[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extensive-stage-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extensive-stage-small-cell-lung-cancer":65},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,40,0,25,[9,49,84,97,136,165,191,215,237,268,289,312,338,357,376,404,428,451,478,499,520,545,566,589,609],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100053826","phase-1-autologous-b7-h3-chimeric-antigen-receptor-t-cells-in-previously-treated-extensive-stage-small-cell-lung-cancer-with-recurrent-or-refractory-disease-100053826",false,"NCT07509034","Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease","A Phase I Study to Assess the Safety and Antitumor Activity of Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease","* INCLUSION CRITERIA:\n* Age \\>=18 years old.\n* Histologically confirmed small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancers (EP-NEC) that has recurred following or is refractory to first-line therapy. Note: small cell cancers of non-lung primary sites are also eligible.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2.\n* Pulse oximetry \\>= 90 percent on room air.\n* Aspartate Transferase (AST) \\\u003C 3 X institutional upper limit of normal (ULN). Note: in case of liver metastases 5 X ULN is acceptable.\n* Alanine Aminotransferase (ALT) \\\u003C 3 X institutional ULN. Note: in case of liver metastases \\\u003C= 5 X ULN is acceptable.\n* Total bilirubin \\\u003C=2 X institutional ULN.\n* Creatinine \\\u003C=1.5 X institutional ULN.\n* Absolute Neutrophil Count (ANC) \\>= 750\u002FmcL.\n* Platelet count \\>= 75,000\u002FmcL.\n* An absolute lymphocyte count (ALC) \\>=300\u002FmcL and CD3 plus cell count \\>=150\u002FmcL.\n* Normal cardiac ejection fraction as defined by \\>= 45 percent by echocardiogram (ECHO) at screening.\n* At least 1 measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 that has not been previously irradiated.\n* Recovered from acute toxic effects of all prior cancer therapy to Grade \\\u003C2 per Common Terminology Criteria for Adverse Events (CTCAE) v.6.0 at least one week before apheresis.\n* The following criteria must be met prior to apheresis:\n\n  * Chemotherapy and biologic\u002Ftargeted agents:\n\n    * \\>=14 days since the last dose of standard myelosuppressive chemotherapy.\n    * \\>= 7 days since the completion of biologic agent, targeted agent, or tyrosine kinase inhibitor therapy.\n    * \\>= 3 weeks or 5 half-lives (whichever is shorter) since prior therapy with a monoclonal antibody.\n  * Radiotherapy:\n\n    * \\>= 1 week since the last radiotherapy session.\n    * No washout period required for palliative radiation to non-target lesions.\n    * \\>= 3 weeks since hepatic radiation, chemoembolization, and\u002For radiofrequency ablation.\n  * Steroids and immunosuppressive therapy:\n\n    * Corticosteroids: \\>= 2 weeks since the therapeutic doses (\\> 0.5 mg\u002Fkg\u002Fday prednisone or equivalent). Note: Inhaled or topical steroids are not exclusionary.\n    * Physiologic replacement doses (up to 5 mg\u002Fday prednisone equivalent) are allowed and can be adjusted based on participant s BMI if warranted.\n    * \\>= 2 weeks since the other immunosuppressive medication (e.g., calcineurin inhibitors, methotrexate, rapamycin, thalidomide, etc.).\n  * Anti-PD-1 and any investigational therapies:\n\n    * \\>= 2 weeks since Anti-PD-1 monoclonal antibody therapy.\n    * \\>= 2 weeks or 5 half-lives of the investigational product (whichever is shorter) since any investigational treatment or clinical trial participation.\n  * Other criteria:\n\n    * 72 hours since small molecule tyrosine kinase inhibitors (e.g., EGFR inhibitors), PARP inhibitors, or KRAS G12C inhibitors.\n* Individuals of childbearing potential (IOCBP) must agree to use highly effective contraception (hormonal, intrauterine device \\[IUD\\], abstinence, surgical sterilization) at the study entry and up to 12 months after the last dose of combined chemotherapy.\n\nNote: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n\n* Individuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and up to 7 months after the last dose of study drugs. We also will recommend individuals able to father a child with partners of childbearing potential ask partners to be on highly effective birth control (hormonal, IUD, surgical sterilization). Individuals able to father a child must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last dose of the study drug(s).\n* Ability of the participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of anaphylactic reactions attributed to anti-B7-H3 antibodies or compounds of similar chemical or biologic composition to autologous B7-H3 CAR T cells, cyclophosphamide, fludarabine, or other agents used in this study.\n* Infection exposure with the human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) as defined below:\n\n  * Positive serology for HIV.\n  * Active HBV infection as demonstrated by test for hepatitis B surface antigen (HBsAg).\n  * Positive serology for HCV.\n* Prior gene therapy using an integrating vector (except for autologous B7-H3 CAR T cells retreatment).\n* History of any previous allogeneic hematopoietic stem cell transplant.\n* Presence of fungal, bacterial, viral, or other infection is permitted if responding to active treatment.\n* Central Nervous System (CNS) disorder such as cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement that may impair the ability to evaluate neurotoxicity.\n* Pregnancy confirmed with beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test in IOCBP at screening.\n* Uncontrolled intercurrent illness or medical condition(s) evaluated by medical history, physical exam, electrocardiogram (ECG) or situations that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study.","ALL","18 Years","120 Years",{"count":5,"type":21},"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Background:\n\nSmall cell lung cancer (SCLC) is the deadliest form of lung cancer. Extrapulmonary neuroendocrine cancer (EPNEC) is a similar type of cancer that develops anywhere other than the lungs. EPNEC is also deadly. B7-H3 is a protein often found in SCLC and EPNEC tumor cells. Researchers can modify a person s own T cells, or immune cells, to target B7-H3. When these modified T cells are returned to the body-a treatment called B7-H3 chimeric antigen receptor (CAR) T cell therapy-they may help kill cancer cells.\n\nObjective:\n\nTo test B7-H3 CAR T cell therapy in people with SCLC or EPNEC.\n\nEligibility:\n\nPeople aged 18 years and older with SCLC or EPNEC that either did not respond or returned after treatment.\n\nDesign:\n\nParticipants will be screened. They will have blood tests and tests of their heart function. They will have imaging scans.\n\nParticipants will undergo apheresis: Blood will be taken from the body through a needle. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different needle. The collected T cells will be altered to make them attack cells with B7-H3.\n\nParticipants will be in the hospital for at least 15 days. They will receive chemotherapy drugs to prepare their body for the treatment. These drugs will be given through a tube attached to a needle inserted into a vein.\n\nThe modified T cells will be infused through a vein. Participants will remain in the hospital until they are well enough to go home.\n\nFollow-up visits will continue for 15 years....",[27,28,29,30],"Extensive-Stage Small Cell Lung Cancer","Extrapulmonary Neuroendocrine Carcinoma","Recurrent or Refractory","Solid Tumors",[32,33,34,35],"B7-H3","CAR-T","Phase I","Immunotherapy","NOT_YET_RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":21},"2026-07-16",{"date":44,"type":21},"2031-01-30",{"name":46,"class":47},"National Cancer Institute (NCI)","NIH",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100054172","phase-1-study-of-eci830-single-agent-or-in-combination-in-patients-with-advanced-hrher2--breast-cancer-and-in-patients-with-other-advanced-solid-tumors-100054172","NCT06726148","Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+\u002FHER2- Breast Cancer and in Patients With Other Advanced Solid Tumors","An Open-label, Multi-center, Phase I\u002FII Study of ECI830 as a Single Agent and in Combination With Ribociclib and Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2-negative Breast Cancer and Advanced Solid Tumors","Inclusion Criteria:\n\nAge ≥ 18 years old.\n\nPatients with one of the following indications:\n\nPhase I:\n\nHR+\u002FHER2- aBC with disease progression on or following at least one line of hormone-based therapy in combination with a CDK4\u002F6i and at least one additional line of systemic therapy for metastatic disease.\n\nHistologically and\u002For cytologically confirmed diagnosis of locally advanced or metastatic cancer with a CCNE1 amplification. For dose expansion only: no more than 3 prior lines of therapy for advanced or metastatic disease.\n\nPatients with ES-SCLC and disease progression on or after standard of care (SoC). For dose expansion only: no more than 2 prior lines of therapy for advanced or metastatic disease are allowed.\n\nPhase II:\n\nHR+\u002FHER2- aBC with disease progression on an aromatase inhibitor or tamoxifen in combination with a CDK4\u002F6 inhibitor for unresectable\u002Fmetastatic disease with no more than 2 lines of endocrine therapy.\n\nMeasurable disease as determined by RECIST v1.1.\n\nBC only: If no measurable disease is present, then at least one predominantly lytic bone lesion must be present that can be accurately assessed at baseline and is suitable for repeated assessment.\n\nExclusion Criteria:\n\nPrevious treatment with a CDK2 inhibitor at any time.\n\nPatients with inadequate bone marrow and\u002For organ functions with out-of-range laboratory values.\n\nClinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality including MI, CABG, long QT syndrome, or risk factors for TdP.\n\nPresence of symptomatic CNS metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.\n\nFor the combination treatment:\n\nPatients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.\n\nPatients who could not tolerate the prescribed dose of ribociclib during a previous course of treatment, requiring dose reduction or permanent discontinuation due to adverse events.\n\nFor patients with BC: Patient is concurrently using hormone replacement therapy.\n\nWOCBP who are unwilling to use highly effective contraception methods, pregnant or nursing women.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","100 Years",{"count":58,"type":21},280,[24,60],"PHASE2","Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization\u002Frecommended dose for future studies.\n\nPhase II: Assess the anti-tumor activity of ECI830 in combination with ribociclib and fulvestrant in patients with hormone receptor-positive\u002Fhuman epidermal growth factor receptor 2-negative (HR+\u002FHER2-) advanced breast cancer.",[63,64,65],"Advanced HR+\u002FHER2- Breast Cancer","Advanced CCNE1-amplified Solid Tumors","Extensive-stage Small Cell Lung Cancer",[67,68,69,70,71,72],"ECI830","Ribociclib","Fulvestrant","Breast cancer","CCNE1 amplification","Small cell lung cancer","RECRUITING","2026-07-09",{"date":39,"type":40},{"date":77,"type":40},"2025-04-03",{"date":79,"type":21},"2028-09-25",{"name":81,"class":82},"Novartis Pharmaceuticals","INDUSTRY",33,{"id":85,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":25,"conditions":88,"keywords":89,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":96,"locationsCount":48},"100632080",{"count":5,"type":21},[24],[27,28,29,30],[32,33,34,35],"2026-07-01",{"date":92,"type":40},"2026-07-02",{"date":94,"type":21},"2026-07-07",{"date":44,"type":21},{"name":46,"class":47},{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100570831","phase-3-safety-and-efficacy-of-bnt327-an-investigational-therapy-in-combination-with-chemotherapy-for-patients-with-untreated-small-cell-lung-cancer-100570831","NCT06712355","Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer","A Phase III, Multisite, Double-blinded Randomized Trial of BNT327 in Combination With Chemotherapy (Etoposide\u002FCarboplatin) Compared to Atezolizumab in Combination With Chemotherapy (Etoposide\u002FCarboplatin) in Participants With First-line Extensive-stage Small-cell Lung Cancer","Inclusion Criteria:\n\n* Have histologically or cytologically confirmed ES-SCLC (using the AJCC \\[American Joint Committee on Cancer\\] tumor node metastasis staging system combined with Veterans Administration Lung Study Group \\[VALG\\]'s two stage classification scheme). For AJCC tumor node metastasis staging system: AJCC 8th edition stage IV (T any, N any, M1a\u002Fb\u002Fc), or T3\\~4 for multiple lung nodules or tumor\u002Fnodule volume that cannot be encompassed in a tolerable radiotherapy plan.\n* Have not had prior systemic therapy for ES-SCLC. However, participants with prior chemoradiotherapy for limited-stage-SCLC must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible.\n* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic and organ function as defined in the protocol.\n\nExclusion Criteria:\n\n* Have histologically or cytologically confirmed SCLC with combined histologies.\n* Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:\n\n  * Within 2 weeks: small molecule agents with half-life of \\\u003C7 days; radiation outside the thoracic cavity including whole brain radiation. Of note, other local radiation for brain lesions (not whole brain) is allowed; local radiation for bone lesions is allowed. Palliative bone radiation or brain stereotactic radiosurgery would not require a washout period, but participants should recover from radiotherapy-related toxicity.\n  * Within 4 weeks: radiation involving the thoracic cavity; small molecule targeted agents with half-life of ≥7 days; monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies.\n  * Have received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or programmed death (ligand)-1 (PD\\[L\\]-1)\u002FVEGF bispecific antibody.\n  * Have received systemic corticosteroids (at a dosage greater than 10 mg\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.\n* Have the following central nervous system metastases:\n\n  * Participants with untreated brain metastases that are symptomatic or large (e.g., greater than 2 cm).\n  * Participants with treated central nervous system (CNS) metastases who are not neurologically stable or on steroids (at a dosage greater than 10 mg\u002FDay of prednisone or an equivalent dose of other corticosteroid) within 7 days before initiating study treatment of this study.\n  * Participants with known leptomeningeal metastases.\n* Have uncontrolled hypertension or poorly controlled diabetes prior to study treatment.\n* Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess for which an interval of 6 months must pass before study entry. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation\u002Ffistula and\u002For the underlying process causing the fistula\u002Fperforation.\n* Have a significant risk of hemorrhage (per investigator clinical judgment) as defined in the protocol.\n* Have superior vena cava syndrome or symptoms of spinal cord compression that requires urgent medical intervention.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.",{"count":105,"type":21},621,[107],"PHASE3","This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (BNT327) combined with chemotherapy (etoposide\u002Fcarboplatin) compared to atezolizumab combined with chemotherapy (etoposide\u002Fcarboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).",[110],"Extensive-stage Small-cell Lung Cancer",[112,113,114,115,116,117,118,35,119,120,121,122,123,124,125,126],"First-line ES-SCLC","SCLC","Immunotherapy in combination with chemotherapy","Untreated","Bispecific antibody","Programmed death-ligand 1 (PD-L1)","Vascular endothelial growth factor (VEGF) A","Combination with other investigational agents","Pumitamig","BNT327","Check point inhibitor","Lung cancer","Etoposide","Carboplatin","Cisplatin","2026-06-30",{"date":90,"type":40},{"date":130,"type":40},"2025-02-03",{"date":132,"type":21},"2029-03",{"name":134,"class":82},"BioNTech SE",211,{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":148,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100565753","phase-3-a-study-to-compare-the-efficacy-and-safety-of-bms-986489-bms-986012-nivolumab-fixed-dose-combination-in-combination-with-carboplatin-plus-etoposide-to-that-of-atezolizumab-with-carboplatin-plus-etoposide-as-first-line-therapy-in-participants-with-extensive-stage-small-cell-lung-cancer-tigos-100565753","NCT06646276","A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).","A Randomized, Double Blind, Multicenter Phase 3 Trial of BMS-986489 (BMS-986012+Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide vs Atezolizumab in Combination With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).","Inclusion Criteria\n\n* Participants must have diagnosis of Extensive-Stage Small Cell Lung Cancer (ES-SCLC).\n* Participants must be Healthy enough to do their normal activities with little or no help based on the ECOG performance scale.\n* Participants must have at least one tumor that can be measured using special imaging techniques like a CT scan or MRI at a site other than the brain and nervous system\n\nExclusion Criteria\n\n* Participants have already received certain types of treatment for extensive stage small cell lung cancer\n* Participants have certain health conditions, like spread of small cell lung cancer to the brain that are causing symptoms, certain lung diseases, heart diseases, infections, autoimmune diseases, other cancers, or a type of nerve damage called peripheral sensory neuropathy\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":144,"type":21},530,[107],"The Purpose of the Study is to Compare the Efficacy and Safety of BMS-986489 (Anti-fucosyl-GM1+ Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide to that of Atezolizumab with Carboplatin plus Etoposide as First-Line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer.",[27],[149,150,27,124,125,151,152,153,113,154,155],"BMS-986489","BMS-986012","Nivolumab","TIGOS","fucGM1","ES-SCLC","atigotatug","2026-06-29",{"date":127,"type":40},{"date":159,"type":40},"2025-02-25",{"date":161,"type":21},"2031-09-05",{"name":163,"class":82},"Bristol-Myers Squibb",183,{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":175,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"100562064","phase-1-subcutaneous-tarlatamab-in-participants-with-extensive-stage-small-cell-lung-cancer-dellphi-308-100562064","NCT06598306","Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)","A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)","DeLLphi-308","Inclusion Criteria:\n\n* Participants ≥ 18 years of age (or ≥ legal adult age within country if it is older than 18 years) at time of signing informed consent.\n* Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based anti-cancer therapy for SCLC.\n\nNote: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease.\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.\n* Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver).\n* Participants must be able to have SC injections administered in the abdomen.\n* Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor.\n\nExclusion Criteria:\n\n* Participants that have received prior DLL3 targeted therapy.\n* Participants with untreated or symptomatic brain metastases or those requiring therapy with steroids.\n* Note: Participants with asymptomatic brain metastatic lesions are allowed following definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic brain metastasis if local therapy is not required per investigator judgment).\n* Participants with leptomeningeal disease.\n* Participants with baseline oxygen requirement.",{"count":174,"type":21},220,[24],"The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.",[178],"Extensive Stage Small Cell Lung Cancer",[180],"Small Cell Lung Cancer","2026-06-25",{"date":183,"type":40},"2026-06-26",{"date":185,"type":40},"2024-10-07",{"date":187,"type":21},"2030-04-24",{"name":189,"class":82},"Amgen",31,{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},"100593337","phase-3-a-study-comparing-tarlatamab-durvalumab-carboplatin-and-etoposide-versus-durvalumab-carboplatin-and-etoposide-in-first-line-extensive-stage-small-cell-lung-cancer-es-sclc-100593337","NCT07005128","A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)","A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in Combination With Durvalumab, Carboplatin and Etoposide Versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)","DeLLphi-312","Inclusion Criteria:\n\n* Participant has provided informed consent before initiation of any study-specific activities\u002Fprocedures.\n* Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years.\n* Histologically or cytologically documented ES-SCLC (American Joint Committee on Cancer, 2017, Stage IV SCLC \\[T any, N any, M1 a\u002Fb\u002Fc\\]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor\u002Fnodal volume that is too large to be encompassed in a tolerable radiation plan.\n* Measurable disease as defined per RECIST 1.1.\n* Suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment.\n* Minimum life expectancy ≥ 12 weeks.\n\nExclusion Criteria:\n\n* Participants can have no history of other malignancy in the last 2 years.\n* Any symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.\n* They will have no history of severe or life-threatening events to immune-mediated therapy.\n* History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.\n* They will have no active autoimmune or inflammatory disorders.\n* Presence of active human immunodeficiency virus (HIV) or active Hepatitis (B\u002FC) infection.\n* Evidence or interstitial lung disease (ILD) or active, non-infectious pneumonitis.\n* History of solid organ transplant.\n* They will not have had a myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\> class II) within 6 months prior to first dose of study treatment.","99 Years",{"count":201,"type":21},330,[107],"The main objective of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS).",[205,206],"Small-cell Lung Cancer","Extensive Stage Small-cell Lung Cancer","2026-06-24",{"date":181,"type":40},{"date":210,"type":40},"2025-08-18",{"date":212,"type":21},"2029-07-15",{"name":189,"class":82},164,{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":225,"phases":4,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":48},"100641634","a-study-to-investigate-treatment-patterns-and-effectiveness-of-tislelizumab-in-european-patients-with-resectable-or-advanced-non-small-cell-lung-cancer-nsclc-and-small-cell-lung-cancer-sclc-100641634","NCT07652736","A Study to Investigate Treatment Patterns and Effectiveness of Tislelizumab in European Patients With Resectable or Advanced Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC)","A Real-World Evaluation of Tislelizumab Treatment Patterns and Effectiveness in European Patients With Resectable or Advanced Non-Small Cell Lung Cancer and Small Cell Lung Cancer","TITANS","Inclusion Criteria:\n\n* Participants are eligible to be included in the study only if they meet all the following criteria:\n\n  1. Participants or their legal representative must sign written inform consent form (ICF)\n  2. Participants receive tislelizumab as part of routine clinical practice as determined by the treating physician per standard of care and in accordance with the SmPC, within the approved indications in the 4 cohorts described.\n\nNote: The decision to treat the patient with a tislelizumab-based regimen, as per its authorized indication, must have been made by the treating physician prior to and independent of the patient's consideration for participation in this study.\n\nExclusion Criteria:\n\n* Participants are excluded from the study if they meet any of the following criteria:\n\n  1. Participants who are unable to understand all implications of study participation.\n  2. Participants who have contraindications for treatment with tislelizumab in the investigator's opinion or have any contraindication as listed in the SmPC of tislelizumab.\n  3. Participants who are deemed ineligible according to the investigator's opinion and the SmPC of tislelizumab.",{"count":224,"type":21},440,"OBSERVATIONAL","The purpose of this study is to collect real-world data on treatment patterns and clinical outcomes in European patients receiving tislelizumab in routine clinical practice",[228,27],"Advanced Non-Small Cell Lung Cancer","2026-06-22",{"date":181,"type":40},{"date":232,"type":40},"2026-06-05",{"date":234,"type":21},"2030-11-17",{"name":236,"class":82},"BeOne Medicines",{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":246,"briefSummary":247,"conditions":248,"keywords":253,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":267},"100597672","phase-2-sintilimab-combined-with-tafolecimab-and-chemotherapy-as-first-line-treatment-for-extensive-stage-small-cell-lung-cancer-100597672","NCT07061535","Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer","Efficacy and Safety of Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (STAR-SCLC)：A Prospective, Single Arm Trial","STAR-SCLC","Key Inclusion Criteria:\n\n* Age ≥18 years, ECOG performance status 0-1;\n* Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to Veterans Administration Lung Study Group criteria;\n* Previously not receiving systemic treatment for ES-SCLC;\n* Greater than or equal to 1 measurable lesion exists according to RECIST v1.1;\n* Expected survival \\>= 12 weeks;\n* Adequate organ system functions (no blood transfusion or component blood use within 14 days before testing).\n\nKey Exclusion Criteria:\n\n* Previously receiving systemic anti-tumor therapy for ES-SCLC;\n* Combined SCLC (mixed SCLC and NSCLC histological types) or transformed SCLC confirmed by histological or cytological examination;\n* Receiving other investigational drugs or participated in other interventional clinical studies within 4 weeks before signing the informed consent form;\n* Receiving systemic immunostimulant treatment within 4 weeks before enrollment;\n* Active central nervous system (CNS) metastases (asymptomatic patients with stable lesions allowed);\n* Severe cardiovascular disease;\n* Severe chronic\u002Factive infections requiring systemic antibacterial, antifungal or antiviral treatment within 2 weeks before enrollment;\n* Active hepatitis B virus (HBV)\u002F hepatitis C virus (HCV)\u002F human immunodeficiency virus (HIV) infection;\n* Active autoimmune diseases, a history of interstitial lung disease, or other uncontrolled systemic diseases;\n* Pregnancy or lactation;\n* Having a disease that requires systemic corticosteroids or other immunosuppressants to be treated within ≤14 days before enrollment;\n* Requiring at least monthly or more frequent drainage of pleural and\u002For pericardial or peritoneal effusion;\n* Using attenuated live vaccines, or planned to receive attenuated live vaccines within 28 days before enrollment;\n* Known to be allergic to Sintilimab or Tafolecimab or its excipients, having a history of severe allergic reaction to any monoclonal antibody, or having a history of allergy to cisplatin, carboplatin or etoposide;\n* Toxicity caused by previous anti-cancer treatment has not recovered to baseline or stable state at the time of enrollment;\n* Creatinine clearance rate \\\u003C 60 mL\u002Fmin (cisplatin) or \\\u003C 45 mL\u002Fmin (carboplatin)\n* Uncontrolled or symptomatic hypercalcemia.",{"count":5,"type":21},[60],"This is a single arm, multi-center clinical trial. The goal of this clinical trial is to evaluate the efficacy, safety and biomarkers of Tafolecimab combined with Sintilimab and Chemotherapy as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). Tafolecimab is a recombinant fully humanized monoclonal antibody against proprotein convertase subtilisin\u002Fkexin type 9 (PCSK-9), which can reduce low-density lipoprotein-C levels and increase the expression level of major histocompatibility complex class I (MHC-I) on tumor cells. Sintilimab is a fully humanized IgG4 monoclonal antibody targeting programmed cell death protein 1 (PD-1).",[249,250,251,252],"Extensive-stage Small Cell Lung Cancer (ES-SCLC)","Extensive Stage Lung Small Cell Cancer","Extensive-Stage Small-Cell Lung Cancer","Extensive Disease Small Cell Lung Cancer",[254,255,256,257,113],"Tafolecimab","Sintilimab","immunotherapy","PCSK9 inhibitor",{"date":259,"type":40},"2026-06-23",{"date":261,"type":40},"2025-07-30",{"date":263,"type":21},"2027-08-01",{"name":265,"class":266},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",5,{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":22,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":48},"100641600","phase-2-a-study-of-bl-m14d1-in-combination-with-atezolizumab-in-patients-with-extensive-stage-small-cell-lung-cancer-100641600","NCT07654400","A Study of BL-M14D1 in Combination With Atezolizumab in Patients With Extensive-stage Small Cell Lung Cancer","A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M14D1 for Injection in Combination With Atezolizumab in Patients With Extensive-stage Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restriction;\n3. Age: ≥18 years;\n4. Expected survival time ≥3 months;\n5. Histopathologically and\u002For cytologically confirmed extensive-stage small cell lung cancer that is incurable or for which there is currently no standard treatment;\n6. Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 3 years, or fresh tissue samples;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n9. Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;\n11. Organ function levels must meet the required criteria;\n12. Urine protein ≤1+ or ≤1000 mg\u002F24h;\n13. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment. Serum pregnancy testing must rule out pregnancy, and the patient must not be breastfeeding. All enrolled trial participants (regardless of gender) should take adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biological therapy, immunotherapy, etc., within 4 weeks or 5 half-lives before the first dose;\n2. Previous treatment with ADC drugs using topoisomerase I inhibitors as toxins;\n3. Small cell carcinoma with non-small cell carcinoma components indicated by pathology must be excluded;\n4. Use of immunomodulatory drugs within 2 weeks before the first dose of the study;\n5. Receiving long-term systemic corticosteroid therapy at a dose \\>10 mg\u002Fday of prednisone or equivalent before the first dose;\n6. History of severe cardiovascular or cerebrovascular diseases;\n7. Prolonged QTc interval, complete left bundle branch block, etc.;\n8. Active autoimmune diseases and inflammatory diseases;\n9. Diagnosis of another malignancy within 5 years before the first dose;\n10. Hypertension poorly controlled by two antihypertensive drugs;\n11. Patients with poorly controlled blood glucose;\n12. History of ILD\u002Finterstitial pneumonia treated with corticosteroids, etc.;\n13. Concomitant pulmonary diseases leading to clinically severe impairment of respiratory function;\n14. Presence of massive serous cavity effusion, or serous cavity effusion with symptoms, etc.;\n15. Imaging findings indicating that the tumor has invaded or encased major blood vessels in the chest, neck, pharynx, etc.;\n16. Any thrombotic event within 6 months before randomization;\n17. Patients with active central nervous system metastases;\n18. History of allergy to recombinant humanized antibodies or chimeric human-mouse antibodies, or allergy to any excipient components of the investigational drug, etc.;\n19. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;\n20. Cumulative anthracycline dose \\>360 mg\u002Fm² during prior (neo)adjuvant anthracycline therapy;\n21. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n22. Active infections requiring systemic treatment, or occurrence of severe infection within 4 weeks before informed consent;\n23. Receipt of other unapproved clinical study drugs or treatments within 4 weeks before the first dose;\n24. Pregnant or breastfeeding women;\n25. History of severe neurological or psychiatric disorders;\n26. Presence of serious non-healing wounds, ulcers, or fractures within 4 weeks before signing informed consent;\n27. Clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing informed consent;\n28. History of intestinal obstruction, inflammatory bowel disease, extensive bowel resection, or presence of Crohn's disease, ulcerative colitis, or chronic diarrhea;\n29. Trial participants who plan to receive or have received live vaccines within 28 days before the first dose;\n30. Other conditions deemed by the investigator to be unsuitable for participation in this clinical trial.",{"count":276,"type":21},36,[60],"This Phase II study is a clinical study exploring the efficacy and safety of BL-M14D1 in combination with Atezolizumab in patients with extensive-stage small cell lung cancer.",[110],"2026-06-12",{"date":282,"type":40},"2026-06-17",{"date":284,"type":21},"2026-07",{"date":286,"type":21},"2027-12",{"name":288,"class":82},"Sichuan Baili Pharmaceutical Co., Ltd.",{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":296,"phases":4,"briefSummary":297,"conditions":298,"keywords":299,"overallStatus":306,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":307,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":309,"locationsCount":311},"100634105","medical-access-program-for-ifinatamab-deruxtecan-in-3l-pretreated-extensive-stage-small-cell-lung-cancer-100634105","NCT07535359","Medical Access Program for Ifinatamab Deruxtecan in 3L+ Pretreated Extensive-stage Small Cell Lung Cancer","Medical Access Program for Ifinatamab Deruxtecan (I-DXd, DS-7300a)","Patients are only eligible after signing the informed consent form and must meet all of the following criteria to be eligible for the Medical Access Program.\n\nInclusion Criteria:\n\n* The patient has at least one SCLC lesion that has not been previously irradiated.\n* The patient is aged ≥18 years or older.\n* The patient has histologically or cytologically documented ES-SCLC.\n* The patient had prior therapy with platinum-based chemotherapy and one additional treatment as systemic therapy for extensive-stage disease.\n* The patient has received prior treatment with a minimum of two previous lines of systemic therapy.\n* The patient has a documented radiological disease progression on or after the most recent systemic therapy.\n* The patient has an ECOG PS of 0-1.\n* The patient has a life expectancy of ≥3 months\n* The patient has adequate organ and bone marrow function as defined in the protocol within 7 days prior to Cycle 1 Day 1 of I-DXd treatment. Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 2 weeks prior to screening laboratory tests.\n* Male and female patients of reproductive\u002Fchildbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the program and for at least 8 months for females and 5 months for males after the last dose of I-DXd.\n* Female patients of childbearing potential must have a negative serum pregnancy test within 3 days prior to enrolment.\n* Female patients agree to not donate, or retrieve for their own use, ova throughout the participation in the MAP and for 8 months following the last dose of I-DXd. Preservation of ova may be considered prior to enrolment in this program.\n* Male patients are surgically sterile or willing to use highly effective birth control throughout the participation in the MAP and for 5 months following the last dose of I DXd.\n* Male patients agree not to freeze or donate sperm throughout participation in the MAP and for 5 months following the last dose of I-DXd. Preservation of sperm may be considered prior to enrolment in this program.\n\nPatients who meet any of the following criteria will not be eligible for the Medical Access Program.\n\nExclusion Criteria:\n\n* The Patient is eligible for other treatment options or can enroll in an open clinical trial with patients with pre-treated ES-SCLC.\n* The patient has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.\n* The patient has been discontinued from an ADC that consists of an exatecan derivative (e.g., trastuzumab deruxtecan) due to treatment-related toxicities.\n* The patient has had an inadequate washout period before randomization as defined in the protocol.\n* The patient has clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.\n* The patient has experienced any of the following events within the past 6 months:\n\n  1. cerebrovascular accident, or\n  2. transient ischemic attack, or\n  3. another arterial thromboembolic event.\n* The patient has a clinically significant corneal disease.\n* The patient has uncontrolled or significant cardiovascular disease as defined in the protocol.\n* The patient has any history of ILD\u002Fpneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening.\n* The patient has a clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses as defined in the protocol.\n* The patient is on chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except for low-dose inhaled steroids (for asthma\u002FCOPD), topical steroids (for mild skin conditions), or intra-articular steroid injections.\n* The patient has a history of allogeneic bone marrow, stem cell, or solid organ transplant.\n* The patient has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE V5.0, Grade ≤1 or baseline.\n* The patient has a history of hypersensitivity to the drug substances, inactive ingredients in the drug product, or severe hypersensitivity reactions to other monoclonal antibodies.\n* The patient has a documented ongoing uncontrolled systemic bacterial, fungal, or viral infection.\n* The patient has active or uncontrolled hepatitis B or C infection.\n* The patient has an active, known, or suspected autoimmune disease. The following patients may be enrolled as an exception:\n\n  1. Type I diabetes mellitus, hypothyroidism only requiring hormone replacement\n  2. Skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or\n  3. Conditions not expected to recur in the absence of an external trigger.\n* The patient has any evidence of severe or uncontrolled systemic diseases (including active bleeding diatheses, psychiatric illness\u002Fsocial situations, substance abuse) or other factors that, in the physician's opinion, make it undesirable for the patient to participate in the MAP or would jeopardize compliance with the protocol. Screening for chronic conditions is not required.\n* The patient has received a live vaccine within 30 days prior to the first dose of I-DXd.\n* Female patients who are pregnant, breastfeeding, or intend to become pregnant during the MAP.\n* The patient has active or uncontrolled human immunodeficiency virus (HIV) infection. Participants must be tested for HIV viral load before enrollment if acceptable by local regulations or independent review boards\u002FIndependent ethics committee.\n* The patient has active or uncontrolled hepatitis B virus (HBV) infection. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have an undetectable HBV viral load prior to enrolment.\n* The patient has active or uncontrolled hepatitis C virus (HCV) infection. Participants with a history of hepatitis C infection are eligible if the HCV viral load is undetectable in the absence of antiviral therapy during the previous 4 weeks.","EXPANDED_ACCESS","The purpose of this Medical Access Program (also referred to as an Expanded Access Program in the USA) is to provide access to I-DXd for eligible patients with extensive-stage small cell lung cancer (ES-SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen), and for eligible patients who have no suitable treatment options and are not able to enter a clinical study.",[113,65],[300,301,302,303,304,305],"Ifinatamab Deruxtecan","Medical Access Program","3L+ SCLC","DS7300a","I-DXd","Extensive-stage small cell lung cancer","AVAILABLE",{"date":308,"type":40},"2026-06-09",{"name":310,"class":82},"Daiichi Sankyo",3,{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":22,"phases":321,"briefSummary":322,"conditions":323,"keywords":324,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":337},"100578156","phase-1-a-study-of-valemetostat-in-combination-with-atezolizumab-in-people-with-lung-cancer-100578156","NCT06807632","A Study of Valemetostat in Combination With Atezolizumab in People With Lung Cancer","Phase I Study of Valemetostat and Atezolizumab as Maintenance Therapy for Patients With Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Signed informed consent form (ICF)\n* Ability to comply with the study protocol as per the investigator's judgment\n* Age ≥ 18 years at the time of signing the ICF\n* Life expectancy ≥ 12 weeks\n* ECOG performance status 0 or 1\n* Pathologically confirmed diagnosis of newly diagnosed extensive-stage small cell lung cancer. Patients with a diagnosis of combined small cell lung cancer with other histologies may be considered for inclusion if the predominant histology is SCLC and only after discussion with the study PI.\n* Radiographically documented RECIST version 1.1 stable disease, partial or complete response after initial treatment with a platinum doublet regimen in combination with atezolizumab for 4 cycles. It is acceptable to have no measurable disease at the start of this study.\n* Must be able to begin therapy within 4 weeks of completing the fourth cycle of chemotherapy and immunotherapy.\n* Adequate hematologic and end-organ function, as defined by the following laboratory test results obtained within 14 days prior to initiation of study treatment. Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 2 weeks prior to screening laboratory tests:\n\n  o Adequate bone marrow function as defined by:\n* Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL (1500\u002FµL)\n* Hemoglobin ≥ 9 g\u002FdL\n* Platelets ≥ 100 x 10\\^9\u002FL o Adequate renal function as defined by:\n* Creatinine clearance ≥ 30 mL\u002Fmin as calculated using the Cockcroft-Gault equation\n\n  o Adequate hepatic function as defined by:\n* AST, ALT, and alkaline phosphatase (ALP) ≤ 3 x ULN with the following exception:\n* Patients with documented liver metastases: AST, ALT and ALP ≤ 5 x ULN\n\nExclusion Criteria:\n\n* Any active uncontrolled systemic diseases or other medical conditions considered to be poorly controlled by the investigator including but not limited to bleeding diatheses, that could in the investigator's opinion, potentially interfere with completion of study procedures or interpretation of study outcomes.\n* Patients who receive consolidative chest radiation after completion of initial chemotherapy and immunotherapy.\n* Symptomatic CNS metastases\n* Patients with treated CNS metastases are allowed on the study if their clinical symptoms are adequately controlled and the daily dose of steroid use is equivalent to or less than 10 mg of prednisone.\n* Receiving concomitant treatment with a moderate or strong inducer of CYP3A within 14 days of first receipt of valemetostat o Consumption of herbs\u002Ffruits that may have an influence on PK of valemetostat (strong CYP3A inhibitors or inducers) such as St. John's wort, star fruit, Seville orange or Seville orange-containing foods and beverages, grapefruit or grapefruit-containing food or beverages should be avoided from 14 days prior to the start of the study and throughout the entire study.\n\nPrior exposure to valemetostat or other inhibitors of enhancer of zeste homologue-2 (EZH2)\n\n* Refractory nausea and vomiting, malabsorption, biliary shunt, significant bowel resection, or any other condition that significantly affects gut motility or absorption and would preclude adequate absorption of valemetostat in the opinion of the treating physician and\u002For PI.\n* Currently receiving radiation therapy, or who have received radiation within 2 weeks prior to the initiation of study treatment, or who plan to receive radiation therapy within the safety evaluation period for dose-limiting toxicity during Cycle 1.\n* Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline.\n\n  o NOTE: Participants may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to Grade \\>2 for at least 3 months prior to enrollment and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of the following:\n* Chemotherapy-induced neuropathy\n* Residual toxicities from prior IO treatment: Grade 1 or Grade 2 endocrinopathies which may include:\n* Hypothyroidism\u002F hyperthyroidism\n* Type I diabetes\n* Hyperglycemia\n* Adrenal insufficiency\n* Adrenalitis\n* Skin hypopigmentation (vitiligo)\n* Patients who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia).\n\n  o NOTE: Procedures such as a percutaneous biopsy, pleural catheter insertion, placement of a central venous catheter or other minor procedures are permitted.\n* Uncontrolled or significant cardiovascular disease, including the following:\n* Evidence of prolongation of QT\u002FQTc interval (e.g., repeated episodes of QT corrected for heart rate using Fridericia's method \\[QTcF\\] \\>470 ms). Electrocardiogram must be registered at rest. For any ECG assessment, if the initial ECG shows a prolonged QTc, then two additional ECGs will be obtained, resulting in three specimens taken after a space of 1 minute, and the mean of the 3 ECGs will be used to determine eligibility and for grading of TRAEs.\n* Myocardial infarction within 6 months prior to screening o Uncontrolled angina pectoris within 6 months prior to screening o New York Heart Association (NYHA) Class 3 or 4 congestive heart failure\n* Uncontrolled hypertension (resting systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg)\n* Have a known hypersensitivity to any of the components of or known hypersensitivity to either the study drug itself or any of the inactive ingredients in the study drug product.\n* Known liver cirrhosis.\n* Uncontrolled active infection requiring IV antibiotic, antiviral, or anti-fungal medications within 14 days prior to initiation of study treatment.\n\n  o Infections controlled on concurrent anti-microbial agents and anti-microbial prophylaxis per institutional guidelines are acceptable.\n* Congenital or acquired immunodeficiency, including patients with known history or infection with human immunodeficiency virus (HIV).\n\n  o NOTE: HIV-positive patients who are taking anti-retroviral therapy are still ineligible due to potential PK interactions with valemetostat.\n* Active tuberculosis\n* Active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test followed by a positive HBV RNA test within 28 days prior to the first dose of study drug. Hepatitis B testing (HBV surface antigen and core antibody) is required only if not done previously.\n\n  o Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study.\n* Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV RNA test within 28 days prior to the first dose of study drug. Hepatitis C testing (HCV antibody) is required only if not done previously.\n\n  o The HCV RNA test will be performed only for patients who have a positive HCV antibody test.\n* Prior malignancy, active within the previous 3 years, except for locally curable cancer that is currently considered as cured or successfully resected, such as basal or squamous cell carcinoma, superficial bladder cancer, gastric cancer or carcinoma in situ of the prostate, cervix, or breast.\n* Female patients who have a positive serum pregnancy test during screening or a positive urine pregnancy test on Day 1 before first dose of study drug.\n* Female patients who are lactating and\u002For plan to breastfeed during the study treatment or at any point leading up to and including 6 months after the last study drug dose.",{"count":320,"type":21},24,[24],"This study will test whether valemetostat in combination with atezolizumab is a safe treatment that causes few or mild side effects in people with extensive-stage small cell lung cancer (SCLC). The researchers will test different doses of valemetostat to find the highest dose that causes few or mild side effects in participants. After the dose is found, researchers will test it in a new group of participants to learn more about the safety of the study treatment and see if it is an effective treatment for extensive-stage SCLC.",[110],[325,326,327,328],"Valemetostat","Atezolizumab","Maintenance therapy","24-290",{"date":330,"type":40},"2026-06-08",{"date":332,"type":40},"2025-01-29",{"date":334,"type":21},"2027-01",{"name":336,"class":266},"Memorial Sloan Kettering Cancer Center",7,{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":22,"phases":347,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":350,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":267},"100416221","phase-2-chemo-immunotherapy-followed-by-durvalumab-and-ceralasertib-in-treatment-nave-patients-with-extensive-stage-small-cell-lung-cancer-100416221","NCT04699838","Chemo-Immunotherapy Followed by Durvalumab and Ceralasertib in Treatment Naïve Patients With Extensive Stage Small Cell Lung Cancer","A Phase II Study of Chemo-Immunotherapy Followed by Durvalumab (MEDI4736) and Ceralasertib (AZD6738) in Treatment Naïve Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Big Ten Cancer Research Consortium BTCRC-LUN18-363","Inclusion Criteria:\n\n* Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n* Age \\>= 18 years at the time of consent.\n* ECOG Performance Status of 0-1 within 14 days prior to registration (Appendix A of Protocol).\n* Histological or cytological confirmed small cell lung carcinoma\n* Extensive stage disease\n* Patient must be considered suitable to receive a platinum-based chemotherapy as 1st line treatment for ES-SCLC. Chemotherapy must contain either Carboplatin or Cisplatin in combination with Etoposide.\n* Measurable disease according to RECIST v1.1 for solid tumors within 28 days prior to registration.\n* Prior treatment must be completed within the following number of days prior to registration:\n\n  --Palliative radiation: for painful bony lesion must be completed prior to registration and recovered from significant bone marrow toxicity. For patients who received WBRT, 14 days washout is required prior to study therapy. Patient's must be off steroids without worsening of symptoms related to brain metastases. Patient should be on stable doses of anti-convulsant.\n* Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 14 days prior to registration\n\n  * Hematological\n\n    * Absolute Neutrophil Count (ANC) \\>\u002F= 1500\u002Fmm\\^3\n    * Platelet \\>\u002F= 100,000\u002Fmm\\^3\n    * Hemoglobin (Hgb) \\>\u002F= 9 g\u002FdL\n  * Renal\n\n    * Creatinine \\\u003C\u002F= 1.5 x ULN\n    * Calculated creatinine clearance \\>\u002F= 50 mL\u002Fmin using the Cockcroft-Gault formula if creatinine is more than 1.5 x ULN (60 mL\u002Fmin if receiving Cisplatin)\n  * Hepatic\n\n    * Bilirubin \\\u003C\u002F= 1.5 x upper limit of normal (ULN), \\\u003C\u002F= 3 x ULN if history of Gilbert Syndrome\n    * Aspartate aminotransferase (AST) \\\u003C\u002F= 2.5 x ULN (if liver metastases then \\\u003C\u002F= 5 x ULN)\n    * Alanine aminotransferase (ALT) \\\u003C\u002F= 2.5 x ULN (if liver metastases then \\\u003C\u002F= 5 x ULN)\n* Female subjects of childbearing potential and non-sterilized male subjects who intend to be sexually active during the study must agree to use a highly effective method of contraception from the time of screening, throughout the total duration of the drug treatment, and for 6 months after the last dose of study drug treatment.\n* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * Women \\\u003C50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n  * Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).\n* As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study\n* Ability to swallow and retain oral medication\n* Must have a life expectancy of at least 12 weeks\n\nExclusion Criteria:\n\n* Prior systemic therapy for extensive stage or recurrent SCLC\n* Patients with recurrent SCLC, who received chemotherapy or definitive chest radiation in the past for limited-stage SCLC.\n* Clinically significant active infection requiring systemic therapy\n* Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).\n* Participants who have undergone major surgery within 28 days before first dose of study drug\n* Participants who are currently receiving any other investigational agents\n* Active malignancy requiring therapy other than small cell lung cancer, excluding: non-melanoma skin cancer, noninvasive colonic polyps, superficial bladder tumors, cervical cancer in-situ, ductal carcinoma in situ of the breast, monoclonal B-cell lymphocytosis, or monoclonal gammopathy of undetermined significance.\n* Diagnosis of immunodeficiency or is receiving systemic steroid therapy (\\> 10 mg of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to study enrolment. Patient's on physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Topical, inhaled or intra-articular steroids are not considered as systemic steroids. Steroids as premedication for hypersensitivity reaction (e.g. CT scan premedication) or prior to chemotherapy is allowed.\n* Active autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], systemic lupus erythematosus, 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 hyperthyroidism or hypothyroidism (e.g., following Hashimoto syndrome) clinically stable on hormone replacement\n  * Any chronic skin condition that does not require systemic immunosuppressive therapy\n  * Patients with celiac disease controlled by diet alone\n  * Diabetes mellitus with or without insulin replacement therapy\n* Has history of immune therapy related pneumonitis that required steroids\n* Patients with untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal carcinomatosis will be excluded. Previously treated CNS metastases and have no requirement for steroids for at least 2 weeks prior to study entry is allowed. Anticonvulsant therapy at a stable dose is permitted and must not have seizures for at least 2 weeks prior to study entry. May have residual symptoms as new baseline. Brain imaging with either MRI (preferred) or CT with contrast must be performed on all subjects at screening to evaluate brain metastases.\n* Known history of Hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1\u002F2 antibodies). Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA\n* Known history of active tuberculosis\n* History of allogeneic stem cell or solid organ transplant\n* History of Ataxia telangiectasia\n* Uncontrolled intercurrent illness including, but not limited to, serious and active uncontrolled infection, symptomatic congestive heart failure (NYHA class III-IV), active inflammatory bowel disease, unstable angina pectoris, uncontrolled seizures, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Participants with a known hypersensitivity to durvalumab, ceralasertib or any excipient of the product\n* Patients who have been vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug\n* Refractory nausea and vomiting, chronic gastrointestinal diseases or previous significant bowel resection, with clinically significant sequelae that would preclude adequate absorption of ceralasertib.\n* Patients weighing \\\u003C= 30 Kg.\n* Participants may not be receiving any medications or substances that are potent inhibitors or inducers of CYP3A4 (Appendix B of the protocol).\n\n  * There is a required wash-out period of 5 half-lives from such agents prior to starting ceralasertib, or three weeks for St. John's Wort.\n  * For non-potent inhibitors or inducers of CYP3A4, the decision to allow a patient to enroll on the study is per investigator best judgement. Note these include common azole antifungals, macrolide antibiotics, and other medications listed in the concomitant medications section. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.\n  * Exposure of other drugs metabolized by CYP3A4 and\u002For CYP2B6 may be reduced and additional monitoring may be required.\n  * The use of herbal supplements or 'folk remedies' (and medications and foods that significantly modulate CYP3A activity) should be discouraged. If deemed necessary, such products may be administered with caution and the reason for use documented in the CRF.",{"count":346,"type":21},30,[60],"The primary objective of this single arm study is to estimate the progression free survival of previously-untreated patients with extensive stage small cell lung cancer. Patients will receive initial chemo-immunotherapy followed by maintenance therapy with durvalumab and oral ceralasertib.",[178],{"date":330,"type":40},{"date":352,"type":40},"2021-04-20",{"date":354,"type":21},"2026-11",{"name":356,"class":266},"Muhammad Furqan",{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":22,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":48},"100554318","phase-2-maintenance-lurbinectedin-in-combination-with-serplulimab-for-patients-with-es-sclc-100554318","NCT06497530","Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC","An Exploratory Study of Maintenance Lurbinectedin in Combination With Serplulimab for Patients With Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria for the Induction Phase:\n\n* Fully informed about the study and voluntarily signed a written informed consent form, and able to comply with the requirements and restrictions listed in the informed consent form;\n* Male or female with age ≥ 18 years;\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1;\n* Histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) and has not received any systemic treatment for ES-SCLC;\n* At least one measurable lesion (according to RECIST 1.1 criteria);\n* Having adequate bone marrow, hepatic, renal and metabolic function, meaning the functional level of the organs meets the following requirements:\n* Platelet count (PLT) ≥ 100×10\\^9\u002FL; Hemoglobin (Hb) ≥ 90 g\u002FL; Absolute neutrophil count (ANC) ≥ 2.0×10\\^9\u002FL;\n* Regardless of whether liver metastasis is present, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0×upper limit of normal (ULN);\n* Alkaline phosphatase (ALP) ≤ 5×ULN;\n* Total bilirubin (TBIL) ≤ 1.5×ULN, and direct bilirubin ≤ 1.0×ULN;\n* Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 30 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n* Creatine phosphokinase (CPK) ≤ 2.5×ULN;\n* Albumin ≥ 3.0 g\u002FdL.\n* Women of childbearing potential(WOCBP) must have a negative serum pregnancy test before enrollment. WOCBP must use effective contraceptive measure during the trial drug treatment and for 6 months after the last administration. Male patients (with partners of WOCBP) must use effective contraceptive measure during the trial drug treatment and for 4 months after the last administration;\n* Human immunodeficiency virus (HIV)-negative, with no active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n\nExclusion Criteria for the Induction Phase:\n\n* Have a history of central nervous system (CNS) metastasis or related history;\n* Have a history of active autoimmune disease or immunodeficiency, or related history;\n* Have a history of malignancies other than SCLC within 5 years before enrollment;\n* Previous treatment with immune checkpoint inhibitors or lurbinectedin;\n* Have a history of idiopathic pulmonary fibrosis or pneumonia, or active pneumonia detected in CT screening;\n* Treatment with any other investigational product within 28 days before enrollment.\n\nInclusion Criteria for the Maintenance Phase:\n\n* Have a continuous response or stable disease according to RECIST 1.1 criteria after 4 cycles of induction therapy;\n* Toxicity from the induction therapy phase has recovered to ≤ Grade 1;\n* Have sufficient bone marrow and organ function.\n\nExclusion Criteria for the Maintenance Phase:\n\n* Have a history of central nervous system (CNS) metastasis or related history;\n* Has received chest consolidation radiotherapy;\n* Severe infection within 2 weeks before enrollment.",{"count":346,"type":21},[60],"This is a single-arm, open-lable exploratory study of Lurbinectedin in combination with Serplulimab as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and Serplulimab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and Serplulimab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will receive lurbinectedin plus Serplulimab in the maintenance phase.",[27],"2026-06-04",{"date":330,"type":40},{"date":371,"type":40},"2024-12-01",{"date":373,"type":21},"2026-12",{"name":375,"class":266},"Guangzhou Institute of Respiratory Disease",{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":384,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":388,"conditions":389,"keywords":390,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":403},"100595846","phase-1-a-study-of-tarlatamab-in-combination-with-ab248-in-participants-with-extensive-stage-small-cell-lung-cancer-dellphi-311-100595846","NCT07037758","A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)","A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)","DeLLphi-311","Inclusion Criteria:\n\n1. Participant has provided informed consent before initiation of any study-specific activities\u002Fprocedures.\n2. Participants ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.\n3. Participants with histologically or cytologically confirmed ES-SCLC that has progressed or recurred following at least 1 line of anti-cancer therapy for ES-SCLC.\n4. Participants must have at least 1 measurable lesion as defined by RECIST 1.1 within 21-day screening period, not previously irradiated.\n5. Participants must have adequate organ function (hematological, coagulation, cardiac, pulmonary, kidney, and liver).\n6. Participants must submit a fresh tumor biopsy at screening unless a new biopsy cannot be performed safely or is infeasible. Participants who cannot provide fresh tissue may provide archival tissue that was collected after last anticancer therapy.\n\nExclusion Criteria:\n\n1. Symptomatic central nervous system (CNS) metastases.\n2. Participants with brain metastases may be eligible if criteria defined in the protocol are met.\n3. Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy (including tarlatamab).\n4. Prior interleukin (IL)-2, IL-7 or IL-15 targeted therapy.\n5. Baseline (at rest) requirement of supplemental oxygen.","90 Years",{"count":386,"type":21},380,[24],"The primary objective for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248.\n\nThe primary objective for dose exploration only is to determine the recommended dose for expansion and\u002For maximum tolerated combination dose (MTCD) of AB248 in combination with tarlatamab.",[178],[154,391,392,393,394],"Tarlatamab","AMG 757","AB248","Imdelltra","2026-05-27",{"date":397,"type":40},"2026-05-29",{"date":399,"type":40},"2025-09-16",{"date":401,"type":21},"2031-01-18",{"name":189,"class":82},19,{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":22,"phases":413,"briefSummary":414,"conditions":415,"keywords":416,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":423,"completionDateStruct":424,"leadSponsor":426,"locationsCount":48},"100628284","phase-2-a-study-of-lurbinectedin-in-combination-with-durvalumab-for-the-treatment-of-participants-with-es-sclc-100628284","NCT07459634","A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC","A Phase 2, Multicenter, Open-Label, Single-Arm Study of Lurbinectedin in Combination With Durvalumab as First-line Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer Following Induction Treatment With Platinum Based Chemotherapy and Durvalumab","Inclusion Criteria:\n\n1. Participant has histologically or cytologically confirmed ES-SCLC (per Veterans Administration Lung Study Group staging system).\n2. Participant has received 4 cycles of definitive platinum-based chemotherapy with durvalumab\n3. Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n4. Must have a life expectancy of ≥ 12 weeks as assessed by the treating physician.\n5. Adequate hematologic and end-organ function for at least 7 days prior to dosing.\n6. Has a body weight \\> 30 kg.\n7. Adequate contraceptive precautions.\n\nExclusion Criteria:\n\n1. History of leptomeningeal carcinomatosis.\n2. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\n3. History of another primary malignancy\n4. Presence or history of Central Nervous System (CNS) metastases\n5. History of allogeneic organ transplantation.\n6. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest CT scan.\n7. Any concurrent chemotherapy, study intervention, biologic, or hormonal therapy for cancer treatment.\n8. Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention.\n9. Concurrent enrollment in another clinical study\n10. Prior enrollment or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.\n11. Pregnant or breastfeeding or intending to become pregnant during the study or within 6 months after the last dose of study intervention.",{"count":412,"type":21},50,[60],"The purpose of this study is to evaluate the efficacy and safety of lurbinectedin in combination with durvalumab for the treatment of participants with extensive stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first line (1L) induction therapy.",[110],[417,418,419,420],"Zepzelca","Lurbinectedin","Durvalumab","Imfinzi","2026-05-22",{"date":395,"type":40},{"date":280,"type":21},{"date":425,"type":21},"2028-04-30",{"name":427,"class":82},"Jazz Pharmaceuticals",{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":435,"enrollmentInfo":436,"targetDuration":4,"studyType":22,"phases":438,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":48},"100532818","phase-1-safety-and-tolerability-of-ldrtsugemalimabchemotherapyolaparib-for-first-line-treatment-of-slfn-11-positive-es-sclc-100532818","NCT06217757","Safety and Tolerability of LDRT+Sugemalimab+Chemotherapy+Olaparib for First-Line Treatment of SLFN-11 Positive ES-SCLC","Phase I Study of Low-Dose Radiotherapy Plus Chemotherapy and Sugemalimab and Olaparib for First-Line Treatment of SLFN-11 Positive Extensive Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Men or women aged more than or equal to (≥) 18 years old and less than or equal to (≤) 75 years old\n2. Histologically or cytologically confirmed ES-SCLC\n3. No prior treatment for ES-SCLC\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n5. Five white slides (unstained paraffin sections) were available for immunohistochemical SLFN-11 detection and SLFN-11 was positive\n6. Extensive clinical stage. American Joint Committee on Cancer (AJCC) 8th edition Stage IV with lesions exceeding one side of the chest and including malignant pleural and pericardial effusions or hematogenous metastases (any T, any N, M1a\u002Fb\u002Fc); or T3-4 due to multiple nodules in the lung or tumor\u002Fnodule size too large to be included in a T3-4 disease within a tolerable radiotherapy schedule\n7. The subjects were considered suitable for combining etoposide with cisplatin chemotherapy and low-dose radiotherapy as first-line treatment for extensive -stage small cell lung cancer\n8. Have measurable lesions as defined by RECIST1.1, with at least one lesion (never previously treated with radiation) of ≥10 mm longest diameter accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) at baseline (except for lymph nodes, which must have a short axis of ≥15 mm) and the lesion is suitable for repeat and accurate measurements\n9. Patients with brain metastases must be asymptomatic or stable on steroids and anticonvulsants for at least 1 month prior to study treatment. Participants with suspected brain metastases during screening should have a CT\u002FMRI of the brain prior to study\n10. No previous treatment with immune checkpoint inhibitors and PARP inhibitors, including but not limited to other anti-PD-1, anti-PD-L1 and anti-programmed cell death ligand 2 (anti-PD-L2) antibodies, with the exception of therapeutic anti-tumor vaccines. No prior chemotherapy or radiation therapy to the chest lesion\n11. Weight over 30 Kg\n12. Life expectancy ≥ 12 weeks\n13. Have adequate organ and bone marrow functional reserve and normal major organ function\n14. Patients were compliant, voluntarily enrolled in the study and signed an informed consent form\n15. For women or men with childbearing potential: use effective contraception to avoid conception or embryonic drug exposure during treatment and for 5 months after the last dose of sugemalimab and for 6 months after the last dose of cisplatin or etoposide. Female subjects are prohibited from donating eggs during this period and males are prohibited from donating sperm during this period\n\nExclusion Criteria:\n\n1. Histopathologic or cytopathologic diagnosis of mixed small cell lung cancer or non-small cell lung cancer\n2. Limited stage small cell lung cancer\n3. Combination of poorly controlled malignant pleural or pericardial effusions requiring continuous drainage\n4. Presence of active or symptomatic brain metastases or Leptomeningeal metastases\n5. Prior systemic antitumor therapy (chemotherapy, targeted agents such as PARP inhibitors) or immune checkpoint inhibitors for SCLC\n6. Presence of active, unstable systemic disease such as active infection, autoimmune disease, inflammatory disease (uncontrolled hypertension, heart failure (NYHA classification \\>= Class II), unstable angina, acute coronary syndrome, severe arrhythmia, severe hepatic, renal or metabolic disease, human immunodeficiency virus (HIV) immunodeficiency virus (HIV) infected patients\n7. Previous allogeneic stem cell or solid organ transplantation\n8. Patients with prior interstitial lung disease, drug-induced interstitial lung disease, or active interstitial pneumonia requiring systemic glucocorticoid or immunosuppressive therapy; Patients with pulmonary interstitial fibrosis or active pulmonary tuberculosis\n9. Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia\n10. Received therapeutic oral or intravenous infusion of antibiotics within 2 weeks prior to the start of study treatment\n11. Been diagnosed or treated for another malignancy (excluding resected basal cell carcinoma of the skin or other carcinoma in situ) within 5 years prior to randomization to this study\n12. For pregnant or lactating females or male or female subjects of reproductive potential who refuse to use effective contraception during treatment and within 5 months of the last dose of sugemalimab and within 6 months of the last dose of cisplatin or etoposide\n13. Allergic to the study drug or its components\n14. The investigator believes that the patients may not be able to complete the study or comply with the requirements of the study\n15. Inadequate bone marrow function and vital organ function reserve\n16. Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study or a follow-up phase of an interventional study, excluding patients who have received any other experimental drug within 28 days prior to the start of study treatment\n17. Patients who are not suitable for etoposide-cisplatin chemotherapy, sugemalimab or olaparib\n18. History of thoracic radiotherapy or plan to receive intensive thoracic radiotherapy prior to systemic therapy. External chest radiotherapy for palliative purposes (e.g., bone metastases) is allowed, but must be completed prior to the first administration of study drug","75 Years",{"count":437,"type":21},45,[24,60],"The purpose of this study was to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) combined with sugemalimab, olaparib, chemotherapy in the first-line treatment of SLFN-11 positive extensive stage small cell lung cancer.",[441,110],"Lung Cancer","2026-04-29",{"date":444,"type":40},"2026-05-05",{"date":446,"type":40},"2024-04-18",{"date":448,"type":21},"2028-10-31",{"name":450,"class":266},"Sichuan University",{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":22,"phases":461,"briefSummary":462,"conditions":463,"keywords":465,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":477},"100508643","phase-2-monalizumab-in-combination-with-durvalumab-medi4736-for-trreatment-of-small-cell-lung-cancer-100508643","NCT05903092","MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer","A Phase II Trial of MOnaliZumab in Combination With durvAlumab (MEDI4736) for tReatmenT of Small Cell Lung Cancer (MOZART)","MOZART","General Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. Note: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent.\n3. Demonstrate adequate organ function. All screening labs to be obtained within 28 days prior to registration.\n\n   * Absolute Neutrophil Count (ANC) \\> 1500mm\\^3\n   * Hemoglobin ≥ 9 g\u002FdL\n   * Platelet Count (PLT) ≥ 100,000 per mm3\n   * Calculated creatinine clearance ≥ 40 mL\u002Fmin\n   * Bilirubin ≤ 1.5 × upper limit of normal (ULN); subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), may be allowed with sponsor-investigator approval.\n   * Apsartate aminotransferase (AST) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN\n   * Alanine aminotransferase (ALT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN\n4. Females of childbearing potential must have a negative serum pregnancy test at screening.\n5. Females of childbearing potential and male subjects must be willing to abstain from heterosexual intercourse or to use an effective method(s) of contraception.\n6. Life expectancy of ≥ 12 weeks.\n7. Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. 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, the HCV viral load must be undetectable through PCR to be eligible for this trial. Testing is not required for screening unless mandated by local authorities. Local guidelines for testing should be followed.\n\nExtensive Stage Specific Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of small cell lung cancer:\n\n   \\- Extensive disease (American Joint Committee on Cancer Stage (8th edition) IV SCLC \\[T any, N any, M1 a\u002Fb\\]), OR T3-4 disease due to multiple lung nodules that are too extensive or have tumor\u002Fnodal volume that is too large to be encompassed in a tolerable radiation plan.\n2. No prior systemic therapy for small-cell lung cancer, with the following exceptions: Up to one cycle of platinum doublet chemotherapy with or without durvalumab is allowed up to 4 weeks prior to registration on this study. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab and monalizumab may be included only after consultation with the sponsor-investigator. Patients should not have received Trilaciclib.\n3. Measurable disease according to RECIST v1.1.\n4. Subjects with treated brain metastasis or untreated asymptomatic brain metastasis that is clinically stable per investigator discretion and not requiring systemic steroids for ≥ 7 days. NOTE: Prophylactic cranial radiation (PCI) is allowed per investigator's discretion.\n5. ECOG Performance Status of 0-2.\n\nLimited Stage Specific Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of small cell lung cancer:\n\n   \\- Limited-stage disease (American Joint Committee on Cancer Stage (8th edition) I-III SCLC \\[T any, N any, M0\\])\n2. Has received platinum (cis- or carboplatin) and etoposide chemotherapy (4 cycles preferred; 3 cycles allowed if disease control is achieved and no additional benefit is expected with an additional cycle of chemotherapy in the opinion of the investigator) administered concurrently with radiation (60-66Gy daily or 45Gy BID). Radiation should have started no later than end of cycle 2 of chemotherapy.\n3. Non-progressive disease following completion of chemo-radiation.\n4. No evidence of brain metastasis. NOTE: PCI is allowed per investigator's discretion.\n5. Ability to start study treatment within 56 days of completing chemo-radiation, counting from whichever ends later\n6. ECOG Performance Status of 0-1.\n\nExclusion Criteria:\n\n1. Body weight ≤ 40 kg.\n2. Active infection requiring intravenous antibiotic therapy.\n3. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n4. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of study treatment. NOTE: Local surgery of isolated lesions for palliative intent is acceptable.\n5. History of active primary immunodeficiency.\n6. Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n7. Presence of neurologic paraneoplastic syndrome.\n8. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., ulcerative colitis or Crohn's disease\\], systemic lupus erythematosus, sarcoidosis, Wegener syndrome \\[granulomatosis with polyangiitis\\], 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 2 years may be included but only after consultation with the study physician\n   * Patients with celiac disease controlled by diet alone\n9. Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment. NOTE: Subjects, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 30 days after the last dose of study treatment.\n10. 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 AEs or compromise the ability of the patient to give written informed consent.\n11. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).\n12. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per investigator discretion.\n13. History of leptomeningeal carcinomatosis.\n14. History of allogeneic organ transplantation.\n15. Treatment with any investigational drug within 28 days prior to registration or concurrent enrolment in another clinical study, unless observational in nature.\n16. Current or prior use of immunosuppressive medication within 7 days before the first dose of monalizumab and durvalumab (applicable to 'on study' durvalumab for MOZART-ES cohort who may have received prior one 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), and for prevention of chemotherapy induced nausea\u002Fvomiting per institutional standards.\n17. Specific for MOZART-ES cohort: Patients who have received prior one dose of durvalumab along with chemotherapy:\n\n    * Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\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 ≤ 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 and not currently require maintenance doses of \\> 10 mg prednisone or equivalent per day.",{"count":460,"type":21},84,[60],"This study has 2 cohorts: MOZART-ES cohort (for extensive-stage SCLC) and MOZART-LS cohort (for limited-stage SCLC).\n\nMOZART-ES cohort: Study treatment will consist of a platinum drug (carboplatin or cisplatin per investigator's choice) plus etoposide plus durvalumab plus monalizumab every 3 weeks for 4 cycles. After 4 cycles, subjects will continue maintenance treatment with durvalumab plus monalizumab every 4 weeks until disease progression, unacceptable toxicity, decision to stop study treatment, or withdrawal of consent. Patients who have received one prior cycle of treatment before enrolling on the study will receive a total of 4 cycles with monalizumab, durvalumab, and chemotherapy. There will be a safety lead-in phase, including 6 to 12 patients, to confirm the safety of the proposed dose of monalizumab to use in combination with chemotherapy and durvalumab.\n\nMOZART-LS cohort: Study treatment will consist of durvalumab and monalizumab following standard of care chemo-radiation consisting of a platinum drug (carboplatin or cisplatin per investigator's choice) plus etoposide for 3-4 cycles and standard dose radiation. Radiation therapy should have started before completion of cycle 2 of chemotherapy. NOTE: Subjects who have non-progressive disease and meet the eligibility criteria can start study treatment up to 56 days from completion of chemo-radiation. Durvalumab and monalizumab will be administered every 4 weeks for up to 2 years (26 cycles), disease progression, unacceptable toxicity, decision to stop study treatment, or withdrawal consent, whichever occurs first.",[180,113,178,464],"Limited Stage Small-Cell Lung Cancer",[72,466,467,35,468],"First-line therapy","Chemoimmunotherapy","Monalizumab","2026-04-24",{"date":442,"type":40},{"date":472,"type":40},"2023-09-26",{"date":474,"type":21},"2030-10-31",{"name":476,"class":266},"Hirva Mamdani",4,{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":485,"enrollmentInfo":486,"targetDuration":4,"studyType":22,"phases":487,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":498},"100557342","phase-2-tislelizumab-combined-with-chemotherapy-and-thoracic-radiotherapy-in-es-sclc-100557342","NCT06536868","Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC","Tislelizumab Plus Chemotherapy and Concurrent Thoracic Radiotherapy as First-line Therapy for Extensive-stage Small-Cell Lung Cancer (ES-SCLC): an Multicenter, Single Arm Prospective Trial","Inclusion Criteria:\n\n* Patients aged between 18 to 80 years old (inclusive of 18th and 80th birthdays), male or female, at the time of signing the informed consent form;\n* Confirmed small cell lung cancer of extensive stage by histology or cytology;\n* At least one measurable lesion by imaging studies (according to RECIST 1.1) with a long diameter of ≥10 mm as examined by spiral CT or MRI;\n* Within 3 days prior to treatment, an ECOG score of 0 to 1;\n* No prior antitumor treatment for extensive stage disease (if the patient has previously received chemotherapy and\u002For radiotherapy in the limited stage of SCLC, the treatment intent must have been curative, and there must be at least a 6-month treatment-free interval between the end of chemotherapy, radiotherapy, or chemoradiotherapy and the diagnosis of extensive stage SCLC);\n* Expected life span of ≥3 months;\n* Good function of vital organs;\n* The subject voluntarily joins this study, signs the informed consent form, has good compliance, and cooperates with follow-up.\n\nExclusion Criteria:\n\n* Concurrent severe respiratory diseases: such as pulmonary fibrosis;\n* Presence of psychiatric disorders, hematologic diseases, autoimmune diseases, and severe primary diseases of the heart, brain, liver, or kidneys;\n* Uncontrolled active infections;\n* Known or suspected allergies to the study medication and its excipients;\n* Female patients who are pregnant or breastfeeding, or women of childbearing potential with a positive baseline pregnancy test;\n* Prior use of antitumor treatment targeting the PD-(L)1 pathway.","80 Years",{"count":5,"type":21},[60],"This study is a single arm, open, multicenter phase II study. The main purpose of this study was to evaluate preliminary efficacy and safety of Tislelizumab combined with thoracic radiotherapy as first line therapy for Extensive stage small cell lung cancer.",[110],"2026-04-21",{"date":469,"type":40},{"date":493,"type":40},"2024-08-01",{"date":495,"type":21},"2026-12-31",{"name":497,"class":266},"Second Hospital of Shanxi Medical University",6,{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":22,"phases":508,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":519},"100631562","phase-3-a-study-comparing-bl-b01d1-combined-with-tislelizumab-versus-platinum-containing-chemotherapy-combined-with-tislelizumab-as-first-line-treatment-in-patients-with-extensive-stage-small-cell-lung-cancerpanku-lung07-100631562","NCT07502300","A Study Comparing BL-B01D1 Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer(PANKU-Lung07)","A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 for Injection Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Age ≥ 18 years;\n3. Expected survival time ≥ 3 months;\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n5. Patients with histopathologically and\u002For cytologically confirmed extensive-stage small cell lung cancer;\n6. Agree to provide archived tumor tissue specimens from the primary or metastatic lesions within 3 years, or fresh tissue samples;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n9. No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%;\n10. Organ function levels must meet the requirements;\n11. Urinary protein ≤ 2+ or \\\u003C 1000 mg\u002F24h;\n12. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, and the serum pregnancy test must be negative; patients must not be breastfeeding. All enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Pathology indicates small cell carcinoma containing non-small cell carcinoma components;\n2. Patients who have previously received systemic treatment;\n3. Previous treatment with ADC drugs where the small molecule toxin is a topoisomerase I inhibitor;\n4. Use of immunomodulatory drugs within 14 days prior to the first dose of the study drug;\n5. History of severe heart disease or cerebrovascular disease;\n6. Receiving long-term systemic corticosteroid therapy at a dose \\>10 mg\u002Fday of prednisone or equivalent prior to the first dose;\n7. Active autoimmune diseases and inflammatory diseases;\n8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;\n9. Prolonged QT interval, complete left bundle branch block, etc.;\n10. Diagnosis of active malignancy within 3 years prior to study randomization;\n11. Hypertension inadequately controlled with two antihypertensive medications;\n12. Poorly controlled diabetes mellitus;\n13. History of interstitial lung disease (ILD)\u002Fpneumonitis requiring steroid therapy, etc.;\n14. Concurrent pulmonary disease resulting in clinically severe impairment of respiratory function;\n15. Patients with active central nervous system (CNS) metastases;\n16. Severe infection within 4 weeks prior to study randomization;\n17. Presence of large serous cavity effusions, or serous cavity effusions with symptoms, etc.;\n18. Imaging findings indicating tumor invasion or encasement of major blood vessels in the abdomen, chest, neck, or pharynx;\n19. Severe, non-healing wound, ulcer, or bone fracture within 4 weeks prior to signing informed consent;\n20. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;\n21. Patients with inflammatory bowel disease, history of extensive bowel resection, history of immune-related enteritis, intestinal obstruction, or chronic diarrhea;\n22. History of allergy to recombinant humanized antibodies or any excipient component of BL-B01D1;\n23. History of autologous or allogeneic stem cell transplantation;\n24. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection;\n25. History of severe neurological or psychiatric disorders;\n26. Receipt of other unapproved clinical study drugs or treatments within 4 weeks prior to study randomization;\n27. Subjects planning to receive or having received live vaccines within 28 days prior to study randomization;\n28. Other conditions deemed by the investigator to make the subject unsuitable for participation in this clinical trial due to complications or other circumstances.",{"count":507,"type":21},562,[107],"This trial is a registrational Phase III, randomized, open-label, multicenter study to compare the efficacy and safety of BL-B01D1 in combination with tislelizumab versus platinum-based chemotherapy in combination with tislelizumab in first-line patients with extensive-stage small cell lung cancer.",[110],"2026-04-15",{"date":513,"type":40},"2026-04-20",{"date":515,"type":21},"2026-04",{"date":517,"type":21},"2029-12",{"name":288,"class":82},2,{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":22,"phases":529,"briefSummary":530,"conditions":531,"keywords":532,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":519},"100444500","phase-2-durvalumab-and-ablative-radiation-in-small-cell-lung-cancer-dares-100444500","NCT05068232","Durvalumab and Ablative Radiation in Small Cell Lung Cancer (DARES)","A Phase II Trial of Durvalumab and Ablative Radiation in Extensive-Stage Small Cell Lung Cancer (DARES)","Inclusion Criteria:\n\nFor inclusion in the study patients must fulfill all of the following criteria:\n\n1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol.\n2. Age \\> 18 years at time of study entry.\n3. Have a histologic\u002Fclinically confirmed diagnosis of small cell lung cancer with known metastatic disease.\n4. Patient is suitable to receive a platinum-based chemotherapy regimen as first line treatment for extensive stage small cell lung cancer.\n5. Brain metastases must be asymptomatic or treated and stable off steroids and anti-convulsant for at least 2 weeks prior to study treatment.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n7. Life expectancy of at least 12 weeks\n8. Body weight \\>30 kg\n9. Adequate normal organ and marrow function as defined by lab values the study doctor will review.\n10. 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.\n11. Have measurable disease based on Response Evaluation Criteria in Solid Tumor (RECIST 1.1) including at least ONE lesion that meets criteria for ablative radiation, including 0.25 cc to 65 cc of viable tumor (i.e. primary disease or metastases) approximately 5cm in maximal dimension. Tumors larger than 65 cc can be partially treated.\n12. Female subject of childbearing potential should have a negative urine or serum pregnancy within 24 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n13. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n14. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n\nExclusion Criteria:\n\nPatients should not enter the study if any of the following exclusion criteria are fulfilled:\n\n1. Participation in another clinical study with an investigational product during the last 2 weeks.\n2. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study\n3. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria:\n\n   1. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n   2. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.\n4. Any concurrent chemotherapy, investigational product (IP), biologic, or hormonal therapy for cancer treatment, outside of those specified as part of this clinical trial. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n5. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug\n6. 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.\n7. History of allogenic organ transplantation.\n8. 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   1. Patients with vitiligo or alopecia\n   2. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n   3. Any chronic skin condition that does not require systemic therapy\n   4. Patients without active disease in the last 5 years may be included but only after consultation with the study physician\n   5. Patients with celiac disease controlled by diet alone\n9. 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 AEs or compromise the ability of the patient to give written informed consent\n10. History of another primary malignancy except for\n\n    1. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence\n    2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n    3. Adequately treated carcinoma in situ without evidence of disease\n11. History of leptomeningeal carcinomatosis\n12. Has a paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS.\n13. All patients at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry. Patients whose brain metastases have been treated may participate provided they show 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 two weeks apart and show no evidence of intracranial progression). 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 ≤10mg\u002Fday of prednisone or its equivalent for at least 14 days prior to the start of treatment. Brain metastases will not be recorded as RECIST Target Lesions at baseline.\n14. History of active primary immunodeficiency\n15. 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 HBV surface antigen (HBsAg) result), hepatitis C, or HIV. 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 hepatitis C (HCV) ribonucleic acid (RNA).\n16. 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    1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n    2. Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n    3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n17. 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.\n18. 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.\n19. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n20. Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.\n21. Has received prior chemotherapy, immunotherapy or thoracic radiation for small cell lung cancer.\n22. Has prior exposure to anti-PD (Programmed death-ligand 1) 1\u002FPD-L1 or anti- cytotoxic T lymphocyte-associated antigen (CTLA4) therapy.\n23. Has had prior radiation therapy (defined as \\>10% of prior prescription dose) to the area planning to be treated with trial RT.\n\nProcedures for withdrawal of incorrectly enrolled patients are presented in Section 4.3",{"count":528,"type":21},49,[60],"This this study is for individuals who have treatment-naïve extensive-stage small cell lung cancer (small cell lung cancer that wont respond to treatment). Doctors leading this study hope to learn if combining durvalumab, carboplatin and etoposide with hyofractionated ablative radiation therapy (radiation focused on certain parts of the body) will help treat your cancer and improve how long you can live with extensive-stage small cell cancer without it getting worse (progression-free survival). Your participation in this research will last about 48 months.\n\nDurvalumab along with chemotherapy has been approved by the Food and Drug Administration (FDA) for the treatment of small cell lung cancer along with chemotherapy. This study is testing the addition of radiation to durvalumab and chemotherapy.",[205,110,441],[533,534,535],"small cell lung cancer","extensive small lung cancer","lung cancer","2026-03-02",{"date":538,"type":40},"2026-03-04",{"date":540,"type":40},"2022-08-19",{"date":542,"type":21},"2027-10-01",{"name":544,"class":266},"University of Chicago",{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":22,"phases":554,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":498},"100601207","phase-1-a-phase-i-study-of-alps12-in-patients-with-extensive-stage-small-cell-lung-cancer-100601207","NCT07107490","A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER","AN OPEN-LABEL, MULTICENTER PHASE I STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY ANTI-TUMOR ACTIVITY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* Aged \\>18 years at time of informed consent\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1\n* Histologically documented extensive stage small cell lung cancer\n* Disease recurrence documented after at least one prior systemic therapy.\n* Confirmed availability of representative archival tumor specimens or fresh tumor specimen.\n* Measurable disease per RECIST v.1.1.\n* Adequate hematologic and end organ function\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study\n* History or complication of clinically significant autoimmune disease\n* a positive HIV antibody test at screening\n* Active hepatitis B or hepatitis C\n* Prior treatment with anti-CD137 antibody drugs, anti-CD3 antibody drugs, and\u002For DLL3-targeted therapies\n* Patients who have received any investigational or approved anticancer therapy, including hormone therapy and\u002For radiotherapy, within 21 days prior to the first administration of the investigational drug.\n* History of Grade 4 immune-related adverse events caused by prior anti-PD-L1\u002FPD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase\u002Flipase)\n* Patients who discontinued immunotherapy due to Grade 3 immune-related adverse events caused by prior anti-PD-L1\u002FPD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase\u002Flipase), and\u002For patients who experienced Grade 3 immune-related adverse events caused by immunotherapy within 6 months prior to the first administration of the investigational drug\n* Patients who received a live attenuated vaccine within 4 weeks prior to the first administration of the investigational drug\n* History or clinical evidence of primary central nervous system (CNS) malignancy, symptomatic CNS metastases, CNS metastases requiring any anti tumor treatment, or leptomeningeal disease\n* Current or past CNS diseases (e.g., stroke, epilepsy, CNS vasculitis, neurodegenerative diseases)",{"count":553,"type":21},122,[24],"This study is a phase I, open-label, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of ALPS12 in patients with extensive-stage small cell lung cancer. The study consists of two parts: a dose-escalation part and an expansion part.",[178],"2026-02-04",{"date":559,"type":40},"2026-02-06",{"date":561,"type":40},"2025-10-08",{"date":563,"type":21},"2028-09-30",{"name":565,"class":82},"Chugai Pharmaceutical",{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":22,"phases":575,"briefSummary":576,"conditions":577,"keywords":579,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":582,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":588},"100543928","phase-1-a-study-of-i-dxd-in-combination-with-atezolizumab-with-or-without-carboplatin-as-first-line-induction-or-maintenance-in-subjects-with-extensive-stage-small-cell-lung-cancer-ideate-lung03-100543928","NCT06362252","A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03)","A Phase 1b\u002F2, Multicenter, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody-Drug Conjugate (ADC), in Combination With Atezolizumab With or Without Carboplatin as First-line Induction or Maintenance, in Subjects With Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung03)","A full list of inclusion\u002Fexclusion criteria are available in the protocol.\n\nInclusion Criteria\n\nParticipants must meet all of the following criteria to be eligible for enrollment into the study:\n\n1. Sign and date the informed consent form (ICF), prior to the start of any study-specific qualification procedures.\n2. Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed.\n3. Has histologically or cytologically confirmed diagnosis of ES-SCLC who will require first-line (IL) therapy.\n4. For Cohort 1, participant has received 4 cycles of 1L induction therapy with carboplatin, etoposide, and atezolizumab for ES-SCLC with ongoing CR PR, CR, or SD per RECIST v1.1 assessed by the investigator.\n\n   For Cohort 2, participant has received no prior treatment for ES-SCLC.\n5. For Cohort 2, participant has at least one measurable lesion according to RECIST v1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by the investigator.\n6. For Cohort 2, participant must have at least one lesion, amenable to core biopsy, and must consent to provide a pretreatment biopsy tissue sample and on-treatment biopsy.\n7. Has ECOG PS of ≤1 (assessed within 7 days before enrollment\u002Frandomization).\n8. Has adequate organ and bone marrow function within 7 days before the start of study treatment as specified in the study protocol.\n9. A female subject of childbearing potential (POCBP) is eligible to participate if the following conditions are met:\n\n   1. Subject is not pregnant as confirmed by highly sensitive pregnancy test during Screening (within 3 days prior to enrollment\u002Frandomization)\n   2. Subject does not breastfeed during the treatment period and for at least 8\u002F5\u002F6 months after last dose of I-DXd\u002Fatezolizumab\u002Fcarboplatin, respectively.\n   3. Subject agrees to adhere to a contraceptive method that is highly effective and agrees not to donate eggs (ova, oocytes) to others or freeze\u002Fstore eggs during the treatment period and for at least the time needed to eliminate each study drug after the last dose. The length of time required to continue contraception and avoid donating\u002Ffreezing eggs after last dose for I-DXd\u002Fatezolizumab\u002Fcarboplatin is 8\u002F5\u002F6 months, respectively. Preservation of eggs may be considered prior to first dose of study drug.\n10. A male subject capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate each study drug. The length of time required to continue contraception and avoid donating sperm after last dose for I-DXd\u002Fatezolizumab\u002Fcarboplatin is 6\u002F5\u002F6 months, respectively.\n\n    1. Avoid donating sperm.\n    2. Adhere to either of the contraception methods: true abstinence from penile-vaginal intercourse or uses a penile\u002Fexternal condom when having penile-vaginal intercourse with a non-subject of childbearing potential plus partner use of an additional contraceptive method.\n11. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.\n\nExclusion Criteria\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.\n2. Prior discontinuation of an ADC that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.\n3. Has received prior treatment with CD137 agonists or ICIs, including anti-cytotoxic T-cell lymphocyte-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, except for atezolizumab for Cohort 1.\n4. Has inadequate washout period before enrollment\u002Frandomization as specified in the study protocol.\n5. Has any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.\n6. Has clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.\n7. Has clinically significant corneal disease.\n8. Has uncontrolled or significant cardiovascular disease,.\n9. Has history of (non-infectious) ILD\u002Fpneumonitis that required corticosteroids, current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at Screening.\n10. Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n11. Is on chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except for low-dose inhaled steroids (for asthma\u002Fchronic obstructive pulmonary disease, topical steroids (for mild skin conditions), or intra-articular steroid injections.\n12. Has history of malignancy other than SCLC within the 5 years prior to randomization\u002Fenrollment, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial gastrointestinal tract tumors, and non-muscle invasive bladder cancer curatively resected by endoscopic surgery.\n13. Has history of allogeneic bone marrow, stem cell, or solid organ transplant.\n14. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE V5.0, Grade ≤1 or baseline.\n15. Has history of hypersensitivity to the drug substances, inactive ingredients in the drug product or severe hypersensitivity reactions to other monoclonal antibodies.\n16. Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.\n17. Has active or uncontrolled human immunodeficiency virus (HIV) infection.\n18. Has active or uncontrolled hepatitis B or C virus (HBV or HCV) infection.\n19. Has history of autoimmune disease.\n20. Has any evidence of severe or uncontrolled systemic diseases.\n21. Has received a live vaccine within 30 days prior to the first dose of study drug.\n22. Is a female who is pregnant or breastfeeding or planning to become pregnant.\n23. Has prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant; alter the absorption, distribution, metabolism, or excretion of the study drug; or confound the assessment of study results.\n24. Has psychological, social, familial, or logistical factors that would prevent regular follow-up",{"count":574,"type":21},123,[24,60],"This study is designed to evaluate the safety and efficacy of ifinatamab deruxtecan (I-DXd) in combination with immune checkpoint inhibitor (ICI) atezolizumab with or without carboplatin in participants with extensive stage-small cell lung cancer (ES-SCLC) in the first-line (1L) setting.",[578],"Extensive Stage-small Cell Lung Cancer",[580,581,304],"Extensive stage-small cell lung cancer (ES-SCLC)","Ifinatamab deruxtecan",{"date":559,"type":40},{"date":584,"type":40},"2024-07-22",{"date":586,"type":21},"2026-12-30",{"name":310,"class":82},58,{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":595,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":597,"targetDuration":4,"studyType":22,"phases":598,"briefSummary":599,"conditions":600,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":607,"locationsCount":4},"100622842","phase-2-sacituzumab-tirumotecan-plus-anlotinib-in-previously-treated-es-sclc-100622842","NCT07388875","Sacituzumab Tirumotecan Plus Anlotinib in Previously Treated ES-SCLC","A Single-arm, Phase II Study of Sacituzumab Tirumotecan Combined With Anlotinib in Patients With Extensive-stage Small Cell Lung Cancer After Failure of PD-(L)1 Inhibitor Plus Chemotherapy","SKB264-ANLO","Inclusion Criteria:\n\n* Age ≥18 years at the time of signing informed consent; male or female.\n* Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).\n* Disease progression after receiving only one prior line of therapy consisting of a PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy.\n* At least one measurable target lesion per RECIST v1.1 as assessed by the investigator, which has not been previously irradiated.\n* Patients with asymptomatic brain metastases, or patients with treated brain metastases and stable symptoms for ≥4 weeks, are eligible.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Estimated life expectancy of at least 12 weeks.\n* Adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin, or colony-stimulating factors within 2 weeks prior to first dose), defined as follows:\n* Hematologic function:\n* Absolute neutrophil count ≥1.5 × 10⁹\u002FL\n* Platelet count ≥100 × 10⁹\u002FL\n* Hemoglobin ≥90 g\u002FL\n* Hepatic function:\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN; for patients with liver metastases, AST and ALT ≤5 × ULN\n* Albumin ≥30 g\u002FL\n* Total bilirubin ≤1.5 × ULN\n* Renal function:\n* Creatinine clearance ≥50 mL\u002Fmin, calculated using the Cockcroft-Gault formula\n* Coagulation function:\n* International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) ≤1.5 × ULN\n* Women of childbearing potential and men with partners of childbearing potential must agree to use effective medical contraception from signing informed consent until 6 months after the last dose of study treatment.\n* Subjects must voluntarily participate in the study, provide written informed consent, and be able to comply with protocol-required visits and study procedures.\n\nExclusion Criteria:\n\n* Participation in another interventional drug clinical trial within 4 weeks prior to enrollment.\n* Tumors with a high risk of massive hemoptysis, as judged by the investigator.\n* Prior systemic anti-tumor therapy with anti-angiogenic agents.\n* Prior treatment with TROP2-targeted therapies and\u002For topoisomerase I inhibitors.\n* History of other malignancies within the past 5 years, except for adequately treated cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.\n* Known hypersensitivity or allergy to any investigational product or its components.\n* Known positive human immunodeficiency virus (HIV) infection, history of acquired immunodeficiency syndrome (AIDS), or known active syphilis infection.\n* History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Receipt of live vaccines within 30 days prior to the first dose of study treatment.\n* History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment; current ILD or non-infectious pneumonitis; or suspected ILD or non-infectious pneumonitis that cannot be excluded by imaging at screening. Severe pulmonary impairment due to pulmonary comorbidities, including but not limited to:\n* Pulmonary embolism within 3 months prior to first dose\n* Severe asthma\n* Severe chronic obstructive pulmonary disease\n* Restrictive lung disease\n* Pleural effusion\n* Autoimmune, connective tissue, or inflammatory diseases involving the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis)\n* Prior pneumonectomy\n* Active autoimmune disease requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, such as type 1 diabetes mellitus, hypothyroidism requiring only thyroid hormone replacement, or adrenal or pituitary insufficiency requiring physiologic doses of corticosteroids).\n* Active infection requiring systemic therapy within 2 weeks prior to the first dose of study treatment.\n* Serious concomitant diseases that, in the investigator's judgment, may compromise patient safety or interfere with completion of the study, including but not limited to uncontrolled hypertension, severe diabetes mellitus, or active infection.\n* Documented severe dry eye syndrome, severe meibomian gland dysfunction and\u002For blepharitis, or a history of corneal disorders that may interfere with delayed corneal healing.\n* Pregnant or breastfeeding women; women of childbearing potential with a positive baseline pregnancy test; or women of childbearing potential who are unwilling to use effective contraception during study treatment and for 6 months after the last dose of study treatment.\n* Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in the study.",{"count":346,"type":21},[60],"This is a Phase II, single-arm, open-label clinical study to evaluate the efficacy and safety of Sacituzumab Tirumotecan (SKB264) combined with Anlotinib in patients with extensive-stage small cell lung cancer (ES-SCLC). The study is designed for patients who have experienced disease progression or treatment failure after prior first-line therapy with a PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy. The primary hypothesis is that this combination therapy will improve the objective response rate compared to historical controls.",[27],"2026-01-28",{"date":603,"type":40},"2026-02-05",{"date":605,"type":21},"2026-02-24",{"date":263,"type":21},{"name":608,"class":266},"China Medical University, China",{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":154,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":616,"targetDuration":4,"studyType":225,"phases":4,"briefSummary":617,"conditions":618,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":48},"100611702","clinical-study-on-using-tcr-to-predict-the-effect-of-tislelizumab--chemotherapy-in-the-first-line-treatment-of-es-sclc-100611702","NCT07244016","Clinical Study on Using TCR to Predict the Effect of Tislelizumab + Chemotherapy in the First-line Treatment of ES-SCLC","Clinical Study on Using T Cell Repertoire Technology to Predict the Therapeutic Effect of Tislelizumab + Standard Chemotherapy in the First-line Treatment of Extensive-stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically proven ES-SCLC (American Joint Cancer Commission (7th Edition) Stage IV SCLC \\[any T, any N and M1a\u002Fb\\]), or T3-4 patients who are unable to be included in a tolerable radiotherapy program due to wide multiple incidences or excessive tumor volume.\n* Patients with brain metastases must have asymptomatic or stable steroid and anticonvulsant treatment for at least 1 month before study treatment. Patients with suspected brain metastasis during screening should undergo brain CT\u002FMRI examination before enrollment of the study.\n* Have at least one measurable tumour lesion according to RECIST v1.1.\n* aged ≥18 years\n* Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1\n\nExclusion Criteria:\n\n* Have a history of chest radiotherapy or plan to undergo intensive chest radiotherapy before systemic treatment. Radiotherapy outside the chest (i.e., bone metastasis) is allowed for palliative care purposes, however, must be done before the first medication of the study drug\n* Previous non-infectious pneumonia requiring systemic glucocorticoid therapy or current non-infectious pneumonia combined with mild to moderate interstitial pneumonia, inactive interstitial pneumonia.\n* Presence of unmitigated toxicity from prior antineoplastic therapy, with unmitigated defined as failure to recover to NCI CTCAE version 5.0 grade 0 or 1 (except alopecia areata) or failure to recover to levels specified in the inclusion\u002Fexclusion criteria.\n* History of known allogeneic organ transplantation and allogeneic haematopoietic stem cell transplantation; history of organ or haematopoietic stem cell transplantation requiring immunosuppression.\n* Patients with chronic hepatitis B or chronic hepatitis B virus carriers with HBV DNA ≥500 IU\u002FmL (2500 copies\u002FmL), or hepatitis C patients.\n* Other circumstances as determined by the investigator.",{"count":5,"type":21},"This is a prospective observational clinical study designed to predict the therapeutic efficacy of first-line treatment with tislelizumab combined with standard chemotherapy in patients with ES-SCLC using TCR repertoire technology. The study plans to enroll 40 treatment-naive patients with ES-SCLC.",[110],"2025-11-21",{"date":621,"type":40},"2025-11-24",{"date":623,"type":40},"2025-02-20",{"date":625,"type":21},"2027-07-01",{"name":627,"class":628},"Henan Cancer Hospital","OTHER_GOV"]