[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"limited-stage-small-cell-lung-cancer-ls-sclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:limited-stage-small-cell-lung-cancer-ls-sclc":192},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,49,74,99,124,146,170],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100599962",false,"NCT07091305","A Study of QL1706 Combined With Chemotherapy Induction on Sequential Immunotherapy Consolidation in Patients With Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy","A Study of QL1706 Combined With Chemotherapy Induction on Sequential Immunotherapy Consolidation in Patients With Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy：A Phase II Trial","Inclusion Criteria:\n\n1. The patient must be aged between 18 and 75 years (inclusive of boundary values), and both males and females are eligible.\n2. Pathologically confirmed LS-SCLC\n3. Investigator confirmation of at least one measurable lesion, as defined by RECIST v1.1\n4. ECOG performance status of 0 or 1\n5. Forced expiratory volume in one second (FEV₁) \\> 1.0 L\n6. No clinically significant interstitial lung disease on baseline CT or PET\u002FCT.\n7. Adequate organ and bone-marrow function (all tests performed within 7 days prior to first dose; no transfusions, growth factors, albumin, or other corrective therapies within 14 days):Hemoglobin ≥ 90 g\u002FL, ANC ≥ 1.5 × 10⁹\u002FL, PLT ≥ 90 × 10⁹\u002FL,Serum creatinine ≤ 1.5 × ULN, TBIL ≤ 1.5 × ULN, ALT and AST ≤ 3 × ULN, Albumin (ALB) ≥ 25 g\u002FL,INR ≤ 1.5 × ULN, PT and APTT ≤ 1.5 × ULN (subjects on prophylactic anticoagulation must have values within a safe therapeutic range, per investigator)\n8. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and agree to use reliable contraception from screening until 3 months after the last dose; male subjects must agree to use effective contraception or have undergone surgical sterilization for the same period.\n9. No prior systemic anti-tumor therapy before enrollment.\n10. Estimated life expectancy ≥ 12 weeks.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to QL1706 or any of its excipients\n2. Histologically confirmed non-small cell lung cancer (NSCLC) or mixed tumor containing an NSCLC component.\n3. History of another primary malignancy or previous allogeneic organ transplantation.\n4. Surgery (other than diagnostic biopsy) within 4 weeks before first dose of study drug.\n5. Active substance abuse (e.g., illicit drug use), chronic alcoholism, AIDS, or known HIV infection.\n6. Active autoimmune disease, or history of autoimmune disease likely to recur. Systemic corticosteroid therapy equivalent to \\>10 mg\u002Fday prednisone (or other immunosuppressive therapies) within 14 days before first dose.\n7. Prior therapy with any antibody or agent targeting T-cell co-regulatory proteins (e.g., PD-1, PD-L1, CTLA-4, TIM-3, LAG-3).\n8. Interstitial lung disease (ILD), or history of ILD requiring steroid therapy. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia (e.g., bronchiolitis obliterans), or evidence of active pneumonia on screening chest CT.\n9. Live vaccine administration within 28 days prior to first study drug dose. Any condition or comorbidity contraindicating chemo- or radiotherapy (e.g., active infection, myocardial infarction within 6 months, symptomatic heart disease including unstable angina, congestive heart failure, uncontrolled arrhythmia, ongoing immunosuppressive therapy).\n10. Pregnant or breastfeeding women; women of childbearing potential or men unwilling to use adequate contraception.\n11. Known hereditary bleeding diathesis or coagulation disorder.\n12. Prior malignancy, except adequately treated non-melanoma skin cancer, or in situ carcinoma (e.g., breast, oral, cervical) with expected survival \\>3 years.\n13. Any other medical, psychiatric, or laboratory abnormality that, in the investigator's judgment, could interfere with trial participation or interpretation of results.","ALL","18 Years","75 Years",{"count":19,"type":20},28,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The study is being conducted to evaluation of the Efficacy and Safety of QL1706 Combined with Chemotherapy Induction in Sequential Immunotherapy Consolidation After Concurrent Chemoradiotherapy for Limited-Stage Small Cell Lung Cancer(LS-SCLC), and Exploration of the Correlation Between Biomarkers (PD-L1, TMB, ctDNA, etc.) Related to QL1706 Treatment and Treatment Efficacy and Prognosis.\n\nQL1706 (Iparomlimab and Tuvonralimab) is a single bifunctional MabPair product against PD-1 and CTLA-4. QL1604 is a monoclonal antibody against PD-1.",[26,27,28,29],"Limited-stage Small Cell Lung Cancer (LS-SCLC)","Chemoradiotherapy","Induction Therapy","Consolidation Immunotherapy",[31,32,33,34,35],"Limited-stage small cell lung cancer","QL1706","chemoradiotherapy","induction therapy","consolidation immunotherapy","RECRUITING","2026-06-10",{"date":39,"type":40},"2026-06-11","ACTUAL",{"date":42,"type":40},"2025-10-23",{"date":44,"type":20},"2028-08-01",{"name":46,"class":47},"Shanghai Chest Hospital","OTHER",1,{"id":50,"slug":4,"hasResults":10,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100634328","NCT07538258","Benmelstobart Plus Anlotinib, Chemotherapy and Thoracic Radiation for Limited-Stage Small Cell Lung Cancer","A Single-Arm, Exploratory Clinical Study of Benmelstobart Combined With Anlotinib and Chemotherapy Concurrent With Thoracic Radiotherapy as First-Line Treatment in Limited-Stage Small Cell Lung Cancer (LS-SCLC)","Aurora004","Inclusion Criteria:\n\n* 1: Histologically or cytologically confirmed inoperable limited-stage small cell lung cancer (LS-SCLC) (per VALG staging).\n\n  2: No prior systemic therapy for limited-stage small cell lung cancer\n\n  3: Presence of measurable lesions as defined by RECIST 1.1. A previously irradiated lesion may be considered measurable only if it has demonstrated clear progression after radiotherapy and is not the sole lesion\n\n  4: Age ≥ 18 and ≤ 75 years\n\n  5: ECOG performance status: 0-1\n\n  6: Expected survival ≥ 3 months\n\n  7: Adequate hematologic and organ function, defined as meeting the following criteria: a) Hematologic function (no transfusion of blood or blood products, no G-CSF or other hematopoietic growth factors within 14 days): i. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL (1,500\u002Fmm³); ii. Platelet count (PLT) ≥ 100 × 10⁹\u002FL (100,000\u002Fmm³); iii. Hemoglobin (HB) ≥ 80 g\u002FL. b) Renal function: i. Calculated creatinine clearance (CrCl) ≥ 50 mL\u002Fmin; ii. Urine protein \\\u003C 2+ or 24-hour urine protein quantification \\\u003C 1.0 g. c) Hepatic function: i. Serum total bilirubin (TBil) ≤ 1.5 × ULN; ii. AST and ALT ≤ 2.5 × ULN; iii. Serum albumin (ALB) ≥ 28 g\u002FL. d) Coagulation function: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. e) Cardiac function: i. Left ventricular ejection fraction (LVEF) ≥ 50%.\n\n  8: Subjects voluntarily participate in this study, provide written informed consent, demonstrate good compliance, and agree to comply with follow-up procedures.\n\nExclusion Criteria:\n\n* 1: Prior use of anti-angiogenic agents such as anlotinib, apatinib, bevacizumab, or related immunotherapeutic agents targeting PD-1, PD-L1, etc\n\n  2: Presence of multiple factors affecting oral medication absorption (e.g., inability to swallow, status post gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.).\n\n  3: Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n\n  4: Patients with imaging evidence of tumor invasion adjacent to major blood vessels, or judged by the investigator to have a high risk of fatal massive hemorrhage due to tumor invasion of major blood vessels during the subsequent study period.\n\n  5: History of severe bleeding tendency or coagulopathy, including but not limited to: clinically significant hemoptysis (more than one tablespoon per day) within 3 months prior to enrollment; or clinically significant bleeding symptoms or bleeding diathesis within 4 weeks prior to randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer (including gastrointestinal perforation and\u002For fistula; however, patients with surgically repaired gastrointestinal perforation or fistula may be eligible), unhealed wounds, ulcers, or fractures, etc.\n\n  6: Undergoing major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to randomization.\n\n  7: History of arterial\u002Fvenous thrombotic events within 6 months prior to randomization, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism.\n\n  8: Development of active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose.\n\n  9: Any other conditions that, in the judgment of the investigator, would render the patient ineligible for study enrollment.",{"count":57,"type":20},27,[23],"This is a single-arm, single-center, exploratory clinical study conducted at Shanghai Pulmonary Hospital, Tongji University. The study evaluates the effectiveness and safety of first-line treatment with benmelstobart (an immunotherapy), anlotinib (an anti-angiogenic drug), platinum-etoposide chemotherapy, and concurrent thoracic radiotherapy in participants with previously untreated, unresectable limited-stage small cell lung cancer (LS-SCLC).\n\nEligible participants are aged 18 to 75 years, with histologically or cytologically confirmed limited-stage SCLC (VALG staging), no prior systemic treatment for lung cancer, measurable lesions by RECIST 1.1, ECOG performance status 0-1, and adequate organ function.\n\nParticipants receive 4 cycles of induction therapy (21 days per cycle), including benmelstobart intravenously every 3 weeks, anlotinib orally for 2 weeks on \u002F 1 week off, and chemotherapy with carboplatin or cisplatin plus etoposide. Thoracic radiotherapy (60-70 Gy in 30-35 fractions) is given concurrently with chemotherapy cycles 1-3. After induction, participants receive maintenance therapy with benmelstobart plus anlotinib for up to 2 years or until disease progression or unacceptable side effects.\n\nThe primary objective is to assess the Objective Response Rate (ORR) as evaluated by investigators using RECIST 1.1. Secondary objectives include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety assessments of adverse events graded by CTCAE 5.0.\n\nA total of 27 participants will be enrolled. The study is expected to start in March 2026, complete enrollment by September 2027, and end in March 2029. All participants will be regularly followed for efficacy and safety.",[26],[31,62,63,64],"benmelstobart","anlotinib","chemotherapy","NOT_YET_RECRUITING","2026-04-12",{"date":68,"type":40},"2026-04-20",{"date":68,"type":20},{"date":71,"type":20},"2029-03-31",{"name":73,"class":47},"Yayi He",{"id":75,"slug":4,"hasResults":10,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100630303","NCT07485920","A Prospective, Multicenter Exploratory Clinical Study on Consolidation Therapy With Tislelizumab Combined With Nintedanib for Limited-stage Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Have a thorough understanding of this study and have voluntarily signed the informed consent form;\n2. Age ≥ 18 years old, gender not restricted;\n3. ECOG score 0-1;\n4. Histologically or cytologically confirmed as limited-stage small cell lung cancer;\n5. At least one measurable lesion (according to RECISTv1.1 criteria);\n6. Expected survival ≥ 3 months;\n7. Prophylactic cranial radiotherapy is permitted before consolidation therapy;\n8. Adequate organ function reserve. The subjects must meet the following laboratory indicators: Before the sample collection during the screening period, the patient has not received blood transfusion or growth factor support treatment for ≤ 14 days and: absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, platelets ≥ 100 × 109\u002FL, hemoglobin ≥ 90 g\u002FL，Calculated creatinine clearance rate (CrCl) (Cockcroft-Gault formula): creatinine clearance rate ≥ 60 mL\u002Fmin，Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) (total bilirubin of Gilbert's syndrome patients must be \\\u003C 3 × ULN)，AST and ALT ≤ 2.5 × ULN，Patients not receiving anticoagulation treatment: international normalized ratio or activated partial thromboplastin time ≤ 1.5 × ULN，Albumin ≥ 25 g\u002FL (2.5 g\u002FdL).\n9. Willing and able to comply with the study plan's visits, treatment plan, laboratory tests and other research procedures;\n10. Pregnant women must undergo a serum pregnancy test 3 days before the first medication administration and the result must be negative. For pregnant women subjects and male subjects whose partners are pregnant women, they must agree to use effective contraceptive methods during the study and within 120 days after the last administration of the study drug.\n\nExclusion Criteria:\n\n1. There are patients with lung metastasis from other primary malignant tumors.\n2. Patients who have previously or concurrently had other systemic malignant tumors (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and\u002For in situ cancer that has undergone radical resection), excluding those with cured skin basal cell carcinoma, skin squamous cell carcinoma, and\u002For in situ cancer that has undergone radical resection.\n3. Patients who have previously received other systemic treatments for the current lung cancer, including chemotherapy, immunotherapy, targeted therapy, or anti-angiogenic therapy, other than induction radiotherapy and chemotherapy.\n4. Patients who received other approved systemic immunomodulators (including but not limited to interferon, interleukin-2, tumor necrosis factor, thymus pentapeptide, and thymalfasin) within 4 weeks prior to the first administration.\n5. Patients whose blood pressure control is not satisfactory after drug treatment (systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg).\n6. Patients with factors that significantly affect the absorption of oral medications, such as inability to swallow, chronic diarrhea, and intestinal obstruction, etc.\n7. The investigator judges that the possibility of tumor invasion of important blood vessels and fatal bleeding caused by the tumor is relatively high during the treatment process.\n8. Within 3 months before the study, there was significant clinical hemoptysis (more than 50 ml of hemoptysis per day), or there were significant clinical bleeding symptoms or obvious bleeding tendencies (such as gastrointestinal bleeding, gastric ulcer bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above baseline, or having vasculitis, etc.)\n9. Within 14 days before the first administration of the study drug, any traditional Chinese medicine used for controlling cancer was used.\n10. Within 30 days before the first administration, the patient received live vaccines. Including but not limited to the following: mumps, rubella, measles, chickenpox\u002Fzoster (chickenpox), yellow fever, rabies, BCG (bacillus Calmette-Guérin), and typhoid vaccine (inactivated virus vaccine is allowed); or it is expected that the patient will need to receive live vaccines or attenuated live vaccines during the study period or within 5 months after the last administration\n11. Within 14 days before the first administration of the study drug, any situation where systemic treatment with corticosteroids (prednisone or equivalent drugs \\> 10 mg\u002Fday) or other immunosuppressive drugs is required, and the investigator assesses that it has an impact on the study treatment\n12. Patients with systemic autoimmune diseases that require systemic treatment, and the investigator assesses that it has an impact on the study treatment\n13. Patients with interstitial lung disease, non-infectious pneumonia, or other uncontrolled diseases, including diabetes, pulmonary fibrosis, acute lung disease, etc., and the investigator assesses that it has an impact on the study treatment\n14. Patients with a significant history of major diseases or clinical manifestations that may affect the function of organ systems, and the investigator assesses that it has an impact on the study treatment.\n15. Within 14 days before the first administration of the study drug, severe chronic or active infections (including tuberculosis infection, etc.) that require systemic antibacterial, antifungal, or antiviral treatment (including HBsAg positive in the screening period and HBV-DNA detection value higher than the upper limit of the laboratory test department of the research center; (for subjects who tested HBV-DNA content \\\u003C 500 IU\u002FmL within 28 days before enrollment and have received at least 14 days of local standard antiviral treatment and are willing to continue antiviral treatment during the study period, they can be enrolled); active hepatitis C (defined as HBsAb positive in the screening period and HCV-RNA positive) subjects.\n16. Uncontrolled active hepatitis B (defined as HBsAg positive in the screening period and HBV-DNA detection value higher than the upper limit of the laboratory test department of the research center; (for subjects who tested HBV-DNA content \\\u003C 500 IU\u002FmL within 28 days before enrollment and have received at least 14 days of local standard antiviral treatment and are willing to continue antiviral treatment during the study period, they can be enrolled); active hepatitis C (defined as HBsAb positive in the screening period and HCV-RNA positive) subjects\n17. Known human immunodeficiency virus (HIV) infection (known HIV antibody positive)\n18. Grade III-IV congestive heart failure (New York Heart Association classification), poorly controlled and with clinically significant arrhythmias\n19. Any occurrence of arterial thrombosis, embolism or ischemia within 6 months prior to the inclusion in the treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, etc.\n20. Concurrent participation in another therapeutic clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n21. Medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the test results and prevent the subject from fully participating in the study, or other conditions that the investigator considers as other potential risks and unsuitable for inclusion in the study. The investigator considers that there are other potential risks that make participation in this study unsuitable.",{"count":80,"type":20},20,[82],"PHASE4","This study is a prospective, single-arm, multicenter, exploratory clinical trial. It aims to evaluate the efficacy and safety of tislelizumab combined with nintedanib as consolidation therapy for patients with limited-stage small cell lung cancer after concurrent chemoradiotherapy, and to explore the prognostic markers related to the therapeutic effect.",[26],[31,86,87,88],"consolidation therapy","tislelizumab","nintedanib","2026-03-17",{"date":91,"type":40},"2026-03-20",{"date":93,"type":20},"2026-05-01",{"date":95,"type":20},"2030-01-31",{"name":97,"class":47},"The Affiliated Hospital of Qingdao University",6,{"id":100,"slug":4,"hasResults":10,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":48},"100571395","NCT06719700","Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer","A Prospective Phase II Study of Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Informed Consent: An informed consent form, signed and dated, must be provided before any steps in the study are performed.\n* Age: Males or females aged 18 to 75 years.\n* Diagnosis: Histologically or cytologically confirmed small cell lung cancer (SCLC).\n* Stage: Stage I-III (AJCC\u002FUICC 8th edition TNM staging), where all lesions can be included in a single radical radiotherapy plan (i.e., limited-stage disease). Stage I-II must be inoperable.\n* Life Expectancy: ≥12 weeks.\n* Performance Status (PS): WHO PS score of 0 or 1.\n* Postmenopausal women or those with a negative urine or serum pregnancy test (HCG sensitivity ≥25 IU\u002FL or equivalent) within 7 days before starting study treatment.\n* Female participants must not be breastfeeding.\n* Women of childbearing potential (WOCBP) must agree to use contraception during study treatment and for 3 months after the last dose of study drug (i.e., 30 days for an ovulation cycle plus approximately 5 half-lives of the investigational drug).\n* Male participants engaging in sexual activity with WOCBP must agree to use contraception during study treatment and for 5 months after the last dose of study drug (i.e., 90 days for sperm regeneration cycle plus approximately 5 half-lives of the investigational drug).\n* Males with azoospermia do not need to follow contraception requirements.\n* WOCBP who are not sexually active do not need to follow contraception requirements but must still undergo pregnancy testing as outlined.\n* Organ and Bone Marrow Function:\n\nPulmonary Function: FEV1 ≥800 mL. Absolute neutrophil count ≥1.5 × 10⁹\u002FL. Platelet count ≥100 × 10⁹\u002FL. Hemoglobin ≥9.0 g\u002FdL. Renal Function: Calculated creatinine clearance ≥50 mL\u002Fmin using the Cockcroft-Gault formula.\n\nSerum bilirubin ≤1.5 × upper limit of normal (ULN). AST and ALT ≤2.5 × ULN.\n\nExclusion Criteria:\n\n* Participation in Another Clinical Trial: Simultaneous participation in another clinical trial, unless it is an observational (non-interventional) study.\n* Mixed Histology: Histological subtype of mixed small cell and non-small cell lung cancer (SCLC).\n* Extensive-Stage SCLC: Diagnosis of extensive-stage SCLC.\n* Malignant Effusions: Pathologically confirmed malignant pleural effusion or pericardial effusion.\n* Hemoptysis: Central cavitary SCLC with hemoptysis (hemoptysis volume \\>50 ml\u002Fday).\n* Immunosuppressive Treatment: Use of immunosuppressive drugs within 28 days prior to the first dose of toripalimab. Physiological doses of intranasal corticosteroids and systemic corticosteroids ≤10 mg daily of prednisone (or equivalent) are exceptions. Steroids used to manage chemoradiotherapy-related toxicities are allowed.\n* Previous Anti-PD-1\u002FPD-L1 Therapy: Prior use of any anti-PD-1 or anti-PD-L1 antibodies.\n* Major Surgery: Underwent major surgery (excluding vascular access) within 4 weeks before study entry.\n* Autoimmune Disease History: History of autoimmune diseases within the last 2 years, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis.\n* Primary Immunodeficiency: History of primary immunodeficiency.\n* Organ Transplant History: History of organ transplantation requiring immunosuppressive treatment.\n* QT Interval Prolongation: QTc interval (corrected by Bazett's formula) \\>470 ms, calculated from three ECG measurements.\n* Uncontrolled Comorbidities: Uncontrolled comorbid conditions, including but not limited to persistent or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmias, active peptic ulcer disease or gastritis, active bleeding disorders, chronic hepatitis C, HIV infection, HBsAg-positive patients with DNA \\>500 IU\u002Fml, or any psychiatric or social conditions that may interfere with study requirements or the patient's ability to provide informed consent.\n* Tuberculosis History: Known history of tuberculosis.\n* Live Vaccination: Received a live attenuated vaccine within 30 days prior to study initiation.\n* Previous Primary Malignancy: History of another primary malignancy within 5 years prior to study entry, except for adequately treated basal or squamous cell carcinoma of the skin, in situ cervical cancer, ductal carcinoma in situ of the breast, or localized prostate cancer.\n* Pregnancy and Breastfeeding: Pregnant or breastfeeding women, or men and women of reproductive potential who are not using effective contraception.\n* Interference with Study Assessment: Any condition that may interfere with the evaluation of toripalimab's efficacy or safety.\n* Investigator's Discretion: Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.",{"count":106,"type":20},47,[23],"Based on the preclinical rationale for combining surufatinib with immunotherapy, and the clinical efficacy observed with surufatinib in extensive-stage small cell lung cancer (ES-SCLC), the investigators hypothesize that incorporating surufatinib into the ADRIATIC regimen could further enhance survival in LS-SCLC. To evaluate this approach, the investigators plan to conduct a single-arm Phase II study to explore the safety and efficacy of concurrent chemoradiotherapy combined with toripalimab and surufatinib in treating LS-SCLC.",[110,111,27,26],"Toripalimab","Surufatinib",[110,111,27,113,114],"Limited-stage small cell lung cancer (LS-SCLC)","Immunotherapy consolidation","2026-02-28",{"date":117,"type":40},"2026-03-03",{"date":119,"type":40},"2024-11-30",{"date":121,"type":20},"2028-11-29",{"name":123,"class":47},"Sun Yat-sen University",{"id":125,"slug":4,"hasResults":10,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":4},"100586336","NCT06914050","Hypofractionated Radiotherapy Followed by Chemo-immunotherapy Induction Therapy","An Exploratory Study on the Treatment of Limited-stage Small Cell Lung Cancer With Induction Therapy of Adebrelimab Combined With Chemotherapy Followed by Thoracic Radiotherapy After Hypofractionated Radiotherapy","Inclusion Criteria:\n\n1\\. Age 18-70 years old; 2. Limited-stage small cell lung cancer (AJCC 8th) confirmed by histology or cytology; 3. Subjects have not received any treatment for SCLC; 4. Have measurable target lesions according to RECIST v1.1; 5. ECOG score of 0-1; 6. Life expectancy ≥ 12 weeks; 7. Normal function of major organs, that is, meet the following criteria:\n\n1. Routine blood tests must meet the following criteria (no blood transfusion, no use of hematopoietic factors, and no use of drug correction within 14 days):\n\n   1. ANC ≥ 1.5×109\u002FL;\n   2. PLT ≥ 100×109\u002FL;\n   3. HB ≥ 90 g\u002FL;\n2. Biochemical tests must meet the following criteria:\n\n   1. TBIL ≤ 1.5×ULN;\n   2. ALT, AST≤ 2.5×ULN;\n   3. Serum creatinine sCr≤1.5×ULN, endogenous creatinine clearance ≥50mL\u002Fmin (Cockcroft-Gault formula);\n3. Coagulation function must meet the following requirements: INR≤1.5×ULN and APTT≤1.5×ULN; 8. Female subjects of childbearing age must undergo a serum pregnancy test within 3 days before starting the study medication, and the result must be negative, and they must be willing to use a medically approved high-efficiency contraceptive measure (such as intrauterine contraceptive device, contraceptive pills or condoms) during the study and within 3 months after the last administration of the study medication; for male subjects whose partners are female subjects of childbearing age, they must be surgically sterilized or agree to use an effective contraceptive method during the study and within 3 months after the last administration of the study medication.\n\n9\\. The subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.\n\nExclusion Criteria:\n\n1. Central nervous system metastasis;\n2. Any active autoimmune disease or history of autoimmune disease (including, but not limited to: moderate interstitial pneumonia and above, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis; patients with vitiligo or childhood asthma that has completely resolved and does not require any intervention as an adult can be included; patients who require bronchodilators for medical intervention are not included;\n3. Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU\u002FmL), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method) or co-infection with hepatitis B and hepatitis C, active pulmonary tuberculosis;\n4. Immunosuppressive drugs have been used within 14 days before the first use of study drugs, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e. no more than 10 mg\u002Fday prednisone or its equivalent);\n5. Vaccination with live attenuated vaccine within 4 weeks before the first dose or planned during the study;\n6. Suffering from other malignant tumors in the past 3 years;\n7. Evidence of past or current pulmonary fibrosis, interstitial pneumonia (grade II or above), pneumoconiosis, radiological pneumonia, drug-induced pneumonia, and severe lung function impairment;\n8. Uncontrolled hypertension;\n9. Suffering from myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including QTc interval ≥450ms for males and ≥470ms for females). According to NYHA standards, patients with grade III-IV heart failure, or left ventricular ejection fraction (LVEF) \\\u003C50% indicated by cardiac ultrasound examination, had myocardial infarction within 6 months before enrollment, New York Heart Association grade II or above heart failure, uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmias, clinically significant pericardial disease, or ECG indicating acute ischemia or abnormal active conduction system;\n10. Severe infection within 4 weeks before the first medication (such as: intravenous infusion of antibiotics, antifungal or antiviral drugs for more than 7 days), or unexplained fever \\>38.5°C during the screening period\u002Fbefore the first medication;\n\n1 1. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 12. Pregnant or lactating women; patients with fertility who are unwilling or unable to take effective contraceptive measures; 13. Known to have allergic reactions, hypersensitivity reactions or intolerance to adebrelimab (SHR-1316), etoposide, cisplatin or its excipients; 14. Subjects who are participating in other clinical studies or whose first medication time is less than 4 weeks from the end of the previous clinical study (last medication) or 5 half-lives of the study drug; 15. Subjects with a history of psychotropic drug abuse, alcoholism or drug abuse; 16. The researcher believes that there are any conditions that may harm the subject or cause the subject to be unable to meet or perform the study requirements.","70 Years",{"count":132,"type":20},30,[23],"Radiotherapy can activate local and systemic immune responses through a variety of mechanisms, which can enhance anti-tumor immune effects. The dose fractionation pattern of radiotherapy has an important influence on the occurrence of immune-induced effects. Stereotactic body radiation therapy (SBRT) has obvious advantages in activating interferon effects and inducing abscopal effects. SBRT combined with immunity can enhance the abscopal effect induced by radiotherapy and play a synergistic role. The 8Gy×3 fractionation scheme is currently the most widely used stereotactic radiotherapy scheme. Because we conducted this study, the primary lesion received large-fraction partial tumor irradiation and then received adebrelimab combined with chemotherapy induction treatment for 2 cycles, followed by sequential chest radiotherapy for the treatment of limited-stage small cell lung cancer, to explore the effectiveness and safety.",[136,26],"Lung Cancer, Small Cell","2025-04-23",{"date":139,"type":40},"2025-04-25",{"date":141,"type":20},"2025-04",{"date":143,"type":20},"2028-04",{"name":145,"class":47},"Tianjin Medical University Cancer Institute and Hospital",{"id":147,"slug":4,"hasResults":10,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":151,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":154,"conditions":155,"keywords":156,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":48},"100582894","NCT06869239","Prediction of Response to PD-L1 Inhibitor After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer Using Multi-omics-based Liquid Biopsy","Inclusion Criteria:\n\n* 1\\. Age 18-75 years, male or female;\n* 2\\. Histologically or cytologically confirmed limited-stage small cell lung cancer (LS-SCLC) (AJCC, 8th edition);\n* 3\\. No more than 2 cycles of chemotherapy or no previous systemic therapy;\n* 4\\. ECOG PS 0-1;\n* 5\\. Measurable disease, as defined by RECIST v1.1 (tumor lesions long axis≥10mm, lymph nodes short axis ≥15mm);\n* 6\\. Life expectancy ≥3 months;\n* 7\\. Adequate pulmonary function;\n* 8\\. Adequate hematologic and end-organ function, defined by the following criteria:\n\n  1. Hematology\n\n     * Hemoglobin (HGB) ≥90 g\u002FL;\n     * Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL;\n     * Platelet count (PLT) ≥ 100 x 10\\^9\u002FL;\n     * White blood cell count (WBC) ≥ 3.0 x 10\\^9\u002FL;\n  2. Serum chemistry\n\n     * Serum albumin (ALB) ≥ 30 g\u002FL;\n     * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 3 x ULN;\n     * Total bilirubin (TBIL) ≤1.5 ULN; Note: Patients diagnosed with Gilbert's syndrome (persistent or recurrent hyperbilirubinemia \\[mainly unconjugated bilirubin\\] without evidence of hemolysis or liver pathology) after consultation with their physician can be allowed;\n     * Creatinine ≤ 1.5 ULN;\n* 9\\. Women of childbearing age must have taken reliable contraceptive measures or undergone a negative pregnancy test (serum or urine) within 7 days prior to enrollment. Both men and women of childbearing age must agree to maintain adequate contraceptive measures throughout the study and for 6 months following the completion of treatment;\n* 10\\. Patients must voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and actively cooperate with follow-up procedures.\n\nExclusion Criteria:\n\n* 1\\. Histological mixture of SCLC and NSCLC components;\n* 2\\. Extensive-stage SCLC;\n* 3\\. Patients with a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or those planned for transplantation;\n* 4\\. Treatment with immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 14 days prior to the first dose of PD-L1 inhibitor, except for intranasal and inhaled corticosteroids or low-dose systemic steroids (i.e., ≤10 mg\u002Fday prednisolone or equivalent);\n* 5\\. History of hypersensitivity to etoposide, cisplatin, PD-L1 antibody, or excipients in the formulation; or history of severe allergic reactions to other monoclonal antibodies;\n* 6\\. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment;\n* 7\\. Active or history of autoimmune disease or immune deficiency (including but not limited to autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism);\n\nNote:\n\n* Patients with vitiligo or alopecia are eligible for this study;\n* Patients with stable hypothyroidism undergoing hormone replacement therapy (e.g., Hashimoto's syndrome) are eligible for this study;\n\n  * 8\\. Poorly controlled asthma despite systemic treatment, such as bronchodilators; Note: Patients with complete remission of asthma during childhood and no need for any intervention in adulthood can be allowed;\n  * 9\\. Urinalysis shows proteinuria ≥ ++ or confirmed 24-hour urine protein ≥ 1.0g;\n  * 10\\. Malignancies other than LS-SCLC, with the following exceptions:\n* Adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix;\n* Malignancy that has been treated with curative intent, with no known active disease for ≥5 years prior to the first dose of the study treatment, and with a low potential risk of recurrence;\n\n  * 11\\. Human immunodeficiency virus (HIV) infection or known to have acquired immunodeficiency syndrome (AIDS);\n  * 12\\. Significant cardiovascular disease within 6 months prior to enrollment, such as myocardial infarction, severe\u002Funstable angina, New York Heart Association cardiac disease (class II or greater), poorly controlled arrhythmias (including QTcF interval \\>450 ms for males and \\>470 ms for females, with QTcF interval calculated using the Fridericia formula), and symptomatic congestive heart failure;\n  * 13\\. Severe infections within 4 weeks prior to first dose of study treatment, including but not limited to infections requiring intravenous antibiotics, antifungal, or antiviral agents , or unexplained fever ≥38.5°C occurring during the screening period or before the first dose of the study treatment;\n  * 14\\. Active tuberculosis, hepatitis B (HBV-DNA ≥ 500 IU\u002Fml), hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection of the assay), or co-infection with both hepatitis B and C;\n  * 15\\. Treatment with any other investigational agent with therapeutic intent within 4 weeks prior to the first dose of the study treatment;\n  * 16\\. History of abuse of psychotropic drugs or drug addiction;\n  * 17\\. Patients with other severe physical or mental illnesses or abnormal laboratory test results that may increase the risk of participating in the study, or interfere with the study results, as well as those whom the investigator deems unsuitable for participation in the study for other reasons.",{"count":152,"type":20},65,"OBSERVATIONAL","This study aims to explore the efficacy and safety of immunotherapy (PD-L1 inhibitor) maintenance following high-dose hyperfractionated simultaneous integrated boost radiotherapy concurrent chemotherapy in patients with limited-stage small cell lung cancer (LS-SCLC). This study is a prospective observational study. Additionally, liquid biopsy technology will be employed to identify biomarkers that can predict the efficacy of PD-L1 inhibitor after chemoradiotherapy in LS-SCLC.",[26],[157,158,159,160],"LS-SCLC","immunotherapy","liquid biopsy","high-dose radiotherapy","2025-03-05",{"date":163,"type":40},"2025-03-11",{"date":165,"type":40},"2025-02-25",{"date":167,"type":20},"2028-01-03",{"name":169,"class":47},"Peking University Cancer Hospital & Institute",{"id":171,"slug":4,"hasResults":10,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":191},"100523430","NCT06095583","Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC)","A Randomized, Double-Blind, Placebo-Controlled, Multi-Regional Phase III Clinical Study of Toripalimab Alone or in Combination With Tifcemalimab (JS004\u002FTAB004) as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Disease Progression Following Chemoradiotherapy","Inclusion Criteria:\n\nPatients must meet all of the following inclusion criteria to be enrolled:\n\n1. Male or female with age ≥ 18 years old at the time of informed consent.\n2. Histologically or cytologically confirmed LS-SCLC using the Veteran's Administration Lung Study Arm (VALSG) staging criteria (Appendix 3). Patients with TNM Stage I or II disease per AJCC 8th edition must be medically inoperable (as determined by the Investigator) or the patient must refuse surgery.\n3. Received CRT defined as: (1) 4 cycles of chemotherapy consisting of carboplatin or cisplatin and intravenously administered etoposide; (2) a total radiation dose of 60-66 Gy for the standard once daily (QD) radiotherapy regimen or 45 Gy for the hyperfractionated twice daily (BID) radiotherapy regimen; (3) Patients must begin investigational interventions within 42 days of the last dose of chemotherapy.\n4. Patients must have achieved a complete response (CR), partial response (PR), or stable disease (SD) after receiving curative platinum-based CRT and must not have developed progressive disease (PD) prior to study entry.\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 .\n6. Adequate organ function\n7. Female patients of childbearing potential and male patients whose partners are women of childbearing age.\n8. Voluntarily agree to participate in the study, sign the informed consent form, and agree to comply with all study and follow-up procedures.\n\nExclusion Criteria:\n\nPatients will be excluded from the study if they meet any of the following criteria.\n\n1. Mixed SCLC and non-small cell lung cancer (NSCLC).\n2. Received sequential chemoradiotherapy for LS-SCLC.\n3. Failure to recover from toxicity of prior anticancer therapy to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1 (except alopecia) or levels specified in the inclusion\u002Fexclusion criteria, whichever is more severe.\n4. Patients with active autoimmune disease, history of autoimmune disease.\n5. History of immunodeficiency, including HIV seropositivity, other acquired congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.\n6. History of confirmed or suspected interstitial lung disease or pneumonitis (except for Grade 1 radiation pneumonitis not treated with corticosteroids).\n7. The presence of active hepatitis B (HBV DNA ≥ 500 IU\u002FmL), hepatitis C (hepatitis C antibodies positive and HCV-RNA higher than the lower limit of detection of the analytical method).\n8. Any other malignancy diagnosed prior to the first dose of investigational intervention, except those with a low risk for the development of metastases (5-year survival rate \\> 90%), such as adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or adequately treated localized prostate cancer.\n9. Women who are pregnant or breastfeeding.",{"count":177,"type":20},756,[179],"PHASE3","The Study is a Phase 3, randomized, three-arm, double-blind, placebo-controlled, multi-regional clinical research study to evaluate the safety and efficacy use of toripalimab alone or in combination with tifcemalimab as consolidation therapy in patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy.\n\nTifcemalimab is a monoclonal antibody against B and T lymphocyte attenuator (BTLA). Toripalimab is a monoclonal antibody against programmed death protein-1 (PD-1). Neither drug is approved for treatment of This combination regimen is investigational in limited stage-small cell lung cancer in any country.",[26],"2024-06-19",{"date":184,"type":40},"2024-06-21",{"date":186,"type":40},"2023-11-15",{"date":188,"type":20},"2029-07-31",{"name":190,"class":47},"Shanghai Junshi Bioscience Co., Ltd.",156,""]