[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iiib-lung-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iiib-lung-cancer-ajcc-v8":512},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,43,64,87,110,128,137,147,156,182,207,320,346,365,386,407,452,470,490],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100054062",false,"NCT04181060","Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer","Randomized Phase III Study of Combination Osimertinib (AZD9291) and Bevacizumab Versus Osimertinib (AZD9291) Alone as First-Line Treatment for Patients With Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n* Patient must have a pathologically-confirmed diagnosis of non-squamous, non-small cell lung cancer (NSCLC)\n* Patient must have advanced disease, defined as - 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) 8th edition staging criteria\n* Patient must have somatic activating sensitizing mutation in EGFR (e.g. but not limited to Exon 19 deletion, L858R, E709X, G719X, exon 19 insertions, L861Q, S768I). Patients with non-sensitizing mutations in EGFR (EGFR exon 20 insertions) are not eligible. Test results originating from a Clinical Laboratory Improvement Act (CLIA)-certified or similarly accredited laboratory are acceptable; no specific assay is mandated. Plasma, cytology, or tumor tissue can be utilized for mutation testing\n* Patient must not have received any prior treatment with an anti-VEGF agent\n\n  * NOTE: Prior treatment with an EGFR TKI is not allowed, however if a candidate for this study has already started osimertinib within 21 days prior to randomization, the exact osimertinib start date is known, and the patient had the required study baseline imaging completed prior to the osimertinib start date, the patient will be eligible\n* Patients that have received prior radiation therapy are eligible. Radiation (limited field stereotactic radiation or conventional radiation) must have been completed at least one week prior to study drug initiation and more extensive field radiation (i.e., whole-brain radiotherapy \\[WBRT\\]) must have been completed at least two weeks prior to drug initiation\n* Patient must not have any risk factors for anti-VEGF administration, specifically, hemoptysis, active cardiovascular disease, uncontrolled hypertension, significant proteinuria (screening urinalysis \\> 300 mg\u002Fdl) and tumor invading major blood vessels\n* Patient must have measurable disease. Baseline measurements of sites of disease must be obtained within 4 weeks prior to study randomization. If a potential target lesion is previously irradiated without subsequent growth and\u002For is radiated after the imaging from which baseline measurements are obtained, they cannot be included as target lesions, and additional target lesions are required to meet criteria for measurable disease\n* Patient must not have had any prior systemic treatment for metastatic disease\n* Patient must be ≥ 18 years of age\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used\n* All females of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy\n* A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patient of childbearing potential and sexually active males must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for 2 weeks prior to the start of treatment, while on study treatment, and for\n\n  * 6 weeks after the last dose of protocol treatment for female patients on the osimertinib (AZD9291) alone arm\n  * 4 months after the last dose of protocol treatment for male patients on osimertinib (AZD9291) alone arm\n  * 6 months after the last dose of protocol treatment for all patients on osimertinib (AZD9291) plus bevacizumab combination arm\n  * NOTE: Female patients should also not breastfeed while on treatment and for 6 months after the last dose bevacizumab\n* Leukocytes \\>= 3,000\u002FmcL (obtained =\\\u003C 14 days prior to randomization)\n* Absolute neutrophil count \\>= 1,500\u002FmcL (obtained =\\\u003C 14 days prior to randomization)\n* Platelets \\>= 100,000\u002FmcL (obtained =\\\u003C 14 days prior to randomization)\n* Hemoglobin \\>= 9 g\u002FdL (obtained =\\\u003C 14 days prior to randomization)\n* Total bilirubin and creatinine =\\\u003C 1.5 x institutional upper limit of normal (ULN) (obtained =\\\u003C 14 days prior to randomization)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional ULN (obtained =\\\u003C 14 days prior to randomization)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if neurologically stable without glucocorticoid therapy after the stated washout period from radiation therapy (RT) or surgery provided the metastatic lesions are non-hemorrhagic\n* Patients with untreated brain metastases or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required provided the metastatic lesions are non-hemorrhagic and are neurologically stable without glucocorticoid therapy\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* Patients with known history or current symptoms of cardiac disease, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Patient must have the ability to understand and the willingness to sign a written informed consent document and comply with study requirements\n* Patient must not have had treatment with any investigational drug within five half-lives or 3 months (whichever is greater), prior to study initiation\n* Patient must not be currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4. For any patient currently receiving such inducers of CYP3A4, they must discontinue use prior to first dose of study treatment. 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* Patient must not have any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of randomization, with the exception of alopecia and grade 2 prior platinum-therapy-related neuropathy\n* Patient must not have any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it challenging for the patient to participate in the study. Screening for chronic conditions is not required\n* Patient must not have refractory nausea and vomiting, chronic gastrointestinal diseases, the inability to swallow the osimertinib tablets or previous significant bowel resection that would preclude adequate absorption of osimertinib\n* Patient must not have a medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease\n* Patient must not have a history of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib\n* Patient must not have mean resting corrected QT interval (QTc) \\> 470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value (using Bazett's correction)\n* Patient must not have any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second-degree heart block\n* Patient must not have any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: potassium \\\u003C lower limit of normal \\[LLN\\]; magnesium \\\u003C LLN; 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 and cause torsades de pointes","ALL","18 Years",{"count":18,"type":19},300,"ESTIMATED","INTERVENTIONAL",[22],"PHASE3","This phase III trial compares the effect of bevacizumab and osimertinib combination vs. osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of the lungs (stage IIIB-IV) and has a change (mutation) in a gene called EGFR. The EGFR protein is involved in cell signaling pathways that control cell division and survival. Sometimes, mutations in the EGFR gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to divide more rapidly. Osimertinib may stop the growth of tumor cells by blocking EGFR that is needed for cell growth in this type of cancer. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving osimertinib with bevacizumab may control cancer for longer and help patients live longer as compared to osimertinib alone.",[25,26,27,28,29],"Advanced Lung Non-Squamous Non-Small Cell Carcinoma","Metastatic Lung Non-Squamous Non-Small Cell Carcinoma","Recurrent Lung Non-Squamous Non-Small Cell Carcinoma","Stage IIIB Lung Cancer AJCC v8","Stage IV Lung Cancer AJCC v8","RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2020-12-28",{"date":38,"type":19},"2026-12-31",{"name":40,"class":41},"National Cancer Institute (NCI)","NIH",603,{"id":44,"slug":4,"hasResults":10,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":10,"sex":15,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":20,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100053809","NCT06096844","Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial","A Randomized Phase III Trial of Chemo-Immunotherapy vs Immunotherapy Alone for the Vulnerable Older Adult With Advanced Non-Small Cell Lung Cancer: The ACHIEVE Study","Inclusion Criteria:\n\n* STEP 1 REGISTRATION\n* Patient must be ≥ 70 years of age\n* Patient must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with PD-L1 Tumor Proportion Score (TPS) range of 1-49%\n* Patient must have Stage IIIB, IIIC or IV disease and not be candidates for combined chemo-radiation. NOTE: Prior chemo-radiation therapy (RT) for stage III with recurrence is allowed\n* Patient must have a tumor that is negative for EGFR mutation\u002FALK translocations or other actionable first line mutations in which patients would receive first-line oral tyrosine kinase inhibitors\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 2\n* Patient must agree not to father children while on study and for 6 months after the last dose of protocol treatment\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FuL (obtained within 14 days prior to Step 1 registration)\n* Platelets ≥ 75,000\u002FuL (obtained within 14 days prior to Step 1 registration)\n* Hemoglobin (Hgb) ≥ 8.0 g\u002FdL (obtained within 14 days prior to Step 1 registration)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to Step 1 registration)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3.0 × institutional ULN (obtained within 14 days prior to Step 1 registration)\n* Creatinine clearance (CrCL) ≥ 45 mL\u002Fmin (estimated using Cockcroft-Gault method with actual body weight or measured) (obtained within 14 days prior to Step 1 registration)\n* Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months of Step 1 registration are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have undetectable HCV viral\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* Patient must be English or Spanish speaking to be eligible for the QOL component of the study\n\n  * NOTE: Sites cannot translate the associated GA or QOL forms\n* Patient must not have symptomatic central nervous system disease (CNS) metastases. Patients with a clinical history of CNS metastases or cord compression are eligible if they have been definitively treated and are clinically stable for at least 14 days prior to Step 1 registration and off all steroids for at least 24 hours prior to Step 1 registration. Patients with asymptomatic CNS metastases are eligible\n* Patient must not have had any prior cytotoxic chemotherapy regimen for metastatic disease. Chemotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed, and they have fully recovered from treatment related adverse events prior to Step 1 registration\n* Patient must not have had any prior immunotherapy for metastatic disease. Immunotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed greater than 6 months prior to Step 1 registration\n* Patient must not have a history of uncontrolled autoimmune conditions with the following exceptions, which are allowed: alopecia, vitiligo, rheumatoid arthritis, psoriasis\u002Fpsoriatic arthritis, Hashimoto's thyroiditis, lupus, inflammatory bowel disease\n* Patient must not be on immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily). Short courses of steroids which are discontinued prior to randomization are acceptable. Patients on inhaled, intranasal and\u002For topical steroids are eligible\n* Patient must have baseline imaging done assessing all measurable or non-measurable sites of disease within 45 days prior to Step 1 registration\n* Investigator must declare their intended chemotherapy regimen should their patient be randomized to Arm B (doublet versus\\[vs\\] singlet)\n* STEP 2 RANDOMIZATION\n* Patient must have completed the baseline Geriatric Assessment (GA) after Step 1 registration and prior to Step 2 randomization","70 Years",{"count":51,"type":19},304,[22],"This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and chemotherapy may help stabilize lung cancer.",[55,28,56,29],"Advanced Lung Non-Small Cell Carcinoma","Stage IIIC Lung Cancer AJCC v8",{"date":33,"type":34},{"date":59,"type":34},"2024-07-19",{"date":61,"type":19},"2035-01-31",{"name":40,"class":41},319,{"id":65,"slug":4,"hasResults":10,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":20,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},"100053647","NCT04267848","Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])","Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO (ACCIO)","Inclusion Criteria:\n\n* A female of childbearing potential is a sexually mature female who:\n\n  * Has not undergone a hysterectomy or bilateral oophorectomy; or\n  * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\n* Local testing of EGFR with no EGFR exon 19 deletion or EGFR L858 R mutation (applicable to non-squamous patients only)\n* Local testing of ALK with no ALK rearrangement (failed testing is considered negative) (applicable to non-squamous patients only)\n* Local testing of PD-L1 immunohistochemistry (IHC) using one of the following assays: DAKO 22C3, DAKO 28-8, EIL3N or SP263\n* Completely resected stage IIA, IIB IIIA or IIIB (T3-4N2) non-small cell lung cancer (NSCLC) (squamous or non-squamous) with negative margins (complete R0 resection). Patients will be staged according to the 8th edition of the American Joint Committee on Cancer (AJCC) Staging Manual, 2017\n\n  * Note: Patients with pathologic N2 disease, completely resected, are eligible. However, patients known to have N2 disease prior to surgery are not eligible; guidelines do not recommend up-front surgery for this population\n* Complete recovery from surgery. Registration to A081801 must be 30-77 days following surgery\n* No prior neoadjuvant or adjuvant therapy for current lung cancer diagnosis\n* No prior allogeneic tissue\u002Fsolid organ transplant\n* Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, unstable angina pectoris, that would limit compliance with study requirements\n* No current pneumonitis or history of (non-infectious) pneumonitis that required steroids\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1\n* No active auto-immune disease that has required systemic treatment within the last 2 years (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid release therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment\n* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects\n\n  * Therefore, for women of childbearing potential only, a negative pregnancy test done =\\\u003C 7 days prior to registration is required\n* No patients with a \"currently active\" second malignancy that is progressing or has required active treatment within the last 3 years. Participants with non-melanoma skin cancers, low grade or low-risk cancers, or stage I malignancies not requiring systemic therapy (e.g., prostate cancer requiring only observation or superficial bladder cancer), or carcinoma in situ (e.g., breast carcinoma or cervical cancer in situ) that have undergone potentially curative therapy are eligible\n* No hypersensitivity (\\>= grade 3) to pembrolizumab and\u002For any of its excipients\n* No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed\n* No known hepatitis C virus (defined as HCV ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected) infection or known history of hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive)\n* Absolute neutrophil count (ANC) \\>= 1,500\u002Fmm\\^3\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Hemoglobin \\>= 8 gm\u002Fdl\n* Calculated (Calc.) creatinine clearance \\>= 45 mL\u002Fmin\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) \u002F alanine aminotransferase (ALT) =\\\u003C 2.5 x upper limit of normal (ULN)",{"count":71,"type":19},1210,[22],"This phase III ALCHEMIST treatment trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with usual chemotherapy may help increase survival times in patients with stage IIA, IIB, IIIA or IIIB non-small cell lung cancer.",[75,76,77,78,79,28],"Lung Non-Small Cell Carcinoma","Lung Non-Small Cell Squamous Carcinoma","Lung Non-Squamous Non-Small Cell Carcinoma","Stage II Lung Cancer AJCC v8","Stage IIIA Lung Cancer AJCC v8",{"date":33,"type":34},{"date":82,"type":34},"2020-06-16",{"date":84,"type":19},"2027-01-31",{"name":40,"class":41},1151,{"id":88,"slug":4,"hasResults":10,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":20,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":109},"100564680","NCT06632327","Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer","Perioperative Versus Adjuvant Systemic Therapy in Patients With Resectable Non-Small Cell Lung Cancer - PROSPECT LUNG","Inclusion Criteria:\n\n* Histologically or cytologically confirmed surgically resectable stage IIA to IIIB NSCLC according to the American Joint Committee on Cancer (AJCC) 9th edition (stage IIA to IIIB NSCLC up to single station N2, according to the AJCC 8th edition)\n\n  \\* Note: Patients with resectable stage N2a or T4 are eligible, but patients with stage N2b or N3 are not eligible. Patients with known EGFR or ALK alterations are excluded\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (or Karnofsky ≥ 60%)\n* No prior systemic treatment for NSCLC within 5 years except stage 1 and 2 cancers treated with curative intent\n* No treatment for another malignancy within 3 years prior to registration, except for stage 1 or 2 cancers treated for curative intent; patients must be disease free for one year prior to registration. Patients with non-melanoma skin cancer, urothelial carcinoma in situ (Tis), noninvasive papillary carcinoma of the urinary bladder (Ta), prostatic intraepithelial neoplasia (PIN), ductal carcinoma in situ (DCIS) of the breast, or cervical intraepithelial neoplasia (CIN) of the uterine cervix are also eligible\n* No active autoimmune disease, interstitial lung disease, or transplant that precludes safe treatment with immune checkpoint inhibitors\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial",{"count":94,"type":19},1100,[22],"This phase III trial compares standard therapy given after surgery (adjuvant) to standard therapy given before and after surgery (perioperative) in treating patients with stage II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable). The usual approach for patients with resectable NSCLC is chemotherapy and\u002For immunotherapy before surgery, after surgery, or both before and after surgery. This study is being done to find out which approach is better at treating patients with lung cancer. Treatment will be administered according to the current standard of care at the time of enrollment. Chemotherapy options may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and vinorelbine at standard doses according to the treating physician. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Other chemotherapy drugs, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading . Immunotherapy with monoclonal antibodies, such as nivolumab, pembrolizumab, and atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with chemotherapy and immunotherapy prior to surgery and continuing treatment after surgery may be a more effective treatment option than adjuvant therapy alone in patients with stage II-IIIB resectable NSCLC.",[98,78,79,28],"Resectable Lung Non-Small Cell Carcinoma","2026-07-01",{"date":101,"type":34},"2026-07-02",{"date":103,"type":34},"2024-12-11",{"date":105,"type":19},"2030-04-30",{"name":107,"class":108},"Alliance for Clinical Trials in Oncology","OTHER",382,{"id":111,"slug":4,"hasResults":10,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":20,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},"100554403","NCT06498635","Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial","Randomized Phase III Trial INcorporating Pathologic Complete ReSponse in Participants With Early StaGe Non Small Cell Lung Cancer to Optimize ImmunotHerapy in The AdjuvanT Setting (INSIGHT)","Inclusion Criteria:\n\n* Participants must have histologically or cytological confirmed diagnosis of clinical stage II-IIIB (excluding clinical N3 disease) non-small cell lung cancer (NSCLC)\n* Participants must have had a complete (R0) resection of NSCLC (with appropriate lymph node sampling as defined by the National Comprehensive Cancer Network \\[NCCN\\] guidelines) within 84 days (12 weeks) prior to randomization. Acceptable types of surgical resection are: lobectomy, sleeve resection, bi-lobectomy, or pneumonectomy. Wedge resection is not allowed.\n\n  * Note the NCCN guidelines: N1 and N2 node resection and mapping is a routine component of lung cancer resections. It is recommended at a minimum one N1 and three N2 stations is sampled or complete lymph node dissection. Formal ipsilateral mediastinal lymph node dissection is indicated for participants undergoing resection for N2 disease\n* Participants must have a pathologic complete response (pCR) (no viable tumor in the resected specimen or lymph nodes), as determined by local pathology review\n* Participants must have a PD-L1 status result (e.g. \\[\\\u003C 1% versus \\>= 1% or unknown\\])\n* Participants must not have known EGFR mutations, or ALK gene fusion\n* Participants must have received at least two cycles of neoadjuvant platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 therapy. The neoadjuvant treatment must be Food and Drug Administration (FDA) approved and standard of care as listed in NCCN guidelines\n* Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for NSCLC treatment while receiving treatment on this study\n* Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 28 days prior to randomization\n* Participants must not have medical contraindications or severe adverse events to receiving anti-PD-1 or anti-PD-L1 therapy\n* Participants must not have received post-operative radiation therapy (PORT) for NSCLC\n* Participants must not have any unresolved toxicity National Cancer Institute (NCI) CTCAE grade ≥ 2 from previous anticancer therapy with the exception of alopecia, and vitiligo. Note, participants with grade ≥2 neuropathy may be included at the discretion of the treating investigator. Note, participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included at the discretion of the treating investigator\n* Participant must be ≥ 18 years old at time of study entry\n* Participants must have body weight \\> 30 kg\n* Participant must have Zubrod performance status of 0-2\n* Participant must have a complete medical history and physical exam within 28 days prior to randomization\n* Hemoglobin \\> 9.0 g\u002FdL (within 28 days prior to randomization)\n* Absolute neutrophil count ≥ 1.5 x 10\\^3\u002FuL (within 28 days prior to randomization)\n* Platelets ≥ 100 x 10\\^3\u002FuL (within 28 days prior to randomization)\n* Total bilirubin ≤ 1 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to randomization)\n* Aspartate transaminase (AST)\u002Falanine transaminase (ALT) ≤ 3 × institutional ULN (within 28 days prior to randomization)\n* Participants must have a calculated creatinine clearance ≥ 40 mL\u002Fmin using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to randomization. For creatinine clearance formula see the tools on the Clinical Research Associate (CRA) Workbench https:\u002F\u002Ftxwb.crab.org\u002FTXWB\u002FTools.aspx\n* Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator\n* Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization\n* Participants with a known history 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\n* Participants with a known 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\n* Participants must not have had an organ transplant\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* Participant must not have medical contraindications to receiving immunotherapy, including history of non-infectious pneumonitis that required steroids or active autoimmune disease that has required systemic treatment with disease modifying agents, corticosteroids or immunosuppressive drugs in the past two years. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed\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 during protocol therapy and for 6 months following completion of protocol therapy 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. Participants should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy\n* Participants must not have received a live or live attenuated vaccine within 28 days prior 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 coronavirus disease 19 (COVID-19) vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated, and are not allowed\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants who can complete FACT-L, FACT-BRM, and PRO-CTCAE questionnaires forms in English, or Spanish must agree to participate in the patient-reported outcome study\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* 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* 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",{"count":117,"type":19},306,[22],"This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are not in a study is to closely watch a patient's condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back. Usually, patients do not receive further treatment unless the cancer returns. This study will help determine whether this different approach with durvalumab is better, the same, or worse than the usual approach of observation. Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach.",[75,78,79,28],{"date":101,"type":34},{"date":123,"type":34},"2025-04-01",{"date":125,"type":19},"2039-07-15",{"name":40,"class":41},266,{"id":129,"slug":4,"hasResults":10,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":10,"sex":15,"minAge":49,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":20,"phases":131,"briefSummary":53,"conditions":132,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":135,"leadSponsor":136,"locationsCount":63},"100523527",{"count":51,"type":19},[22],[55,28,56,29],{"date":101,"type":34},{"date":59,"type":34},{"date":61,"type":19},{"name":40,"class":41},{"id":138,"slug":4,"hasResults":10,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":20,"phases":140,"briefSummary":73,"conditions":141,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":144,"leadSponsor":145,"locationsCount":146},"100383070",{"count":71,"type":19},[22],[75,76,77,78,79,28],{"date":101,"type":34},{"date":82,"type":34},{"date":84,"type":19},{"name":40,"class":41},1150,{"id":148,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":20,"phases":150,"briefSummary":23,"conditions":151,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":154,"leadSponsor":155,"locationsCount":42},"100376403",{"count":18,"type":19},[22],[25,26,27,28,29],{"date":101,"type":34},{"date":36,"type":34},{"date":38,"type":19},{"name":40,"class":41},{"id":157,"slug":4,"hasResults":10,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":20,"phases":164,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":179,"locationsCount":181},"100449773","NCT05136846","Papaverine in Combination With Chemoradiation for the Treatment of Stage II-III Non-small Cell Lung Cancer","A Phase I Trial Targeting Mitochondrial Metabolism With Papaverine in Combination With Chemoradiation for Stage II-III Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) =\\\u003C grade 1 (except alopecia) at the time of enrollment\n* Absolute neutrophil count \\>=1.5 x 10\\^9\u002FL\n* Hemoglobin \\>= 9 g\u002FdL\n* Platelets \\>= 100 x 10\\^9\u002FL\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN\n* Creatinine \\\u003C 1.5 mg\u002FdL or calculated creatinine clearance\\* \\>= 50 mL\u002Fmin or 24-hour urine creatinine clearance \\>= 50 mL\u002Fmin\n\n  * Calculated by the Cockcroft-Gault formula •\\>= 18 years old\n* Non-small cell lung cancer (NSCLC), histologically and\u002For cytologically proven\n* Clinical American Joint Committee on Cancer (AJCC) stage II-III NSCLC (T1-4N0-3M0) and select patients with stage IV oligometastatic disease.\n\n  * For patients with oligometastatic disease (up to 5 total sites of disease) for whom definitive CRT or RT to the primary and regional lymph nodes is recommended by the multidisciplinary team, each individual metastatic tumor would be considered an additional site of disease with the exception of brain metastases. Up to 10 brain metastases would be considered as 1 site.\n  * Patients with oligometastatic disease will be allowed to receive adjuvant systemic therapy at the discretion of the medical oncologist and additional local therapy to metastatic sites at the discretion of the multidisciplinary team\n* Patients must be considered unresectable or medically-inoperable if stage II-III NSCLC\n\n  * Patients with a local or regional recurrence following surgical resection for whom definitive CRT or RT to disease in the chest is recommended by the multidisciplinary team will be considered eligible\n* Patients must have fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)-computed tomography (CT) scan (or CT chest\u002Fabdomen\u002Fpelvis with IV contrast), and magnetic resonance imaging (MRI) brain with IV contrast (preferred) or CT scan of the brain with contrast. Non-contrast MRI scans of the chest\u002Fabdomen\u002Fpelvis or brain are permitted for workup if patient has allergy to CT contrast or renal insufficiency\n* Patients must have vital signs, history\u002Fphysical examination, laboratory studies (complete blood count \\[CBCP\\] with differential, chemistries including liver function tests, creatinine clearance (CrCl) assessment; pregnancy test if needed within 14 days of registration)\n* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* No history of complete atrioventricular block, hepatic dysfunction (e.g. cirrhosis), glaucoma, or priapism\n* Patients must be a minimum of 3 weeks from thoracotomy (if performed) and well-healed before starting treatment\n* Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed\n* Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of registration. Urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment\n* Nursing women may participate only if nursing is discontinued, due to the possibility of harm to nursing infants from the treatment regimen\n* Women\u002Fmen of reproductive potential must be counselled on contraception\u002F abstinence while receiving the study treatment\n\n  * Women of childbearing potential are required to use an effective method of contraception from the time of negative serum pregnancy test, throughout the study duration, and until 6 months after the last dose of radiation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n  * Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after completion of study drug administration\n* For patients planning to undergo CRT, patient is suitable to receive standard chemotherapy per treating medical oncologist with radiation during study treatment\n\nINCLUSION CRITERIA FOR MRI IMAGING SUB-STUDY:\n\n•Patients must consent to participate in the main part of this study and be enrolled into the expansion cohort, or consent to participate in the main part of this study and also consent to participate in the optional MRI Imaging study\n\nExclusion Criteria:\n\n* Patients with history of pneumonectomy\n* History of active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis\n* History of previous radiation therapy which would result in overlapping radiation fields\n* Subjects who are breast-feeding and plan to continue breast-feeding during therapy, or have a positive pregnancy test will be excluded from the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n* Hepatic insufficiency resulting in jaundice, or not meeting laboratory values above (albumin, total bilirubin, AST\u002FALT)\n* Patients enrolled into the expansion cohort must be able to complete the MRI Sub-study, or at a minimum attempt the first scan of the MRI Sub-study\n* Any serious and\u002For unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the treating physicians. This could include severe, active co-morbidities such as:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n  * Transmural myocardial infarction within the last 6 months\n  * Acquired immune deficiency syndrome (AIDS) based upon the current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive\n  * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration\n* Patients who are presently receiving nitrates or nitroglycerin, or have received these medications within 30 days of day 1 of protocol treatment\n* Patients who are currently taking Sildenafil should agree to discontinue use for 2 days prior to initiation of papaverine, during the duration of study, and for 2 days after last dose of papaverine\n\nEXCLUSION CRITERIA FOR MRI IMAGING SUB-STUDY:\n\n* Any medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, pregnancy, nursing mothers, weight greater than 350 pounds)\n* Severe anxiety\u002Fclaustrophobia related to MR imaging despite medications to relieve anxiety\u002Fclaustrophobia\n* Patients who use supplemental oxygen and are not able to stop their oxygen for up to a few hours at a time, or who use oxygen because they have breathing when they are laying down",{"count":163,"type":19},28,[165],"PHASE1","This phase I trial finds out the best dose, possible benefits and\u002For side effects of papaverine when given together with chemoradiation intreating patients with stage II-III non-small cell lung cancer. Papaverine targets mitochondrial metabolism to decrease the cancer growth process. Giving papaverine with chemoradiation may work best to treat patients with non-small cell lung cancer.",[168,78,169,170,171,79,28,56,172],"Locally Advanced Lung Non-Small Cell Carcinoma","Stage IIA Lung Cancer AJCC v8","Stage IIB Lung Cancer AJCC v8","Stage III Lung Cancer AJCC v8","Unresectable Lung Non-Small Cell Carcinoma","2026-06-26",{"date":175,"type":34},"2026-06-30",{"date":177,"type":34},"2021-12-06",{"date":38,"type":19},{"name":180,"class":108},"Ohio State University Comprehensive Cancer Center",2,{"id":183,"slug":4,"hasResults":10,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":20,"phases":190,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":196,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"100588612","NCT06943664","Photoimmunotherapy With ASP-1929 and Cemiplimab for the Treatment of Refractory, Inoperable, and Metastatic Stage IIIB-IV Non-small Cell Lung Cancer","Phase II Trial: Photoimmunotherapy and Anti-PD1 in Patients With Refractory Inoperable and Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Subjects with histologically or cytologically confirmed stage IIIB-IV NSCLC\n* Subjects lacking actionable genetic mutations must have been previously treated with (a) anti-PD-1\u002FPD-L1 therapy; and (b) platinum-based chemotherapy, either as combination or sequentially for metastatic disease and have progressed on or after therapy. Individuals who cannot tolerate or have previously refused platinum-based chemotherapy or who are unable to receive it are eligible to enroll based on progression after anti-PD-1\u002FPD-L1 therapy alone\n* NSCLC with known actionable genomic alteration (e.g., EGFR, ALK, ROS1, BRAF) must have received all approved targeted therapies and have progressed (data capture not necessary for ALK, ROS1, BRAF)\n* Subjects have at least two lesions of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* At least one site of disease accessible to photoimmunotherapy. Thus, the therapeutic 690-nm laser light can be administered via insertion of optical fiber\u002Fs in the target tumor for interstitial photoimmunotherapy (I-PIT), or target tumors can be illuminated with external beam photoimmunotherapy (EB-PIT)\n* Absolute neutrophil count: ≥ 1,000\u002FµL\n* Platelets: ≥ 100,000\u002FµL\n* Total bilirubin: ≤ institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]): ≤ 3 x institutional ULN\n* Creatinine clearance (CrCl) ≥ 50 mL\u002Fmin (Cockcroft-Gault)\n* Patient has not received a transfusion within 2 weeks prior to screening\n* Female patients of childbearing potential must have a negative pregnancy test at screening and must be willing to use 2 methods of highly effective birth control while on study or be surgically sterile, or abstain from heterosexual sexual activity for the course of the study through 120 days after the last dose of anti-PD1 treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Male participants must agree to use a highly effective method of contraception starting with the first dose of study medication through 120 days after the last dose of anti-PD1 treatment\n* Participant must understand the investigational nature of this study and sign an independent ethics committee\u002Finstitutional review board approved written informed consent form prior to receiving any study related procedures\n\nExclusion Criteria:\n\n* Has received an investigational agent within 30 days prior to initial treatment or less than 4 half-lives of a previous drug\n* Had a major surgery, (e.g., requiring general anesthesia) within 4 weeks before the first dose of study treatment or, will not have fully recovered from surgery prior to the first dose\n* Patients who received chemotherapy or chemoimmunotherapy within 21 days or those who have not recovered from reversible adverse events prior to the scheduled surgery and interstitial or intraoperative PIT\n* The participants received high dose or curative radiotherapy to the target tumor\u002Fs within 30 days prior to the planned I-PIT or EB-PIT\n* Toxicity related to prior anticancer therapy that has not returned to grade ≤ 1 or baseline levels (except for alopecia, vitiligo, grade ≤ 2 peripheral neuropathy, and endocrinopathies that are stable on hormone replacement, which may be grade 2)\n* History of immune-related adverse events (irAEs) from prior anticancer therapy leading to permanent treatment discontinuation\n* History of solid organ or hematologic stem cell transplantation\n* Prolonged corrected QT interval by Fredericia (QTcF) \\> 470 msec or clinically significant cardiac arrhythmia or electrophysiologic disease (e.g., placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate or abnormalities in conduction or morphology of electrocardiogram \\[ECG\\] \\[e.g., complete left bundle branch block, third- or second-degree heart block, PR interval \\> 250 msec\\]). Note: Participants with cardiac pacemakers who are clinically stable are eligible\n* Clinically significant cardiovascular disease, including any of the following within 6 months prior to signature of informed consent:\n\n  * Myocardial infarction, severe or unstable angina, or coronary artery bypass surgery\n  * Clinically significant arrhythmias (e.g., ventricular arrhythmias or atrial fibrillation with uncontrolled heart rate)\n  * Congestive heart failure (New York Heart Association \\[NYHA\\] class III\u002FIV)\n  * Cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event\n  * Myocarditis\n* Active bleeding diathesis or requirement for therapeutic anticoagulation that cannot be interrupted or altered for procedures\n* Patients with untreated or symptomatically unstable treated brain metastases or history of leptomeningeal disease should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with treated and stable brain metastases (at least 28 days from last radiotherapy treatment) are eligible as long as steroids are not required for symptom management\n* Known history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV). Exceptions include past or resolved hepatitis B (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of hepatitis B virus surface antigen \\[HBsAg\\]) and patients positive for hepatitis C (hepatitis C virus \\[HCV\\]) antibody if polymerase chain reaction is negative for HCV ribonucleic acid (RNA). HIV testing is not required in absence of clinical suspicion of HIV\n* History of, or active autoimmune disorder, requiring systemic steroids or immunosuppressive agents. Exceptions allowed: Patients with autoimmune dermatologic conditions not requiring systemic steroids or immunosuppressive agents (e.g. vitiligo, eczema, etc.), endocrine-related autoimmune conditions receiving appropriate hormonal supplementation\n\n  * Use of immunosuppressant drugs such as steroids, azathioprine, tacrolimus, cyclosporine, etc. is not permitted within 4 weeks before recruitment (exception allowed is use of steroids as hormone replacement therapy or as supportive medication e.g. anti-emesis, contrast allergy, pre-medication, etc. or other short-course therapy less than 2 weeks continuously within 4 weeks of study treatment)\n* History of significant (≥ grade 3) cetuximab infusion reactions\n* Evidence of interstitial lung disease or current active, noninfectious pneumonitis\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g. colitis or Crohn's disease\\], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion:\n\n  * Patients with vitiligo or alopecia\n  * Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement\n  * Any chronic skin condition that does not require systemic therapy\n  * Patients without active disease in the last 5 years may be included\n  * Patients with celiac disease controlled by diet alone\n* 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* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive ASP-1929\n* Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive the experimental PIT or immunotherapy\n* Pregnant or nursing female participants\n* Unwilling or unable to follow protocol requirements",{"count":189,"type":19},27,[191],"PHASE2","This phase II trial tests how well photoimmunotherapy (PIT) with ASP-1929 in combination with cemiplimab works in treating patients with stage IIIB-IV non-small cell lung cancer (NSCLC) that has not responded to previous treatment (refractory), that is not suitable for surgery (inoperable), or that has spread from where it first started to other places in the body (metastatic). PIT is a treatment that combines drugs that become active when exposed to light, such as ASP-1929, with immunotherapy to target and kill tumor cells. ASP-1929 combines cetuximab with a light-sensitive component, sarotalocan. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called epidermal growth factor receptor (EGFR), which is found on some types of tumor cells. This may help keep tumor cells from growing. Sarotalocan is a fluorescent dye, infrared-activated fluorescent dye 700, that is light sensitive, and when activated by a special type of laser light, helps destroy or change tumor cells. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving PIT with ASP-1929 in combination with cemiplimab may kill more tumor cells in patients with refractory, inoperable, or metastatic stage IIIB-IV NSCLC.",[75,194,195,28,56,29],"Metastatic Lung Non-Small Cell Carcinoma","Refractory Lung Non-Small Cell Carcinoma","NOT_YET_RECRUITING","2026-06-18",{"date":199,"type":34},"2026-06-22",{"date":201,"type":19},"2026-08-15",{"date":203,"type":19},"2028-05-01",{"name":205,"class":108},"Roswell Park Cancer Institute",1,{"id":208,"slug":4,"hasResults":10,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":10,"sex":15,"minAge":214,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":20,"phases":217,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":206},"100459958","NCT05269381","Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors","A Phase I\u002FII Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)","PNeoVCA","Inclusion Criteria COHORT 1 and COHORT 2 are no longer enrolling.\n\nPHASE I PRE-REGISTRATION, ALL:\n\n* Willing to provide tissue specimens per protocol\n\n  * NOTE: includes fresh tissue specimen at pre-registration for complete exome and transcriptome sequencing. Patients who had tumor sequencing under certain Mayo Institutional Review Board (IRB) protocols and neoantigen has been identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and\u002For registration.\n* Measurable disease as defined by RECIST (version 1.1) criteria or non-measurable disease\n\n  * NOTE: Tumor lesions in previously irradiated area are not considered measurable disease\n* Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up\n* Willing to provide blood specimens for research\n* Negative pregnancy test =\\\u003C 7 days prior to pre-registration for persons of childbearing potential. If urine test cannot be confirmed negative, serum pregnancy test will be required.\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one =\\\u003C 1 year prior to pre-registration\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1\n* Anticipated life expectancy \\> 6 months\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status (see specified inclusion limits for laboratory toxicity) or National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo).\n* The following lab values obtained =\\\u003C 28 days prior to pre-registration:\n\n  * Hemoglobin \\>= 9.0 g\u002FdL (Must be \\>= 7 days after most recent transfusion)\n  * Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3 or \\>= 1.5 X 10\\^9\u002FL\n  * Platelet count \\>= 100,000\u002Fmm\\^3 or \\>= 100 X 10\\^9\u002FL (Must be \\>=7 days after most recent transfusion)\n  * Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n  * Aspartate transaminase (AST) and alanine transaminase (ALT) =\\\u003C 3 x ULN or =\\\u003C 5 x ULN with liver metastases\n  * Creatinine =\\\u003C 1.5 x ULN OR calculated creatinine clearance must be \\>= 50 ml\u002Fmin using Cockcroft-Gault formula\n  * International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy in which case PT or PTT must be within target range of therapy\n\nPHASE I REGISTRATION, ALL:\n\n* Successful sequencing and production of REAL-Neo vaccine\n* Measurable disease as defined by RECIST (version 1.1) criteria or non-measurable disease\n\n  * NOTE: Tumor lesions in previously irradiated area are not considered measurable disease\n* ECOG PS 0 or 1\n* Anticipated life expectancy \\> 6 months\n* The following lab values obtained =\\\u003C 14 days prior to registration:\n\n  * Hemoglobin \\>= 9.0 g\u002Fdl\n  * ANC \\>= 1500\u002Fmm\\^3\n  * Platelet count \\>= 100,000\u002Fmm\\^3\n  * Total bilirubin =\\\u003C 1.5 x ULN\n  * ALT and AST =\\\u003C 3 x ULN (=\\\u003C 5 x ULN with liver involvement)\n  * PT\u002FINR and aPTT =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy in which case INR or aPTT must be within target range of therapy\n  * Calculated creatinine clearance \\>= 50 ml\u002Fmin using Cockcroft-Gault formula\n* Provide written informed consent\n* Willing to provide blood and tissue specimens for research\n* Willing to return to enrolling institution for follow-up\n* Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have also received and progressed on at least one line of prior FDA-approved targeted therapy\n* Negative pregnancy test =\\\u003C 14 days prior to registration for persons of childbearing potential only\n\n  * NOTE: If urine test cannot be confirmed negative, serum pregnancy test will be required\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one =\\\u003C 1 year prior to pre-registration\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicity see specified limits for inclusion) or NCI CTCAE version 5.0 Grade of 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo)\n\nPHASE II PRE-SCREENING COHORT 3 ONLY:\n\n* ECOG PS 0 or 1\n* Histological confirmation of adenocarcinoma of the breast with estrogen receptor (ER) \\\u003C 10%, progesterone receptor (PR) \\\u003C 10%, and HER2 negative based on current American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guideline\n* Stage I-III based on 7th edition of TNM staging system from American Joint Committee on Cancer (AJCC)\n* Evidence of residual disease \\>= 1 cm after neoadjuvant pembrolizumab-based chemotherapy on imaging for patients who have not had surgery\n* Willing to proceed with surgery and provide tissue and blood specimens for patients who have not had surgery\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up\n\nPHASE II PRE-SCREENING COHORT 4 ONLY:\n\n* ECOG PS 0 or 1\n* Histological confirmation of lung NSCLC\n* No actionable EGFR mutations and ALK fusions\n* Stage II or stage III based on AJCC 8th\n* Tumor \\>= 2 cm on pre-surgery evaluation imaging (residual disease \\>= 2 cm after neoadjuvant therapy on pre-surgery evaluation imaging in patient who receives neoadjuvant therapy) for patients who have not had surgery. Patients with or without neoadjuvant chemotherapy or immunotherapy are allowed\n* Provide written informed consent\n* Willing to proceed with surgery and provide tissue and blood specimens for patients who have not had surgery\n* Willing to return to enrolling institution for follow-up\n\nPHASE II PRE-REGISTRATION COHORT 3 (TNBC) ONLY:\n\n* Histologically confirmed residual cancer burden 2 and 3 in surgical specimens\n\nPHASE II PRE-REGISTRATION COHORT 4 (NSCLC) ONLY:\n\n* Tumor without complete pathologic response is confirmed in pathology\n* Willing to proceed with surgery and provide tissue specimens for complete exome and transcriptome sequencing\n\n  * NOTE: Patients who had sequencing under certain Mayo IRB protocols and neoantigens identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and\u002For registration\n* Negative pregnancy test ≤7 days prior to pre-registration for persons of childbearing potential only. If urine test cannot be confirmed negative, serum pregnancy test will be required.\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* ECOG PS of 0 or 1\n* Anticipated life expectancy \\> 6 months\n\nPHASE II REGISTRATION:\n\n* Successful sequencing and production of REAL-Neo vaccine\n* Patients will receive \\>= 2 additional cycles of maintenance pembrolizumab\n* ECOG PS 0 or 1\n* Anticipated life expectancy \\> 6 months\n* The following lab values obtained =\\\u003C 14 days prior to registration:\n\n  * Hemoglobin \\>= 9.0 g\u002Fdl\n  * ANC \\>= 1500\u002Fmm\\^3\n  * Platelet count \\>= 100,000\u002Fmm\\^3\n  * Total bilirubin =\\\u003C 1.5 x ULN\n  * ALT and AST =\\\u003C 3 x ULN (=\\\u003C 5 x ULN with liver involvement)\n  * PT\u002FINR and aPTT =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy in which case INR or aPTT must be within target range of therapy\n  * Calculated creatinine clearance \\>= 50 ml\u002Fmin using Cockcroft-Gault formula\n* Provide written informed consent\n* Willing to provide blood specimens for research\n* Willing to return to enrolling institution for follow-up\n* Negative pregnancy test =\\\u003C 14 days prior to registration for persons of childbearing potential only. If urine test cannot be confirmed negative, serum pregnancy test will be required.\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one =\\\u003C 1 year prior registration\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status NCI CTCAE version 5.0 Grade of 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo)\n\nExclusion Criteria\n\nALL PHASES:\n\n* Any of the following because study involves investigational agent whose genotoxic, mutagenic and teratogenic effects on developing fetus and newborn are unknown:\n\n  * Pregnant person\n  * Nursing person unwilling to stop breast feeding\n  * Person of childbearing potential unwilling to employ adequate contraception from registration through 6 months after final vaccine cycle\n* Co-morbid systemic illnesses or other severe concurrent disease which, in judgment of investigator, would make patient inappropriate for entry into this study or interfere significantly with proper assessment of safety and toxicity of prescribed regimens\n* History of myocardial infarction =\\\u003C 6 months prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.\n* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy\n\nPHASE I PRE-REGISTRATION:\n\n* Acute, reversible effect(s) of prior therapy not recovered to baseline regardless of interval since last treatment\n* Uncontrolled illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Psychiatric illness\u002Fsocial situations\n  * Congestive heart failure with New York Heart Association (NYHA) class III or IV moderate to severe objective evidence of cardiovascular disease\n  * Stroke =\\\u003C 3 months prior to pre-registration\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered treatment for primary neoplasm, except pembrolizumab\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy =\\\u003C 3 years prior to pre-registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If there is history of prior malignancy, they must not be receiving other specific treatment for their cancer\n* History of active autoimmune disease (AD) that required systemic treatment in =\\\u003C 30 days (i.e., use of disease modifying agents, corticosteroids \\> 10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to pre-registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with celiac disease controlled with diet modification are not excluded PHASE I REGISTRATION\n* Any of the following prior therapies:\n\n  * Chemotherapy, experimental drugs (except pembrolizumab), or small molecules inhibitors (except for endocrine therapies) =\\\u003C 3 weeks prior to registration\n  * Radiation =\\\u003C 2 weeks prior to registration\n  * Major Surgery =\\\u003C 4 weeks prior to registration\n  * Received live vaccine =\\\u003C 30 days prior to registration\n  * Palliative radiation therapy for symptoms control including, but not limited to, bone metastatic lesion radiation therapy is allowed, but last dose of radiation therapy should be \\> 14 days from first dose of vaccination on study\n* CTCAE \\>= Grade 3 treatment-emergent adverse event (TEAE) to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids (\\> 10 mg daily prednisone equivalent), or permanent treatment discontinuation due to toxicity\n* Neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or history of rhabdomyolysis\n* Active ADs that require chronic systemic steroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive agents\n* Systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications =\\\u003C 14 days prior to registration\n\n  * NOTE: Inhaled or topical steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent permitted in absence of active AD\n* Evidence of leptomeningeal disease or central nervous system metastases that are untreated, symptomatic, or require steroids \\>10 mg daily prednisone equivalent\n\n  * NOTE: Patients with history of stable treated brain metastases are eligible. Stable treated metastases defined as no evidence of progression for ≥4 weeks on brain imaging (MRI or CT scan)\n\nPHASE II PRE-SCREENING:\n\n* Uncontrolled illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Congestive heart failure with NYHA class III or IV; moderate to severe objective evidence of cardiovascular disease\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy =\\\u003C 3 years prior to pre-screening\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If there is history of prior malignancy, they must not be receiving other specific treatment for their cancer\n* Known history of active AD that has required systemic treatment in the =\\\u003C 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-screening\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.\n\nPHASE II PRE-REGISTRATION\n\n* Uncontrolled illness including, but not limited to:\n\n  * Congestive heart failure with NYHA class III or IV; moderate to severe objective evidence of cardiovascular disease\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy =\\\u003C 3 years prior to pre-registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If history of prior malignancy, must not be receiving other specific treatment for cancer\n* Known history of active AD that has required systemic treatment in the =\\\u003C 30 days (i.e., with use of disease modifying agents, corticosteroids \\> 10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to pre-registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.\n* Patients will also be excluded based on tissue\u002Fribonucleic acid (RNA)\u002Fdeoxyribonucleic acid (DNA) quality and quantity. If any of the following quality and quantity thresholds are not met, patient will be excluded: (1) tumor tissue cellularity equal to or greater than 30%; (2) there are \\>= 2 cores with passing cellularity; (3) \\>= 30% of tumor RNA with fragment sizes are \\>= 200 base pairs (DV200 \\>= 30); (4) \\\u003C 10% of DNA fragments are smaller than 1 kb; and (5) sufficient amount of both DNA (blood and tumor) and RNA (tumor) for exome sequencing and whole transcriptome sequencing (RNAseq) according to Mayo sequencing core. (Kits and technologies change overtime, so these are not fixed numbers.)\n\nPHASE II REGISTRATION\n\n* Evidence of metastatic disease or recurrence\n* Any of the following prior therapies:\n\n  * Chemotherapy, experimental drugs (except pembrolizumab), or small molecules inhibitors (except for endocrine therapies) =\\\u003C 3 weeks prior to registration\n  * Radiation =\\\u003C 2 weeks prior to registration\n  * Major surgery =\\\u003C 4 weeks prior to registration\n  * Received live vaccine =\\\u003C 30 days prior to registration\n\n    * NOTE: Continuation of pembrolizumab per standard of care is allowed\n    * NOTE: Palliative radiation therapy for symptoms control including, but not limited to, bone metastatic lesion radiation therapy is allowed, but last dose of radiation therapy should be \\> 14 days from first dose of vaccination on study\n* CTCAE \\>= grade 3 TEAE to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids (\\> 10 mg daily prednisone equivalent), or permanent treatment discontinuation due to toxicity\n* Neuromuscular disorders (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy), or history of rhabdomyolysis\n* Active ADs that require chronic systemic steroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive agents\n* Requirement for systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications =\\\u003C 14 days prior to registration\n\n  * NOTE: Inhaled or topical steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent are permitted in","16 Years",{"count":216,"type":19},132,[165,191],"This phase I\u002FII trial tests the safety and tolerability of an experimental personalized vaccine when given by itself and with pembrolizumab in treating patients with solid tumor cancers that have spread to other places in the body (advanced). The experimental vaccine is designed target certain proteins (neoantigens) on individuals' tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving the personalized neoantigen peptide-based vaccine with pembrolizumab may be safe and effective in treating patients with advanced solid tumors.",[220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242,168,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257,258,259,260,194,261,262,263,264,265,266,267,268,269,270,171,271,272,273,79,274,275,276,28,277,56,278,279,280,281,282,283,29,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,172,300,301,302,303,304,305,306,307,308,309,310,311],"Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIB Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage III Merkel Cell Carcinoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IV Merkel Cell Carcinoma AJCC v8","Clinical Stage IVA Gastric Cancer AJCC v8","Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IVB Gastric Cancer AJCC v8","Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Locally Advanced Cervical Carcinoma","Locally Advanced Endometrial Carcinoma","Locally Advanced Gastric Adenocarcinoma","Locally Advanced Gastroesophageal Junction Adenocarcinoma","Locally Advanced Head and Neck Squamous Cell Carcinoma","Locally Advanced Hepatocellular Carcinoma","Locally Advanced Malignant Solid Neoplasm","Locally Advanced Melanoma","Locally Advanced Merkel Cell Carcinoma","Locally Advanced Renal Cell Carcinoma","Locally Advanced Skin Squamous Cell Carcinoma","Locally Advanced Triple-Negative Breast Carcinoma","Locally Advanced Unresectable Breast Carcinoma","Locally Advanced Unresectable Cervical Carcinoma","Locally Advanced Unresectable Gastric Adenocarcinoma","Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma","Locally Advanced Unresectable Renal Cell Carcinoma","Locally Advanced Urothelial Carcinoma","Metastatic Cervical Carcinoma","Metastatic Endometrial Carcinoma","Metastatic Gastric Adenocarcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Hepatocellular Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Melanoma","Metastatic Merkel Cell Carcinoma","Metastatic Renal Cell Carcinoma","Metastatic Skin Squamous Cell Carcinoma","Metastatic Triple-Negative Breast Carcinoma","Metastatic Urothelial Carcinoma","Skin Squamous Cell Carcinoma","Stage III Cervical Cancer AJCC v8","Stage III Hepatocellular Carcinoma AJCC v8","Stage III Renal Cell Cancer AJCC v8","Stage IIIA Cervical Cancer AJCC v8","Stage IIIA Hepatocellular Carcinoma AJCC v8","Stage IIIA Uterine Corpus Cancer AJCC v8","Stage IIIB Cervical Cancer AJCC v8","Stage IIIB Hepatocellular Carcinoma AJCC v8","Stage IIIB Uterine Corpus Cancer AJCC v8","Stage IIIC Uterine Corpus Cancer AJCC v8","Stage IIIC1 Uterine Corpus Cancer AJCC v8","Stage IIIC2 Uterine Corpus Cancer AJCC v8","Stage IV Cervical Cancer AJCC v8","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IVA Cervical Cancer AJCC v8","Stage IVA Hepatocellular Carcinoma AJCC v8","Stage IVA Lung Cancer AJCC v8","Stage IVA Uterine Corpus Cancer AJCC v8","Stage IVB Cervical Cancer AJCC v8","Stage IVB Hepatocellular Carcinoma AJCC v8","Stage IVB Lung Cancer AJCC v8","Stage IVB Uterine Corpus Cancer AJCC v8","Triple-Negative Breast Carcinoma","Unresectable Cervical Carcinoma","Unresectable Endometrial Carcinoma","Unresectable Gastric Adenocarcinoma","Unresectable Gastroesophageal Junction Adenocarcinoma","Unresectable Head and Neck Squamous Cell Carcinoma","Unresectable Hepatocellular Carcinoma","Unresectable Malignant Solid Neoplasm","Unresectable Melanoma","Unresectable Merkel Cell Carcinoma","Unresectable Renal Cell Carcinoma","Unresectable Skin Squamous Cell Carcinoma","Unresectable Triple-Negative Breast Carcinoma","Unresectable Urothelial Carcinoma","Breast Adenocarcinoma","Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8",{"date":313,"type":34},"2026-06-23",{"date":315,"type":34},"2022-03-31",{"date":317,"type":19},"2028-03-31",{"name":319,"class":108},"Mayo Clinic",{"id":321,"slug":4,"hasResults":10,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":20,"phases":328,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":206},"100423117","NCT04789681","Canakinumab for the Prevention of Lung Cancer, the Can-Prevent-Lung Trial","Single Arm Phase II Trial Using Canakinumab for the Prevention of Lung Cancer (Can-Prevent-Lung)","Inclusion Criteria:\n\n* The participant (or legally authorized representative if applicable) provides written informed consent for the trial\n* Participants are eligible to be included in the study if one of the following criteria applies:\n\n  * Patients with no history of lung cancer, who have persistent IPNs (on two computed tomography \\[CT\\] scans at least 3 months apart with no evidence of shrinkage or regression) detected by low dose computed tomography \\[LDCT\\]-guided lung cancer screening or imaging studies for other reasons (incidentalomas) with 10-30% cancer probability by Brock University cancer prediction equation as following\n  * Patients with no history of lung cancer, who have persistent IPNs (on two CT scans at least 3 months apart with no evidence of shrinkage or regression) detected by LDCT-guided lung cancer screening or imaging studies for other reasons (incidentalomas) with \\> 30% cancer probability by Brock University cancer prediction equation as following, but biopsy showed no clear evidence of malignancy\n  * Patients with history of stage I-III non-small cell lung cancer (NSCLC), who have completed treatment with curative intent, who have persistent IPNs (on two CT scans at least 3 months apart with no evidence of shrinkage or regression) with 5-30% cancer probability by Brock University cancer prediction equation as following\n  * Patients with history of stage I-III NSCLC, who have completed treatment with curative intent, who have persistent IPNs (on two CT scans at least 3 months apart with no evidence of shrinkage or regression) with \\> 30% cancer probability by Brock University cancer prediction equation, but biopsy showed no clear evidence of malignancy\n* At least 18 years of age on the day of signing informed consent\n* A male participant must agree to use a contraception during the treatment period plus an additional 6months (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period\n* A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n  * Not a woman of childbearing potential (WOCBP) OR\n  * A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 6 months after study treatments with risk of genotoxicity after the last dose of study treatment\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the start of study treatment\n* Absolute neutrophil count (ANC) \\>= 1500\u002FuL (collected within 10 days prior to the start of study treatment)\n* Platelets \\>= 100 000\u002FuL (collected within 10 days prior to the start of study treatment)\n* Hemoglobin \\>= 9.0 g\u002FdL or \\>= 5.6 mmol\u002FL (collected within 10 days prior to the start of study treatment)\n\n  * Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.\n* Creatinine =\\\u003C 1.5 x upper limit or normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance \\[CrCl\\]) \\>= 30 mL\u002Fmin for participant with creatinine levels \\> 1.5 x institutional ULN (collected within 10 days prior to the start of study treatment)\n\n  * Creatinine clearance (CrCl) should be calculated per institutional standard\n* Total bilirubin =\\\u003C 1.5 x ULN OR direct bilirubin =\\\u003C ULN for participants with total bilirubin levels \\> 1.5 x ULN (collected within 10 days prior to the start of study treatment)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 2.5 x ULN (collected within 10 days prior to the start of study treatment)\n\nExclusion Criteria:\n\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication\n* Has received prior therapy with an anti-IL1beta\n* Has a known additional malignancy that is progressing or has required active treatment within the past year. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded\n* Has an active infection requiring systemic therapy\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through 6 months after the last dose of trial treatment\n* Is receiving the following therapies during the screening and treatment phases (including retreatment for post-complete response relapse) of this trial: antineoplastic systemic chemotherapy or biological therapy, immunotherapy not specified by this protocol, chemotherapy not specified by this protocol, investigational agents other than canakinumab\n* Has received live vaccines within 30 days prior to first dose of study treatment and while participating in the study. Examples of live vaccines include but are not limited to: measles, mumps, rubella, varicella\u002Fzoster, yellow fever, rabies, Bacillus Calmette-Guerin (BCG) and typhoid vaccine. (Note: Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (eg FluMist are live attenuated vaccines are not allowed)",{"count":327,"type":19},50,[191],"This phase II trial studies the effects of canakinumab in preventing lung cancer in patients who have high-risk pulmonary nodules. Canakinumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving canakinumab may prevent the development of lung cancer.",[331,332,333,334,335,336,78,169,170,171,79,28,56],"Lung Carcinoma","Stage I Lung Cancer AJCC v8","Stage IA1 Lung Cancer AJCC v8","Stage IA2 Lung Cancer AJCC v8","Stage IA3 Lung Cancer AJCC v8","Stage IB Lung Cancer AJCC v8","2026-06-10",{"date":339,"type":34},"2026-06-12",{"date":341,"type":34},"2021-07-20",{"date":343,"type":19},"2027-12-31",{"name":345,"class":108},"M.D. Anderson Cancer Center",{"id":347,"slug":4,"hasResults":10,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":20,"phases":354,"briefSummary":355,"conditions":356,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":206},"100367710","NCT04067830","Respiratory Muscle Training Before Surgery in Preventing Lung Complications in Patients With Stage I-IIIB Lung Cancer","Preoperative Respiratory Muscle Training to Prevent Postoperative Pulmonary Complications in Patients Undergoing Resection for Lung Cancer","Inclusion Criteria:\n\n* Documented stage I-IIIb lung cancer or is undergoing surgery for diagnosis\n* Participant is able to speak, read, and comprehend English\n* Participant must be undergoing or is anticipated to either video-assisted thoracic surgery (VATS or robotic surgery) or laparoscopic surgery for curative intent lung resection\n* Patients with or without neoadjuvant chemoradiotherapy (CRT) prior to surgery will be included\n* Ability to follow written and verbal instructions\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Documented ischemic heart disease; congestive heart failure or; significant cardiac arrhythmias that would exclude them from having surgery\n* Overall medical frailty (clinician discretion) or ECOG \\> 2\n* Pregnant or nursing female participants\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to participate in this study",{"count":353,"type":19},220,[191],"This phase II trial studies how well respiratory muscle training before surgery works in preventing lung complications after surgery in patients with stage I-IIIB lung cancer. Patients with lung cancer who choose to undergo surgical resection often have complications after surgery such as pneumonia, unplanned intubations, difficulty breathing and reduced physical functioning, and increased medical costs and a reduced quality of life. Improving pre-surgical pulmonary health through respiratory muscle training may improve respiratory muscle strength, response to surgery, and quality of life after surgery in patients with lung cancer.",[332,333,334,335,336,78,169,170,79,28],"2026-05-14",{"date":359,"type":34},"2026-05-18",{"date":361,"type":34},"2019-03-20",{"date":363,"type":19},"2027-03-22",{"name":205,"class":108},{"id":366,"slug":4,"hasResults":10,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":20,"phases":373,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":385},"100615086","NCT07288034","Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatment in Stage IIIB-IV Non-small Cell Lung Cancer, IMMUNO-BIOMAP Trial","Immunotherapy Biomarker Collection for Metastatic NSCLC to Inform Adaptive Personalized Models Targeting Resistance (IMMUNO-BIOMAP)","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative. (Adult patients lacking capacity to consent may participate if they have a caretaker that could ensure compliance.)\n* Participants must have either A) HopeSeq or Tempus molecular testing results reported within 3 months prior to enrollment or currently in process OR B) archival or new biopsy tissue available (to be sent to Tempus). Acceptable sample types include: two formalin-fixed paraffin-embedded (FFPE) tissue core biopsies, or two 25um sections of 5-10mm\\^2 tissue, or 15-20 unstained slides at 10um thickness (a minimum of 10 unstained slides must be provided)\n* Agreement to blood collection for ctDNA research\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Histologically confirmed stage IIIB or IV NSCLC\n* Absence of sensitizing EGFR mutation or ALK\u002FROS1 alteration\n* Scheduled to begin treatment with a Food and Drug Administration (FDA) approved PD1\u002FPDL1 antibody with or without chemotherapy. Participants who have already started treatment with anti-PD1\u002FPDL1 in this setting may enroll if they have only received up to 4 cycles of treatment so far. Patients who have received PD1\u002FPDL1 antibody for early-stage NSCLC are allowed to enroll if they completed the therapy at least 6 months before starting trial therapy\n* Measurable disease by RECIST version (v) 1.1\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 14 days of ANC assessment\n* Platelets ≥ 100,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment\n* Hemoglobin ≥ 9g\u002FdL\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)\n* Creatinine clearance of ≥ 50 mL\u002Fmin per the Cockcroft-Gault formula\n* If seropositive for HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV), nucleic acid quantitation must be performed. Viral load must be undetectable\n\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n* PART II: Documented informed consent (for Part II) of the participant and\u002For legally authorized representative.\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* PART II: ECOG ≤ 2\n* PART II: Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy\n* PART II: ANC ≥ 1,500\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 14 days of ANC assessment\n* PART II: Platelets ≥ 100,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment\n* PART II: Hemoglobin ≥ 9g\u002FdL\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment\n* PART II: Total bilirubin ≤ 1.5 x ULN\n* PART II: AST ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)\n* PART II: ALT ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)\n* PART II: Creatinine clearance of ≥ 50 mL\u002Fmin per the Cockcroft-Gault formula\n\nExclusion Criteria:\n\n* Surgical intervention within 4 weeks prior to study treatment, except for minor procedures such as port placement\n* Patients with a condition requiring systemic treatment with corticosteroids (\\> 10 mg daily prednisone equivalent) within 7 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Radiation therapy within 7 days prior to day 1 of protocol therapy\n* Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association \\[NYHA class\\] ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication\n* Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs\n* Symptomatic central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have 1) previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroid medication for 1 week prior to the first dose of study drug and have completed radiation 2 weeks prior to the first dose of study drug OR 2) untreated brain metastases that are asymptomatic and stable\n* Prior history of interstitial lung disease (ILD) or non-infectious pneumonitis requiring high-dose glucocorticoids\n* Active infection requiring antibiotics\n* Other active malignancy. Patients with concurrent malignancy other than non-melanoma skin cancer are not eligible for this trial due to potential confounding of the ctDNA results\n* Females only: Pregnant or breastfeeding\n* PART II: Surgical intervention within 4 weeks prior to study treatment, except for minor procedures such as port placement\n* PART II: Radiation therapy within 7 days prior to day 1 of protocol therapy\n* PART II ARM A ONLY: Patients with a condition requiring systemic treatment with corticosteroids (\\> 10 mg daily prednisone equivalent) within 7 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* PART II ARM A ONLY: Patients with prior history of cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) treatment\n* PART II ARM B ONLY: Patients with prior history of KRAS G12C inhibitors\n* PART II: Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication\n* PART II ARM A ONLY: Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs\n* PART II ARM B ONLY: Grade ≥ 2 proteinuria as demonstrated by ≥ 2+ protein and ≥ 1.0 g of protein with 24-hour urine collection (patients found to have ≥ 2+ protein on dipstick urinalysis must have 24-hour urine collection and demonstrate \\\u003C 1g of protein in 24 hours in order to be eligible for treatment)\n* PART II: Clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have 1) previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroid medication for 1 week prior to the first dose of study drug and have completed radiation 2 weeks prior to the first dose of study drug OR 2) untreated brain metastases that are asymptomatic and stable\n* PART II: Clinically significant uncontrolled illness\n* PART II: Active infection requiring antibiotics\n* PART II: Other active malignancy\n* PART II FEMALES ONLY: Pregnant or breastfeeding\n* PART II: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures",{"count":372,"type":19},535,[191],"This phase II trial tests the impact of biomarkers in predicting initial treatment (first-line) PD1 or PD-L1 (PD\\[L\\]-1)-based immunotherapy response and in selecting second-line treatment in patients with stage IIIB-IV non-small cell lung cancer (NSCLC). Response and survival rates in advanced stage NSCLC, unlike other cancers, rely on response to first-line therapy. Immunotherapy with PD(L)1-based therapy, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. While immunotherapy has improved survival rate, the prognosis remains poor with most patients receiving chemotherapy after immunotherapy. Many types of tumors tend to lose cells or release different types of cellular products including their deoxyribonucleic acid (DNA) which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. The first part of this trial, studying samples of blood and tissue in the laboratory from patients receiving immunotherapy may help doctors learn more about the effects PD(L)1-based therapy on cells. It may also help doctors understand how well patients respond to treatment and may help develop new individualized treatment strategies. The second part of this trial also tests the effect of second-line immunotherapy, such as tremelimumab and durvalumab or adagrasib and bevacizumab, in treating patients with NSCLC with specific genetic mutations that is growing, spreading or getting worse (progressive). Tremelimumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Adagrasib, a type of targeted therapy, may stop the growth of tumor cells by blocking a protein needed for tumor cell growth and may kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving second-line immunotherapy, tremelimumab and durvalumab or adagrasib with bevacizumab, may be safe, tolerable, and\u002For effective in treating patients with stage IIIB\u002FIV NSCLC with specific genetic mutations.",[75,28,29],"2026-04-13",{"date":378,"type":34},"2026-04-15",{"date":380,"type":34},"2026-04-08",{"date":382,"type":19},"2028-10-08",{"name":384,"class":108},"City of Hope Medical Center",13,{"id":387,"slug":4,"hasResults":10,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":392,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":20,"phases":395,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":206},"100358517","NCT03948100","Dyadic Yoga Intervention in Improving Physical Performance and Quality of Life in Patients With Stage I-IV Non-small Cell Lung or Esophageal Cancer Undergoing Radiotherapy and Their Caregivers","Dyadic Behavioral Interventions to Manage Physical Performance, Symptoms and Quality of Life for Patient Undergoing Radiotherapy and Their Family Caregivers","Inclusion Criteria:\n\n* PATIENT ONLY: Diagnosed with stage I-IV non-small cell lung cancer (NSCLC) or esophageal cancer and going to receive at least 3 weeks of thoracic radiotherapy (RT)\n* PATIENT ONLY: Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* PATIENT ONLY: Able to read, write and speak English\n* PATIENT ONLY: Able to provide informed consent\n* PATIENT ONLY: Having a family caregiver (e.g., spouse, sibling, adult child) who assists the patient during the cancer treatment (e.g., emotional support, transportation, meal preparation, care coordination, etc) per patient self-report. Note, patients must identify a family caregiver; however, the participation of the family caregiver is optional. For caregivers to be eligible, they must be at least 18 years old; able to read, write and speak English; and able to provide informed consent. Family caregivers may consent to participate in the intervention and caregiver assessments or only the assessments based on their preference.\n\nExclusion Criteria:\n\n* PATIENT ONLY: Who have regularly (self-defined) participated in a mind-body practice in the year prior to diagnosis\n* PATIENT ONLY: Patients who metastatic disease involving the central nervous system",true,{"count":394,"type":19},400,[396],"NA","This trial studies how well dyadic yoga intervention works in improving physical performance and quality of life in patients with stage I-IV non-small cell lung or esophageal cancer undergoing radiotherapy and their caregivers. Dyadic yoga intervention may help to improve physical function, fatigue, sleep difficulties, depressive symptoms, and overall quality of life for patients with non-small cell lung cancer and\u002For their caregivers.",[399,75,332,333,334,335,336,78,169,170,171,79,28,56,29,287,291],"Esophageal Carcinoma","2026-04-10",{"date":378,"type":34},{"date":403,"type":34},"2018-12-20",{"date":405,"type":19},"2027-04-30",{"name":345,"class":108},{"id":408,"slug":4,"hasResults":10,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":20,"phases":415,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":206},"100348630","NCT03819296","Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer","Role of Microbiome in the Realm of Immune-Checkpoint Inhibitor Induced GI Complications In Cancer Population","Inclusion Criteria:\n\n1. Diagnosis of any stage melanoma, Non-Small Cell Lung Cancer or genitourinary (GU) malignancies (Project 1).\n2. Diagnosis of any cancer type (Projects 2 and 3)\n3. Treatment with any ICPI agent\n4. Ability to understand and willingness to sign an informed consent form and rate surveys\n5. Life expectancy \\> 4 months (Project 3)\n6. ICPI-related diarrhea and\u002For colitis of any grade with or without concurrent non- GI toxicity as the toxicity group (project 1)\n7. Patients with no organ toxicity as the control group (project 1)\n8. ICPI-related colitis and\u002For diarrhea of grade ≥ 2 as GI toxicity (initial episode or recurrence) receiving standard treatment of immunosuppressive agents (steroid, infliximab, vedolizumab, or ustekinumab) any time during the colitis disease course until sustained resolution of GI toxicity, or one- year time point after enrollment (Project 2)\n9. ICPI-related colitis and\u002For diarrhea of grade ≥ 2 as GI toxicity without involvement of non- GI toxicity within 45 days prior to FMT (Project 3)\n10. ICPI-related colitis and\u002For diarrhea of grade ≥ 2 within 45 days prior to FMT with ANY of the following characteristics (project 3):\n\n    (i) refractory to treatment of steroid and two doses of non-steroidal immunosuppressants e.g. infliximab, vedolizumab or ustekinumab,\n\n    (ii) contraindication for immunosuppressive treatment,\n\n    (iii) recurrence after successful initial treatment,\n\n    (iv) recurrent symptoms once steroid is tapered down\u002Foff or diarrhea\u002Fcolitis symptoms are steroid dependent, or\n\n    (v) patients with a history of refractory ICPI-related colitis and\u002For diarrhea to medical treatment, even if they have improved symptoms from supportive care within 45 days prior to FMT\n11. No concern for active concomitant GI infection for the ICPI diarrhea\u002Fcolitis work up at the time of protocol therapy initiation as confirmed by stool tests or as per the treating physician based on clinical presentation (project 3)\n12. Patient who has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g. lifelong positive T-spot due to BCG inoculation, chronic colonization) prior to initiation of diarrhea\u002Fcolitis treatment (project 3)\n\nExclusion Criteria:\n\n1. Age younger than 18 years\n2. History of inflammatory bowel disease, and\u002For radiation enteritis or colitis with active disease status at the time of study treatment initiation\n3. Pregnant and breastfeeding women\n4. Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was \\> 1 year prior to consent and\u002F or clear documentation states that patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to date of study treatment\n5. Patients who develop concurrent non- GI toxicity at the time of FMT treatment (project 3)\n6. Patients with active bacterial or fungal infection (Project 3)\n7. Donors at risk for monkeypox infection and\u002F or exposure as determined by a questionnaire (Project 3)\n\nWithdrawal Criteria\n\n1. Patients may withdraw from the trial at any time\n2. Patients who develop GI perforation or toxic colitis that require surgery from ICPI colitis\n3. In project 3, if the first 30% of cases fail the fecal transplant treatment, then project 3 will be terminated",{"count":414,"type":19},800,[165],"This trial studies the role of the gut microbiome and effectiveness of a fecal transplant on medication-induced gastrointestinal (GI) complications in patients with melanoma or genitourinary cancer. The gut microbiome (the bacteria and microorganisms that live in the digestive system) may affect whether or not someone develops colitis (inflammation of the intestines) during cancer treatment with immune-checkpoint inhibitor drugs. Studying samples of stool, blood, and tissue from patients with melanoma or genitourinary cancer may help doctors learn more about the effects of treatment on cells, and help doctors understand how well patients respond to treatment. Treatment with fecal transplantation may help to improve diarrhea and colitis symptoms.",[418,419,420,421,422,423,424,425,225,229,426,75,427,428,429,430,431,432,433,434,435,436,437,438,439,440,441,442,443,332,333,334,335,336,78,169,170,171,79,28,56,29,287,291],"Clinical Stage 0 Cutaneous Melanoma AJCC v8","Clinical Stage I Cutaneous Melanoma AJCC v8","Clinical Stage IA Cutaneous Melanoma AJCC v8","Clinical Stage IB Cutaneous Melanoma AJCC v8","Clinical Stage II Cutaneous Melanoma AJCC v8","Clinical Stage IIA Cutaneous Melanoma AJCC v8","Clinical Stage IIB Cutaneous Melanoma AJCC v8","Clinical Stage IIC Cutaneous Melanoma AJCC v8","Colitis","Malignant Genitourinary System Neoplasm","Malignant Solid Neoplasm","Pathologic Stage 0 Cutaneous Melanoma AJCC v8","Pathologic Stage I Cutaneous Melanoma AJCC v8","Pathologic Stage IA Cutaneous Melanoma AJCC v8","Pathologic Stage IB Cutaneous Melanoma AJCC v8","Pathologic Stage II Cutaneous Melanoma AJCC v8","Pathologic Stage IIA Cutaneous Melanoma AJCC v8","Pathologic Stage IIB Cutaneous Melanoma AJCC v8","Pathologic Stage IIC Cutaneous Melanoma AJCC v8","Pathologic Stage III Cutaneous Melanoma AJCC v8","Pathologic Stage IIIA Cutaneous Melanoma AJCC v8","Pathologic Stage IIIB Cutaneous Melanoma AJCC v8","Pathologic Stage IIIC Cutaneous Melanoma AJCC v8","Pathologic Stage IIID Cutaneous Melanoma AJCC v8","Pathologic Stage IV Cutaneous Melanoma AJCC v8","Stage 0 Lung Cancer AJCC v8","2026-03-10",{"date":446,"type":34},"2026-03-11",{"date":448,"type":34},"2021-02-21",{"date":450,"type":19},"2026-10-31",{"name":345,"class":108},{"id":453,"slug":4,"hasResults":10,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":20,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":206},"100440039","NCT05010109","Cardiovascular Injury and Cardiac Fitness in Locally Advanced Non-Small Cell Lung Cancer Patients Receiving Model Based Personalized Chemoradiation","Longitudinal Assessment of Cardiovascular Injury and Cardiac Fitness in LA-NSCLC Patients Receiving Model Based Personalized Chemoradiation - an Adaptive Cohort Registration Study","Inclusion Criteria:\n\n1. Patient with histologic diagnosis of non-small cell lung cancer, small cell lung cancer, or limited stage - small cell lung cancer (L-SCLC)\n2. The recommended treatment is thoracic radiation therapy combined with concurrent systemic therapy (chemotherapy and\u002For immunotherapy) with or without neoadjuvant and\u002For adjuvant systemic therapy (chemotherapy, immunotherapy, targeted therapy)\n3. \\>\u002F= 18 years of age\n4. KPS \\>\u002F= 70\n5. Willing and able to sign informed consents\n6. Willing to perform 6minute walking test\n7. Willing to preform required cardiac biomarker test for primary end point assessment.\n\nExclusion criteria:\n\n1. Unable or unwilling to give written informed consent\n2. Previous history of RT to the thorax overlapping with the current treatment field.\n3. Pregnant or breast-feeding\n4. Renal failure necessitating dialysis\n5. Unwilling to perform protocol tests\n6. Contraindication for any protocol tests",{"count":459,"type":19},100,[396],"This study assesses cardiovascular injury and cardiac fitness in patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (locally advanced) receiving model based personalized chemoradiation. The goal of this study is to learn more about the risk of developing heart disease as a result of chemoradiation treatment for lung cancer. Researchers also want to learn if the risk can be reduced by using a patient's individual risk profile to guide cancer treatment and help protect the heart.",[168,171,79,28,56],"2026-03-09",{"date":446,"type":34},{"date":466,"type":34},"2021-07-05",{"date":468,"type":19},"2027-02-02",{"name":345,"class":108},{"id":471,"slug":4,"hasResults":10,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":20,"phases":479,"briefSummary":480,"conditions":481,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":206},"100586650","NCT06918132","Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer","Phase II Single Arm Study of Neoadjuvant Dual Checkpoint Blockade With Programmed Death-ligand 1 (PD1) and Lymphocyte Activation Gene 3 (LAG-3) Inhibition in Resectable Non-Small Cell Lung Cancer (N-PLANC)","N-PLANC","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Disease characteristics:\n\n  * Histologically or cytologically confirmed stage IB-IIIB (N2) non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition\n  * T4 tumors will only be eligible if they are defined as T4 based only on their size (more than 7 cm). All other T4 tumors will be ineligible.\n  * Pathologic status of lymph nodes must be known for suspicious or enlarged lymph nodes. Note: suspicious or enlarged lymph nodes must be discussed with sponsor\u002Fprincipal investigator.\n  * PD-L1 expression ≥ 1% by tumor proportion score (TPS) using immunohistochemistry (IHC)\n\n    * Group A: PD-L1 expression ≥ 1% \\\u003C 50%\n    * Group B: PD-L1 expression ≥ 50%\n  * Complete surgical resection of the primary NSCLC must be deemed achievable by thoracic surgeon at screening\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 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* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Adequate pulmonary function ascertained by treating surgeon obtained ≤ 30 days prior to registration. A pre- or post-bronchodilator forced expiratory volume in 1 second (FEV1) of 1.0 L or \\> 40% postoperative predicted value or diffusing capacity of the lungs for carbon monoxide (DLCO) \\> 40% predicted value are required prior to enrollment\n* Hemoglobin ≥ 8.0 g\u002FdL (obtained ≤ 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (obtained ≤ 15 days prior to registration)\n* Prothrombin time (PT)\u002Finternational normalized ratio (INR)\u002Factivated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained ≤ 15 days prior to registration)\n* Calculated creatinine clearance ≥ 45 ml\u002Fmin using the Cockroft-Gault formula (obtained ≤ 15 days prior to registration)\n* Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only\n* Provide written informed consent\n* Willingness to provide mandatory blood specimens for correlative research\n* Willingness to provide mandatory tissue specimens for correlative research\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ highly effective contraception during the study and up to 6 months after the last dose\n* Presence of targetable alterations \\[Epiderman Growth Factor Receptor (EGFR), anaplastic lymphoma kinase (ALK), receptor tyrosine kinase (ROS1)\\] in tumor\n* Unresectable or metastatic disease\n* Active or history of the following:\n\n  * Prior systemic anti-cancer therapy or radiation therapy for the same cancer being studied in this protocol\n  * Interstitial lung disease (e.g., idiopathic pulmonary fibrosis or organizing pneumonia), or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or pneumonitis within the last 5 years\n  * Autoimmune disease (including any history of inflammatory bowel disease)\n  * Any syndrome that required systemic steroids or immunosuppressive medications EXCEPTIONS: patients with vitiligo; resolved childhood asthma\u002Fatopy; residual hypothyroidism that requires only hormone replacement; or psoriasis not requiring systemic treatment, type-1 diabetes mellitus, or rheumatoid arthritis managed without disease modifying anti-rheumatic drugs or \\>10 mg prednisone equivalent\n* Patients requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications ≤14 days prior to registration.\n\nNOTE: Inhaled or topical steroids and adrenal replacement doses \\\u003C 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease\n\n* Patients with organ transplantation\n* History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias; or prior immune-related myocarditis\n* Uncontrolled intercurrent non-cardiac illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Psychiatric illness\u002Fsocial situations\n  * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy\n  * Any other conditions that would limit compliance with study requirements\n* Uncontrolled infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) or diagnosis of immunodeficiency that is related to, or results in chronic infection.\n\nNote: No testing is required for this study unless mandated by local health authority.\n\nEXCEPTIONS:\n\n* Patients with known HIV who have controlled infection \\[undetectable viral load and cluster of differentiation 4 (CD4) count above 350 either spontaneously or on a stable antiviral regimen\\] are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.\n* Patients with known hepatitis B (hepatitis B surface antigen positive \\[HBsAg+\\]) who have controlled infection (serum hepatitis B virus DNA polymerase chain reaction (PCR) that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.\n* Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV ribonucleic acid (RNA) by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n* Patients with HIV or hepatitis must be reviewed by a qualified specialist (e.g., infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n\n  * Receiving any other investigational agent which would be considered as a treatment for the primary malignancy\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 and toxicity of the prescribed regimens\n  * Patients with a prior or concurrent malignancy whose natural history or treatment does have the potential to interfere with the safety or efficacy assessment of the investigational regimen\n  * Known hypersensitivity to the active substances or to any of the excipients\n  * Receipt of live vaccine ≤ 30 days prior to registration",{"count":478,"type":19},60,[191],"This phase II trial tests how well a fixed dose combination (FDC) of cemiplimab and fianlimab before surgery (neoadjuvant) works in treating patients with stage IB-IIIB non-small cell lung cancer (NSCLC). The current standard of care (SOC) for NSCLC is to give chemotherapy and immunotherapy before going to surgery to have the cancer removed (neoadjuvant therapy). Immunotherapy with monoclonal antibodies, such as cemiplimab and fianlimab, 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 FDC of cemiplimab and fianlimab before surgery may kill more tumor cells in treating patients with stage IB-IIIB NSCLC.",[75,336,78,79,28],"2026-02-20",{"date":484,"type":34},"2026-02-24",{"date":486,"type":34},"2025-04-29",{"date":488,"type":19},"2027-04-29",{"name":319,"class":108},{"id":491,"slug":4,"hasResults":10,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":20,"phases":498,"briefSummary":499,"conditions":500,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":206},"100431043","NCT04892953","Local Consolidative Therapy and Durvalumab for Oligoprogressive and Polyprogressive Stage III NSCLC After Chemoradiation and Anti-PD-L1 Therapy","Local Consolidative Therapy (LCT) and Durvalumab (MEDI4736) for Oligoprogressive and Polyprogressive Stage III NSCLC After Chemoradiation and Anti-PD-L1 Therapy (ENDURE)","Inclusion Criteria:\n\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol\n* Stage III NSCLC (AJCC 7th and 8th edition) patients who received standard chemoradiation followed by durvalumab therapy with either progressive disease or persistent disease. Persistent disease defined as residual positron emission tomography (PET) avidity 6 months after completion of initial definitive therapy and confirmed with biopsy\n* For lung adenocarcinoma patients, patients must not harbor any EGFR sensitizing mutations, ALK fusion, ROS1 rearrangements, RET fusions, or MET exon 14 skipping mutations where there are standard of care therapy options available. For patients with histologies other than adenocarcinoma, EGFR and ALK status is not required. Adenocarcinoma patients may be consented prior to the EGFR, ALK, and ROS1 status being known, but EGFR, ALK, and ROS1 status must be determined prior to initiating therapy. EGFR, ALK, and ROS ALK status may be determined using either tumor- or plasma-based, Clinical Laboratory Improvement Act (CLIA)-certified assays. For patients with NSCLC, not otherwise specified (NOS), EGFR testing is not required, as the frequency of alterations is exceedingly rare in this histology\n* Cohort A: Oligoprogressive disease is defined as having 3 or fewer lesions of progression (sites can be local, distant, or both). Multiple mediastinal lesions will be counted as 1 lesion\n* Cohort B: Polyprogressive disease defined as having greater than 3 lesions of progression (sites can be local, distant, or both). Multiple mediastinal lesions will be counted as 1 lesion\n* Candidate for radiation therapy to at least one lesion\n* Tumor assessment by computed tomography (CT) scan with contrast chest\u002Fabdomen\u002Fpelvis or PET-CT, and magnetic resonance imaging (MRI) brain must be performed within 28 days prior to study entry\n* Age \\>= 18 years at time of study entry\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Body weight \\> 30 kg\n* Hemoglobin \\>= 9.0 g\u002FdL\n* Platelet count \\>= 75 × 10\\^9\u002FL\n* Serum bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be =\\\u003C 5 x ULN\n* Measured creatinine clearance (CL) \\> 15 mL\u002Fmin or calculated creatinine CL \\> 15 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n* Must have a life expectancy of at least 12 weeks\n\nExclusion Criteria:\n\n* Patients who rapidly progressed on the PACIFIC regimen (chemoradiotherapy \\[CRT\\] + durvalumab). This is defined as any progression on the first 3-month imaging scan after starting durvalumab post-CRT\n* Patients who were treated with anti-PD-(L)1 therapy other than durvalumab\n* Participation in another clinical study with an investigational product during the last 4 weeks\n* Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study. No other investigational therapy is permitted after durvalumab and start of this protocol\n* Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) =\\\u003C 28 days prior to the first dose of study drug. This 28 day washout period is not required for durvalumab. If sufficient wash-out time has not occurred due to the schedule or pharmacokinetic (PK) properties of an agent, a longer wash-out period will be required, as agreed by AstraZeneca and the investigator\n* Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade \\>= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\n\n  * Patients with grade \\>= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician\n  * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the study physician\n* Any concurrent chemotherapy (with the exception of protocol directed chemotherapy in the polyprogression cohort), investigational product (IP), biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable\n* Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable\n* History of allogenic organ transplantation\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion:\n\n  * Patients with vitiligo or alopecia\n  * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n  * Any chronic skin condition that does not require systemic therapy\n  * Patients without active disease in the last 5 years may be included but only after consultation with the study physician\n  * Patients with celiac disease controlled by diet alone\n* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent\n* History of another primary malignancy except for\n\n  * Malignancy treated with curative intent and with no known active disease \\>= 3 years before the first dose of IP and of low potential risk for recurrence\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n  * Adequately treated carcinoma in situ without evidence of disease\n* History of leptomeningeal carcinomatosis\n* Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry. Brain metastases must be treated prior to enrolment and demonstrate radiographic stability (defined as 2 brain images, both of which are obtained after treatment to the brain metastases. These imaging scans should both be obtained at least four weeks apart and show no evidence of intracranial progression). Treated brain metastases will be counted as lesions treated as part of the protocol. In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable either, without the use of steroids, or are stable on a steroid dose of =\\\u003C 10mg\u002Fday of prednisone or its equivalent and anticonvulsants for at least 14 days prior to the start of treatment\n* Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) \\>= 470 ms calculated from 3 electrocardiograms (ECGs) (within 15 minutes at 5 minutes apart)\n* History of active primary immunodeficiency\n* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis (TB) testing in line with local practice), hepatitis B (known positive hepatitis B virus \\[HBV\\] surface antigen (HBsAg) result), hepatitis C patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n  * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n  * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n  * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP\n* Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy\n* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients\n* Patients who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4:\n\n  * Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy\n  * All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study\n  * Must not have experienced a \\>= grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE: Patients with endocrine AE of =\\\u003C grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic\n  * Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \\> 10 mg prednisone or equivalent per day\n* Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements",{"count":497,"type":19},51,[191],"This phase II trial finds out the effect of local consolidative therapy and durvalumab in treating patients with stage III non-small cell lung cancer that has 3 or fewer lesions of progression (oligoprogressive) and greater than 3 lesions of progression (polyprogressive) after chemoradiation and anti-PD-l1 therapy. Local consolidative therapy, such as surgery and\u002For radiation, after initial treatment may kill any remaining tumor cells. Immunotherapy with durvalumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving local consolidative therapy and durvalumab may help to control the disease.",[171,501,79,502,28,503,56],"Stage III Lung Non-Small Cell Cancer AJCC v7","Stage IIIA Lung Non-Small Cell Cancer AJCC v7","Stage IIIB Lung Non-Small Cell Cancer AJCC v7","2026-02-17",{"date":506,"type":34},"2026-02-19",{"date":508,"type":34},"2021-07-07",{"date":510,"type":19},"2026-09-30",{"name":345,"class":108},""]