[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extensive-stage-small-cell-lung-cancer-es-sclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extensive-stage-small-cell-lung-cancer-es-sclc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,41,74,95,125,154,181,205,230,256,282,304,325,347,373,394,417,437,461,482],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100577710","phase-3-study-of-sacituzumab-govitecan-versus-standard-of-care-in-participants-with-previously-treated-extensive-stage-small-cell-lung-cancer-100577710",false,"NCT06801834","Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer","A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)","EVOKE-SCLC-04","Key Inclusion Criteria:\n\n* Histologically confirmed diagnosis of SCLC.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by investigator per RECIST v1.1 criteria.\n* Documentation of radiological disease progression after 1 prior line of platinum-containing chemotherapy (defined as at least 2 cycles of treatment) with or without therapy directed against programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1; PD-1 and PD-L1 are hereafter referred to as PD-(L)1) for ES-SCLC.\n* Individuals treated with a platinum-based therapy for prior limited stage small cell lung cancer will be counted as 1 prior line of platinum-containing chemotherapy if the disease has progressed within 30 to 180 days from last dose of platinum treatment.\n* If the investigator believes a participant may benefit from platinum rechallenge it can be considered per investigator discretion and local SOC; however, participants with platinum rechallenge may not participate in the study.\n* If the investigator believes a participant may benefit from tarlatamab treatment, it can be considered per investigator discretion and local SOC and such participants may participate in the study following tarlatamab treatment.\n\nNote: at least 85% of participants included in the study must be pretreated with anti-PD-\\[L\\]1 therapy.\n\nRefer to protocol for country-specific requirements for participants in China.\n\nKey Exclusion Criteria:\n\n* Chemotherapy-free interval (CTFI) time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) \\\u003C 30 days (independent of the immunotherapy maintenance).\n* Received any prior treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives, and similar agents targeting topoisomerase I. Received lurbinectedin after progression on or after platinum-based chemotherapy.\n* Have carcinomatous meningitis and\u002For non-carcinomatous meningitis central nervous system (CNS) metastasis apart from the following noted exceptions. Participants with previously treated brain metastases may participate provided they have stable CNS disease (ie, without evidence of progression) for at least 4 weeks (independent from completion of definitive treatment) prior to randomization and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking ≤ 10 mg\u002Fday of prednisone or its equivalent. Participants with untreated, clinically stable brain metastases will be allowed if they are asymptomatic and the investigator determines there is no immediate CNS-specific treatment required, there is no surrounding edema, and the brain metastases are of 5 mm or less in size and 3 or fewer lesions.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":20,"type":21},695,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC).\n\nThe primary objectives of this study are to compare the effect of SG to SOC on overall survival (OS).",[27],"Extensive Stage Small Cell Lung Cancer (ES-SCLC)","RECRUITING","2026-06-23",{"date":31,"type":32},"2026-06-24","ACTUAL",{"date":34,"type":32},"2025-04-04",{"date":36,"type":21},"2029-10",{"name":38,"class":39},"Gilead Sciences","INDUSTRY",218,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100636339","phase-1-a-study-to-evaluate-dji136-a-dll3-targeted-car-t-therapy-100636339","NCT07564401","A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy","A Phase I\u002FII Open-label Study of DJI136, a DLL3-targeted CAR-T Therapy, in Adult Patients With ES-SCLC","Inclusion Criteria:\n\n* Phase I: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (that included a platinum-based doublet chemotherapy in combination with a PD-L1 inhibitor) according to the local SOC (2L+), unless the patient was ineligible to receive such therapies or was not a candidate for any available standard therapy, according to the investigator's judgement. Prior DLL3 (Delta-like ligand 3) targeted therapy is allowed.\n* Phase II: Patients with ES-SCLC who have received a platinum-based doublet chemotherapy in combination with a PD-L1 inhibitor according to local standard of care, unless the patient was ineligible to receive such therapies or was not a candidate for any available standard therapy, as determined by the investigator's judgment. Prior DLL-3 targeted therapy is not allowed.\n* Male or female patients must be ≥ 18 years of age.\n* Histologically or cytologically confirmed small cell lung cancer (SCLC).\n* At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Patients must have an archival tumor tissue available, collected within 6 months prior to screening. If an archival tumor sample, collected within 6 months prior to screening, is not available, patients must be willing to undergo a new tumor biopsy at screening; , however this specimen need not be collected prior to scheduling leukapheresis. If a new biopsy is not medically feasible, exceptions may be considered after documented discussion with the Novartis medical monitor.\n* Patient must be deemed suitable by the investigator to undergo the lymphodepletion (LD) regimen.\n* Patient must have an apheresis product of non-mobilized cells accepted for manufacturing.\n\nExclusion Criteria:\n\n* Prior administration of a genetically modified cellular product, including prior DLL3-targeted CAR-T cell therapy.\n* Unstable or symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Stable brain metastases may participate provided they meet the specific criteria.\n* Uncontrolled seizure disorder.\n* Clinically significant active infections, including Hepatitis B\u002FC and Human Immunodeficiency Virus (HIV).\n* Has a known additional malignancy that is progressing or requires active treatment, with specific exceptions as defined in the study protocol.\n* History of prior solid organ transplant or allogenic hematopoietic cell transplant\n* Other significant pulmonary, cardiac, hepatic, renal or neurologic disease, parameters for which are defined in the study protocol.\n* Pregnant or nursing women.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":49,"type":21},80,[51,52],"PHASE1","PHASE2","This is a Phase I\u002FII, open-label, non-randomized, multi-center study in patients with extensive-stage small cell lung cancer (ES-SCLC) to determine the recommended dose(s) (RD) and to evaluate the safety, tolerability and preliminary efficacy of DJI136.",[55],"Extensive-stage Small Cell Lung Cancer (ES-SCLC)",[57,58,59,60,61,62,63,64],"Small cell lung cancer","SCLC","Extensive-stage small cell lung cancer","ES-SCLC","Chimeric antigen receptor (CAR)-T cell therapy","Delta-like ligand 3","DLL3","DJI136","2026-06-22",{"date":29,"type":32},{"date":68,"type":32},"2026-06-16",{"date":70,"type":21},"2031-03-03",{"name":72,"class":39},"Novartis Pharmaceuticals",4,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100629272","phase-3-dareon---lung-1-a-study-in-people-with-advanced-small-cell-lung-cancer-to-compare-obrixtamig-plus-atezolizumab-carboplatin-and-etoposide-treatment-with-standard-chemotherapy-100629272","NCT07472517","DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemotherapy","DAREON ® -Lung-1: A Phase III Multi-center, Open-label, Randomised Trial of Intravenous Obrixtamig in Combination With Atezolizumab, Carboplatin, and Etoposide vs. Atezolizumab, Carboplatin, and Etoposide as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer","Inclusion Criteria :\n\n1. Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC)\n2. Patients without any previous systematic anti-cancer treatment for ES-SCLC. Patients who received previous systematic anti-cancer treatment during limited stage are eligible if the treatment has been completed more than 6 months before the diagnosis of ES-SCLC.\n3. Adequate archival formalin-fixed paraffin-embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status and other biomarkers. The central laboratory investigational VENTANA DLL3 (SP347) RxDx test result must be available prior to randomisation.\n4. Patients with asymptomatic brain metastasis are eligible if they meet one of the following criteria:\n\n   * Treatment for brain metastases (e.g. whole brain radiation therapy, stereotactic radiotherapy, or radiosurgery) completed at least 14 days prior to randomisation and neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 7 days prior to randomisation\n   * Untreated brain metastases that do not require treatment and are neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 28 days prior to randomisation\n5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n6. Eligible for continuing carboplatin + etoposide + atezolizumab regimen as first-line Standard of care (SoC) treatment within 28 days after the start of the initial cycle of standard therapy\n7. Eligible to receive treatment with full dose of atezolizumab, carboplatin, and etoposide as first-line SoC treatment, in accordance with the approved Summary of Product Characteristics if provided centrally or approved local product label if provided by the trial site Further inclusion criteria apply.\n\nExclusion Criteria :\n\n1. Presence of leptomeningeal disease and\u002For carcinomatous meningitis\n2. Previous treatment targeting DLL3 (e.g. T cell engagers (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)\n3. Radiotherapy of any anatomical sites within 14 days prior to randomisation\n4. Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia\u002Ffatigue, amenorrhea\u002Fmenstrual disorders, CTCAE Grade 2 peripheral neuropathy, and CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks prior to randomisation, per investigator judgment)\n5. Patient with active autoimmune disease or a documented history of autoimmune disease that requires systemic treatment (e.g. glucocorticoids or immunosuppressive drugs). Patients with vitiligo, resolved childhood asthma\u002Fatopy, alopecia, or any chronic skin condition that does not require systemic therapy, patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and\u002For controlled Type 1 diabetes mellitus on a stable insulin regimen may be included if in the opinion of the investigator it is appropriate and safe to do so.\n\nFurther exclusion criteria apply.",{"count":82,"type":21},670,[24],"This study is open to adults with advanced small cell lung cancer (SCLC). The purpose of this study is to find out if a study medicine called obrixtamig plus standard treatment (atezolizumab, carboplatin, and etoposide) improves survival when compared to standard treatment alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker DLL3.\n\nParticipants are put into 2 groups randomly, which means by chance. One group receives obrixtamig and standard treatment. The other group receives standard treatment without obrixtamig. All treatments are given as infusions into a vein.\n\nParticipants are in the study for up to 3 years. During this time, they visit the study site regularly. Participants in the group receiving obrixtamig stay overnight at the study site following the first 2 obrixtamig treatments. At the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[86,55],"Small Cell Lung Cancer (SCLC)",{"date":29,"type":32},{"date":89,"type":32},"2026-04-13",{"date":91,"type":21},"2029-07-30",{"name":93,"class":39},"Boehringer Ingelheim",237,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":111,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":124},"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":104,"type":21},40,[52],"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).",[55,108,109,110],"Extensive Stage Lung Small Cell Cancer","Extensive-Stage Small-Cell Lung Cancer","Extensive Disease Small Cell Lung Cancer",[112,113,114,115,58],"Tafolecimab","Sintilimab","immunotherapy","PCSK9 inhibitor",{"date":29,"type":32},{"date":118,"type":32},"2025-07-30",{"date":120,"type":21},"2027-08-01",{"name":122,"class":123},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",5,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":4},"100635026","phase-2-nab-paclitaxel-combined-with-local-therapy-in-relapsed-sclc-100635026","NCT07547332","Nab-Paclitaxel Combined With Local Therapy in Relapsed SCLC","A Single-arm, Multicenter, Exploratory Study to Evaluate the Efficacy and Safety of Nab-paclitaxel Combined With Local Therapy in Patients With Small-cell Lung Cancer Receiving Second-line or Subsequent Treatment","Inclusion Criteria:\n\n* (1) Written informed consent has been signed. (2) Male or female, aged 18-75 years. (3) Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n\n  (4) Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to the Veterans Administration Lung Group (VALG) staging system.\n\n  (5) Patients with ES-SCLC who have received at least one prior line of systemic therapy.\n\n  (6) Patients with previously treated asymptomatic central nervous system (CNS) metastases are eligible if all of the following criteria are met:\n  * Only supratentorial and cerebellar metastases (i.e., no metastases in the midbrain, pons, medulla oblongata, or spinal cord);\n\n    * No requirement for ongoing corticosteroid therapy for CNS disease;\n\n      * No stereotactic radiotherapy within 7 days prior to randomization;\n\n        * No disease progression observed on imaging from completion of CNS-directed therapy through screening;\n\n          ⑤ If new asymptomatic CNS metastases are detected on screening imaging, patients must receive radiotherapy and\u002For resection of CNS lesions. After such treatment, these patients may be randomized without additional brain scans if all other eligibility criteria are satisfied.\n\n          (7) Presence of measurable disease as defined by RECIST v1.1. A previously irradiated lesion may be considered measurable only if clear disease progression has occurred after radiotherapy and the lesion is not the only site of disease.\n\n          (8) Adequate hematologic and end-organ function as defined by laboratory results obtained within 14 days prior to randomization:\n  * Absolute neutrophil count (ANC) ≥ 1500 cells\u002FμL without granulocyte colony-stimulating factor support; lymphocyte count ≥ 500 cells\u002FμL;\n\n    * Platelet count ≥ 100,000\u002FμL without transfusion; hemoglobin ≥ 9.0 g\u002FdL (may be achieved by transfusion); ③ International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤ 1.5 × upper limit of normal (ULN). This criterion applies only to patients not receiving anticoagulation. Patients on anticoagulation must be on a stable dose; ④ Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5 × ULN, except: Patients with confirmed liver metastases: AST and\u002For ALT ≤ 5 × ULN; Patients with confirmed liver or bone metastases: alkaline phosphatase ≤ 5 × ULN;\n\n      * Serum bilirubin ≤ 1.25 × ULN. For patients with known Gilbert's disease, serum bilirubin ≤ 3 × ULN is permitted;\n\n        * Serum creatinine ≤ 1.5 × ULN. (9) Patients must provide a pre-treatment tumor tissue sample during the study. Any available tumor tissue sample is acceptable. Submission may be completed after enrollment.\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria are ineligible:\n\nActive or untreated CNS metastases detected by computed tomography (CT) or magnetic resonance imaging (MRI) during screening or on prior imaging.\n\nSpinal cord compression not radically treated with surgery and\u002For radiotherapy, or previously diagnosed spinal cord compression without clinical evidence of stable disease for at least 1 week prior to randomization.\n\nLeptomeningeal metastases. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once per month or more frequently); indwelling catheters are not permitted.\n\nUncontrolled or symptomatic hypercalcemia (\\> 1.5 mmol\u002FL ionized calcium, serum calcium \\> 12 mg\u002FdL, or corrected serum calcium \\> ULN).\n\nHistory of malignancy other than SCLC within 5 years prior to randomization, except for malignancies with negligible risk of metastasis or death (e.g., 5-year OS \\> 90%) and curative potential after treatment, such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer with radical surgery, or ductal carcinoma in situ with radical surgery.\n\nPregnant or lactating women, or women planning pregnancy during the study period.\n\nHistory of severe allergic, hypersensitivity, or anaphylactic reactions to chimeric, humanized, or human antibodies or fusion proteins.\n\nKnown hypersensitivity to any component of biologic medicinal products produced in Chinese hamster ovary (CHO) cells or to the study drug formulation.\n\nHistory of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, and glomerulonephritis.\n\nPatients with a history of autoimmune hypothyroidism on a stable dose of thyroid hormone replacement therapy are eligible.\n\nPatients with type 1 diabetes mellitus controlled on a stable insulin regimen are eligible.\n\nPatients with eczema, psoriasis, lichen simplex chronicus, or vitiligo only (patients with psoriatic arthritis are excluded) may be enrolled if:\n\n* Rash involves \\\u003C 10% of body surface area; ② Disease is well controlled at baseline requiring only low-potency topical corticosteroids; ③ No acute exacerbation of underlying disease in the past 12 months (no requirement for PUVA, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high-potency or oral corticosteroids).\n\nHistory of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonia, or active pneumonitis on screening chest CT scan.\n\nSevere interstitial lung disease. Positive human immunodeficiency virus (HIV) test. Active hepatitis B (chronic or acute; defined as positive hepatitis B surface antigen \\[HBsAg\\] at screening) or hepatitis C virus (HCV) infection.\n\nPatients with resolved or prior HBV infection (positive hepatitis B core antibody \\[HBcAb\\] and negative HBsAg) are eligible. HBV DNA testing must be performed prior to randomization.\n\nAmong patients positive for HCV antibody, only those with negative HCV RNA by PCR are eligible.\n\nActive tuberculosis. Severe infection at enrollment, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc.\n\nSevere cardiovascular disease, such as New York Heart Association (NYHA) Class II or higher heart failure, myocardial infarction within 3 months prior to randomization, unstable arrhythmia, or unstable angina.\n\nPatients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction \\\u003C 50% must be on optimal stable therapy as judged by the treating physician, with cardiology consultation if necessary.\n\nMajor surgery within 28 days prior to randomization (except diagnostic surgery) or expected major surgery during the study.\n\nHistory of allogeneic bone marrow transplantation or solid organ transplantation.\n\nAny other disease, metabolic dysfunction, physical finding, or laboratory abnormality that, in the investigator's judgment, would contraindicate use of the study drug, interfere with interpretation of study results, or place the patient at high risk of treatment-related complications.\n\nPrior receipt of anti-tumor therapy for ES-SCLC. Treatment with any other investigational agent or participation in another therapeutic clinical trial within 28 days prior to randomization.\n\nLive attenuated vaccine within 4 weeks prior to randomization or anticipated need for such vaccines during the study.\n\nPrior treatment with CD137 agonists, immune checkpoint blockade therapy, anti-PD-1, or anti-PD-L1 therapeutic antibodies.\n\nSystemic immunosuppressive therapy within 2 weeks prior to randomization, including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (anti-TNF) agents.\n\nPatients receiving short-term, low-dose systemic immunosuppression (e.g., single-dose dexamethasone for nausea) may be eligible after discussion and approval by the investigator and medical monitor.\n\nUse of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for orthostatic hypotension, and low-dose corticosteroid replacement for adrenal insufficiency is permitted.\n\nHistory of hypersensitivity to platinum agents or etoposide.","75 Years",{"count":134,"type":21},84,[52],"This is a prospective, single-arm, investigator-initiated clinical study (IIT) designed to evaluate the efficacy and safety of nab-paclitaxel combined with local radiotherapy for patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed after first-line treatment.\n\nSmall cell lung cancer (SCLC) is an aggressive type of lung cancer, and extensive-stage SCLC (ES-SCLC) refers to its advanced stage. For patients whose cancer progresses after first-line treatment, there are very limited effective second-line and later-line treatment options. Commonly used clinical regimens such as topotecan and lurbinectedin only provide modest improvements in tumor response and survival, and often cause severe hematological toxicities (represented by bone marrow suppression). This leaves patients in a persistent dilemma of \"insufficient efficacy and limited tolerability\", highlighting a clear unmet medical need for better treatment options in this population.\n\nAgainst this background, this study explores a comprehensive treatment strategy using nab-paclitaxel as the chemotherapy backbone, combined with local radiotherapy in eligible patients. Nab-paclitaxel is a nanoparticle albumin-bound form of paclitaxel, with a relatively controllable toxicity profile and manageable administration in clinical practice. Local radiotherapy may create a synergistic effect by improving the tumor immune microenvironment and enhancing local tumor control, with the goal of providing better evidence for a \"chemotherapy ± local therapy\" combination as a second-line treatment option.",[138,27],"Small Cell Lung Cancer",[140,141,142,143],"small cell lung cancer","sclc","extensive stage small cell lung cancer","es-sclc","NOT_YET_RECRUITING","2026-04-20",{"date":147,"type":32},"2026-04-23",{"date":149,"type":21},"2026-04-06",{"date":151,"type":21},"2030-12-31",{"name":153,"class":123},"Shanghai Pulmonary Hospital, Shanghai, China",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":180},"100619010","phase-2-study-of-sacituzumab-govitecan-with-atezolizumabdurvalumab-as-maintenance-therapy-for-extensive-stage-small-cell-lung-cancer-100619010","NCT07339059","Study of Sacituzumab Govitecan With Atezolizumab\u002FDurvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer","Phase II Study of Sacituzumab Govitecan With Atezolizumab\u002FDurvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the trial.\n* Male or Female aged 18 years or above.\n* Participants must have a histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC) and extensive stage at diagnosis or locally advanced disease and unable to receive curative intent radiation.\n* Participants must have received at least four cycles of platinum plus etoposide and at least 2-3 cycles of atezolizumab\u002F Durvalumab.\n* No evidence of progression on restaging CT CAP following 4-6 cycles of Chemo\u002FIO from the last dose of the chemotherapy cycle.\n* ECOG performance status of 0-2\n* Patients must not have active uncontrolled HIV, HBV, and HCV infections. Well-controlled infections on treatment will be allowed to participate in the trial.\n* Patients with stable and asymptomatic brain metastasis.\n* Adequate organ function - bone marrow, kidney, and liver.\n\nExclusion Criteria:\n\n* Significant renal impairment requiring dialysis or hepatic impairment with end-stage liver disease.\n* Participants with leptomeningeal disease.\n* Participants with a recent diagnosis of heart failure and acute coronary disease within 3 months.\n* Participants who are unable to receive immunotherapy with chemotherapy for induction will be excluded, or those immunotherapy was discontinued to manage immune-related adverse events\n* Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrolment.\n* Patients with prior exposure to anti-PD-1, anti-PD-L1, or anti-PD-L2 agents or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4) within 12 months of the study is not allowed.",{"count":162,"type":21},35,[52],"The goal of this clinical trial is to learn if the combination of sacituzumab govetican (SG) and atezolizumab\u002Fdurvalumab is effective in controlling cancer tumor growth in adults with extensive stage small cell lung cancer. These drugs are FDA approved individually in different cancers. This combination is evaluated in breast cancer and showed promising combination.\n\nThe effectiveness of this treatment combination will be measured by changes in tumor size and appearance of new tumors.\n\nParticipants in the trial will:\n\n* receive treatment SG and immunotherapy every 21 days for up to 2 years or until it is no longer works for the patient.\n* CT scans at 6weeks for first 6 cycles and then every 9-12 weeks and MRI brain every 12 weeks.\n* provide tissue (optional) and blood for additional testing (learn about the cancer).",[166,27],"Small Cell Lung Cancer ( SCLC )",[168,169,170,140,141,143,171,172],"atezolizumab","durvalumab","sactizumab govetican","lung cancer","extensive stage",{"date":147,"type":32},{"date":175,"type":21},"2026-06-01",{"date":177,"type":21},"2029-12-01",{"name":179,"class":123},"Bindu R Potugari",1,{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":132,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":194,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":180},"100631476","phase-2-sacituzumab-tirumotecan-in-combination-with-anlotinib-in-previously-treated-patients-with-extensive-stage-small-cell-lung-cancer-es-sclc-100631476","NCT07501169","Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC)","Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC): A Prospective, Single-Arm, Phase II Study (STAR-01)","STAR-01","Inclusion Criteria:\n\n* 1.Voluntary participation with written informed consent obtained prior to any study-specific procedures.\n* 2.Age ≥ 18 years and ≤ 75 years, regardless of sex.\n* 3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* 4.Life expectancy of at least 3 months.\n* 5.Histologically or cytologically confirmed small cell lung cancer (SCLC) based on pathology and immunohistochemistry\u002Fimmunophenotyping results; disease staged as extensive-stage SCLC (ES-SCLC) according to the Veterans Administration Lung Study Group (VALG) staging system.\n* 6.Disease progression (at the time of enrollment) after at least two cycles of platinum-based systemic therapy with or without PD-1\u002FL1 inhibitors; no more than two prior lines of therapy.\n\nNote: Adjuvant therapy is considered one prior line if disease progression occurs during treatment or within 6 months of the last adjuvant dose.\n\n* 7.At least one measurable lesion as defined by RECIST version 1.1. Lesions previously treated with local therapy may be considered target lesions only if progression has been clearly documented at that site post-treatment. Brain lesions as sole target lesions are not acceptable.\n* 8.Adequate bone marrow function without transfusion or growth factor support within 14 days prior to screening: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet count ≥ 100 × 10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL.\n* 9.Adequate hepatic function: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), or ≤ 2 × ULN for patients with Gilbert's syndrome; TBIL ≤ 3.0 × ULN is permitted if direct bilirubin suggests extrahepatic obstruction. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (or ≤ 5 × ULN in the presence of liver metastases).\n* 10.Adequate renal function: Creatinine (Cr) ≤ 1.5 × ULN and creatinine clearance (Ccr) ≥ 50 mL\u002Fmin (calculated by Cockcroft-Gault formula or other clinically validated method).\n* 11.Adequate coagulation function: Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; International normalized ratio (INR) ≤ 1.5 × ULN;\n* 12.Adequate cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% assessed by echocardiography within 28 days prior to enrollment. New York Heart Association (NYHA) classification \\\u003C 3.\n* 13.Female patients of childbearing potential must agree to use medically effective contraception from the time of signing informed consent until 6 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n* 1.History of other primary malignancies within 5 years prior to signing informed consent, except for: radically treated malignancies with no recurrence within 5 years; adequately treated non-melanoma skin cancer, cervical carcinoma in situ, thyroid cancer, or other malignancies considered cured.\n* 2.Prior pathological diagnosis of combined small cell lung cancer (e.g., mixed SCLC and NSCLC), transformed NSCLC (SCLC transformed to NSCLC), or transformed SCLC (NSCLC transformed to SCLC).\n* 3.Prior anti-tumor therapy within specified washout periods before first study dose: chemotherapy, radiotherapy, biologics, endocrine therapy, immunotherapy within 4 weeks; topical anti-tumor agents within 5 half-lives; nitrosoureas or mitomycin C within 6 weeks; oral fluoropyrimidines or small-molecule targeted agents within 5 half-lives; anti-tumor traditional Chinese medicine within 2 weeks.\n* 4.Treatment with any other investigational drug or therapy within 4 weeks prior to first study dose.\n* 5.Prior or current use of topoisomerase I inhibitors, including antibody-drug conjugates with topoisomerase I inhibitor payloads (e.g., topotecan, irinotecan, trastuzumab deruxtecan, sacituzumab govitecan, datopotamab deruxtecan \\[DS-1062\\]).\n* 6.Brain metastases unless asymptomatic (stable for ≥4 weeks, requiring ≤10 mg\u002Fday prednisone or equivalent for ≥14 days prior to first dose, and no significant peritumoral edema on imaging); leptomeningeal or brainstem metastases; spinal cord compression (radiographically confirmed, symptomatic or asymptomatic); bone marrow metastases.\n* 7.Imaging evidence of tumor lesions located ≤5 mm from major blood vessels, invading major vessels, or assessed by the investigator as having high risk of major bleeding during the study.\n* 8.History of deep vein or arterial thromboembolic events within 6 months (e.g., cerebrovascular accident including TIA, deep vein thrombosis, pulmonary embolism); DVT adequately treated or superficial vein thrombosis with low bleeding risk per investigator may be enrolled.\n* 9.Prior treatment-related toxicities (CTCAE v5.0) ≥ Grade 2, except for alopecia, residual neurotoxicity, or stable hypothyroidism on hormone replacement.\n* 10.Major surgery (excluding biopsy or vascular access) or significant trauma within 4 weeks prior to first study dose, or planned elective surgery during the study period.\n* 11.Receipt of live or live-attenuated vaccines within 4 weeks prior to first study dose.\n* 12.Systemic corticosteroids (prednisone \\>10 mg\u002Fday or equivalent) or other immunosuppressive agents within 14 days prior to first study dose, except for: topical, ocular, intra-articular, intranasal, or inhaled corticosteroids; short-term corticosteroids for prophylaxis (e.g., contrast allergy).\n* 13.History of non-infectious interstitial lung disease\u002Fpneumonitis requiring steroid maintenance (requiring 14-day washout), current ILD, or suspected ILD not ruled out by imaging at screening.\n* 14.Active tuberculosis; active or uncontrolled autoimmune disease; acquired or congenital immunodeficiency disorders; history of allogeneic stem cell, bone marrow, or solid organ transplantation.\n* 15.Serious infection within 4 weeks prior to first study dose, including but not limited to infection requiring systemic antibiotics, bacteremia, or severe pneumonia.\n* 16.Positive serology results: HIV antibody positive; untreated active hepatitis B (HBsAg positive with HBV-DNA \\> ULN); Note: Patients meeting certain criteria may be enrolled with antiviral prophylaxis\u002Fmonitoring; HCV-Ab positive with detectable HCV-RNA.\n* 17.Significant cardiovascular disease history, including but not limited to: severe cardiac arrhythmia or conduction abnormalities (e.g., requiring intervention, Mobitz II or third-degree AV block); QTcF \\>450 ms (male) or \\>470 ms (female); congestive heart failure (NYHA class ≥II), unstable angina, acute coronary syndrome, aortic dissection, stroke or TIA within 6 months; deep vein thrombosis or pulmonary embolism within 6 months (excluding catheter-related or superficial thrombosis); uncontrolled hypertension (systolic \\>160 mmHg and\u002For diastolic \\>100 mmHg).\n* 18.Clinically uncontrolled third-space fluid collections (e.g., pleural or ascitic effusion requiring intervention; patients with stable effusions \\>1 week post-drainage may enroll); pericardial effusion (asymptomatic minimal effusion not requiring intervention may enroll). If intra-cavity anti-tumor agents were used, a washout of ≥5 half-lives or 4 weeks (whichever is shorter) is required.\n* 19.Known hypersensitivity or delayed allergic reaction to any component of the study drugs or comparators (e.g., topotecan, irinotecan, paclitaxel monotherapy).\n* 20.Substance abuse, alcohol\u002Fdrug dependence, or any medical condition (e.g., anxiety, depression) that may interfere with study participation or outcomes per investigator judgment.\n* 21.Pregnant or breastfeeding women; men or women planning to conceive during the study.\n* 22.Expected poor compliance, or any other severe systemic disease or condition that, in the investigator's opinion, makes the patient unsuitable for this study.\n* 23.Bleeding diathesis (e.g., active peptic ulcer) or requirement for anticoagulants\u002Fvitamin K antagonists (e.g., warfarin, heparin); low-dose prophylactic warfarin (≤1 mg\u002Fd), heparin (≤12,000 U\u002Fd), or aspirin (≤100 mg\u002Fd) permitted if INR ≤1.5. Imaging evidence of tumor invasion, significant necrosis, or cavitation with high bleeding risk per investigator.\n* 24.Any severe or uncontrolled systemic disease, including but not limited to: active tuberculosis\u002Fpulmonary fibrosis; active or uncontrolled infection requiring systemic therapy; clinically active diverticulitis, intra-abdominal abscess, GI obstruction; liver disease (e.g., cirrhosis, decompensated liver disease, acute\u002Fchronic hepatitis); poorly controlled diabetes (two consecutive FBG \\>10 mmol\u002FL); urine protein ≥2+ confirmed by 24-hour urine protein \\>1.0 g; uncontrolled hypercalcemia (\\>1.5 mmol\u002FL ionized calcium or \\>12 mg\u002FdL calcium or corrected serum calcium \\>ULN) or symptomatic hypercalcemia requiring bisphosphonates; non-healing wounds or fractures; psychiatric disorders interfering with treatment compliance.\n* 25.Factors affecting oral drug absorption (e.g., inability to swallow, post-, chronic diarrhea, intestinal obstruction).\n* 26.Documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or history of corneal disease affecting\u002Fdelaying corneal healing.\n* 27.Any other condition deemed unsuitable for participation by the investigator.",{"count":190,"type":21},33,[52],"This is an single-arm, multicenter phase II study to evaluate the safety and efficacy of Sacituzumab Tirumotecan (sac-TMT) plus anlotinib in previously treated extensive-stage small cell lung cancer (ES-SCLC). The study is expected to enroll up to 33 eligible patients.",[55],[58,195,196],"Trop2-ADC","Anlotinib","2026-04-08",{"date":89,"type":32},{"date":200,"type":21},"2026-04-01",{"date":202,"type":21},"2028-12-31",{"name":204,"class":123},"Sichuan University",{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":213,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":22,"phases":216,"briefSummary":217,"conditions":218,"keywords":219,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":180},"100601684","phase-1-iadademstat--sbrt-with-atezo-in-es-sclc-100601684","NCT07113691","Iadademstat + SBRT With Atezo in ES-SCLC","Iadademstat and Radiation Therapy With Atezolizumab in Extensive Stage Small-cell Lung Cancer (ES-SCLC) Patients With Persistent, Recurrent or Progressive Disease After First Line Systemic Therapy","TIARA","Inclusion Criteria:\n\n1. Signed informed consent form.\n2. Ability to comply with protocol, in the treating investigator's judgment.\n3. Age 18 years or older.\n4. Participant must have a body weight of at least 50 Kg.\n5. Histologically documented ES-SCLC previously treated with at least one regimen, including a platinum containing chemotherapy regimen, with progression of disease on or after their most recent therapy or achieving only SD after completion of one line of a platinum containing chemotherapy-based regimen.\n\n   a. Participants previously diagnosed with limited stage SCLC treated with concurrent chemoradiation with a platinum doublet now diagnosed with recurrent extensive disease in the relapsed setting are eligible.\n6. Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, antiPD-1, and anti-PD-L1 therapeutic antibodies is allowed.\n7. ECOG performance status of 0 to 2.\n8. At least one identified tumor lesion to be treated with SBRT.\n9. At least one additional tumor lesion, separate from the site of SBRT, preferably outside of the 5Gy isodose line, amenable to incisional, excisional, core or forceps (transbronchial) biopsy. Participants must be willing to undergo tumor biopsies before starting trial therapy and 2 weeks (+\u002F- 1 week) after the completion of SBRT.\n\n   1. If the initial biopsy is excisional, the excised tumor cannot be counted as a biopsy target lesion and there must be another lesion amenable to incisional, excisional, core or forceps biopsy. In this scenario, the second biopsy can only be excisional if the lesion to be excised is not a target lesion.\n   2. Cytology tumor specimens (e.g., from fine-needle biopsies, or drainage of pleural\u002F pericardial or ascites fluid) are not acceptable. Biopsies of bone lesions that do not have a soft tissue component are also not acceptable (i.e., decalcified tumor samples are not acceptable). Non-lymph node sites will be biopsied preferentially.\n   3. If enrolled with stable, but not progressive, disease at the completion of first line platinum-based therapy regimen, participants may undergo biopsy of the same site that is to be irradiated. If a separate site is identified for biopsy, it should be preferentially biopsied over the site that is to be irradiated.\n10. Participants must agree to submit blood samples for exploratory biomarker research at the times identified in the study calendar.\n11. Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can be counted as target lesions if clearly progressing after radiation.\n12. Participants may have asymptomatic CNS metastases or treated CNS metastases if they are not currently receiving corticosteroids equal to or greater than prednisone 10 mg daily or equivalent for seven days prior to the first dose of study drug. Participants should have completed stereotactic radiation at least 7 days or whole brain radiation at least 2 weeks prior to Cycle 1, Day 1.\n\n    1. Participants with new asymptomatic CNS metastases detected on their screening scan will undergo repeat CNS imaging at four weeks to ensure safety.\n    2. Participants must have no history of intracranial hemorrhage or spinal cord hemorrhage from CNS disease.\n    3. Metastases are limited to the cerebellum and supratentorial region (i.e. no metastases to the midbrain, pons, medulla or spinal cord).\n13. Prior palliative radiotherapy must have been completed at least 1 week before the first dose of the study drug.\n14. Anticonvulsants are allowed.\n15. Participants must adhere to the following reproductive and contraceptive requirements while on study treatment and for at least five months after the last dose of the study drugs.\n\nExclusion Criteria:\n\n1. History of leptomeningeal disease.\n2. Untreated symptomatic CNS metastases. Participants with asymptomatic CNS metastases are eligible. Participant with treated symptomatic brain metastases is eligible provided they meet all of the following criteria:\n\n   1. Completed stereotactic radiosurgery at least seven days prior to Cycle 1, Day 1 or completed whole brain radiation at least two weeks prior to Cycle 1, Day 1.\n   2. No evidence of interim progression between the completion of CNS-directed therapy and the start of trial therapy.\n   3. Ongoing steroid requirement of \\\u003C10 mg of prednisone per day (or equivalent) as therapy for CNS disease; anticonvulsants are allowed.\n   4. The participant has no history of intracranial hemorrhage or spinal cord hemorrhage.\n3. Spinal cord compression not definitively treated with surgery and\u002For radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for more than or equal to 1 week prior to enrollment.\n4. Uncontrolled tumor-related pain.\n5. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Participants should be recovered from the effects of radiation. There is no required minimum recovery period.\n6. Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment.\n7. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n\n   a. Participants with indwelling catheters (e.g., PleurX) are allowed.\n8. Uncontrolled or symptomatic hypercalcemia (ionized calcium greater than 1.5 mmol\u002FL, calcium greater than 12 mg\u002FdL or corrected serum calcium greater than ULN)\n9. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis (see Appendix 1. Preexisting Autoimmune Diseases and Immune Deficiencies for a more comprehensive list of autoimmune diseases and immune deficiencies), with the following exceptions:\n\n   1. Participants with a history of autoimmune related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n   2. Participants with controlled type 1 diabetes mellitus and are on an insulin regimen will be eligible for the study.\n   3. Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis are excluded) are eligible for the study provided all of the following conditions are met:\n\n   i. Rash must cover less than 10% of body surface area. ii. The disease is well controlled at baseline and requires only low-potency topical corticosteroids.\n\n   iii. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.\n10. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n\n    a. History of radiation pneumonitis in the prior radiation field (fibrosis) is permitted.\n11. Active tuberculosis.\n12. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within three months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n\n    a. Unstable angina, symptomatic or otherwise uncontrolled arrhythmia (does not include stable, alone atrial fibrillation), QTcF \\> 500 ms based on screening electrocardiogram (ECG), myocardial infarction ≤ 3 months prior to first study treatment, cerebrovascular accidents ≤ 3 months before study treatment start. Participant has congestive heart failure New York Heart Association (NYHA) class 2, 3 or 4 or participants with a history of congestive heart failure NYHA class 2, 3 or 4 in the past, unless a screening echocardiogram performed within one month prior to study entry demonstrates a left ventricular ejection fraction that is ≥ 45%.\n13. Major surgical procedure, other than for diagnosis, within four weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study.\n14. History of malignancy within one year prior to screening (other than SCLC), with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate greater than 90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.\n15. Severe infection within four weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection or bacteremia.\n\n    a. Participant has evidence of active uncontrolled viral, bacterial, or systemic fungal infection. Participants with active infection are permitted to enroll provided that the infection is clearly under control (i.e., no signs of severe systemic inflammatory response that makes participant clinically unstable in the opinion of the treating investigator, and participant is hemodynamically stable, with sustained body temperature under 38° Celsius for 48-72 hours before starting study treatment and does not need oxygen supplementation or pressors to maintain blood pressure). Participants with uncontrolled infection shall not be enrolled until the infection is treated and brought under control, as defined above.\n16. Treatment with therapeutic oral or IV antibiotics within two weeks prior to initiation of study treatment.\n\n    a. Participants receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n17. Prior allogeneic stem cell or solid organ transplantation.\n18. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications.\n19. Treatment with a live, attenuated vaccine within four weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab or iadademstat treatment or within five months after the final dose of atezolizumab or one month after the final dose of iadademstat.\n20. Current treatment with anti-viral therapy for HBV.\n21. Treatment with investigational therapy within 28 days prior to initiation of study treatment.\n22. Any approved systemic anti-cancer treatment within three weeks prior to initiation of study treatment.\n23. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2, IL-2) within four weeks or five half-lives of the drug (whichever is longer) prior to initiation of study treatment.\n24. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antiTNFagents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n    1. Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after sponsor-investigator confirmation has been obtained.\n    2. Participants who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n25. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.\n26. Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation.\n27. Known allergy or hypersensitivity to any component of the iadademstat formulation.\n28. Malabsorption syndrome or other conditions that would interfere with enteral absorption.\n29. Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within five months after the final dose of study treatment.\n30. Known infection with HIV, HBV or HCV. Participants with prior exposure to hepatitis virus, but no evidence of active or chronic infection, may be eligible.\n31. Evidence of end-organ damage as defined by the following laboratory results obtained within 14 days prior to the first study treatment:\n\n    1. ANC \\\u003C1,500 cells\u002FµL (without granulocyte colony stimulating factor support within 14 days prior to Cycle 1, Day 1).\n    2. Platelet count \\\u003C100,000\u002FµL (without transfusion within 14 days prior to Cycle 1, Day 1).\n    3. Lymphocyte count less than or equal to 0.5 x10\\^9\u002FL.\n    4. Hemoglobin \\\u003C9.0 g\u002FdL (Participants may be transfused to meet this criterion).\n    5. AST, ALT, and ALP \\>2.5 x ULN, with the following exceptions: Participants with documented liver metastases: AST and\u002For ALT \\>5 x ULN. Participants with documented liver or bone metastases: ALP \\>5 x ULN.\n    6. Serum bilirubin \\>1.5 x ULN (Participants with known Gilbert disease who have serum bilirubin level \\\u003C3 x ULN may be enrolled).\n    7. CrCl \\\u003C 40mL\u002Fmin (Cockcroft-Gault formula).\n32. INR and aPTT \\>1.5 x ULN.\n\n    a. This applies only to participants who are not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation are allowed.\n33. Participants with uncontrolled hypertension (i.e., systolic blood pressure \\>180 mm Hg, diastolic blood pressure \\> 95 mm Hg). Use of anti-hypertensive agents to control hypertension before Cycle1 Day 1 is allowed.\n34. Participants receiving antidepressants reported to have KDM1A\u002FLSD1 inhibitory activity: Tranylcypromine or Phenelzine.\n35. Participants who have not recovered from grade ≥2 AEs due to prior anti-cancer therapy with the exception of alopecia, and vitiligo.\n36. Participants with grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the sponsor-investigator.\n37. Participants with history of clinically significant bleeding, specifically any history of intracranial hemorrhage \u002F hemorrhagic cardiovascular accident (CVA), or participants with gastrointestinal bleeding within the 3 months prior to study entry.\n38. Participants with uncontrolled disseminated intravascular coagulation.\n39. Participants who refuse or are unable to potentially receive blood products.\n40. Participants should be carefully questioned regarding their history of acquired or congenital immune deficiencies or autoimmune disease. Participants with any history of immune deficiencies or autoimmune disease listed in the table below are excluded from participating in the study. Possible exceptions to this exclusion could be participants with a medical history of such entities as atopic disease or childhood arthralgias where the clinical suspicion of autoimmune disease is low. Participants with a history of autoimmune related hypothyroidism on thyroid replacement hormone may be eligible for this study. In addition, transient autoimmune manifestations of an acute infectious disease that resolved upon treatment of the infectious agent are not excluded (e.g., acute Lyme arthritis). Contact the sponsor-investigator regarding any uncertainty over autoimmune exclusions.",true,{"count":215,"type":21},15,[51],"This is a phase 1b dose escalation, open-label, non-randomized study of participants with residual, progressive or recurrent ES-SCLC who previously received platinum-based chemotherapy with or without immune checkpoint inhibitor therapy; participants who have achieved only stable disease at the completion of initial platinum-based treatment are eligible for enrollment.",[27],[220],"persistent, recurrent or progressive disease after first line systemic therapy","2026-03-24",{"date":223,"type":32},"2026-03-27",{"date":225,"type":32},"2026-01-20",{"date":227,"type":21},"2030-01",{"name":229,"class":123},"Yale University",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":132,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":180},"100625681","phase-2-tislelizumab-combined-with-chemotherapy-followed-by-thoracic-consolidation-radiotherapy-in-the-first-line-treatment-of-extensive-stage-small-cell-lung-cancer-100625681","NCT07425795","Tislelizumab Combined With Chemotherapy Followed by Thoracic Consolidation Radiotherapy in the First-line Treatment of Extensive Stage Small Cell Lung Cancer","A Prospective, Single Arm, Phase II Clinical Study of Tislelizumab Combined With Chemotherapy Followed by Thoracic Consolidation Radiotherapy in the First-line Treatment of Extensive Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Signed informed consent;\n* Age 18-75 years;\n* According to the judgment of the investigator, the patient was able to comply with the study protocol;\n* Histologically or cytologically confirmed extensive stage small cell lung cancer (es-sclc) (according to the Veterans Administration lung cancer association \\[valg\\] staging system);\n* No previous systemic treatment for ES-SCLC;\n* With measurable lesions assessed by the investigator according to RECIST version 1.1;\n* ECOG physical status score was 0 or 1;\n* Life expectancy ≥ 3 months;\n* Adequate hematology and end organ function, as defined by the following laboratory findings, which should be obtained within 14 days before the first study treatment: absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002Fl (without granulocyte colony-stimulating factor treatment); Lymphocyte count ≥ 0.5 × 10\\^9\u002Fl (500 \u002F μ L); Platelet count ≥ 100 × 10\\^9\u002Fl (100000 \u002F μ L); Hemoglobin ≥ 90g\u002Fl (9.0g\u002Fdl); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN), with the following exceptions: Patients with confirmed liver metastasis: AST and alt ≤ 5 × ULN; Patients with confirmed liver or bone metastasis: ALP ≤ 5 × ULN; Total bilirubin ≤ 1.5 × ULN, with the following exceptions: patients known to have Gilbert syndrome: total bilirubin ≤ 3 × ULN; Creatinine clearance ≥ 60ml\u002Fmin (calculated by Cockcroft Gault formula); Albumin ≥ 25g\u002Fl (2.5g\u002Fdl).\n\nExclusion Criteria:\n\n* Symptomatic, untreated, or actively progressive central nervous system (CNS) metastases; ·Patients with CNS lesions who were treated and asymptomatic were eligible for this study if they met all of the following criteria: measurable lesions that met the recistv1.1 definition were outside the CNS; The patient had no history of intracranial hemorrhage or spinal cord hemorrhage; Patients did not receive stereotactic radiotherapy within 7 days before the start of study treatment, whole brain radiotherapy within 14 days before the start of study treatment, or neurosurgical resection within 28 days before the start of study treatment; Patients do not need to continue to receive corticosteroids for CNS disease. Treatment with stable doses of anticonvulsants was allowed. Metastasis was limited to the cerebellum or supratentorial region (i.e., not to the midbrain, pons, medulla oblongata, or spinal cord); There was no evidence of progression between the completion of CNS local therapy and the initiation of study therapy asymptomatic patients with CNS metastases who could be enrolled according to the assessment of other investigators could be enrolled;\n* History of leptomeningeal disease;\n* Poorly controlled pleural effusion, pericardial effusion or ascites requiring repeated drainage (once a month or more frequently);\n* Poorly controlled or symptomatic hypercalcemia (ionized calcium \\>1.5mmol\u002Fl, calcium \\>12mg\u002Fdl or corrected calcium \\>uln);\n* Have active or ever suffered from autoimmune disease or immunodeficiency;\n* Have a history of idiopathic pulmonary fibrosis, organized pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia or idiopathic pneumonia;\n* Active pulmonary tuberculosis;\n* Untreated chronic hepatitis B patients, chronic hepatitis B virus carriers with HBV DNA ≥ 500 iu\u002Fml (2500 copies \u002Fml), active hepatitis C patients: inactive HBsAg carriers, patients with stable active HBV infection after drug treatment (HBV dna\\\u003C500 iu\u002Fml (2500 copies \u002Fml)) can be enrolled. HBV DNA testing was only performed in patients who tested positive for hepatitis B core antibody (anti HBC antibody). Patients with negative hepatitis C virus (HCV) antibody test at screening, or patients with positive HCV antibody and negative HCV RNA test at screening can be enrolled in the study. HCV RNA testing will only be performed in patients with positive hepatitis C virus (HCV) antibody. Note: Patients with detectable hepatitis B surface antigen (HBsAg) or detectable HBV DNA should be treated according to treatment guidelines. Patients treated with antiviral drugs at the time of screening should have been treated for \\>2 weeks before enrollment and continue to be treated for 6 months after termination of study drug treatment.",{"count":238,"type":21},36,[52],"This study is a prospective, single arm, phase II clinical trial. We plan to include 36 newly diagnosed ES-SCLC patients who meet the inclusion criteria and receive induction therapy (tislelizumab+EP regimen, 4-6 cycles). After completing the induction therapy, efficacy evaluation will be conducted. Patients with remission will receive tislelizumab combined with consolidation chest radiotherapy (TRT) sequentially. After the consolidation therapy is completed, they will receive tislelizumab maintenance therapy until disease progression, intolerable toxicity, or withdrawal of informed consent occurs, whichever occurs first. The treatment duration will not exceed 2 years.",[27],[243,244,245,246],"Extensive stage small cell lung cancer","tislelizumab","thoracic consolidation radiotherapy","first-line treatment","2026-02-20",{"date":249,"type":32},"2026-02-23",{"date":251,"type":32},"2025-10-10",{"date":253,"type":21},"2028-07-31",{"name":255,"class":123},"Chongqing University Cancer Hospital",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":132,"enrollmentInfo":263,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":270,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":180},"100574393","phase-2-post-line-treatment-with-teniposide-for-c-myc-driven-extensive-stage-small-cell-lung-cancer-100574393","NCT06758700","Post-line Treatment With Teniposide for c-Myc-driven Extensive-stage Small Cell Lung Cancer","Phase II Clinical Study to Evaluate the Efficacy and Safety of Teniposide as a Post-Line Therapy for c-Myc-Driven Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n1. extensive stage small cell lung cancer\n2. Progression after receiving at least one chemotherapy drug treatment in the past;\n3. ECOG score 0-1\n4. c-Myc-driven\n5. Expected survival period ≥3 months\n6. Age: 18-75 years old;\n7. The informed consent form complies with the ICH-GCP principles.\n\nExclusion Criteria:\n\n1. No measurable lesions\n2. Other severe and persistent diseases or organ system dysfunction;\n3. Women planning pregnancy or men planning family planning;\n4. Women who are pregnant or breastfeeding;\n5. Those who cannot follow the research protocol provided by the investigator.",{"count":215,"type":21},[52],"The study is being conducted to investigate the efficacy and safety of teniposide in patients with extensive-stage small cell lung cancer who have failed standard treatment and with high expression of the c-Myc-driven FBXW2\u002FMYC gene. Based on the results, the study will explore the correlation between the expression of FBXW2\u002FMYC and the efficacy of teniposide.",[55,267,268,269],"Thoracic Neoplasms","Lung Neoplasms","Lung Diseases",[271,58,272,273],"c-Myc","Phase II","Post-line","2025-11-30",{"date":276,"type":32},"2025-12-05",{"date":278,"type":32},"2025-02-07",{"date":280,"type":21},"2026-12-31",{"name":153,"class":123},{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":132,"enrollmentInfo":289,"targetDuration":4,"studyType":22,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":303},"100611812","phase-2-a-study-of-ivonescimab-in-first-line-es-sclc-100611812","NCT07245446","A Study of Ivonescimab in First-Line ES-SCLC","A Phase II Clinical Study of Ivonescimab Combination Therapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (ES-SCLC)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).\n* No prior systemic therapy for ES-SCLC.\n* At least one measurable lesion as defined by RECIST v1.1.\n* Age 18 to 75 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Active or untreated central nervous system (CNS) metastases (Treated, stable brain metastases are allowed).\n* History of severe hypersensitivity to monoclonal antibodies.\n* Active autoimmune disease requiring systemic treatment within the past 2 years.\n* Significant cardiovascular disease.\n* Active hepatitis B or C, or HIV infection.\n* Interstitial lung disease or non-infectious pneumonitis.\n* Significant bleeding tendency or risk, including tumor invasion of major blood vessels.\n* Pregnancy or lactation.\n* Other active malignancies within 5 years prior to enrollment.",{"count":290,"type":21},180,[52],"The goal of this clinical trial is to learn if different combinations of a drug called Ivonescimab, along with chemotherapy and other investigational drugs, are safe and effective for the initial treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).\n\nThe main questions the study aims to answer are:\n\n* What side effects do participants experience from these combination treatments?\n* How well do the treatments work to shrink tumors?\n\nResearchers will compare three groups to see which combination works best. All participants will receive Ivonescimab and chemotherapy (etoposide and carboplatin). The differences are:\n\n* Group 1 will also receive an additional drug called AK117.\n* Group 2 will also receive a different additional drug called Cadonilimab.\n* Group 3 will receive Ivonescimab and chemotherapy only.\n\nParticipants will:\n\n* Be assigned by chance to one of the three groups.\n* Undergo an initial treatment phase (about 3 months), receiving chemotherapy plus the specific study drugs for their group.\n* If the treatment is effective and side effects are manageable, continue with a maintenance phase using only the study drugs (without chemotherapy) for up to 2 years.\n* Attend regular clinic visits for check-ups, blood tests, and imaging scans (like CT scans) to see how they are responding to the treatment.",[55],"2025-11-17",{"date":296,"type":32},"2025-11-24",{"date":298,"type":32},"2025-10-29",{"date":300,"type":21},"2028-06",{"name":302,"class":39},"Akeso",3,{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":22,"phases":313,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":180},"100580508","phase-2-tislelizumab-combined-with-chemotherapy-and-relayed-radiotherapy-in-first-line-treatment-of-es-sclc-100580508","NCT06838208","Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in First-line Treatment of ES-SCLC","Efficacy and Safety of Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in the First-line Treatment of Extensive Small Cell Lung Cancer: a Prospective, Multicenter, Phase II Clinical Study","Inclusion Criteria:\n\n1. Age≥18 years old, male or female, signed Informed Consent Form (ICF);\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n3. Histologically or cytologically confirmed ES-SCLC;\n4. No prior systemic treatment for ES-SCLC;\n5. At least one measurable (RECIST 1.1) chest lesion capable of 15Gy\u002F5f irradiation;\n6. Adequate hematologic and end organ function;\n\nExclusion Criteria:\n\n1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis;\n2. Prior therapy with an antibody or drug against immune checkpoint pathways, including but not limited to, anti program death receptor-1 (anti-PD-1), anti-PD-L1, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA-4) antibody;\n3. Was administered a live vaccine ≤ 4 weeks before treatment;\n4. Active autoimmune diseases or history of autoimmune diseases that may relapse;\n5. Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before treatment;\n6. With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases;\n7. Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks prior to treatment, including but not limited to tuberculosis infection;\n8. Received therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to starting treatment;",{"count":312,"type":21},56,[52],"To explore the efficacy and safety of Tislelizumab combined with chemotherapy and relayed radiotherapy in the first-line treatment of extensive small cell lung cancer",[55],"2025-09-18",{"date":318,"type":32},"2025-09-24",{"date":320,"type":32},"2025-02-25",{"date":322,"type":21},"2028-04-01",{"name":324,"class":123},"Anhui Provincial Cancer Hospital",{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":22,"phases":334,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":4},"100601133","phase-2-organoid-guided-vs-topotecan-therapy-in-relapsed-extensive-stage-small-cell-lung-cancer-100601133","NCT07106528","Organoid-guided vs Topotecan Therapy in Relapsed Extensive-Stage Small Cell Lung Cancer","Organoid-Based Drug Sensitivity Model Guided Personalized Precision Treatment for Extensive-Stage Small Cell Lung Cancer: A Prospective, Multicenter, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged 18 years or older.\n2. Pathologically confirmed extensive-stage small cell lung cancer (ES-SCLC) (AJCC 9th edition, Stage IV).\n3. Previously received first-line platinum-based systemic chemotherapy and experienced recurrence or progression during first-line treatment or within ≤ 6 months after completion of first-line treatment.\n4. Availability of sufficient tumor tissue or malignant serous effusion for organoid culture.\n5. Presence of measurable lesions based on RECIST 1.1.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Adequate bone marrow and organ function, confirmed by baseline blood count, blood biochemistry, and urine biochemistry tests.\n8. Asymptomatic and stable central nervous system (CNS) metastases are allowed.\n9. Expected survival of at least 3 months.\n10. For male participants: Agreement to use effective contraception during treatment and for at least 180 days after the last dose of study treatment; prohibition of sperm donation during this period.\n11. For female participants: Not pregnant or breastfeeding, and meeting at least one of the following:\n\n    Women of non-childbearing potential; or Agreement to use effective contraception during treatment and for at least 180 days after the last dose of study treatment; or Women of childbearing potential must have a negative serum or urine pregnancy test (with a minimum sensitivity of 25 IU\u002FL or HCG equivalent units) within 72 hours before initiating treatment.\n12. Voluntary participation with signed informed consent and willingness to comply with study follow-up procedures.\n\nExclusion Criteria:\n\n1. Mixed tumor pathology or lack of histological confirmation.\n2. Previous receipt of second-line or higher systemic anti-tumor therapy for ES-SCLC.\n3. Symptomatic or progressive brain metastases, or meningeal metastases.\n4. History of other malignant tumors that are progressive or require active treatment within the past 5 years.\n5. Presence of active infections, severe organ dysfunction, or other contraindications to anti-tumor treatment.\n6. Inability to obtain tumor tissue or insufficient malignant serous effusion for collection.\n7. Expected survival of less than 3 months.\n8. Inability to complete standardized clinical diagnosis\u002Ftreatment or regular follow-up.",{"count":333,"type":21},128,[52,24],"This study aims to provide personalized treatment options for patients with extensive-stage small cell lung cancer (SCLC) whose disease has worsened after initial chemotherapy.\n\nResearchers will use a novel approach called \"tumor organoid drug sensitivity testing\":\n\nA small sample of the patient's tumor (from biopsy or fluid) is grown into miniature 3D tumor models (\"organoids\") in the lab.\n\nThese organoids are exposed to various FDA-approved second-line drugs (including chemotherapy and newer targeted\u002Fimmunotherapy drugs if available).\n\nThe most effective drug for each patient's organoids will be recommended for their treatment.\n\n128 participants will be randomly assigned to one of two groups:Experimental Group: Receive organoid-guided personalized therapy; Control Group: Receive standard second-line chemotherapy (Topotecan).\n\nThe study will compare: How long the cancer remains controlled (Progression-Free Survival); Overall survival time; Treatment response rates and side effects.\n\nPotential benefits: May identify more effective treatments for individual patients; Could extend time without cancer progression.\n\nRisks: Organoid testing requires an additional tumor biopsy\u002Ffluid collection; Possible side effects from second-line drugs.",[55,337,166],"Extensive-stage Small Cell Lung Cancer (SCLC)","2025-08-05",{"date":340,"type":32},"2025-08-06",{"date":342,"type":21},"2025-08",{"date":344,"type":21},"2028-12",{"name":346,"class":123},"Peking Union Medical College Hospital",{"id":348,"slug":349,"hasResults":11,"nctId":350,"briefTitle":351,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":11,"sex":17,"minAge":353,"maxAge":354,"enrollmentInfo":355,"targetDuration":357,"studyType":358,"phases":4,"briefSummary":359,"conditions":360,"keywords":361,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":371,"locationsCount":180},"100598324","small-extracellular-vesicle-mirnas-as-predictive-biomarkers-for-immunochemotherapy-efficacy-in-extensive-stage-small-cell-lung-cancer-100598324","NCT07070011","Small Extracellular Vesicle miRNAs as Predictive Biomarkers for Immunochemotherapy Efficacy in Extensive-stage Small Cell Lung Cancer","Inclusion Criteria:\n\nRequirements for patients enrolled in the project:\n\n1. The pathological diagnosis of the patient is ESSCLC;\n2. ECOG score 0 or 1；\n3. The patient is receiving immunotherapy combined with chemotherapy for the first time and has no history of chemotherapy treatment;\n4. Patients with complete clinical sample information who meet the inclusion requirements\n\nExclusion Criteria:\n\n1. Patients whose pathological diagnosis does not meet the requirements;\n2. Patients whose ECOG staging does not meet the requirements;\n3. Patients with a history of chemotherapy, immunotherapy, or immunotherapy combined with chemotherapy;\n4. Patients with incomplete clinical sample information and follow-up information;","45 Years","80 Years",{"count":356,"type":21},38,"38 Days","OBSERVATIONAL","This study aims to investigate the clinical value of small extracellular vesicle (sEV) miRNAs as predictive biomarkers for immunochemotherapy efficacy in extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC represents a highly aggressive neuroendocrine malignancy, where the current standard first-line treatment combining immune checkpoint inhibitors with chemotherapy lacks predictive biomarkers for individualized therapeutic strategies.\n\nA prospective observational cohort will be established at Shanghai Chest Hospital, enrolling treatment-naïve ES-SCLC patients. Distinct miRNA signatures differentiating responders from non-responders will be identified through pretreatment serum sEV miRNA sequencing and differential expression analysis. These findings may provide novel liquid biopsy biomarkers to guide personalized treatment strategies and optimize clinical decision-making in ES-SCLC management.",[55],[140,362,363,364],"immunochemotherapy","sEV miRNAs","predictive biomarkers","2025-07-16",{"date":367,"type":32},"2025-07-17",{"date":369,"type":32},"2023-01-03",{"date":280,"type":21},{"name":372,"class":123},"Shanghai Chest Hospital of Shanghai Jiao Tong University",{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":22,"phases":382,"briefSummary":383,"conditions":384,"keywords":4,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":4},"100597816","phase-1-phase-1-study-of-hs-20093-combinations-in-patients-with-extensive-stage-small-cell-lung-cancer-100597816","NCT07063407","Phase 1 Study of HS-20093 Combinations in Patients With Extensive Stage Small Cell Lung Cancer","A Phase I Clinical Study Evaluating Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous HS-20093 Combinations in Patients With Extensive Stage Small Cell Lung Cancer","Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria to be eligible for participation in this study:\n\n1. Men or women aged more than or equal to (≥) 18 years.\n2. Pathologically diagnosed as ES-SCLC.\n3. Without disease progression after receiving first-line standard induction therapy (Platinum + Etoposide +PD- (L) 1 inhibitor combination therapy).\n4. Eastern Cooperative Oncology Group (ECOG) performance status: 0\\~1.\n5. Estimated life expectancy \\>12 weeks.\n6. Adequate bone marrow reserve or serious organ dysfunction\n7. Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.\n8. Females must have evidence of non-childbearing potential.\n9. Signed and dated Informed Consent Form.\n\nExclusion Criteria:\n\n1. Uncontrolled pleural effusion or ascites or pericardial effusion.\n2. Known and untreated, or active central nervous system metastases.\n3. Active autoimmune diseases or active infectious disease\n4. Known to have interstitial pneumonia or immune pneumonia\n5. History of severe allergic reaction, serious transfusion reactions or Allergy to any component of HS-20093\n6. The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator.\n7. The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator.\n8. Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study.\n9. History of neuropathy or mental disorders, including epilepsy and dementia.",{"count":381,"type":21},50,[51],"This is a Phase I clinical study of HS-20093. The purpose of this study is to evaluate the safety, tolerability, PK and efficacy of HS-20093 in combination with Adebrelimab in patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).",[27],"2025-07-03",{"date":387,"type":32},"2025-07-14",{"date":389,"type":21},"2025-07-31",{"date":391,"type":21},"2027-05-31",{"name":393,"class":39},"Shanghai Hansoh Biomedical Co., Ltd",{"id":395,"slug":396,"hasResults":11,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":401,"enrollmentInfo":402,"targetDuration":4,"studyType":22,"phases":404,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":180},"100589960","phase-3-nano-crystalline-megestrol-acetate-combined-with-standard-treatment-versus-standard-treatment-for-first-line-extensive-stage-small-cell-lung-cancer-in-the-cachexia-phase-100589960","NCT06961201","Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment for First-line Extensive-stage Small Cell Lung Cancer in the Cachexia Phase","A Prospective, Randomized, Parallel-controlled Clinical Study of Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment for First-line Extensive-stage Small Cell Lung Cancer (ES-SCLC) in the Cachexia Phase","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n* Life expectancy of ≥6 months.\n* Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) (according to the Veterans Administration Lung Study Group (VALG) staging system).\n* Participants must not have previously received systemic chemotherapy for ES-SCLC. For participants who have previously received adjuvant\u002Fneoadjuvant chemotherapy for non-metastatic disease with curative intent or concurrent\u002Fsequential chemoradiotherapy for locally advanced disease, they are eligible for this study if disease progression occurs \\>6 months after the completion of the last treatment.\n* Participants who have previously received PD-1\u002FL1 inhibitors in the neoadjuvant setting are allowed to participate in this study after investigator assessment and agreement. Participants who have previously received PD-1\u002FL1 inhibitors in the adjuvant setting or as consolidation therapy after curative chemoradiotherapy are not eligible for this study.\n* At least one measurable tumor lesion according to RECIST v1.1.\n* Meet the criteria for pre-cachexia or cachexia diagnosis (based on the Fearon diagnostic criteria).\n\nExclusion Criteria:\n\n* Presence of conditions that may affect gastrointestinal absorption, such as dysphagia, malabsorption, history of gastrectomy, or uncontrollable vomiting; ongoing enteral feeding or parenteral nutrition; or anorexia due to neurological causes, psychiatric conditions, or pain that makes eating difficult.\n* Currently taking or planning to take other medications that increase appetite or weight, such as corticosteroids (excluding short-term use of dexamethasone during chemotherapy), androgens, progestogens, thalidomide, olanzapine, anamorelin, or other appetite stimulants.\n* Patients with Cushing's syndrome, adrenal or pituitary insufficiency; patients with poorly controlled diabetes mellitus.\n* Concurrent enrollment in another clinical trial, unless it is an observational, non-interventional trial or the follow-up period of an interventional study.\n* Presence of unresolved toxicities from prior anti-tumor treatments. Unresolved is defined as not having returned to Grade 0 or 1 according to NCI CTCAE Version 5.0 (except for alopecia) or not having returned to the levels specified in the enrollment\u002Fexclusion criteria.","85 Years",{"count":403,"type":21},94,[24],"This study is a prospective, randomized, parallel-controlled clinical trial, aiming to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone as first-line therapy for extensive-stage small cell lung cancer (ES-SCLC) in both the pre-cachexia and cachexia phases. Participants enrolled in the study are those with ES-SCLC in the pre-cachexia or cachexia phase who have not received systemic treatment and are not eligible for curative therapy.",[55,407],"The Pre-cachexia or Cachexia Patients Who Have Not Received Systemic Treatment and Are Not Eligible for Curative Therapy","2025-04-29",{"date":410,"type":32},"2025-05-07",{"date":412,"type":21},"2025-05-01",{"date":414,"type":21},"2027-06-30",{"name":416,"class":39},"Changchun GeneScience Pharmaceutical Co., Ltd.",{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":132,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":435,"locationsCount":4},"100585977","phase-2-nanocrystalline-megestrol-acetate-for-the-treatment-of-anorexia-cachexia-syndrome-in-extensive-stage-small-cell-lung-cancer-a-prospective-open-label-single-arm-phase-ii-clinical-study-100585977","NCT06909383","Nanocrystalline Megestrol Acetate for the Treatment of Anorexia-Cachexia Syndrome in Extensive-Stage Small Cell Lung Cancer: A Prospective, Open-Label, Single-Arm Phase II Clinical Study","Inclusion Criteria:\n\nPatients who have been confirmed by histological or cytological examination to have small cell lung cancer (SCLC), and who have been identified as having extensive-stage small cell lung cancer based on the 8th edition of the AJCC staging system or the Veterans Administration Lung Group (VALG) criteria (excluding patients with combined small cell lung cancer).\n\nThe subjects have not received systemic chemotherapy for metastatic diseases in the past. For subjects who have previously received adjuvant\u002Fneoadjuvant chemotherapy aimed at cure for non-metastatic diseases, or radical concurrent or sequential chemoradiotherapy, if the disease progression occurs more than 6 months after the end of the last treatment, they are eligible to participate in this study.\n\nAccording to RECIST v1.1, there is at least one measurable tumor lesion. Meet the diagnostic criteria for the pre-cachexia or cachexia stage. -\n\nExclusion Criteria:\n\n1. Cancer-specific exclusion criteria:\n\n   1. Active or untreated CNS metastases (e.g., brain or leptomeningeal metastases) determined by CT or magnetic resonance imaging (MRI) evaluation during screening and previous imaging evaluations. Patients who have previously received treatment for brain or leptomeningeal metastases, have been stable for ≥ 2 months, and have discontinued systemic hormonal therapy (\\> 10 mg\u002Fday of prednisone or equivalent) for \\> 4 weeks before randomization may participate in the study.\n   2. Uncontrolled tumor-related pain;\n   3. Thromboembolic disease, ascites, or lower extremity edema within the past 6 months;\n   4. A history of malignant tumors other than lung cancer within 5 years before random assignment, except for malignant tumors with a negligible risk of metastasis or death \\[e.g., with an expected 5-year overall survival rate \\> 90%\\] and those expected to be cured after treatment, such as appropriately treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery;\n   5. Persistent toxicity from previous anti-tumor treatment that has not been resolved. \"Not resolved\" is defined as not having recovered to grade 0 or 1 according to NCI CTCAE version 5.0 (excluding alopecia) or not having recovered to the level specified in the inclusion\u002Fexclusion criteria.\n2. General medical exclusion criteria:\n\n   1. Women who are pregnant, lactating, or planning to become pregnant during the study period;\n   2. Patients with hepatitis B (known to be positive for HBV surface antigen HBsAg and with HBV DNA detected at each study center ≥ 1000 cps\u002Fml or 200 IU\u002Fml or ≥ the upper limit of the normal value) or hepatitis C:\n\n      * For patients with a previous history of hepatitis B virus (HBV) infection, HBV deoxyribonucleic acid (DNA) testing must be performed on this group of patients. Only those with a negative HBV DNA result (HBV DNA \\\u003C 1000 cps\u002Fml or 200 IU\u002Fml or below the upper limit of the normal value) are eligible to participate in this study;\n      * Among patients with a positive hepatitis C virus (HCV) antibody, only those with a negative polymerase chain reaction (PCR) HCV ribonucleic acid (RNA) result can participate in this study.\n   3. Patients with a positive test result for human immunodeficiency virus (HIV);\n   4. Those who have undergone major surgery (excluding diagnostic surgery) within 28 days before random assignment, or are expected to undergo major surgery during the study period;\n   5. Significant cardiovascular diseases, such as heart diseases defined by the New York Heart Association (Class II or higher), myocardial infarction occurred within 3 months before random assignment, unstable arrhythmia, unstable angina pectoris, cerebrovascular accident or transient ischemic attack; Patients known to have coronary artery disease, congestive heart failure that does not meet the above criteria, or with a left ventricular ejection fraction \\\u003C 50% must receive the optimal stable treatment regimen considered by the attending physician, and consultation with a cardiologist is advisable if necessary;\n   6. Severe infections occurred within 4 weeks before the first administration, including but not limited to those with comorbidities requiring hospitalization, sepsis, or severe pneumonia; Active infections (excluding antiviral treatment for hepatitis B or hepatitis C) for which systemic anti-infective treatment was received within 2 weeks before the first administration.\n3. Exclusion criteria related to drug use:\n\n   1. Any condition that affects gastrointestinal absorption, such as dysphagia, malabsorption, uncontrollable vomiting, etc.; Patients with difficulty in food intake or those who require enteral or parenteral nutritional support; Patients with anorexia nervosa, anorexia caused by mental illness, or difficulty in eating due to pain.\n   2. Currently taking or planning to take other drugs that increase appetite or body weight, such as adrenal corticosteroids (except for short-term use of dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants.\n   3. Patients with Cushing's syndrome, adrenal or pituitary insufficiency; Patients with poorly controlled diabetes; Patients with current hypertension whose systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg after treatment with oral antihypertensive drugs.\n   4. A history of esophageal-gastric varices, severe ulcers, gastrointestinal perforation and\u002For fistula, a history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months before the first administration.\n   5. Known allergy to any component of the study drug.\n   6. Other situations that the investigator deems unsuitable.\n\n      \\-",{"count":424,"type":21},41,[52],"Patients with extensive-stage small cell lung cancer are a high-risk group for cancer cachexia and anorexia. Meanwhile, the adverse reactions of chemotherapy and immunotherapy potentially exacerbate the occurrence and development of cancer cachexia and anorexia. Cancer cachexia and anorexia also severely affect the quality of life of patients with extensive-stage small cell lung cancer, significantly shortening their overall survival (OS) and progression-free survival (PFS), thus forming a vicious cycle.\n\nNumerous previous studies have shown that for patients with advanced tumors, the combination of supportive treatments such as megestrol acetate during chemotherapy or concurrent chemoradiotherapy is a treatment mode with clinical significance and practical feasibility in clinical practice. However, the efficacy and the optimal treatment timing of its combination with the current first-line immunochemotherapy regimen remain unclear. Although mechanistic studies have shown that anti-cachexia treatment may synergistically enhance the efficacy of immunotherapy, there is a lack of relevant clinical research evidence.",[55,428],"Cancer - Associated Anorexia - Cachexia Syndrome","2025-03-27",{"date":431,"type":32},"2025-04-03",{"date":433,"type":21},"2025-06-01",{"date":280,"type":21},{"name":436,"class":123},"Guangzhou Institute of Respiratory Disease",{"id":438,"slug":439,"hasResults":11,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":22,"phases":447,"briefSummary":448,"conditions":449,"keywords":450,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":460},"100567047","phase-2-atezolizumab-and-rechallenge-chemotherapy-in-relapsed-patients-with-extensive-stage-small-cell-lung-cancer-es-sclc-100567047","NCT06663098","Atezolizumab and Rechallenge Chemotherapy in Relapsed Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC).","Continued PD-L1 Inhibition With Atezolizumab With Rechallenge Chemotherapy in Patients With Sensitive Relapse SCLC Progressing on First-line Platinum-etoposide Chemotherapy and a PD-L1 Inhibitor: CARRY-ON Study-GOIRC-01-2023","CARRY-ON","Inclusion Criteria:\n\n1. Diagnosis of small-cell lung cancer (SCLC) (according to WHO classification 2015) confirmed at pathology (histology or cytology).\n2. Male or female and ≥ 18 years of age.\n3. Life expectancy ≥ 12 weeks.\n4. Disease progression at least 60 days after the completion of first-line chemotherapy consisting of at least 4 cycles of platinum-etoposide plus either atezolizumab or durvalumab and have not received any other treatment (except for immunotherapy as maintenance treatment); the 60 day-interval is calculated from the date of the last chemotherapy administration to the date of the first radiologically documented progressive disease.\n5. No previous radiotherapy on the only one site disease progression, unless that site had subsequent evidence of progressive disease.\n6. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2.\n7. Patients with treated brain metastases (or untreated but asymptomatic) and off steroids or on a stable dose of steroids (≤10 mg of prednisone-equivalent) are also eligible. Radiotherapy must have been completed a minimum of 14 days prior to registration, and patients must have recovered from AEs related to radiotherapy to \\\u003C grade 1 (except alopecia)\n8. For Females: must be postmenopausal (defined as occurring 12 months after last menstrual period) before the screening visit, or are surgically sterile. If they are of childbearing potential, a negative serum pregnancy test prior to study entry has to be documented; furthermore, they agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form (ICF) through 5 months after the last dose of study drug,or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject.\n9. For Males: even if surgically sterilized (i.e., post-vasectomy status) agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, or practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject.\n10. Normal baseline laboratory values as specified below:\n\n    * Absolute neutrophil count (ANC) ≥1500\u002Fmm3\n    * Platelet count ≥ 100 x 109\u002FL (≥100,000\u002FμL) without transfusion\n    * Hemoglobin ≥ 90 g\u002FL (≥ 9 g\u002FdL); patients may be transfused to meet this criterion.\n    * Total bilirubin \\\u003C 1.5x the institutional upper limit of normal (ULN)\n    * Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\\u003C 2.5x the institutional ULN (\\\u003C 5x if liver function test elevations are due to liver metastases)\n    * Creatinine \\\u003C 1.5x institutional ULN or estimated creatinine clearance using the Cockcroft-Gault formula ≥ 30 mL\u002Fminute for patients with creatinine levels above institutional limits\n    * For patients not receiving therapeutic anticoagulation: INR and aPTT ≤ 1.5 x ULN\n    * Negative HIV test at screening {with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥ 200\u002FμL, and have an undetectable viral load}\n    * Negative hepatitis B surface antigen (HBsAg) test at screening\n    * Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following:\n\n      * Negative total hepatitis B core antibody (HBcAb)\n      * Positive total HBcAb test followed by a negative (per local laboratory definition) hepatitis B virus (HBV) DNA testNegative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening The HCV RNA test must be performed for patients who have a positive HCV antibody test.\n11. Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 4 weeks before registration, and otherwise noted in other inclusion\u002Fexclusion criteria.\n12. Recovered (i.e., ≤ grade 1 toxicity) from effects of prior anticancer therapy, except alopecia.\n13. Prior radiotherapy is allowed provided that it has been completed more than 2 weeks before starting protocol treatment and patients have recovered from AEs related to radiotherapy to \\\u003C grade 1\n14. Ability to comply with protocol requirements.\n15. The patient or the patient's legal representative has to be able to provide written informed consent. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.\n\nExclusion Criteria:\n\n1. More than 1 line of prior treatment for ES-SCLC.\n2. First-line treatment without either atezolizumab or durvalumab.\n3. First-line chemotherapy other than platinum-etoposide.\n4. Less than 4 cycles of first-line platinum-etoposide.\n5. Presence of resistant relapse (progressive disease within 60 days from the end of first-line chemotherapy) or refractory disease (progressive disease during the first 4 cycles of first-line chemoimmunotherapy).\n6. Symptomatic brain metastases or spinal cord compression (CT or MRI of the head is required within 4 weeks prior to randomization)requiring immediate radiotherapy for palliation. Patients with treated brain metastases (or untreated but asymptomatic) and off steroids or on a stable dose of steroids (≤10 mg of prednisone-equivalent) are also eligible provided that all of the following criteria are met:\n\n   * If treated, at least 14 days between the end of stereotactic radiotherapy or whole brain radiotherapy and initiation of study treatment and recovery from AEs related to radiotherapy to ≤ grade 1 (except alopecia), or at least 28 days between neurosurgical resection and initiation of study treatment;\n   * Anticonvulsant therapy at a stable dose is permitted;\n   * Metastases are limited to the cerebellum or the supratentorial region (i.e., no metastases to the midbrain, pons, medulla or spinal cord);\n   * There is no evidence of interim intracranial progression between completion of CNS directed therapy (if administered) and initiation of study treatment.\n7. Evidence of leptomeningeal disease.\n8. Any comorbid condition or unresolved toxicity that would preclude administration of second-line chemotherapy.\n9. Patient has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines and COVID vaccines that do not contain live virus are permitted. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.\n10. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment except for PD-L1 inhibitor maintenance as part of first-line treatment.\n11. Any condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of registration . 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).\n12. Diagnosed with or treated for another malignancy within 3 years before the first dose of study drug, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type may be enrolled in the study if they have undergone complete resection and no evidence of active disease is present.\n13. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment other than those in the present study. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n14. Treatment with any other investigational agent within 30 days prior to starting study treatment, or concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n15. Infection requiring intravenous antibiotic therapy or other serious infection within 14 days before the first dose of study drug.\n16. Prior allogeneic stem cell or solid organ transplantation.\n17. For female subjects: positive serum pregnancy test, pregnancy, or breastfeeding.\n18. Surgery within 4 weeks (or 2 weeks for a minor surgery) before study enrolment and not fully recovered to baseline or to a stable clinical status. Insertion of a vascular device is allowed.\n19. Patients who experienced medically significant or NCI CTCAE Grade 3 or higher toxicities in response to first-line immunotherapy\n20. Unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel.",{"count":446,"type":21},142,[52],"The goal of this clinical trial is to learn if a combination of atezolizumab and standard chemotherapy works to treat sensitive Extensive-stage Small Cell Lung Cancer, progressing after first-line of treatment.\n\nThe main questions it aims to answer are:\n\n* Does combination of atezolizumab and standard chemotherapy increase overall survival?\n* What medical problems do participants have when taking combination of atezolizumab and standard chemotherapy?\n\nParticipants will:\n\n* take atezolizumab and standard chemotherapy every 3 weeks for 4 cycles and than atezolizumab every 3 weeks up to 18 cycles.\n* visit the clinic once every 3 weeks for checkups and tests\n* perform Radiological assessments after 6 weeks and then every 12 weeks to determine response to treatment.",[27],[59,168],"2025-03-11",{"date":453,"type":32},"2025-03-13",{"date":455,"type":32},"2025-01-24",{"date":457,"type":21},"2029-06-01",{"name":459,"class":123},"Gruppo Oncologico Italiano di Ricerca Clinica",25,{"id":462,"slug":463,"hasResults":11,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":22,"phases":470,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":180},"100581697","second-line-immunotherapy-for-es-sclc-100581697","NCT06853678","Second-line Immunotherapy for ES-SCLC","Selinexor Combined With Nab-paclitaxel and Adebrelimab as Second-line Treatment for ES-SCLC：A Prospective, Single-center, Single-arm Clinical Study","Inclusion Criteria:\n\n* Age ≥ 18 years old, male or female;\n* ECOG PS score 0-1 points;\n* Expected survival period is not less than 12 weeks;\n* Patients with pathologically (histologically or cytologically) confirmed small cell lung cancer (according to the 2015 classification of the World Health Organization);\n* Patients with extensive stage small cell lung cancer confirmed by imaging (staging according to the eighth edition of TNM staging);\n* With measurable lesions (according to RECIST 1.1 standards, the long diameter of the tumor lesion on CT scan is ≥ 10mm);\n* Need to have failed standard first-line treatment before enrollment;\n* Agree to collect tumor histological specimens required for this study and use them in related research;\n* Main organ function is normal, without severe abnormal blood, heart, lung, liver, kidney function and immunodeficiency diseases.\n* Female subjects of childbearing potential must undergo a serum or urine pregnancy test within 72 hours before starting the trial drug, and the result must be negative, and they must be willing to use a medically approved high-efficiency contraceptive method (such as intrauterine contraceptive device, contraceptive pills or condoms) during the study and within 90 days after the last administration of the trial drug; male subjects whose partners are female subjects of childbearing potential should be surgically sterilized or agree to use effective contraceptive methods during the study and within 90 days after the last administration of the trial drug.\n* Subjects voluntarily join this study and sign the Informed Consent Form (ICF), have good compliance, and can follow up the efficacy and adverse reactions as required by the protocol\n\nExclusion Criteria:\n\n* Any active autoimmune disease or history of autoimmune disease with expected recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism \\[subjects who can be controlled only by hormone replacement therapy can be included\\]; subjects with skin diseases that do not require systemic treatment such as vitiligo, psoriasis, alopecia, type I diabetes or asthma that has been completely relieved in childhood and does not require any intervention in adulthood can be included; asthma patients who require bronchodilators for medical intervention are not included);\n* Suffering from congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, untreated active hepatitis B (HBsAg positive or HBV DNA ≥ 500 IU\u002Fml and abnormal liver function), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method and liver function is abnormal) or co-infection with hepatitis B and hepatitis C;\n* Subjects who need systemic treatment with corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent dose of similar hormones) or other immunosuppressants within 14 days before the first use of the trial drug;\n* Subjects who received live attenuated vaccines within 4 weeks before the first dose or planned to receive them during the study;\n* Subjects who have previously or are currently using any other anti-tumor treatment for SCLC;\n* Subjects who have suffered from malignant tumors other than SCLC in the past 5 years, excluding fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;\n* Evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia, and severe lung function impairment;\n* Suffering from grade II or above myocardial ischemia or myocardial infarction, and poorly controlled arrhythmias (including QTc interval ≥450ms for men and ≥470ms for women). According to NYHA standards, patients with grade III-IV heart failure, or left ventricular ejection fraction (LVEF) \\\u003C50% indicated by cardiac ultrasound examination, had the following conditions within 6 months before entering the study: myocardial infarction, severe\u002Funstable angina, NYHA grade 2 or above heart failure, and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;\n* Urinalysis indicated urine protein ≥ (++), or 24-hour urine protein ≥ 1.0 g;\n* Patients with thrombotic diseases requiring long-term anticoagulation therapy with warfarin or heparin, or requiring long-term antiplatelet therapy (aspirin ≥ 300 mg\u002Fday or clopidogrel ≥ 75 mg\u002Fday);\n* Systemic antibiotics used for ≥7 days within 4 weeks before the first dose, or unexplained fever \\>38.5℃ during the screening period\u002Fbefore the first dose (fever caused by tumors can be included in the study as determined by the investigator);\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n* Pregnant or lactating women; patients of fertile potential who are unwilling or unable to take effective contraceptive measures;\n* Known allergic reactions, hypersensitivity reactions, or intolerance to carrelizumab and other monoclonal antibodies, pemetrexed, albumin-paclitaxel, prophylactic medications, or their excipients;\n* Any condition that the investigator believes may harm the subject or cause the subject to be unable to meet or perform the study requirements.",{"count":469,"type":21},30,[471],"NA","At present, the first-line standard treatment for patients with extensive-stage small cell lung cancer (ES-SCLC) is immunotherapy combined with chemotherapy. For patients who relapse within 6 months after first-line chemotherapy, conventionally recommended chemotherapy drugs include topotecan, irinotecan, gemcitabine, paclitaxel or vinorelbine, etc., but due to limited benefits to patients, patients are also recommended to participate in relevant clinical studies. New treatment methods are constantly being explored in second-line treatment, including fluzoparib combined with adebelimumab. The current status of second-line treatment is still worrying.\n\nSelinexor is a class of nuclear export selective inhibitors (SINEs) for the export protein receptor XPO1. PO1 promotes the transport of mRNA and cargo proteins, including tumor suppressor proteins (TSPs), hormone receptors (GRs), and immune response regulators. Selinexor covalently binds to the XPO1 protein, blocking the export of TSPs and GRs and accumulating them in the nucleus, preventing the translation of oncoprotein mRNA, stopping the cell cycle process, and initiating apoptosis. Multiple in vitro and in vivo studies have verified that selinexor combined with chemotherapy\u002Fradiotherapy\u002Ftargeted therapy exhibits significant anti-tumor activity.\n\nThis study plans to use selinexor combined with adebrelimab and albumin-paclitaxel as a second-line treatment for ES-SCLC to explore the efficacy and safety of this regimen.",[27],{"date":475,"type":32},"2025-03-03",{"date":477,"type":21},"2025-02-28",{"date":479,"type":21},"2027-03-01",{"name":481,"class":123},"Tianjin Medical University Cancer Institute and Hospital",{"id":483,"slug":484,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":358,"phases":4,"briefSummary":490,"conditions":491,"keywords":492,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":4},"100556875","a-multicenter-real-world-cohort-study-of-adebrelimab-injection-in-the-treatment-of-extensive-stage-small-cell-lung-cancer-100556875","NCT06530797","A Multicenter Real-World Cohort Study of Adebrelimab Injection in the Treatment of Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Patients must meet all of the following criteria to be eligible for inclusion in this study:\n\n  1. Voluntarily sign the informed consent form and agree to participate in the study.\n  2. Histopathologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).\n  3. Age ≥ 18 years.\n  4. Determined by the investigator to be eligible for Adebrelimab treatment.\n\nExclusion Criteria:\n\n* Patients with any of the following conditions are not eligible for inclusion in this study:\n\n  1. Evidence of being a pregnant or lactating female.\n  2. Currently receiving treatment as part of a blinded study protocol.\n  3. Any other condition that the investigator deems unsuitable for inclusion in the study.",{"count":489,"type":21},2000,"The purpose of this observational study is to evaluate the safety and efficacy of Adebrelimab Injection in extensive-stage small cell lung cancer (ES-SCLC) under real-world conditions. Specifically, the study aims to assess the treatment of Adebrelimab Injection across various subgroups of ES-SCLC patients. The goal is to provide information on treatment patterns and effectiveness in real-life settings, explore potential predictive or prognostic biomarkers, and preliminarily evaluate the pharmacoeconomic indicators of Adebrelimab Injection treatment for extensive-stage small cell lung cancer.",[55],[493,494],"Extensive-stage small cell lung cancer (ES-SCLC)","Adebrelimab","2024-07-26",{"date":497,"type":32},"2024-07-31",{"date":499,"type":21},"2024-08-01",{"date":501,"type":21},"2026-09-01",{"name":153,"class":123}]