection, including known active tuberculosis or known ongoing or active infection with the human immunodeficiency virus.\n* Recent (within 30 days before enrollment) or concurrent yellow fever vaccination.\n* Any condition that would prohibit the understanding or rendering of informed consent.\n* Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial.\n* Radiation within 14 days before beginning study drugs.\n* Prior EGFR monoclonal antibody treatment (i.e., necitumumab or cetuximab) or HER2 directed treatment (i.e., trastuzumab deruxtecan) for dose expansion only.\n* Any systemic therapy within 3 weeks of enrollment with the exception of EGFR-TKI. \\* Platinum-based chemotherapy or other lines of intervening systemic therapy after progression on osimertinib or EGFR TKIs is allowed but must be completed no later than 3 weeks before study enrollment.\n* Prior EGFR-TKI (if not osimertinib) must be discontinued at least 7 days prior to start of study treatment.",{"count":419,"type":19},36,[22],"This phase I trial tests the safety, side effects, and best dose of osimertinib, cetuximab, and tucatinib in treating patients with EFGR-mutant non-small cell lung cancer that is stage IV or has come back (recurrent). Osimertinib and tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.\n\nCetuximab is a chimeric human\u002Fmouse IgG1 monoclonal antibody that targets epidermal growth factor receptor (EGFR), a receptor overexpressed in many types of cancer, and may interfere with the ability of tumor cells to grow and spread. Giving osimertinib, cetuximab, and tucatinib may work better in treating patients with non-small cell lung cancer.",[66,26,129],"2023-10-02",{"date":425,"type":37},"2023-10-05",{"date":427,"type":19},"2024-01-01",{"date":429,"type":19},"2026-11-01",{"name":431,"class":44},"Jonathan Riess",""]