[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"small-cell-lung-cancer-extensive-stage\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:small-cell-lung-cancer-extensive-stage":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,41,53,84,117,149,176,202,226,247,272,293,318,343,367,389,409,430,456,480,505,528,554],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100053963","phase-1-a-clinical-study-of-gocatamig-mk-6070-and-infinatamab-deruxtecan-mk-2400-in-people-with-small-cell-lung-cancer-mk-6070-003-100053963",false,"NCT07227597","A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)","A Phase 1b\u002F2 Open-label Study Evaluating Different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-Based Regimens in First-line Extensive Stage Small Cell Lung Cancer","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC)\n* For participants receiving gocatamig + ifinatamab deruxtecan (I-DXd) in maintenance only:\n\n  * Completed 3 to 4 cycles of platinum + etoposide chemotherapy with concurrent approved anti-programmed cell death 1\u002FLigand 1 (anti PD-1\u002FL1) as first line (1L) treatment of ES-SCLC within 6 weeks prior to enrollment\n  * No radiological disease progression per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)\n  * No other prior systemic ES-SCLC therapy allowed\n  * Rechallenge therapy counts as an additional line and leads to exclusion\n* For participants receiving gocatamig + I-DXd in induction and maintenance, or gocatamig + I-DXd in induction followed by gocatamig + atezolizumab in maintenance, or carboplatin + etoposide + atezolizumab in induction followed by atezolizumab in maintenance: No prior systemic ES-SCLC treatment allowed\n* Applicable to all participants: prior limited-stage small cell lung cancer (SCLC) is allowed if \\> 6 months have passed since the end of previous therapy and progression\n* Must be able to provide a pretreatment archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated\n* Measurable disease by RECIST 1.1 as assessed by the local site investigator\u002Fradiology. Lesions situated in a previously irradiated area are considered measurable if growth has been shown in such lesions since the completion of radiation\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\n* Has any history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use, current ILD, ILD that cannot be ruled out by imaging at screening, or suspected ILD\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Has history of clinically significant intracranial bleeding or spinal cord bleeding\n* Has active neurologic paraneoplastic syndrome\n* Has history of coronary\u002Fperipheral artery bypass graft and\u002For any coronary\u002Fperipheral angioplasty or clinically significant cardiovascular disease such as myocardial infarction, symptomatic congestive heart failure (CHF), and\u002For uncontrolled cardiac arrhythmia within 6 months before the first dose of study intervention\n* Has other uncontrolled or significant protocol specified cardiovascular disease\n* Has history of arterial thrombosis within 6 months before the first dose of study intervention\n* Has chronic liver disease\n* Has history of allogeneic tissue\u002Fsolid organ transplant\n* Has history of leptomeningeal disease\n* Is infected with human immunodeficiency virus (HIV) and has a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor\n* Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has major surgery within 4 weeks or minor surgery within 2 weeks of allocation\u002Frandomization (or first dose), or is anticipated to require a major surgical procedure during the study","ALL","18 Years",{"count":19,"type":20},170,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","Researchers are looking for new ways to treat extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC is a type of lung cancer that has spread throughout the lung, to the other lung, or to other parts of the body.\n\nA standard (usual) treatment for ES-SCLC uses both chemotherapy and immunotherapy.\n\n* Chemotherapy is a treatment that works to destroy cancer cells or stop them from growing.\n* Immunotherapy is a treatment that helps the immune system fight cancer.\n\nGocatamig and I-DXd (short for ifinatamab deruxtecan) are study medicines. Researchers want to know if giving gocatamig and I-DXd together can treat ES-SCLC. Researchers will also look at giving the study medicines with standard treatment. Gocatamig is a T-cell engager therapy. I-DXd is an antibody drug conjugate.\n\n* T-cell engager therapy is a certain type of immunotherapy that uses T-cells to find and destroy cancer cells.\n* A T-cell is a type of white blood cell, which are cells that help the body fight infection.\n* An antibody drug conjugate (ADC) is a treatment that attaches to a protein on cancer cells and delivers treatment to destroy those cells.\n\nThe goals of this study are to learn:\n\n* About the safety of combining gocatamig and I-DXd and if people tolerate them together\n* If people who receive gocatamig and I-DXd have ES-SCLC respond, which means the cancer gets smaller or goes away",[27],"Small Cell Lung Cancer Extensive Stage","RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":32},"2026-01-29",{"date":36,"type":20},"2030-12-30",{"name":38,"class":39},"Merck Sharp & Dohme LLC","INDUSTRY",35,{"id":42,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":43,"targetDuration":4,"studyType":21,"phases":44,"briefSummary":25,"conditions":45,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":49,"completionDateStruct":50,"leadSponsor":51,"locationsCount":52},"100610439",{"count":19,"type":20},[23,24],[27],"2026-06-24",{"date":48,"type":32},"2026-06-26",{"date":34,"type":32},{"date":36,"type":20},{"name":38,"class":39},32,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":64,"conditions":65,"keywords":70,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100642878","the-ease-study-randomized-trial-of-a-novel-approach-to-addressing-fear-of-progression-in-advanced-cancer-100642878","NCT07636200","The EASE Study: Randomized Trial of a Novel Approach to Addressing Fear of Progression in Advanced Cancer","EASE","Inclusion Criteria:\n\n* Adults, age 18 or older\n* Have been diagnosed with either (a) Stage IV metastatic cancer of any solid tumor type, (b) Stage III ovarian cancer that has recurred, (c) 'extensive stage' small cell lung cancer, or (d) glioblastomas of any staging\n* Are capable at time of consent of understanding and voluntarily consenting themselves to the study, attending intervention sessions, and writing for 30 minutes, confirmed by an Eastern Cooperative Group Performance Status Scale of ≤2\n* Report elevated FoP and cancer-related trauma symptoms on the screening measures: FoP-Q 12-item short version: mean score of 2.5 (or total score of 30), IES-R: mean of 1.5 (or total score of 33)\n* Are fluent in English or Spanish and can read English proficiently (for the surveys, which are in English)\n\nExclusion Criteria:\n\n* Patients who have a history of chronic untreated trauma unrelated to their cancer, psychiatric hospitalization or suicide attempt(s) in the past 2 years, or current high suicide risk, as identified in the screening.\n* EMR-noted cognitive impairment (such as dementia) is an exclusion due to potential impairments in neural learning mechanisms that may affect the efficacy of exposure therapy.",{"count":61,"type":20},250,[63],"NA","Precision oncology has led to a growing population of adults with advanced cancer living increasingly longer lives in the face of profound uncertainty about the future, with over half reporting moderate to high fear of cancer progression (FoP). These fears are associated with anxiety and depression, over-use of healthcare, physical symptom burden, higher treatment regret, fatigue, and, in many studies, poorer quality of life. Moreover, FoP is strongly correlated with cancer-related trauma symptoms-physical hyperarousal, intrusiveness of cancer thoughts\u002Fimages, and avoidance of cancer-related thoughts and feelings, suggesting overlapping symptoms. While behavioral interventions exist to target fear of recurrence in early-stage cancer survivors, there is a dearth of behavioral interventions to address FoP or cancer-related trauma symptoms in adults with advanced cancer, and no known published randomized trials of such interventions in the United States. In addition, cutting-edge developments for the treatment of trauma in general populations have not been adapted to cancer populations. To address these critical gaps, we adapted a cutting-edge behavioral treatment for trauma to reduce FoP and cancer-related trauma symptoms among adults with advanced cancer. The intervention, titled EASE, is based on written exposure therapy, an efficacious approach for reducing trauma symptoms in general populations that is better accepted and far briefer than other gold-standard approaches. EASE adapts this approach to help advanced cancer patients with elevated FoP and cancer-related trauma symptoms reduce their fear of the future by using written exposure focused on their future worst-case scenario with cancer. Informed by the NIH stage model, we evaluated EASE delivered by telehealth in an open pilot trial for 29 adults with late-stage cancer and elevated FoP and cancer-related trauma symptoms. Pilot findings show strong acceptability, feasibility, and efficacy potential. We now propose to conduct the first randomized trial of EASE, and, thus, first known randomized trial in the United States of a behavioral intervention for FoP and cancer-related trauma symptoms among adults with advanced cancer. This 2-arm trial (N=250) will compare EASE delivered by telehealth with Usual Care (UC). We aim to compare EASE to UC on FoP and cancer-related trauma symptoms (primary outcomes) and anxiety, depression, hopelessness, and quality of life, at post-intervention (Aim 1) and follow-up (Aim 2). We will evaluate mechanisms for EASE relative to UC (Aim 3). Offering EASE in both English and Spanish, and by telehealth, increases access. Simple content increases scalability. Rigorous evaluation of EASE has the potential to provide a paradigm-shifting intervention ready for dissemination and to inform evidence-based care guidelines for distressed adults with advanced cancer.",[66,67,68,69,27],"Advanced Solid Tumor Cancer","Stage IV Cancer (Solid Tumors Only)","Glioblastoma","Stage III Ovarian Cancer",[71,72],"Fear of cancer progression","Cancer-related trauma symptoms","2026-06-04",{"date":75,"type":32},"2026-06-09",{"date":77,"type":32},"2026-05-04",{"date":79,"type":20},"2030-05",{"name":81,"class":82},"University of Colorado, Boulder","OTHER",2,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100493347","phase-1-quaratusugene-ozeplasmid-reqorsa-and-atezolizumab-maintenance-therapy-in-es-sclc-patients-100493347","NCT05703971","Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients","A Phase 1\u002F2 Clinical Trial of Quaratusugene Ozeplasmid and Atezolizumab Maintenance Therapy in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)","Acclaim-3","Inclusion Criteria:\n\n* Male or female aged ≥18 years.\n* Documented history of histologically or cytologically confirmed ES-SCLC, prior to starting treatment with the combination of atezolizumab, carboplatin, and etoposide\n* Complete Response (CR), Partial Response (PR), or Stable Disease (SD) after receiving at least three cycles, and no more than four cycles, of atezolizumab, carboplatin, and etoposide.\n* Eastern Cooperative Oncology Group performance status (ECOG PS) score from 0 to 1.\n* Must be ≥28 days beyond major surgical procedures such as thoracotomy, laparotomy, or joint replacement, and must not have evidence of wound dehiscence, active wound infection, or comparable major residual complications of the surgery per Investigator assessment.\n* Asymptomatic brain metastases must meet ALL criteria of the following (a-d):\n\n  1. No history of seizures in the preceding six months.\n  2. Definitive treatment must be completed ≥21 days prior to enrollment.\n  3. Must be off steroids administered because of brain metastases or related symptoms for ≥7 days.\n  4. If had previous brain irradiation, post-treatment imaging must demonstrate stability or regression of the brain metastases.\n* Absolute neutrophil count (ANC) \\>1500\u002Fmm3, platelet count \\>100,000\u002Fmm3 within ≤28 days.\n* Adequate renal function documented by serum creatinine of ≤1.5 mg\u002FdL or calculated creatinine clearance \\>50 ml\u002Fmin within ≤28 days.\n* Adequate hepatic function as documented by serum bilirubin \\\u003C1.5 mg\u002FdL and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X upper limit of normal (ULN) within ≤28 days.\n* Stable cardiac condition with a left ventricular ejection fraction ≥40% within ≤28 days.\n* If female of childbearing potential (FOCBP), must have negative serum pregnancy test (serum beta-human chorionic gonadotropin \\[β-hCG\\]) within ≤7 days of first dose.\n* FOCBP and non-sterile men who are sexually active with FOCBP must agree to use two forms of contraception including one highly effective and one effective methods beginning ≥2 weeks prior to enrollment through for four months following the last dose of study treatment.\n* If male, must agree to no sperm donation during study treatment and for an additional four months following the last dose of study treatment.\n* Must have voluntarily signed an informed consent in accordance with institutional policies.\n\nExclusion Criteria:\n\n* Unable to tolerate atezolizumab treatment, leading to early treatment discontinuation or prolonged\u002Ffrequent dosage modifications in previous atezolizumab treatment as determined by the Investigator.\n* Received prior gene therapy.\n* Received prophylactic cranial irradiation or consolidation thoracic radiation.\n* Active systemic viral, bacterial, or fungal infection(s) requiring treatment.\n* Serious concurrent illness or psychological, familial, sociological, geographical, or other concomitant conditions that, in the opinion of the Investigator, would not permit adequate follow-up and compliance with the study protocol.\n* History of autoimmune disease requiring immunosuppression.\n* History of myocardial infarction or unstable angina within ≤6 months.\n* Known human immunodeficiency virus (HIV) infection or has active hepatitis infection.\n* Female who is pregnant or breastfeeding",{"count":93,"type":20},62,[23,24],"This clinical trial will evaluate the combination of quaratusugene ozeplasmid with atezolizumab as maintenance therapy for patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).\n\nThe study is comprised of 2 phases, a dose selection phase (Phase 1) and a safety and efficacy evaluation phase (Phase 2).",[27],[98,99,100,101,102,103,104,105,106],"atezolizumab","atezolizumab and hyaluronidase-tqjs","Tumor Suppressor Gene 2 (TUSC2)","Lipid Nanoparticle (LNP)","Gene Therapy","TECENTRIQ","ES-SCLC","REQORSA","quaratusugene ozeplasmid","2026-05-31",{"date":109,"type":32},"2026-06-03",{"date":111,"type":32},"2024-05-09",{"date":113,"type":20},"2027-08",{"name":115,"class":39},"Genprex, Inc.",17,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":21,"phases":126,"briefSummary":128,"conditions":129,"keywords":137,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100638863","phase-3-evaluate-bl-m14d1-plus-atezolizumab-vs-standard-of-care-in-first-line-extensive-stage-small-cell-lung-cancer-100638863","NCT07625644","Evaluate BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer","A Phase 3 Open-Label, Randomized Controlled Trial of BL-M14D1 and Atezolizumab vs. Standard-of-Care Therapy in Patients With First-Line Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed first-line (1L), extensive-stage (ES) small cell lung cancer (SCLC)\n* Must be eligible to receive a platinum-based chemotherapy regimen in combination with an anti-PD-L1 inhibitor.\n* At least one measurable lesion based on RECIST v1.1 per investigator assessment.\n* An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Received any kind of platinum or etoposide treatment for limited stage (LS) SCLC within 6 months prior to enrollment.\n* Participants who have received prior topoisomerase inhibitor-based ADC therapy.\n* Participants with history of severe heart disease\n* Participants with active autoimmune diseases and inflammatory diseases,\n* Participants with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and\u002For carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":125,"type":20},550,[127],"PHASE3","The objective of the study is to evaluate the efficacy and safety of BL-M14D1 in combination with Atezolizumab compared to Standard-of-Care Therapy in adult participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).",[27,130,131,132,133,134,135,136],"Small-cell Lung Cancer","Small Cell Carcinoma","Sclc","SCLC,Extensive Stage","Lung Cancer","Lung Cancer Metastatic","Lung Cancer Stage IV",[138,139],"DLL3","First Line","NOT_YET_RECRUITING","2026-05-28",{"date":73,"type":32},{"date":144,"type":20},"2026-06",{"date":146,"type":20},"2031-06",{"name":148,"class":39},"SystImmune Inc.",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":158,"briefSummary":159,"conditions":160,"keywords":161,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":175},"100634920","phase-1-dsp-0390-in-combination-with-atezolizumab-for-small-cell-lung-cancer-100634920","NCT07545954","DSP-0390 in Combination With Atezolizumab for Small Cell Lung Cancer","A Pilot Study of DSP-0390 in Combination With Atezolizumab as Maintenance Therapy for Extensive Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed small cell lung cancer.\n* Completed 3-4 cycles of induction chemoimmunotherapy as first line treatment of ES-SCLC without disease progression.\n* Measurable disease per RECIST 1.1.\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.0 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 8.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN (≤ 5.0 x IULN for patients with liver metastases)\n  * Calculated creatinine clearance \\> 40 mL\u002Fmin by Cockcroft-Gault\n* The effects of DSP-0390 on the developing human fetus are unknown. For this reason, people of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study treatment, and for 6 months after the last dose of DSP-0390.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition (following discussion with the PI) are eligible for this trial\n* Currently receiving any other investigational agents, or received within 4 weeks prior to Day 1 (unless investigational immunotherapy, which may not have been received within 6 weeks prior to Day 1).\n* Patients with untreated symptomatic brain metastases or with clinically evident CNS hemorrhage. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression. Patients with asymptomatic, punctate brain metastases \\\u003C 5 mm are allowed.\n* Known contraindications to use of PD-L1 inhibitor as assessed by the treating physician.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to DSP-0390 or atezolizumab.\n* Undergone major surgery within 28 days prior to Cycle 1 Day 1.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to Cycle 1 Day 1.\n* Patient is known to have short-gut syndrome, or other condition that may significantly limit the ingestion or gastrointestinal absorption of drugs administered orally.\n* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.\n* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.\n* Concurrent use of prohibited medications: carbamazepine, phenytoin, phenobarbital, other strong or moderate CYP3A4 inhibitor or inducer, or strong CYP2D6 inhibitors. These should be discontinued 1 week or 5 half-lives (whichever is greater) prior to study day 1. Note that both oral and IV ondansetron at doses ≤ 8 mg Q6h are permitted.\n* Patient has a clinically significant abnormal ECG, including those where QT prolongation is determined by the Fridericia formula (QTcF \\>450 msec for males and \\>470 msec for females); and\u002For the patient has a history of Torsade de Pointes.",{"count":157,"type":20},20,[23],"This is a single center pilot, phase Ib study with a safety lead-in evaluating the safety and preliminary efficacy of the EBP inhibitor DSP-0390 in combination with atezolizumab in patients with extensive stage small cell lung cancer (ES-SCLC) whose disease has not progressed after initial induction therapy with platinum-based chemotherapy and anti-PD-L1 immunotherapy (atezolizumab or durvalumab per treating physician's discretion). This trial is testing the hypothesis that inhibition of de novo cholesterol synthesis by DSP-0390 when used in combination with atezolizumab in the maintenance therapy of patients with ES-SCLC will be tolerable.",[130,27],[162,163,164,165],"Small cell","Lipid metabolism","Immunotherapy","Maintenance","2026-04-15",{"date":168,"type":32},"2026-04-22",{"date":170,"type":20},"2026-07-31",{"date":172,"type":20},"2030-01-31",{"name":174,"class":82},"Washington University School of Medicine",1,{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":183,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":187,"conditions":188,"keywords":189,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":175},"100563020","phase-2-multicenter-phase-ii-randomized-controlled-study-of-adebrelimab-combined-with-chemotherapy-and-concurrent-low-dose-radiotherapy-ldrt-for-the-treatment-of-extensive-stage-small-cell-lung-cancer-sclc-100563020","NCT06610734","Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined With Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)","SKY","Inclusion Criteria:\n\n* Participants aged 18 to 75 years, regardless of gender;\n* ECOG Performance Status (PS) score of 0-1;\n* Expected survival duration of no less than 8 weeks;\n* Histologically or cytologically confirmed extensive small cell lung cancer (according to the VALG staging system);\n* Subjects must not have received systemic therapy or radical radiotherapy for extensive SCLC prior to enrollment.\n\nExclusion Criteria:\n\n* Tissue classifications of mixed small cell lung cancer and non-small cell lung cancer;\n* Patients who have undergone major surgical procedures within 28 days prior to the initial administration of the study drug, or those planning to undergo major surgery during the study period (as determined by the investigator);\n* Receipt of live attenuated vaccines within 28 days before the first dose or planned for the duration of the study;\n* Participation in another clinical trial within 28 days preceding initial dosing, involving any experimental agents;\n* History of receiving chest radiotherapy or plans for intensive chest radiotherapy prior to systemic therapy;\n* Any previous T-cell co-stimulation or immune checkpoint therapies administered;\n* Documented history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\\"","75 Years",{"count":185,"type":20},202,[24],"Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined with Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)",[27],[190,191,192],"SCLC","Adebrelimab","LDRT","2026-02-04",{"date":195,"type":32},"2026-02-09",{"date":197,"type":32},"2024-12-23",{"date":199,"type":20},"2028-12",{"name":201,"class":82},"Sichuan University",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":21,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":175},"100603705","phase-1-personalized-radiotherapy-for-individualized-treatment-strategies-and-monitoring-prism-100603705","NCT07139990","Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM)","Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM): A Multi-cohort Platform Trial of Adaptive Radiotherapy Approaches in Multiple Cancer Types","PRISM","Inclusion Criteria:\n\nCohort A:\n\n* \\>=18 years old\n* Performance status ECOG 0-2\n* Extensive stage small cell lung cancer diagnosed by tissue biopsy within 180 days of registration.\n* Patient must be planned for or receiving standard of care chemoimmunotherapy.\n* Patient must have received no more than 3 cycles by time of study enrollment.\n* Able and indicated according to investigator to receive thoracic radiotherapy\n\nCohort B:\n\n* 18 years old\n* Diagnosis of solid tumor malignancy with MRI-defined brain metastasis lesions (1-5 lesions allowed) within 60 days of registration\n* Each brain metastasis lesion enrolled must be 2 - 5 cm, except brainstem lesions which may be 1.5 - 5cm in size.\n\nExclusion Criteria:\n\nCohort A:\n\n⨀ Prior thoracic Radiotherapy\n\nCohort B:\n\n* Prior whole brain Radiotherapy\n* Prior surgical resection or focal radiotherapy of a target brain metastasis\n* Leptomeningeal disease",{"count":211,"type":20},45,[23],"To characterize feasibility, safety, and\u002For preliminary efficacy of personalized strategies to adapt standard radiotherapy treatments to individual patient responses.",[27,215,216],"Brain Metastases","Solid Tumor, Adult","2025-11-06",{"date":219,"type":32},"2025-11-10",{"date":221,"type":32},"2025-10-28",{"date":223,"type":20},"2030-09-01",{"name":225,"class":82},"University of Texas Southwestern Medical Center",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":235,"phases":4,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":4},"100591581","a-retrospective-real-world-study-on-the-efficacy-and-safety-of-anlotinib-hydrochloride-combined-with-immunotherapy-maintenance-therapy-following-standard-chemoimmunotherapy-for-es-sclc-alter-l059-100591581","NCT06982287","A Retrospective Real-World Study on the Efficacy and Safety of Anlotinib Hydrochloride Combined With Immunotherapy Maintenance Therapy Following Standard Chemoimmunotherapy for ES-SCLC (ALTER-L059)","A Retrospective Real-World Study on the Efficacy and Safety of Anlotinib Hydrochloride Combined With Immunotherapy as Maintenance Therapy Following First-Line Chemoimmunotherapy in Treatment-Naïve Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (ALTER-L059)","Inclusion Criteria:\n\n1. Male or female patients aged 18 years or older;\n2. Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) (per the Veterans Administration Lung Study Group \\[VALG\\] staging criteria);\n3. Patients who previously received chemotherapy for limited-stage SCLC must have undergone curative-intent therapy (e.g., chemotherapy, radiotherapy, or chemoradiotherapy) and have a treatment-free interval of at least 6 months from the end of prior therapy (last chemotherapy cycle or radiotherapy) to the diagnosis of ES-SCLC;\n4. At least one measurable target lesion (per RECIST version 1.1 criteria);\n5. No disease progression after receiving 4-6 cycles of first-line chemoimmunotherapy induction therapy for ES-SCLC;\n6. ECOG performance status: 0-2;\n7. Life expectancy ≥3 months.\n\nExclusion Criteria:\n\n1. Patients with limited-stage SCLC who previously received chemotherapy and underwent curative-intent therapy (e.g., chemotherapy, radiotherapy, or chemoradiotherapy) but experienced disease recurrence within 6 months after completion of prior therapy;\n2. Patients with limited-stage SCLC who previously received immunotherapy agents (e.g., PD-1\u002FPD-L1 inhibitors) or anti-angiogenic agents (e.g., Anlotinib, Apatinib, Bevacizumab);\n3. Patients with extensive-stage small cell lung cancer (ES-SCLC) who developed disease progression during induction therapy with a standard chemoimmunotherapy regimen;\n4. Active autoimmune diseases requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose;\n5. Patients with coagulation dysfunction, defined as an International Normalized Ratio (INR) \\>1.5 or activated partial thromboplastin time (APTT) \\>1.5 × upper limit of normal (ULN), and\u002For those with a bleeding tendency;\n6. Patients deemed by the inves.",{"count":234,"type":20},100,"OBSERVATIONAL","This retrospective real-world study aims to evaluate the efficacy and safety of anlotinib hydrochloride combined with immunotherapy as maintenance therapy following standard chemoimmunotherapy in extensive-stage small cell lung cancer (ES-SCLC).The study population consists of treatment-naïve ES-SCLC patients who did not progress after induction chemoimmunotherapy and subsequently received maintenance therapy with anlotinib plus immunotherapy. The primary objectives are progression-free survival (PFS)，overall survival (OS)\n\n, and safety.",[27],"2025-07-04",{"date":240,"type":32},"2025-07-08",{"date":242,"type":20},"2025-08-01",{"date":244,"type":20},"2025-12-31",{"name":246,"class":82},"Yong Fang",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":21,"phases":256,"briefSummary":257,"conditions":258,"keywords":259,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":175},"100589425","phase-3-a-study-of-mhb088c-injection-versus-treatment-of-physicians-choice-in-subjects-with-relapsed-small-cell-lung-cancer-100589425","NCT06954246","A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer","A Phase 3, Multicenter, Randomized, Open-label Study of MHB088C for Injection Versus Treatment of Physician's Choice (TPC) in Comparing the Efficacy and Safety in Subjects With Relapsed Small Cell Lung Cancer (SCLC)","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be eligible for randomization into the study:\n\n1. Voluntarily consent to participate in this study and sign the informed consent form.\n2. Adults ≥18 years, regardless of gender.\n3. ECOG performance status score of 0-1.\n4. Estimated survival time of more than 3 months.\n5. Capable of understanding trial requirements, willing and able to comply with trial and follow-up procedures.\n6. Has histologically or cytologically documented small cell lung cancer (SCLC).\n7. Extensive-stage SCLC with disease progression after at least two cycles of platinum-based and PD-1\u002FL1 systemic therapy, with no more than two prior lines of therapy. Prior PD-1\u002FL1 systemic therapy was allowed to use with or without platinum-based regimens.\n8. Agrees to provide pre-treatment tumor tissue samples for retrospective analysis of B7-H3 expression and other biomarkers.\n9. Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.\n10. Sufficient bone marrow and organ function.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Diagnosis of other primary malignancies within 5 years prior to signing the informed consent form.\n2. Prior pathological diagnosis of combined SCLC, or any transformed non-small cell lung cancer or transformed SCLC.\n3. Receipt of chemotherapy within 4 weeks prior to the first administration of study drug, or receipt of radiotherapy, biologics, endocrine therapy, immunotherapy, or other anti-tumor therapy within 4 weeks prior to the first dose.\n4. Previous or ongoing treatment with topoisomerase I inhibitors, including antibody-drug conjugates (ADCs) containing topoisomerase I inhibitor payloads.\n5. Brain metastases (unless asymptomatic and stable for more than 4 weeks prior to randomization); presence of leptomeningeal metastases or brainstem metastases; spinal cord compression (identified via imaging, regardless of symptoms).\n6. Bone marrow metastasis.\n7. Prior B7-H3-targeted therapy.\n8. Has uncontrolled or significant cardiovascular disease.\n9. Moderate-to-severe pulmonary disease significantly impairing lung function, including idiopathic pulmonary fibrosis, autoimmune\u002Fconnective tissue disorders with lung involvement, or prior pneumonectomy.\n10. Has history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required corticosteroids, current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at Screening.\n11. Moderate or severe pulmonary diseases severely affecting lung function.\n12. Active tuberculosis, autoimmune diseases not in clinical remission, other acquired or congenital immunodeficiency diseases, or history of allogeneic stem cell, bone marrow, or organ transplantation.\n13. Serious infections within 4 weeks before the first dose, including but not limited to those requiring systemic antibiotic therapy, bacteremia, or severe pneumonia.\n14. Clinically uncontrolled third-space effusion requiring intervention, including pleural or peritoneal effusions.\n15. Known hypersensitivity to investigational product components, analogues, or control drugs (e.g., topotecan, irinotecan, paclitaxel).\n16. Pregnant or lactating women, or women\u002Fmen intending to conceive.",{"count":255,"type":20},450,[127],"This study was designed to compare the efficacy and safety of MHB088C for Injection with treatment of physician's choice (TPC) in participants with relapsed small cell lung cancer (SCLC).",[27],[260,261,262],"MHB088C","B7H3","Small Cell Lung Cancer","2025-06-15",{"date":265,"type":32},"2025-06-18",{"date":267,"type":32},"2025-06-04",{"date":269,"type":20},"2028-04",{"name":271,"class":39},"Qilu Pharmaceutical Co., Ltd.",{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":4},"100594657","phase-2-sintilimab-plus-anlotinib-as-second-or-further-line-therapy-for-es-sclc-who-have-progressed-after-anti-pd-1l1-therapy-100594657","NCT07022301","Sintilimab Plus Anlotinib as Second or Further-line Therapy for ES-SCLC Who Have Progressed After Anti-PD-1\u002FL1 Therapy","A Phase II Study Evaluating the Safety and Efficacy of Sintilimab Plus Anlotinib as Second or Further-line Therapy for ES-SCLC Who Have Progressed After Anti- PD- 1\u002FL1 Therapy","Inclusion Criteria:\n\n* 1\\. At the time of signing the informed consent form, both men and women must be at least 18 years old.\n* 2\\. Widespread recurrent small cell lung cancer diagnosed by histology or cytology and progressing after 3 months of standard immunization.\n* 3\\. According to RECIST 1.1 criteria, patients must have at least one measurable lesion (lesions that have undergone radiotherapy must show clear progression in order to be considered measurable lesions).\n* 4\\. ECOG PS score: 0-1 points.\n* 5\\. Expected survival period ≥ 3 months.\n* 6\\. Important organ functions must meet the following standards:\n\n  1\\) Blood routine examination: (No blood transfusion or use of cytokine drugs such as G-CSF for corrective treatment within 2 weeks before screening)\n  1. Hemoglobin (HB) ≥ 90 g\u002FL;\n  2. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\*9\u002FL;\n  3. Platelet count (PLT) ≥ 90 × 10\\*9\u002FL;\n  4. White blood cell count (WBC) ≥ 3.0 × 109\u002FL and\\\u003C15 × 10\\*9\u002FL; 2) Other tests: (did not receive human serum albumin injection within 14 days before screening)\n  5. AST and ALT ≤ 3 x ULN;\n  6. ALP ≤ 2.5 x ULN (≤ 5 x ULN if there is bone metastasis);\n  7. TBiL≤1x ULN；\n  8. ALB≥30g\u002FL；\n  9. Cr ≤ 1.5 x ULN, while creatinine clearance rate (CrCL) ≥ 60mL\u002Fmin (Cockcroft Gault formula);\n  10. TSH ≤ 1 x ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously. If FT3 and FT4 levels are normal, they can be included in the group)\n  11. APTT ≤ 1.5 x ULN, while INR or PT ≤ 1.5 x ULN (not receiving anticoagulant therapy).\n  12. Male QTc\\\u003C450 ms, female QTc\\\u003C470 ms, LVEF ≥ 50%\n* 7\\. Non surgical sterilization or female patients of childbearing age must undergo a serum pregnancy test within 3 days before the first medication, and the result must be negative; And it must be non lactating. Female patients of childbearing age or male patients with partners of childbearing age must agree to use efficient contraception methods during the study period and within 6 months after the last administration of the study drug.\n* 8\\. The patient voluntarily joined this clinical study and signed an informed consent form, with good compliance and the ability to cooperate with follow-up.\n\nExclusion Criteria:\n\n* 1\\. Imaging shows that the tumor has invaded large blood vessels or has unclear boundaries with blood vessels.\n* 2\\. Imaging shows the presence of obvious pulmonary hollow or necrotic tumors.\n* 3\\. Symptomatic central nervous system metastases (such as brain metastases or meningeal metastases).\n* 4\\. Patients with conditions such as malignant meningitis and spinal cord compression.\n* 5\\. Persons who have suffered from other malignant tumors in the past or at the same time, unless they are skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma, cervical carcinoma in situ or other carcinoma in situ that have achieved complete remission at least 5 years before screening and do not need or are not expected to need other treatment during the study period.\n* 6\\. Those who have had or currently have objective evidence of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, tissue pneumonitis (such as bronchitis, occlusive vasculitis), drug-induced pneumonia, or screening period CT showing active pneumonia or lung function examination confirming severe impairment of lung function.\n* 7\\. Individuals with any active, known or suspected autoimmune diseases (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple sclerosis, vasculitis, glomerulonephritis, uveitis, pituitary inflammation, hyperthyroidism, etc.). Type I diabetes patients who are allowed to receive stabilizing dose insulin treatment, hypothyroidism patients who only need hormone replacement treatment, and skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and have no acute deterioration within 1 year before the screening period.\n* 8\\. Patients suspected of having active pulmonary tuberculosis should undergo chest X-ray, sputum examination, and exclusion based on clinical symptoms and signs. Individuals with a history of active pulmonary tuberculosis infection within the previous year should be excluded, even if they have been treated; Subjects with a history of active pulmonary tuberculosis infection more than one year ago should also be excluded unless it is proven that the previous course and type of anti tuberculosis treatment used were appropriate.\n* 9\\. Clinical symptoms or diseases of the heart that have not been well controlled, such as: (1) NYHA grade 2 or above heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, and (4) clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention.\n* 10\\. Patients with hypertension who cannot achieve good control with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).\n* 11\\. Urine routine showed urinary protein ≥++, and 24-hour urinary protein quantification was confirmed to be\\>1.0 g through quantitative detection of urinary protein.\n* 12\\. For individuals with a tendency towards thrombosis or undergoing thrombolytic\u002Fanticoagulant therapy, prophylactic use of low-dose aspirin (≤ 100mg\u002Fd) and low molecular weight heparin (≤ 40mg\u002Fd) is allowed.\n* 13\\. Those who have received\\>30 Gy of chest radiation therapy within the first 6 months of randomization, and have undergone major surgical treatment within the first 4 weeks of randomization, but have not recovered from the toxicity and\u002For complications of previous intervention measures to NCI-CTC AE ≤ 1 degree (except for hair loss and indicators clearly defined in the inclusion criteria).\n* 14\\. Within the first 6 months of randomization, there have been arterial\u002Fvenous thrombotic events, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.\n* 15\\. Individuals with a daily cough\u002Fhemoptysis volume greater than 2.5mL within the first month of randomization. Individuals with a history of hereditary or acquired bleeding or coagulation dysfunction. Within the first 3 months of randomization, there have been significant clinical bleeding symptoms or clear bleeding tendencies, such as gastrointestinal bleeding, hemorrhagic gastric ulcers, etc.\n* 16\\. Participants who have experienced severe infections within the previous month prior to randomization, including but not limited to infection complications requiring hospitalization, bacteremia, severe pneumonia, etc; Subjects with any active infection, or experiencing unexplained fever\\>38.5 ℃ during screening or before the first dose.\n* 17\\. Patients who have received anti-tumor vaccines or other immunomodulatory drugs (such as interleukin-2, thymosin, shiitake polysaccharides, etc.) within the previous month of randomization, or patients who will receive attenuated live vaccines.\n* 18\\. Subjects who have received systemic therapy with corticosteroids (\\>10 mg\u002Fday of prednisone or other equivalent hormones) or other immunosuppressive agents within the previous month prior to randomization. In the absence of active autoimmune diseases, inhalation or topical use of corticosteroids, as well as adrenal hormone replacement therapy with a dose ≤ 10 mg\u002Fday of prednisone efficacy dose, are allowed.\n* 19\\. Known to have a positive history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). It is known that there is active hepatitis or co infection with hepatitis B and hepatitis C. (hepatitis B reference: HBsAg is positive, and the HBV DNA detection value exceeds the upper limit of normal value; Hepatitis C reference: HCV antibody positive and HCV virus titer detection value exceeding the upper limit of normal.\n* 20\\. are known to have experienced allergic reactions to other monoclonal antibodies or any component of anlotinib.\n* 21\\. Those who are currently participating in other clinical studies or have been randomized for less than 4 weeks (or 5 half lives of the study drug) since the end of the previous clinical study (last dose);\n* 22\\. According to the researchers' assessment, there are other factors that may affect the research results or lead to the forced termination of this study, such as alcohol abuse, drug use, drug abuse, other serious illnesses (including mental illnesses) that require concurrent treatment, serious laboratory test abnormalities, and family or social factors that may affect medication safety.",{"count":280,"type":20},25,[24],"The phase II study enrolled ES-SCLC patients who had disease progression after anti-PD-1\u002FL1 therapy. Participants received intravenous sintilimab 200 mg on day one and oral daily anlotinib 8-12 mg on days 1-14 once every three weeks per cycle. The primary endpoint was objective response rate (ORR). The secondary endpoints included overall survival (OS), progression-free survival (PFS) , disease control rate (DCR) and safety.",[27,284],"Resistance to Immunotherapy","2025-06-12",{"date":263,"type":32},{"date":288,"type":20},"2025-07",{"date":290,"type":20},"2029-05",{"name":292,"class":82},"First Affiliated Hospital of Wannan Medical College",{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":183,"enrollmentInfo":300,"targetDuration":4,"studyType":21,"phases":302,"briefSummary":303,"conditions":304,"keywords":305,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":175},"100549106","phase-2-pd-l1-inhibitor-combined-with-apatinib-as-first-line-maintenance-treatment-for-extensive-stage-small-cell-lung-cancer-100549106","NCT06429696","PD-L1 Inhibitor Combined With Apatinib as First-line Maintenance Treatment for Extensive-stage Small Cell Lung Cancer","Single-arm, Prospective Clinical Study of PD-L1 Inhibitor Combined With Apatinib as First-line Maintenance Treatment for Extensive-stage Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Aged 18-75 years old, both men and women are welcome;\n2. Extensive-stage small cell lung cancer confirmed by histology or cytology (staging according to the American Veterans Lung Cancer Association, VALG);\n3. Patients whose induction therapy must receive the first-line standard treatment regimen of PD-L1 monoclonal antibody combined with chemotherapy, and whose efficacy evaluation is CR, PR or SD (according to RECIST 1.1); patients who have previously undergone surgical treatment and receive curative adjuvant therapy such as radiotherapy , chemotherapy patients, there is a treatment-free interval of at least 6 months from the last chemotherapy, radiotherapy or chemoradiotherapy to the diagnosis of extensive-stage SCLC;\n4. Expected survival time ≥12 weeks;\n5. ECOG physical status score 0\\~1 points;\n6. Before the first dose of study drug, laboratory test values must meet the following conditions:\n\n   1. Blood routine (no blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days before screening): WBC ≥3.0 × 109\u002FL; ANC ≥1.5 × 109\u002FL; PLT ≥100 × 109\u002FL; HGB ≥90 g\u002FL;\n   2. Liver function: AST ≤2.5 × ULN in subjects without liver metastasis; ALT ≤2.5 × ULN; ALT and AST in subjects with liver metastasis ≤5 × ULN; TBIL ≤1.5 × ULN;\n   3. Renal function: serum Cr ≤1.5 × ULN or CrCl ≥50 mL\u002Fmin (using Cockcroft\u002FGault formula);\n   4. Coagulation function: INR ≤1.5 × ULN, APTT ≤1.5 × ULN (only applicable to patients who are not currently receiving anticoagulation therapy);\n7. Women of childbearing age must have a serum pregnancy test within 7 days before taking the drug for the first time, and the result is negative. Female subjects of childbearing age and male subjects whose partners are women of childbearing age must agree to use contraception within 24 weeks from signing the informed consent form to the last administration of the study drug;\n8. The subjects voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.\n\nExclusion Criteria:\n\n1. Patients transformed from non-small cell carcinoma (NSCLC) to SCLC or SCLC with mixed histology;\n2. Meningeal metastasis or symptomatic central nervous system metastasis; for patients with asymptomatic brain metastasis or stable symptoms for ≥ 2 weeks after treatment of brain metastasis, they can participate in this study as long as they meet all the following criteria: Outside the central nervous system Have measurable lesions, no metastasis to the meninges, midbrain, pons, cerebellum, medulla oblongata or spinal cord, no previous history of intracranial hemorrhage, and stop hormone therapy 14 days before the first dose of study drug;\n3. Third space effusion with clinical symptoms requires repeated drainage, such as pericardial effusion, pleural effusion and peritoneal effusion that cannot be controlled by pumping or other treatments;\n4. Have a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, infectious pneumonia, radiation pneumonitis requiring steroid treatment, active tuberculosis, or other serious effects on the lungs Functional moderate to severe lung disease;\n5. There is an active autoimmune disease and corticosteroids (\\>10 mg\u002Fday prednisone or equivalent dose) or other immunosuppressants are used within 14 days before the first medication;\n6. Have serious cardiovascular diseases, such as New York Heart Association (NYHA) grade 2 or above heart failure, unstable angina, unstable arrhythmia, and myocardial infarction occurring within 3 months before enrollment or cerebrovascular accident;\n7. Other malignant tumors ≤5 years before the first dose of medication (fully treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery can be admitted) group and allows hormone therapy for non-metastatic prostate or breast cancer);\n8. Hypertension that cannot be controlled by oral antihypertensive drugs (systolic blood pressure ≧140mmHg or diastolic blood pressure ≧90mmHg);\n9. Urine routine shows urine protein ≥++ and confirms that the 24-hour urine protein quantification is \\>1.0 g;\n10. Risk of bleeding: Have clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, bleeding gastric ulcer, etc.; suffer from hereditary or acquired bleeding diseases or coagulation Functional disorders, such as aplastic anemia, etc.; taking anticoagulant or antiplatelet drugs (such as warfarin, phenprocoumon);\n11. Those who have recently experienced intestinal obstruction or gastrointestinal perforation (within 3 months); or those who are unable to swallow tablets normally, which may affect drug absorption as judged by the researcher;\n12. People with the following infectious diseases are not allowed to join the group:\n\n    1. HBsAg is positive and the HBV DNA copy number is greater than the upper limit of normal value (1000 copies\u002Fml or 500IU\u002Fml) in the laboratory of the research center;\n    2. HCV positive (HCV RNA or HCV Ab detection indicates acute or chronic infection);\n    3. Known history of HIV positivity or known acquired immunodeficiency syndrome;\n13. Have undergone major surgery within 28 days before the screening period, or plan to undergo major surgery during the study period;\n14. Have received systemic immunosuppressive drug treatment (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide and anti-tumor necrosis factor \\[anti-tumor necrosis factor\\] within 1 week before the first medication) TNF\\] drugs). Patients receiving short-term, systemic immunosuppressive therapy, such as glucocorticoids for nausea, vomiting, or allergic reaction management or prophylaxis, may be enrolled in the study after approval by the investigator;\n15. Live attenuated vaccines are used within 28 days before the first dose, or live attenuated vaccines are expected to be needed during the study;\n16. Known to be allergic to study drugs or excipients, known to have severe allergic reactions to any monoclonal antibody drug;\n17. Have received any other experimental drug treatment or participated in another interventional clinical study within 4 weeks before the first use of the drug;\n18. Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation;\n19. According to the researcher's judgment, the subject has other factors that may lead to the forced termination of this study, such as non-compliance with the protocol, other serious diseases (including mental illness) that require combined treatment, and family or social factors that may affect the study. to the safety of subjects or the collection of information and samples",{"count":301,"type":20},40,[24],"This is a prospective, single-arm clinical study designed to evaluate the 6-month progression-free survival rate (6-month PFS rate) of a PD-L1 inhibitor combined with apatinib as first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC). The study plans to recruit 40 patients. After receiving 4-6 cycles of induction therapy, patients whose efficacy is evaluated as CR, PR or SD (according to RECIST 1.1) will enter maintenance therapy with PD-L1 inhibitor + apatinib 250 mg po qd. , the selection of PD-L1 inhibitors in the maintenance phase is consistent with the first-line standard treatment in the induction phase. Efficacy was assessed using RECISIT 1.1, with imaging evaluations every 6 weeks (±7 days) for 48 weeks after the first dose and every 9 weeks (±7 days) after week 48, regardless of treatment delays or interruptions, until Disease progression or study termination, whichever occurs first. The primary efficacy endpoint of this study is 6-month PFS rate, and secondary efficacy endpoints include median PFS, median OS and safety.",[27],[306,307,308,104],"first-line maintenance treatment","PD-L1 inhibitor","apatinib","2025-05-25",{"date":311,"type":32},"2025-05-28",{"date":313,"type":32},"2024-07-14",{"date":315,"type":20},"2026-04-30",{"name":317,"class":82},"Nanfang Hospital, Southern Medical University",{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":325,"enrollmentInfo":326,"targetDuration":4,"studyType":21,"phases":328,"briefSummary":329,"conditions":330,"keywords":331,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":175},"100542894","phase-1-phase-i-clinical-study-of--pd-l1dll3-car-t-in-patients-with-rr-sclc-100542894","NCT06348797","Phase I Clinical Study of α-PD-L1\u002FDLL3 CAR-T in Patients With R\u002FR SCLC","Phase I Clinical Study on Safety and Feasibility of DLL3 Targeted α-PD-L1\u002F4-1BB Modifying Chimeric Antigen Receptor T-cells in Patients With Relapsed or Refractory Small Cell Lung Cancer (SCLC)","Inclusion Criteria:\n\n* Patients with recurrent or refractory small cell lung cancer (SCLC) confirmed by histology or cytology who have relapsed or progressed after treatment with one previous platinum-based regimen;\n* Patients can provide sufficient tumor tissue (fresh or paraffin sections, etc.);\n* Age 18 \\~70 (including boundary), for both men and women;\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n* Life expectancy ≥3 months;\n* At least one extracranial measurable lesion (RECIST v1.1) exists；for lesion after radiotherapy， must be confirmed that the lesion has progressed ;\n* Patients in limited-stage at the initial diagnosis must undergo radical thoracic radiotherapy and the time of tumor progression is not less than 3 months from the end of radiotherapy, or radical thoracic dose radiotherapy cannot be performed for specific reasons;\n* The test results of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C and syphilis were negative at screening;\n* Female patients or male reproductive age patients and their partners should agree to effective contraception from sighing Informed Consent Form (ICF) to 6 months after the last BHP01 infusion.\n\nExclusion Criteria:\n\n* Patients with known primary Central Nervous System (CNS) tumor, or meningeal metastasis, or patients with unstable CNS metastasis (symptomatic, requiring hormonal therapy within 4 weeks before investigational treatment, or no radiographic evidence of stabilization of the lesion for more than 4 weeks);\n* Received major surgical procedures （except for diagnosis） within 4 weeks before PBMCs collection, or are expected to require major surgical procedures during the study;\n* Received Chinese herbal medicine or Chinese patent medicine for anti-tumor indications within 7 days before Peripheral Blood Mononuclear Cells (PBMCs) collection;\n* Patients with a history of idiopathic pulmonary fibrosis, mechanical pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia or idiopathic pneumonia, or evidence of active pneumonia by chest computer tomography (CT) at screening \\[a history of radiation pneumonia (fibrosis) in the irradiated field may participate in this study\\];\n* Poorly controlled pleural effusion, pericardial effusion, or ascites requiring repeated drainage procedures (once a month or more frequently);\n* Poorly controlled or symptomatic hypercalcemia (ionic calcium\\> 1.5 mmol\u002FL, calcium\\> 12 mg\u002FdL or corrected calcium\\> ULN);\n* Presence of active or previous autoimmune diseases or immunodeficiencies, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, etc.;\n* Severe infection within 4 weeks before the start of PBMCs collection, including but not limited to hospitalization due to infection, bacteremia, severe pneumonia, or any active infection that may affect the patient's safety;\n* Serious cardiovascular and cerebrovascular diseases (such as heart disease ≥New York Heart Association class II, myocardial infarction or cerebrovascular accident), unstable arrhythmia or unstable angina pectoris within 3 months before PBMCs collection;\n* Previous treatment with DLL 3 target drugs or CAR-T or other gene-modified T cells;\n* Received any other Investigational drug within 28 days prior to PBMCs collection;\n* A history of mental illness;\n* Incapacitated persons or persons with limited capacity;\n* pregnant or lactating females; Males or females who are unwilling to use adequate contraception; Females of childbearing potential are required to undergo a pregnancy study during the screening period;","70 Years",{"count":327,"type":20},28,[23],"A study to evaluate the safety and feasibility of α-PD-L1\u002F4-1BB DLL3 Chimeric Antigen Receptor (CAR)-T (BHP01) in patients with Relapsed\u002FRefractory Small Cell Lung Cancer (SCLC) and determine the appropriate CAR-T cell dose. Next, In dose expansion phase, patients were assign two groups with\u002Fwithout bridge radiotherapy.",[27],[332,333,334],"Extensive Stage-SCLC","DLL3 CAR-T","Bridge Radiotherapy","2025-05-13",{"date":337,"type":32},"2025-05-16",{"date":339,"type":32},"2025-04-03",{"date":341,"type":20},"2026-12-31",{"name":201,"class":82},{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":183,"enrollmentInfo":350,"targetDuration":4,"studyType":21,"phases":352,"briefSummary":353,"conditions":354,"keywords":355,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":366},"100518416","phase-1-in10018-combination-therapy-in-treatment-nave-es-sclc-100518416","NCT06030258","IN10018 Combination Therapy in Treatment-naïve ES-SCLC","A Phase Ib\u002FII Clinical Trial to Evaluate the Anti-tumor Efficacy, Safety, Tolerability, and Pharmacokinetics of IN10018 Combined With Anti-PD-1\u002FL1 Antibody and Chemotherapy as First-line Treatment in Extensive-stage Small Cell Lung Cancer","Inclusion Criteria\n\n1. Male or female aged 18-75 years old at the time of signing informed consent.\n2. Be able to understand and be willing to sign informed consent.\n3. Histologically confirmed ES-SCLC (according to the Veterans Administration Lung Study Group (VALG) staging system), which is not suitable for locally radical therapy.\n4. Has not received any systemic antitumor therapy for ES-SCLC.\n5. Has at least one measurable tumor lesion per RECIST 1.1.\n6. Has an ECOG performance status of 0 or 1.\n7. Estimated life expectancy is more than 3 months.\n8. Has adequate organ function of bone marrow, liver, kidney, and coagulation. Relative laboratory tests must be performed within 7 days prior to first dose of study treatment\u002Frandomization.\n9. AEs due to prior antitumor therapy must be recovered to ≤ Grade 1 (CTCAE v5.0) or a steady state as assessed by investigators\n10. Subjects (male and female) with childbearing potential must agree to use contraception during the treatment phase and through 3 months after the last dose of study treatment.\n\nExclusion Criteria\n\n1. Has known active or untreated central nervous system (CNS) metastases, and\u002For carcinomatous meningitis.\n2. Spinal cord compression without surgery and\u002For radiation therapy, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 7 days prior to the first dose of study treatment\u002Frandomization.\n3. Pleural, pericardial or abdominal effusion that are clinically symptomatic and require puncture or drainage.\n4. Symptomatic hypercalcemia.\n5. Malignancies other than the study disease within 3 years prior to the first dose of study treatment\u002Frandomization.\n6. Have received palliative radiotherapy for bone metastasis within 14 days prior to the first dose of study treatment\u002Frandomization.\n7. Have had allogeneic haematopoietic stem cell transplantation or organ transplantation.\n8. History of active autoimmune disease required systemic treatment (including but not limited to drugs for disease control, corticosteroids, or immunosuppressive drugs) within the past 2 years.\n9. Have an immunodeficiency disorder or have received systemic steroid therapy (prednisone or equivalent corticosteroid \\> 10 mg\u002Fday) or other immunosuppressants within 7 days prior to the first dose of study treatment\u002Frandomization.\n10. History of idiopathic pulmonary fibrosis, idiopathic pneumonia and organizing pneumonia, and interstitial pneumonitis or active pneumonia diagnosed per imaging examination at baseline.\n11. Have had FAK inhibitors treatment.\n12. Has a history of major cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment\u002Frandomization.\n13. Have malabsorption syndrome or cannot take study drugs orally.\n14. Any active infection requiring systemic therapy within 14 days prior to the first dose of study treatment.\n15. Active pulmonary tuberculosis\n16. Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.\n17. Known hypersensitivity or allergy to IN10018, anti-PD-1\u002FL1 monoclonal antibodies, carboplatin or etoposide or to their drug components.\n18. Pregnant or lactating women or are expected to be pregnant or lactating during study treatment.",{"count":351,"type":20},120,[23,24],"This is a multicenter, open-label, Randomized, phase Ib\u002FII clinical study to evaluate the anti-tumor efficacy, safety, tolerability, and PK of IN10018 in combination with anti-PD-1\u002FL1 monoclonal antibody (Tislelizumab is proposed as the combination drug) and chemotherapy (platinum and etoposide) as the first-line treatment in Extensive-stage small cell lung cancer (ES-SCLC).",[27],[356],"First-line","2025-04-28",{"date":359,"type":32},"2025-04-30",{"date":361,"type":32},"2023-10-30",{"date":363,"type":20},"2025-12-24",{"name":365,"class":39},"InxMed (Shanghai) Co., Ltd.",3,{"id":368,"slug":369,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":21,"phases":377,"briefSummary":378,"conditions":379,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":175},"100581554","phase-2-tislelizumab-in-combination-with-chemotherapy--radiotherapy-for-extensive-stage-oligometastatic-small-cell-lung-cancer-100581554","NCT06851819","Tislelizumab in Combination with Chemotherapy ± Radiotherapy for Extensive-Stage Oligometastatic Small Cell Lung Cancer.","The Efficacy and Safety of Tislelizumab in Combination with Chemotherapy(etoposide\u002Fcisplatin )± Radiotherapy for Extensive-Stage Oligometastatic Small Cell Lung Cancer, a Randomized，Controlled , Phase II Clinical Trial.","TERE","Inclusion Criteria:\n\n1. Patients must be ≥ 18 years old;\n2. Signed written informed consent;\n3. Histologically or cytologically confirmed oligometastatic extensive-stage small cell lung cancer (oligometastasis is defined as the number of distant metastatic organs≤ 3, and the number of metastases ≤ 5; The ninth edition of the AJCC\u002FUICC\u002FIASLC TNM Staging Criteria for Lung Cancer (Annex 1), extensive-stage SCLC for any T stage, any N stage, M1a\u002Fb\u002Fc or T3-4 cannot be included in a tolerable radiotherapy program due to multiple nodules in the lungs or excessive tumor size);\n4. chemotherapy must include a combination of cisplatin and etoposide;\n5. Expected survival≥ 12 weeks;\n6. ECOG score of 0 or 1 (Annex 2);\n7. Weight\\> 40 kg;\n8. At least 1 lesion (no prior radiotherapy) according to RECIST 1.1 guidelines, with a maximum diameter of ≥10 mm as accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) at baseline (except for lymph nodes, which must be ≥15 mm in their short axis); And the lesion is suitable for repeated and accurate measurement.\n9. Have not received anti-tumor therapy in the past;\n10. Have adequate organ and bone marrow function,\n11. Echocardiography: Left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%)\n12. Evidence of postmenopausal status in female patients, or negative urine or serum pregnancy test results in premenopausal female patients. A woman is considered menopausal when she stops menstruation for 12 months without an other medical cause.\n13. Within 2 weeks (±1 week) prior to enrollment, the following examinations required for staging must be completed: 1) MRI of the head, CT scan of the chest and upper abdomen, ultrasound of superficial lymph nodes and whole-body ECT; Whole-body PET\u002FCT scan is done if necessary.\n14. Patients with asymptomatic or stable brain metastases after treatment are allowed to enroll, and patients are required to do not need glucocorticoid therapy or discontinue glucocorticoids within 3 days before the first study dose.\n\nExclusion Criteria:\n\n1. Personnel involved in the design and\u002For conduct of this study.\n2. Previous receipt of investigational drug in this study.\n3. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up phase of an interventional study.\n4. There are medical contraindications to etoposide-platinum-based chemotherapy.\n5. History of thoracic radiotherapy prior to systemic therapy.\n6. Concomitant administration of any chemotherapy, biologics, or hormonal therapy for cancer treatment. Hormone therapy for noncancer-related conditions, such as hormone replacement therapy, is acceptable.\n7. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose.\n8. History of allogeneic organ transplantation.\n9. Patients who have been cured of aplastic anemia or other blood diseases and patients who have undergone stem cell transplantation.\n10. Have an autoimmune paraneoplastic syndrome (PNS) that requires systemic therapy (systemic steroids or immunosuppressants) or have clinical symptoms suggestive of an exacerbation of PNS.\n11. Active or previously documented autoimmune or inflammatory disease (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[except diverticular disease\\], systemic lupus erythematosus, Sarcoidosis syndrome, nephrotic syndrome or nephritis, Wegener syndrome \\[granulomatous vasculitis, Graves' disease, rheumatoid arthritis, hypophysitis and uveitis, etc.\\]). The following exceptions are made to this criterion: patients with vitiligo or alopecia; Patients with hypothyroidism (e.g., after Hashimoto syndrome) who are stable after receiving hormone replacement therapy; Any chronic skin condition that does not require systemic therapy; Patients with no active disease in the past 3 years may be included in the study after discussion with the study physician; Patients with celiac disease who can be controlled by diet alone.\n12. Uncontrolled intercurrent illness including, but not limited to: persistent or active infection, interstitial lung disease, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, cardiac arrhythmia, severe chronic gastrointestinal disease with diarrhea, or psychiatric\u002Fsocial problems that may limit compliance with study requirements, recent (within 3 months) new cerebral infarction\u002Fintracerebral hemorrhage, psychiatric\u002Fsocial problem conditions that result in a significantly increased risk of AEs, or affect the subject's ability to provide written informed consent.\n13. History of another primary malignancy, with the following exceptions: malignancy treated with curative intent, no known active disease for 5 years ≥ prior to the first dose and a low risk of potential recurrence; adequately treated non-melanoma skin cancer or lentigo maligna nevus with no evidence of disease; Carcinoma in situ that has been adequately treated and has no evidence of disease.\n14. History of leptomeningeal carcinoma.\n15. History of active primary immunodeficiency.\n16. Active infection, including tuberculosis (clinical evaluation, including clinical history, physical examination, imaging findings, and TB examination consistent with local clinical practice), hepatitis B (known to be HBV surface antigen \\[HbsAg\\] positive), hepatitis C, or human immunodeficiency virus (HIV1\u002F2 antibody positive). Patients with prior HBV infection or who have been cured (defined as the presence of hepatitis B core IgG antibodies and the absence of HBsAg) are eligible. Patients who are positive for hepatitis C virus (HCV) antibodies are eligible only if they are negative for HCV RNA polymerase chain reaction.\n17. Female patients who are pregnant or lactating.\n18. Those who are considered inappropriate by the investigator to participate in this study.",{"count":376,"type":20},64,[24],"The goal of this clinical trial is to learn the efficacy and safety of tislelizumab in combination with chemotherapy(etoposide\u002Fcisplatin ) ± concurrent radiotherapy for extensive-stage oligometastatic small cell lung cancer. 64 Patients with Extensive-Stage Oligometastatic Small Cell Lung Cancer will be randomly divided into the experimental group (tislelizumab combined with chemotherapy and radiotherapy) and the control group (tislelizumab combined with chemotherapy).Researchers will compare treatment efficacy and safety between the two groups.",[27],"2025-02-24",{"date":382,"type":32},"2025-02-28",{"date":384,"type":20},"2025-03-01",{"date":386,"type":20},"2029-06-30",{"name":388,"class":82},"Hebei Medical University Fourth Hospital",{"id":390,"slug":391,"hasResults":11,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":21,"phases":397,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":175},"100496524","phase-2-first-line-pembrolizumab-plinabulin-plus-etoposide-and-platinum-ep-for-es-sclc-100496524","NCT05745350","First Line Pembrolizumab, Plinabulin Plus Etoposide and Platinum (EP) for ES-SCLC","An Open-Label, Single-Arm, Phase II Study of Pembrolizumab, Plinabulin Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer","Inclusion Criteria:\n\n1. Have a documented new diagnosis of SCLC by histology or cytology from brushing, washing, or needle aspiration of a defined lesion.\n2. Have extensive stage disease defined as Stage IV (T any, N any, M 1a\u002Fb) by the American Joint Committee on Cancer, Eighth Edition.\n3. Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1, and is appropriate for selection as a target lesion, as determined by local site investigator\u002Fradiology review.\n4. Life expectancy ≥3 months.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n6. Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent.\n7. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n8. Have adequate organ function.\n9. Criteria for known Hepatitis B and C positive subjects 9.1 Hepatitis B positive subjects\n\n   * Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to treatment.\n   * Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.\n\n   9.2 Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. Participants must have completed curative anti-viral therapy at least 4 weeks prior to the first treatment.\n10. Male participants:\n\n    A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period.\n11. A female participant is eligible to participate if she is not pregnant, not breastfeeding.\n\nExclusion Criteria:\n\n1. Has received prior systemic therapy for the treatment of SCLC.\n2. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n3. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment for another health-related problem.\n4. Is expected to require any other form of antineoplastic therapy for SCLC, including radiation therapy, while on study.\n\n   Note: Patients with PR or CR will be offered PCI therapy at the investigator's consideration at the completion of the 4 cycles of chemotherapy with pembrolizumab\n5. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n6. Has had major surgery within 3 weeks prior to receiving the first dose of trial treatment or has not recovered adequately from toxicity and\u002For complications from an intervention prior to receiving the first dose of study treatment\n7. Has active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.\n8. Has symptomatic ascites, pleural effusion, or pericardial effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco or paracentesis) is eligible.\n9. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.\n10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n\n    Has severe hypersensitivity (≥Grade 3) to plinabulin and\u002For any of its excipients.\n11. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n12. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n13. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n14. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (ie, CTLA-4, OX-40, CD137) or has previously participated in a MSD pembrolizumab (MK-3475) clinical trial and Beyond Spring Plinabulin clinical trial.\n15. Has had an allogenic tissue\u002Fsolid organ transplant.\n16. Has received a live vaccine within 30 days prior to the first dose of trial drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n17. Has a known history of active TB (Bacillus Tuberculosis).\n18. Any medical conditions that in the Investigator's opinion, would impose excessive risk to the patient. Examples of such conditions include uncontrolled diabetes, infection requiring parenteral anti-infective treatment, liver failure, any altered mental status or any psychiatric condition that would interfere with the understanding of the ICF.\n19. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of trial treatment.\n20. Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.\n21. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.",{"count":211,"type":20},[24],"Monoclonal antibodies against programmed death 1 (PD-1) and its ligand PD-L1 have shown efficacy in patients with ES-SCLC in the monotherapy and combination therapy settings. Up to now, Atezolizumab and Durvalumab has been approved for first line treatment for ES-SCLC in China combined with EP or EC. Besides, KEYNOTE-604 study revealed that adding pembrolizumab to standard first-line EP significantly improves PFS in patients with ES-SCLC and is associated with durable responses in a subset of patients. 12-m PFS rate were 13.6% with pembrolizumab plus EP and 3.1% with placebo plus EP. The statistical threshold for declaring significant prolongation of OS was narrowly missed. Considering sicker pts was enrolled and the interim analysis was quite often, even though the investigators narrowly missed the OS endpoint, longer numerical OS data was observed. The latest version of NCCN SCLC guidelines still recommended pembrolizumab as an option for ES-SCLC patients.\n\nPlinabulin received breakthrough designation from both US and China FDA for CIN (Chemotherapy Induced Neutropenia) prevention indication. As a \"pipeline in a drug,\" plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1\u002FPD-L1 antibodies and re-sensitize PD-1\u002FPD-L1 antibody resistant patients. In a poster released at 2021 ASCO conference, a phase I trial of Plinabulin in combination with nivolumab and ipilimumab in patients with relapsed small cell lung cancer: Big Ten Center Research Consortium (BTCRC-LUN17-127) study. Plinabulin in combination with nivolumab and ipilimumab was safe and well tolerated with promising efficacy signal of 46% ORR.\n\nFrom above, Pembrolizumab, Plinabulin plus Etoposide and Platinum as First-Line Therapy for ES-SCLC should be a promising combination therapy, as the investigators expect increased efficacy and reduced toxicity with the addition of Plinabulin. In this proof of concept phase II study, the investigators will investigate that the efficacy and safety of Pembrolizumab, Plinabulin plus Etoposide and Platinum as First-Line Therapy for ES-SCLC.",[27],"2025-02-10",{"date":402,"type":32},"2025-02-11",{"date":404,"type":32},"2024-03-07",{"date":406,"type":20},"2025-12",{"name":408,"class":82},"Xiaorong Dong",{"id":410,"slug":411,"hasResults":11,"nctId":412,"briefTitle":413,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":16,"minAge":325,"maxAge":415,"enrollmentInfo":416,"targetDuration":4,"studyType":235,"phases":4,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":4},"100579508","etoposide-plus-benmelstobart-followed-by-maintenance-therapy-of-benmelstobart-plus-anlotinib-in-first-line-treatment-of-elderly-patients-with-extensive-stage-small-cell-lung-cancer-a-single-arm-prospective-trial-100579508","NCT06825208","Etoposide Plus Benmelstobart Followed by Maintenance Therapy of Benmelstobart Plus Anlotinib in First-line Treatment of Elderly Patients with Extensive Stage Small Cell Lung Cancer: a Single-arm, Prospective Trial","Inclusion Criteria:\n\n* Patients with pathologically proven extensive small-cell Lung cancer (according to the Veterans Administration Lung Study Group, VALG stage) who have not previously received systematic treatment for extensive small-cell lung cancer;\n* Patients who have previously received chemoradiotherapy for limited-stage SCLC must have received radical therapy and have at least 6 months of treatment-free intervals between the end of chemotherapy, radiotherapy, or chemoradiotherapy and the diagnosis of extensive SCLC (end time of last chemotherapy cycle\u002Fend time of last radiotherapy).\n* There was no gender limitation. The subjects voluntarily joined the study, signed the informed consent, and the compliance was good\n* Aged eligibility criteria are considered to be met if the following criteria are met:\n\nPatient requirements: Between 70 and 85 years old, and after independent assessment by two chief physicians, the patient's physical condition may not be able to tolerate platinum-containing chemotherapy regimen, and the patient's informed consent to accept the platinum treatment regimen;\n\n* ECOG score: 0-2;\n* At least one lesion can be measured by CT.\n* Expect to survive for at least 3 months.\n* The main organ functions within 7 days before treatment should meet the following criteria:\n\n  1\\) Blood routine examination (under the condition of no blood transfusion or use of hematopoietic stimulating factor drugs for correction within 14 days): Hemoglobin (Hb) ≥ 90g\u002FL; Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; ； 1) Platelet count (PLT) ≥ 100×10⁹\u002FL; white blood cell count (WBC) ≥ 3.0×10⁹\u002FL.\n\n  2\\) Biochemical tests: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (for patients with liver metastasis from tumors, ≤ 5×ULN); total bilirubin (TBIL) ≤ 1.5×ULN (for Gilbert's syndrome patients, ≤ 3×ULN); serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance rate ≥ 50 ml\u002Fmin; 3) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN; 4) Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ 50%. 。\n* Men should agree that contraception must be used during the study period and for 6 months after the end of the study period;\n\nExclusion Criteria:\n\n* Used antiangiogenic drugs or related immunotherapy drugs such as PD-1 and PD-L1 in the past;\n* Subjects with known central nervous system metastatic and\u002For cancerous meningitis; (Unless asymptomatic, or treated and stable, no radiographic evidence of new BMS or enlarged BMS was found at least 2 weeks after BMS treatment, and steroid or anticonvulsant therapy was discontinued for at least 14 days before study therapy began. If active or new untreated, asymptomatic CNS metastases are found on imaging in subjects during the screening period, radiation therapy or untreated imaging evidence of new or enlarged BMS is required for at least 2 weeks.)\n* Subject has had or co-developed other malignancies (except cured basal cell carcinoma of the skin and cervical carcinoma in situ) within 5 years;\n* Subject has multiple factors that affect oral medication (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction);\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n* Spinal cord compression that has not been cured or alleviated by surgery and\u002For radiotherapy, or previously diagnosed spinal cord compression with no clinical evidence of disease stabilization ≥1 week prior to randomization after treatment;\n* Imaging (CT or MRI) shows that the tumor invades the large blood vessels or has an unclear boundary with the large blood vessels;\n* Subjects with evidence or history of bleeding tendencies, regardless of severity, within 2 months prior to initial dosing; A history of hemoptysis (defined as bright red or 1\u002F2 teaspoon of blood) or unhealed wounds, ulcers, or fractures within 2 weeks prior to initial medication;\n* Subjects whose adverse events (other than alopecia) from prior treatment did not recover to ≤CTCAE Class 1;\n* Received major surgical treatment or significant traumatic injury within 28 days prior to randomization;\n* Those who had experienced an arterial\u002Fvenous thrombosis event, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism, within 6 months before randomization;\n* have a history of psychotropic drug abuse and can not quit or have mental disorders;\n* Subjects with any severe and\u002For uncontrolled medical condition, including:\n\n  a) Subjects with unsatisfactory blood pressure control (systolic ≥150 mmHg or diastolic ≥100mmHg); b) have grade 2 myocardial ischemia or myocardial infarction, arrhythmias (including QTc≥450ms in men, QTc≥ 470ms in women), and grade 2 congestive heart failure (NYHA); c) Active or uncontrolled severe infection (≥CTC AE grade 2 infection); d) Cirrhosis, active hepatitis \\*;\n\n  \\* Active hepatitis (Hepatitis B reference :HBsAg positive, and HBV DNA test value exceeds the upper limit of normal; Hepatitis C reference :HCV antibody positive, and HCV virus titer test value exceeds the upper limit of normal value); e) HIV positive test; f) Poor diabetes control (fasting blood glucose (FBG)\\>10mmol\u002FL); g) Urine routine indicated urine protein ≥++, and confirmed 24-hour urine protein quantity \\>1.0 g;\n* have received prophylactic or attenuated vaccine within 4 weeks before the first dose;\n* Severe hypersensitivity after administration of other monoclonal antibodies;\n* The need for systemic treatment (e.g., use of disease-modifying drugs, Active autoimmune diseases with corticosteroids or immunosuppressants (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; Patients with asthma requiring medical intervention with bronchodilators were not included). Replacement therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic.\n* have been diagnosed with an immune deficiency or are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose \\>10mg\u002F day prednisone or other therapeutic hormone) and continue to use within 2 weeks before the first dose;\n* Have participated in other clinical trials within four weeks;\n* concomitant diseases that, in the investigator's judgment, seriously endanger the safety of the subject or interfere with the patient's completion of the study.","85 Years",{"count":417,"type":20},29,"This is a prospective, single-arm clinical study to evaluate the efficacy and safety of etoposide in combination with bemosubezumab and sequential Benmelstobart in combination with Anlotinib as first-line treatment for elderly patients with extensive small-cell lung cancer.\n\nParticipants who met the inclusion criteria were selected to enter the study and received etoposide combined with Benmelstobart followed by bemosubezumab combined with Anlotinib. The primary endpoint was PFS (Progression-free Survival), the secondary endpoint was OS (Overall Survival) and safety (CTCAE 5.0), and the exploratory endpoint was the screening of various potential molecular markers.",[27,420],"ELDERLY PEOPLE","2025-02-09",{"date":423,"type":32},"2025-02-13",{"date":425,"type":20},"2025-02",{"date":427,"type":20},"2027-06",{"name":429,"class":82},"Nanjing First Hospital, Nanjing Medical University",{"id":431,"slug":432,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":183,"enrollmentInfo":436,"targetDuration":4,"studyType":21,"phases":438,"briefSummary":439,"conditions":440,"keywords":441,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":455},"100576516","phase-2-a-single-arm-multicenter-prospective-phase-ii-clinical-study-of-apatinib-in-combination-with-adebrelimab-and-ec-regimen-in-the-first-line-treatment-of-extensive-small-cell-lung-cancer-100576516","NCT06786312","A Single-arm, Multicenter, Prospective Phase II Clinical Study of Apatinib in Combination With Adebrelimab and EC Regimen in the First-line Treatment of Extensive Small Cell Lung Cancer","Inclusion Criteria:\n\n* 1\\. Patients with extensive stage small cell lung cancer confirmed by histopathology or cytology (excluding complex small cell lung cancer);\n* 2\\. Age at the time of signing the informed consent: 18-75 years old (including 18 and 75 years old), male or female;\n* 3\\. The physical status of the Eastern Oncology Consortium (ECOG) was 0 or 1 (see Annex 1 for the ECOGPS scoring criteria);\n* 4\\. Have not received systematic treatment for extensive small cell lung cancer;\n* 5\\. Have at least one measurable lesion that meets the RECIST v1.1 standard (see Annex 3);\n* 6\\. Expected survival \\>=3 months;\n* 7\\. If the major organs function normally, the following criteria are met:\n\n  1. Blood routine test: hemoglobin (Hb) \\>=90g\u002FL; Absolute neutrophil count (ANC) \\>=1.5×10\\^9\u002FL; Platelet (PLT) \\>=100×10\\^9\u002FL; White blood cell count (WBC) \\>= 3.0×10\\^9\u002FL;\n  2. Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C=2.5×ULN (tumor liver metastasis, \\\u003C=5×ULN); Serum total bilirubin (TBIL) \\\u003C=1.5×ULN (Gilbert syndrome subjects, \\\u003C=3×ULN; In patients with liver metastasis, total bilirubin \\\u003C=3× ULN); Serum creatinine (Cr) \\\u003C=1.5×ULN or creatinine clearance \\>=50ml\u002Fmin;\n  3. Coagulation function: activated partial thromboplastin time (APTT), International standardized ratio (INR), prothrombin time (PT) \\\u003C=1.5×ULN;\n  4. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF)\\>=50%;\n* 8\\. BMS must be asymptomatic or treated and stable after discontinuation of steroids and anticonvulsants for at least 1 month prior to study therapy;\n* 9\\. Women of reproductive age should agree that they must use contraceptives (such as intrauterine devices \\[IUD\\], birth control pills or condoms) during the study period and for 6 months after the study ends; Have a negative serum pregnancy test within 28 days prior to study enrollment and must be a non-lactating subject; Men should be subjects who agree to use contraception during the study period and for 6 months after the end of the study period.\n* 10\\. Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n* 1\\. Known allergy to any of the drugs in the study;\n* 2\\. Previous or co-existing malignancies other than cured basal cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast (DCIS), papillary carcinoma of the thyroid gland, and other malignancies that have been adequately treated and cured for ≥5 years prior to the first dose with evidence of no recurrence or metastasis;\n* 3\\. Presence of symptomatic or active central nervous system (CNS) metastases or cancerous meningitis (patients with asymptomatic or stable brain metastases after treatment are allowed to be included);\n* 4\\. Active or previously suffering from autoimmune disease or immune deficiency;\n* 5\\. In the first study, patients with clinically significant bleeding symptoms or bleeding tendency, such as hemoptysis, hematemesis, hematochezia, gastrointestinal bleeding, hemorrhagic gastric ulcer, etc., occurred within 3 months before medication;\n* 6\\. Imaging (CT or MRI) shows that the tumor has invaded the large blood vessels or the boundary with the large blood vessels is unclear; Or if the investigator determines that the subject's tumor has a high risk of invading vital blood vessels during treatment and causing fatal bleeding;\n* 7\\. Have high blood pressure that is not well controlled by antihypertensive medication (systolic blood pressure \\>= 150mmHg or diastolic blood pressure \\>= 100 mmHg);\n* 8\\. Cardiovascular and cerebrovascular diseases of significant clinical significance:\n\n  1. Cerebrovascular accident (excluding lacunar infarction, minor cerebral ischemia, or transient ischemic attack), myocardial infarction, unstable angina pectoris, and poorly controlled arrhythmias (including QTc interval \\>= 450ms for men and 470 ms for women) occurred within 6 months before the first administration of the study drug (QTc interval \\>= 450ms for women) Fridericia formula);\n  2. New York Heart Association (NYHA) heart function Grade \\> II or left ventricular ejection fraction (LVEF) \\\u003C 50%;\n* 9\\. Active or uncontrolled severe infection;\n\n  1. Known human immunodeficiency virus (HIV) infection;\n  2. Known history of clinically significant liver disease, including viral hepatitis \\[active HBV infection, i.e., HBV DNA positive (\\>1×104 copies \u002FmL or \\>2000 IU\u002Fml) must be excluded for a known HBV carrier;\n  3. Known hepatitis C virus infection (HCV) and HCV RNA positive (\\>1×103 copies \u002FmL), or other hepatitis, cirrhosis;\n* 10\\. Patients with uncontrolled pleural effusion, pericardial effusion or peritoneal effusion in the third space, as judged by researchers, requiring puncture and drainage; Or received ascites, pleural effusion drainage within 14 days before the first medication;\n* 11\\. Patients with interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or other pulmonary fibrosis, chronic pneumonia, pneumonia due to drug or radiation therapy, a history of congenital pneumonia, or any evidence of active pneumonia on chest CT scan that may interfere with the judgment of immune-related pulmonary toxicity; Patients with severe impairment of lung function confirmed by current pulmonary function examination;\n* 12\\. Subjects who required systemic corticosteroids (\\> 10 mg\u002F day effective dose of prednisone) or other immunosuppressive agents within 14 days prior to initial dosing or during the study period. However, in the absence of active autoimmune disease, subjects were allowed to receive topical or inhaled steroids and adrenal hormone replacement therapy at a dose \\\u003C=10 mg\u002F day of prednisone effectiveness;\n* 13\\. The subject has any current disease or condition that affects drug absorption, or the subject is unable to take apatinib orally;\n* 14\\. Urine routine indicated urinary protein \\>=2+, and 24-hour urinary protein quantity \\>1.0g;\n* 15\\. The investigator considers that the subject is not suitable to participate in the clinical study due to any clinical or laboratory abnormalities or other reasons.",{"count":437,"type":20},34,[24],"To evaluate the efficacy and safety of apatinib combined with adebrelizumab and EC in the first-line treatment of extensive small cell lung cancer",[27],[191,442,443,444],"Apatinib","EC","Small cell lung cancer","2025-01-20",{"date":447,"type":32},"2025-01-22",{"date":449,"type":20},"2025-01-25",{"date":451,"type":20},"2028-09-25",{"name":453,"class":454},"Fujian Cancer Hospital","OTHER_GOV",4,{"id":457,"slug":458,"hasResults":11,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":183,"enrollmentInfo":464,"targetDuration":4,"studyType":21,"phases":466,"briefSummary":467,"conditions":468,"keywords":469,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":175},"100573700","phase-2-liposomal-irinotecan-and-apatinib-in-es-sclc-100573700","NCT06749691","Liposomal Irinotecan and Apatinib in ES-SCLC","Study of Liposomal Irinotecan Combined with Apatinib in the Treatment of Extensive Stage Small Cell Lung Cancer After First-line Progression","LIAES","Inclusion Criteria:\n\n1. Age range of 18-75 years;\n2. Expected survival period ≥ 12 weeks;\n3. At least one measurable lesion (according to RECIST V 1.1);\n4. For patients who have failed first-line or second-line treatment.\n\nExclusion Criteria:\n\n1. Have received any systemic treatment targeting VEGF or VEGFR in the past, such as treatment with anti angiogenic drugs such as ranibizumab, fipronib, apatinib, anlotinib, lenvatinib, sunitinib, sorafenib.\n2. Active or uncontrolled severe infection (CTCAE 5.0 ≥ 2) and\u002For antibiotic treatment within 2 weeks prior to enrollment;\n3. There are multiple factors that affect the absorption of oral medication, such as inability to swallow, nausea and vomiting, chronic diarrhea, and intestinal obstruction;\n4. Those deemed unsuitable for inclusion by doctors;",{"count":465,"type":20},30,[24],"The purpose of this study is to observe the efficacy and safety of liposomal irinotecan combined with apatinib in the treatment of extensive stage small cell lung cancer progressed from first-line regimen.",[27],[262,470,442],"Liposomal Irinotecan","2024-12-24",{"date":473,"type":32},"2024-12-27",{"date":475,"type":20},"2024-12-28",{"date":477,"type":20},"2027-12",{"name":479,"class":82},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":481,"slug":482,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":325,"enrollmentInfo":487,"targetDuration":4,"studyType":21,"phases":488,"briefSummary":489,"conditions":490,"keywords":491,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":175},"100572950","phase-2-irinotecan-liposome-ii-or-etoposide-combined-with-adebrelimab-and-carboplatin-in-the-treatment-of-es-sclc-100572950","NCT06739928","Irinotecan Liposome (II) or Etoposide Combined With Adebrelimab and Carboplatin in the Treatment of ES-SCLC","A Safety and Efficacy Evaluation Study of Irinotecan Liposome (II) or Etoposide Combined With Adebrelimab and Carboplatin in the Treatment of ES-SCLC","Inclusion Criteria:\n\n* Pathologically confirmed small cell lung cancer (SCLC), staged as extensive-stage SCLC (ES-SCLC) according to the VALG staging system;\n* No prior systemic treatment received;\n* At least a 6-month interval between the last treatment (radiation therapy and chemotherapy) and diagnosis of extensive-stage SCLC;\n* Showing at least one target lesion (RECIST 1.1) that has not been previously irradiated;\n* Male or female patients aged ≥18 and ≤70 years;\n* ECOG performance status (PS) score of 0 or 1;\n* Life expectancy of ≥12 weeks;\n* Adequate organ function: (1) Hematologic: WBC ≥ 3.0 × 10⁹\u002FL, ANC ≥ 1.5 × 10⁹\u002FL, PLT ≥ 100 × 10⁹\u002FL, HGB ≥ 9.0 g\u002FdL.(2) Hepatic function: AST ≤ 2.5 × ULN, ALT ≤ 2.5 × ULN, liver metastases allowed if ALT and AST ≤ 5 × ULN, TBIL ≤ 1.5 × ULN (except for Gilbert's syndrome, where total bilirubin ≤ 3.0 mg\u002FdL),(3) Renal function: Cr ≤ 1.5 × ULN or CrCl ≥ 50 mL\u002Fmin, (4) Coagulation: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN;\n* Agreement to use an appropriate contraceptive method from the first dose of the study treatment until 6 months after the last dose of the study treatment. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment;\n* The patient must have fully understood the study and voluntarily consent to participate by signing the informed consent form (ICF).\n\nExclusion Criteria:\n\n* Histologically or cytologically confirmed mixed small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC);\n* Previous treatment with immune checkpoint inhibitors, or treatment with irinotecan or other DNA topoisomerase inhibitors;\n* Use of a strong CYP3A4 inducer within 2 weeks prior to the first dose of the investigational drug, or a strong CYP3A4 inhibitor or UGT1A1 inhibitor within 1 week prior to the first dose;\n* Presence of clinically symptomatic brain metastasis, leptomeningeal metastasis, or spinal cord compression;\n* Hematologic disorders, including but not limited to lymphoma, acute or chronic leukemia, multiple myeloma, aplastic anemia, myelodysplastic syndrome, etc;\n* Clinically symptomatic third-space fluid accumulation, such as pericardial effusion, pleural effusion, or ascites that cannot be controlled by drainage or other treatments;\n* Active, known, or suspected autoimmune disease;\n* Use of corticosteroids (doses\\> 10 mg\u002Fday of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of the study drug;\n* Receipt of live vaccines or planned vaccination with a live vaccine within 4 weeks prior to the first dose of the study drug;\n* Interstitial lung disease, drug-induced pneumonia, radiation-induced pneumonia requiring steroid treatment, or clinically symptomatic active pneumonia, or severe pulmonary dysfunction;\n* Active tuberculosis or a history of active tuberculosis within 48 weeks prior to screening, regardless of whether it was treated;\n* Any toxicity from previous anticancer therapy, that has not resolved to grade ≤1 (according to CTCAE v5.0) prior to the first dose of the investigational drug;\n* Underwent a minor surgery (including catheter placement) within 48 hours prior to the first dose of the study drug;\n* Presence of uncontrolled cardiovascular symptoms or diseases;\n* Hypersensitivity to the investigational drug or its excipients;\n* A history of any other malignancy within 5 years prior to the first dose of the study drug, except for adequately treated non-melanoma skin cancer or in situ carcinoma;\n* A history of psychiatric disorders, alcohol abuse, drug abuse, or substance misuse;\n* HBsAg-positive and HBV DNA levels exceeding the upper limit of normal, or HCV-positive (HCV RNA or HCV Ab indicating acute or chronic infection); a history of HIV-positive status or acquired immunodeficiency syndrome (AIDS);\n* Received any other investigational drug or participated in another interventional clinical trial within 4 weeks prior to signing the informed consent form (ICF);\n* A history of allogeneic bone marrow transplantation or solid organ transplantation;\n* Any other factors as determined by the investigator.",{"count":351,"type":20},[24],"This study is a prospective, randomized, parallel, multicenter phase II study aimed at evaluating the efficacy and safety of irinotecan liposome (II) or etoposide combined with adebrelimab and carboplatin as first-line treatment for extensive stage small cell lung cancer. The primary endpoint of the study was the 1-year overall survival rate.",[27],[104,492,493,494,495],"extensive stage-small cell lung cancer","adebrelimab","Irinotecan liposome (II)","zhou chengzhi","2024-12-13",{"date":498,"type":32},"2024-12-18",{"date":500,"type":20},"2025-01-01",{"date":502,"type":20},"2027-12-30",{"name":504,"class":82},"Guangzhou Institute of Respiratory Disease",{"id":506,"slug":507,"hasResults":11,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":235,"phases":4,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":175},"100511922","molecular-analysis-and-treatment-options-of-sclc-100511922","NCT05945745","Molecular Analysis and Treatment Options of SCLC","Molecular Landscape Analysis and Clinical Implications for SCLC","Inclusion Criteria:\n\n* Histologically proven diagnosis of SCLC\n* 18 years of age or older\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Histologically proven diagnosis of non-SCLC",{"count":513,"type":20},500,"Small cell lung cancer (SCLC) is an aggressive disease that is characterized by rapid growth and the early development of metastases. Patients typically respond to initial chemotherapy but quickly experience relapse, resulting in a poor long-term outcome. Therapeutic innovations that substantially improve survival have historically been limited, and reliable, predictive biomarkers are lacking.\n\nOngoing research has advanced the understanding of molecular categories and the immunologic microenvironment of SCLC, which in turn has helped improve disease classification and staging. Considering the role of molecular alterations has not yet fully to be defined in the treatment of SCLC, there is an urgent recognition that molecular alterations in the SCLC are important to predict response and survival for novel therapies and ongoing clinical trials. Advances in research have revealed critical information regarding biologic characteristics of the disease, which may lead to the identification of vulnerabilities and the development of new therapies. Further research focused on identifying biomarkers and evaluating innovative therapies will be paramount to improving treatment outcomes for patients with SCLC.\n\nIn summary, identification of (genetic) biomarkers in SCLC is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with SCCL to further the characterization of molecular alterations and develop (novel) treatments based on the detection.",[130,516,517,27,518],"Small Cell Lung Cancer, Combined Type","Small Cell Lung Carcinoma","Small Cell Lung Cancer Limited Stage","2024-11-26",{"date":521,"type":32},"2024-11-29",{"date":523,"type":32},"2016-01-01",{"date":525,"type":20},"2028-12-31",{"name":527,"class":82},"Shanghai Chest Hospital",{"id":529,"slug":530,"hasResults":11,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":21,"phases":536,"briefSummary":537,"conditions":538,"keywords":540,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":552,"locationsCount":175},"100565901","phase-2-toripalimab-and-js004-combined-with-platinum-based-chemotherapy-for-relapsed-and-extensive-stage-small-cell-lung-cancer-100565901","NCT06648200","Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer","Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer: a Single-center, Randomized Trial","Inclusion Criteria:\n\n1. The patient shall sign the Informed Consent Form;\n2. Aged 18 ≥ years;\n3. Histological or cytological diagnosis of SCLC by needle biopsy or EBUS, and extensive stage or recurrent confirmed by imageological examinations or relapsed within more than six months after radical treatment SCLC;\n4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1;\n5. Life expectancy is at least 12 weeks;\n6. At least 1 measurable lesion according to RECIST 1.1;\n7. Patients with good function of other main organs (liver, kidney, blood system, etc.);\n8. Fertile female patients must voluntarily use effective contraceptives from the start of the trial to within 30 days after its completion, and urine or serum pregnancy test results within 7 days prior to enrollment are negative;\n9. Unsterilized male patients must voluntarily use effective contraception during the trial period and for 30 days after its conclusion.\n\nExclusion Criteria:\n\n1. Patients with a malignancy other than SCLC within five years prior to the start of this trial;\n2. Participants with any unstable systemic disease (including uncontrolled hypertension, severe arrhythmia, etc.);\n3. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;\n4. Participants who are allergic to the test drug or any auxiliary materials;\n5. Participants with active hepatitis B, hepatitis C or HIV;\n6. Participants with Interstitial lung disease currently;\n7. Pregnant or lactating women;\n8. Any malabsorption;\n9. Participants suffering from nervous system diseases or mental diseases that cannot cooperate;\n10. Other factors that researchers think it is not suitable for enrollment.",{"count":234,"type":20},[24],"For extensive-stage small cell lung cancer (SCLC), platinum-chemotherapy (cisplatin or carboplatin) combined with etoposide as the first-line treatment is recommended. However, the recurrence rate is extremely high after the initial first-line treatment. For those who relapse or progress within more than six minths after the end of the-first-line treatment, chose the current guideline recommendation trearment plan has the poor prognosis. A new immunotherapeutic strategy is needed to achieve better anti-tumor effects. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA), which restrains immune cells; function and leads to immune escape of tumor cells. The combination of PD-1 and BTLA antibodies has shown a good therapeutic effect in solid tumors. This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 combined with platinum-based doublet chemotherapy in extensive-stage SCLC or relapsed within more than six months after radical treatment SCLC.",[27,539],"Small Cell Lung Cancer Recurrent",[541,542,543,544,545],"small cell lung cancer","Toripalimab","JS004","Extensive-stage","Recurrent","2024-10-16",{"date":548,"type":32},"2024-10-18",{"date":550,"type":20},"2024-11-01",{"date":223,"type":20},{"name":553,"class":82},"Shanghai Pulmonary Hospital, Shanghai, China",{"id":555,"slug":556,"hasResults":11,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":561,"enrollmentInfo":562,"targetDuration":4,"studyType":235,"phases":4,"briefSummary":563,"conditions":564,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":571,"locationsCount":4},"100444401","application-of-ctdna-in-the-evaluation-of-curative-effect-and-prognosis-of-sclc-patients-100444401","NCT05066945","Application of ctDNA in the Evaluation of Curative Effect and Prognosis of SCLC Patients","Application of Circulating Tumor (ctDNA) in the Evaluation of Curative Effect and Prognosis of Small Cell Lung Cancer (SCLC) Patients","Inclusion Criteria:\n\n* Provision of informed consent；\n* Newly diagnosed and histological or cytological confirmed extensive stage small cell lung cancer;\n* All indicators has confirmed and allow to receive radiotherapy and chemotherapy;\n* Follow-up can be carried out and the peripheral blood samples can be collected;\n* Cooperate with the provision of clinical pathological data required by the research.\n\nExclusion Criteria:\n\n* Patients have other primary cancers;\n* Patients unable to cooperate with the study for follow-up according to the determined clinical follow-up cycle;\n* Unable to accept the judgment of curative effect evaluation by the designated methods such as CT.","80 Years",{"count":301,"type":20},"The purpose of this study is to evaluate the application value of circulating tumor DNA(ctDNA) with efficacy evaluation and prognostic assessment in patients with unresectable SCLC, who were receiving radiotherapy and chemotherapy treatment.",[27],"2021-09-22",{"date":567,"type":32},"2021-10-04",{"date":569,"type":20},"2022-01-01",{"date":341,"type":20},{"name":572,"class":82},"Xiangya Hospital of Central South University"]