[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extensive-stage-lung-small-cell-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extensive-stage-lung-small-cell-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,60,91,117],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100054047","phase-2-phase-ii-study-of-platinumetoposide-plus-ivonescimab-for-extensive-stage-small-cell-lung-cancer-100054047",false,"NCT07057791","Phase II Study of Platinum\u002FEtoposide Plus Ivonescimab for Extensive-Stage Small Cell Lung Cancer","Phase II Dose Optimization Study of Platinum\u002FEtoposide Plus Ivonescimab (CEI) as First-Line Treatment of Extensive-Stage Small Cell Lung Cancer","PrE0510","Selection Criteria:\n\n* Patients must have pathologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC).\n* No prior systemic therapy for the disease under study (ES-SCLC).\n* Patients must have measurable disease according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.\n* Patient must be ≥ 18 years of age.\n* Patient must have an ECOG performance status of 0-1.\n* Patient must have the ability to understand and willingness to sign a written informed consent document.\n* Willing to provide archived tumor tissue (if sufficient tumor tissue available) and blood samples for research.\n* Patient must have adequate organ function and marrow function as defined below, obtained ≤ 14 days prior to registration\u002Frandomization. No blood transfusions or growth factor therapy allowed within 7 days of screening labs.\n\n  * Absolute Neutrophil Count (ANC) ≥ 1500\u002Fmicroliter (mcL)\n  * Platelets ˃100,000\u002FmcL\n  * Hemoglobin \\>9.0 gram\u002Fdeciliter (g\u002FdL)\n  * Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5x Upper Limit Normal (ULN), and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5x ULN\n  * Serum Creatinine ≤ 2x ULN\n  * Creatinine clearance (CrCl) ≥ 50 milliliter\u002Fminute (mL\u002Fmin)\n  * Urine Protein \\\u003C2+\n  * Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5x ULN or ≤ 5x ULN for patients with liver metastasis\n  * Total Bilirubin ≤ 1.5x ULN or ≤ 3x ULN for patients with liver metastasis or suspected\u002Fdocumented Gilbert's disease\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.\n* Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study, and for 120 days after the last dose of study drug(s).\n* Patients must not have symptomatic central nervous system (CNS) metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease.\n* Patients must not have imaging during the screening period that shows:\n\n  1. Radiologically documented evidence of major blood vessel invasion (central pulmonary artery, central pulmonary veins, aorta, brachiocephalic artery, common carotid artery, subclavian artery, superior vena cava) or tumor invading organs (heart, trachea, esophagus, central bronchi \\[not including segmental bronchi\\]) or if there is a risk of esophagotracheal or esophagopleural fistula .\n  2. Radiographic evidence of major blood vessel encasement with narrowing of the vessel or intratumor lung cavitation or necrosis that the investigator determines will pose a significantly increased risk of bleeding.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patients must not have major surgical procedures or serious trauma within 28 days prior to randomization or plans for major surgical procedures within 28 days after the first dose.\n* Patients must not have history of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to randomization, including but not limited to:\n\n  1. Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots). Transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n  2. Nasal bleeding\u002Fepistaxis (bloody nasal discharge is allowed).\n  3. Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to randomization is not allowed.\n* Patients must not have history of major diseases before randomization, specifically:\n\n  1. Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association (NYHA) classification ≥ Grade 2) or unstable vascular disease (e.g., aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial ischemia).\n  2. History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to randomization.\n  3. History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to randomization.\n  4. History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to randomization.\n* Patients must not have poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.\n* Patients must not have prolongation of QTc interval \\>480 msec\n* Patients must not have active autoimmune or lung disease requiring systemic therapy (e.g., with disease modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to randomization.\n* Patients must not have severe infection within 4 weeks prior to randomization, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to randomization (excluding antiviral therapy for hepatitis B or C).\n* Patients must not have uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic.\n* Patients must not have history of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease.\n* Patients must not have active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea.\n* Patients must not have pre-existing peripheral neuropathy ≥ Grade 2 by CTCAE V5.0.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration\u002Frandomization are eligible for this trial.\n* Patient must not have received any live vaccine within 28 days prior to registration\u002Frandomization.\n* Patients with a known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent are not eligible.\n* Patients with any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of the treatment according to the protocol are not eligible.\n* Patients may not participate in any other therapeutic clinical trials, including those with other investigational agents not included in this trial during treatment on this study without prior approval from PrECOG.","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Eligible untreated participants with Extensive Stage Small Cell Lung Cancer (ES-SCLC) who are ≥ 18 years of age will be randomized to receive ivonescimab 10 milligrams per kilogram (mg\u002Fkg) or ivonescimab 20 mg\u002Fkg in combination with carboplatin and etoposide.\n\nIvonescimab is a type of drug called a bispecific antibody. Antibodies are proteins that specifically recognize and bind to other types of proteins called antigens. Antibodies and antigens can work together to help the immune system fight cancer cells. Bispecific antibody, meaning it targets two different molecules at the same time.\n\nIvonescimab is a new drug that may help the immune system attack cancer cells and may also block certain pathways that cancer uses to grow and spread. This dual action of ivonescimab aims to help the immune system to fight the cancer and also disrupt tumor growth by blocking blood vessel formation that tumors use to grow.\n\nParticipants will receive induction with 4 cycles of ivonescimab (dose determined by randomization) with standard of care carboplatin and etoposide followed by maintenance therapy with ivonescimab at the same dose received during induction. Treatment will continue until disease progression, unacceptable toxicity or participant withdrawal.\n\nThe purpose of this study is to determine what dose of ivonescimab works best in combination with carboplatin and etoposide chemotherapy in ES-SCLC. We will also examine the side effects, good and bad, associated with ivonescimab.",[27],"Extensive Stage Lung Small Cell Cancer",[29,30,31,32,33],"Extensive Stage Small Cell Lung Cancer","Small Cell Lung Cancer","Ivonescimab","Carboplatin","Etoposide","RECRUITING","2026-07-09",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2026-03-30",{"date":42,"type":21},"2030-01",{"name":44,"class":45},"PrECOG, LLC.","OTHER",11,{"id":48,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":25,"conditions":51,"keywords":52,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":57,"leadSponsor":58,"locationsCount":59},"100597384",{"count":20,"type":21},[24],[27],[29,30,31,32,33],"2026-06-25",{"date":55,"type":38},"2026-06-29",{"date":40,"type":38},{"date":42,"type":21},{"name":44,"class":45},10,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":70,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":5},"100597672","phase-2-sintilimab-combined-with-tafolecimab-and-chemotherapy-as-first-line-treatment-for-extensive-stage-small-cell-lung-cancer-100597672","NCT07061535","Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer","Efficacy and Safety of Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (STAR-SCLC)：A Prospective, Single Arm Trial","STAR-SCLC","Key Inclusion Criteria:\n\n* Age ≥18 years, ECOG performance status 0-1;\n* Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to Veterans Administration Lung Study Group criteria;\n* Previously not receiving systemic treatment for ES-SCLC;\n* Greater than or equal to 1 measurable lesion exists according to RECIST v1.1;\n* Expected survival \\>= 12 weeks;\n* Adequate organ system functions (no blood transfusion or component blood use within 14 days before testing).\n\nKey Exclusion Criteria:\n\n* Previously receiving systemic anti-tumor therapy for ES-SCLC;\n* Combined SCLC (mixed SCLC and NSCLC histological types) or transformed SCLC confirmed by histological or cytological examination;\n* Receiving other investigational drugs or participated in other interventional clinical studies within 4 weeks before signing the informed consent form;\n* Receiving systemic immunostimulant treatment within 4 weeks before enrollment;\n* Active central nervous system (CNS) metastases (asymptomatic patients with stable lesions allowed);\n* Severe cardiovascular disease;\n* Severe chronic\u002Factive infections requiring systemic antibacterial, antifungal or antiviral treatment within 2 weeks before enrollment;\n* Active hepatitis B virus (HBV)\u002F hepatitis C virus (HCV)\u002F human immunodeficiency virus (HIV) infection;\n* Active autoimmune diseases, a history of interstitial lung disease, or other uncontrolled systemic diseases;\n* Pregnancy or lactation;\n* Having a disease that requires systemic corticosteroids or other immunosuppressants to be treated within ≤14 days before enrollment;\n* Requiring at least monthly or more frequent drainage of pleural and\u002For pericardial or peritoneal effusion;\n* Using attenuated live vaccines, or planned to receive attenuated live vaccines within 28 days before enrollment;\n* Known to be allergic to Sintilimab or Tafolecimab or its excipients, having a history of severe allergic reaction to any monoclonal antibody, or having a history of allergy to cisplatin, carboplatin or etoposide;\n* Toxicity caused by previous anti-cancer treatment has not recovered to baseline or stable state at the time of enrollment;\n* Creatinine clearance rate \\\u003C 60 mL\u002Fmin (cisplatin) or \\\u003C 45 mL\u002Fmin (carboplatin)\n* Uncontrolled or symptomatic hypercalcemia.",{"count":69,"type":21},40,[24],"This is a single arm, multi-center clinical trial. The goal of this clinical trial is to evaluate the efficacy, safety and biomarkers of Tafolecimab combined with Sintilimab and Chemotherapy as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). Tafolecimab is a recombinant fully humanized monoclonal antibody against proprotein convertase subtilisin\u002Fkexin type 9 (PCSK-9), which can reduce low-density lipoprotein-C levels and increase the expression level of major histocompatibility complex class I (MHC-I) on tumor cells. Sintilimab is a fully humanized IgG4 monoclonal antibody targeting programmed cell death protein 1 (PD-1).",[73,27,74,75],"Extensive-stage Small Cell Lung Cancer (ES-SCLC)","Extensive-Stage Small-Cell Lung Cancer","Extensive Disease Small Cell Lung Cancer",[77,78,79,80,81],"Tafolecimab","Sintilimab","immunotherapy","PCSK9 inhibitor","SCLC","2026-06-22",{"date":84,"type":38},"2026-06-23",{"date":86,"type":38},"2025-07-30",{"date":88,"type":21},"2027-08-01",{"name":90,"class":45},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":104,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":116},"100608553","phase-2-a-trial-of-tarlatamab-in-patients-with-pretreated-extensive-stage-small-cell-lung-cancer-es-sclc-and-ecog-ps-2-100608553","NCT07203053","A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2","A Multicentre Phase II Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2","START-lung","Inclusion Criteria:\n\n* Histologically or cytologically confirmed ES-SCLC.\n* Previous treatment with only one line of platinum-etoposide doublet chemotherapy with immune-checkpoint inhibition for SCLC.\n\nPatients treated with a platinum-etoposide doublet chemotherapy for prior limited stage (LS)-SCLC may be eligible for the study if the disease has progressed on treatment or within 6 months from chemotherapy completion (i.e. during durvalumab consolidation): the platinum-etoposide line of therapy will count as one prior line of therapy.\n\n* Progressive disease on or after the first-line treatment for SCLC.\n* ECOG Performance Status 2.\n* Age ≥18 years.\n* Adequate haematological, renal and liver function.\n* Coagulation function: Prothrombin time (PT)\u002Finternational normalised ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤1.5x ULN, except for patients receiving anticoagulation, who must be on a stable dose of anticoagulation therapy for 6 weeks prior to enrolment.\n* Pulmonary function:\n\n  * No clinically significant pleural effusion. Pleural effusion managed with indwelling pleural catheter (e.g., PleurX) are allowed.\n  * Baseline oxygen saturation \\>90% on room air.\n* Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan (preferred), and no clinically significant electrocardiogram (ECG) findings.\n* Women of childbearing potential, must have a negative urinary or serum pregnancy test within 5 weeks before enrolment. Pregnancy test must be repeated within 3 days before the first dose of tarlatamab treatment.\n* Written Informed Consent must be signed and dated by the patient and the investigator prior to any trial-related intervention.\n\nExclusion Criteria:\n\n* Symptomatic CNS metastases Patients with untreated asymptomatic brain metastases and patients with treated and stable brain metastases are eligible.\n* Diagnosis or evidence of leptomeningeal disease or spinal cord compression\n* Prior history of immune-checkpoint inhibitor treatment resulting in:\n\n  * any severe or life-threatening immune-mediated adverse event,\n  * history of immune-mediated encephalitis or another immune-mediated CNS event (any grade),\n  * grade ≥2 immune-mediated recurrent pneumonitis,\n  * infusion-related reactions leading to permanent discontinuation of the immunotherapy agent.\n\nException: patients with a history of immune-checkpoint inhibitor-induced endocrinopathy which is clinically stable on replacement therapy.\n\n* Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.\n* History of solid organ transplantation.\n* Treatment with live virus, including live-attenuated vaccination within 14 days prior to enrolment and inactive vaccines (e.g., non-live or non-replicating agent) and live viral non-replicating vaccines (e.g., Jynneos for Monkeypox infection) within 3 days prior to enrolment.\n* History of other malignancy within the past 2 years, with the following exceptions:\n\n  * Low-risk malignancy treated with curative intent and with no known active disease present for ≥1 year before enrolment and believed to be at low risk for recurrence per investigator discretion.\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n  * Adequately treated cervical carcinoma in situ without evidence of disease.\n  * Adequately treated breast ductal carcinoma in situ without evidence of disease.\n  * Prostatic intraepithelial neoplasia without evidence of prostate cancer.\n  * Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ.\n* Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\>class II) within 12 months prior to enrolment.\n* History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 12 months prior to enrolment.\n* Presence\u002Fhistory of an uncontrolled viral infection:\n\n  * Known uncontrolled human immunodeficiency virus (HIV) infection.\n  * Active hepatitis C infection (patients with detectable hepatitis C antibody \\[HCV Ab\\] and HCV RNA viral load above the limit of quantification).\n  * Patients with presence of HCV Antibodies and HCV RNA viral load below the limit of quantification (HCV RNA negative) with or without prior treatment are allowed.\n  * Active hepatitis B infection (presence of hepatitis B surface antigen \\[HBsAg\\] and hepatitis B virus \\[HBV\\] DNA viral load above the limit of quantification \\[HBV DNA positive\\]).\n  * Patients with resolved HBV infection defined as absence of HBsAg and presence of HBV core antibody (anti-HBc) followed by an HBV DNA viral load below the limit of quantification (HBV DNA negative) are allowed, with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines.\n  * Patients with chronic HBV infection inactive carrier state defined as presence of HBsAg and HBV DNA viral load below the limit of quantification \\[HBV DNA negative\\] are allowed, with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines.\n* Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment.\n\n  * Prophylactic dexamethasone for the management of tarlatamab-related adverse events and any anti-emetic therapies are allowed.\n  * Low-dose corticosteroids (prednisone ≤10 mg per day or equivalent) is permitted during the trial.\n* Patients with symptoms and\u002For clinical signs and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active systemic infection within 7 days prior to the first dose of study treatment.\n\n  * Patient has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the patient may be considered eligible for the study from an infection standpoint.\n  * Note: Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment. Subjects requiring oral antibiotics who have been afebrile for \\>24 hours, have no leucocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required unless otherwise noted as exclusion criteria.\n* Evidence of interstitial lung disease or active, non-infectious pneumonitis.\n* Major surgical procedures within 5 weeks prior to enrolment.\n* Any concurrent medical condition which, in the opinion of the investigator, would compromise patient safety or interfere with the evaluations for tarlatamab.\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.\n* Women who are pregnant or in the period of lactation.\n* Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the trial until at least 60 days after the last dose of tarlatamab treatment.",{"count":100,"type":21},48,[24],"START-lung is an international, multicentre, single-arm phase II trial. Protocol treatment consists of tarlatamab administered as an intravenous infusion until disease progression according to RECIST v1.1 criteria, unacceptable toxicity, or patient decision, whichever comes first. The primary objective of the trial is to assess the clinical efficacy of tarlatamab, in terms of 12-month OS rate, in patients with ES-SCLC and ECOG PS 2 who have previously received only one line of platinum-etoposide doublet chemotherapy with immune-checkpoint inhibition and whose disease has progressed.",[27],[105,106],"ES-SCLC","Tarlatamab","2026-06-18",{"date":82,"type":38},{"date":110,"type":38},"2026-04-15",{"date":112,"type":21},"2029-10",{"name":114,"class":115},"ETOP IBCSG Partners Foundation","NETWORK",19,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100606196","phase-2-open-label-biomarker-integrated-umbrella-trial-for-first-line-treatment-of-extensive-stage-small-cell-lung-cancer-100606196","NCT07172412","Open-Label, Biomarker-Integrated Umbrella Trial for First-Line Treatment of Extensive-stage Small Cell Lung Cancer","An Umbrella Ib\u002FII Phase Study Evaluating the Efficacy and Safety of First-Line Combination Therapy in the Treatment of Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* The diagnosis of SCLC is confirmed by histology or cytology, and according to VALSG and AJCC9, the imaging diagnosis is extensive stage.\n* Patients who have not previously received systemic therapy for advanced or metastatic disease, or patients who have relapsed after concurrent chemo-radiotherapy during the localized stage.\n* The expected survival time is not less than 12 weeks.\n* According to RECIST V1.1, there is at least one measurable lesion that has not undergone radiation therapy.\n* The Eastern Cooperative Oncology Group (ECOG) physical condition score is evaluated as 0 or 1.\n* When screening, there is sufficient bone marrow reserve, and no blood transfusion or hematopoietic stimulating factor treatment has been received 10 days before the test. The definition is as follows: absolute neutrophil counts (ANC) ≥ 1.5×109\u002FL, platelet (PLT) ≥ 100×109\u002FL and hemoglobin (HGB) ≥ 90g\u002FL.\n* Appropriate organ function during screening, meeting the following criteria: aspartate aminotransferase (AST) ≤ 2.5×ULN (with liver metastasis ≤ 5×ULN); alanine aminotransferase (ALT) ≤ 2.5ULN (with liver metastasis ≤ 5ULN); total serum bilirubin ≤ 1.5×ULN (with tumor infiltration ≤ 3×ULN); serum creatinine (Scr) ≤ 1.5×ULN, or creatinine clearance rate ≥ 60mL\u002Fmin; international normalized ratio (INR) ≤ 1.5×ULN, and activated partial thromboplastin time (APTT) ≤ 1.5×ULN; the urine pregnancy test for women of childbearing age needs to be negative, and any male and female patients with fertility must agree to use effective contraceptive methods throughout the entire study process and for at least 1 year after treatment.\n\nExclusion Criteria:\n\n* During screening, patients with symptomatic central nervous system (CNS) metastasis (asymptomatic CNS metastasis, or asymptomatic and stable condition after local treatment for 4 weeks can be enrolled).\n* Individuals with a history of central nervous system diseases before screening, such as epilepsy, cerebral ischemia\u002Fbleeding, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, mental illness, or any autoimmune disease associated with central nervous system involvement.\n* Received chemotherapy, radiation therapy, immunotherapy, targeted therapy, biological therapy, endocrine therapy within 4 weeks of screening, and was evaluated by the researcher as not suitable for enrollment.\n* The adverse reactions of previous anti-tumor treatments have not yet recovered to level 1 (CTCAE5.0), except for toxicity that the researchers have determined to have no safety risk, such as hair loss and level 2 peripheral neurotoxicity.\n* Those who discontinue systemic hormone therapy for less than 72 hours before the first administration, but are allowed to use physiological replacement doses of hormones (such as prednisone \\\u003C 10mg\u002Fd or equivalent).\n* Received organ\u002Ftissue transplantation before screening.\n* Prior to screening, it was known that the patient had active systemic autoimmune diseases and was currently undergoing treatment.\n* Those who meet any of the following conditions during screening: hepatitis B surface antigen (HBsAg) is positive, and the copy number of HBV DNA is greater than the measurable lower limit; hepatitis C antibody (HCV Ab) is positive; treponema pallidum antibody (TP-Ab) is positive; HIV antibody is positive; The copy numbers of EBV-DNA and CMV-DNA are higher than the measurable lower limit.\n* Individuals who have undergone major surgery or experienced significant trauma within 4 weeks prior to screening, or who require elective surgery during the trial period, have been evaluated by the researchers as unsuitable for inclusion.\n* Within 2 years prior to screening or currently suffering from other malignant tumors.\n* When screening, the heart meets any of the following conditions: New York Heart Association (NYHA) ≥ Level II, Left Ventricular Ejection Fraction (LVEF) ≤ 50% (ECHO); Hypertension (systolic blood pressure ≥ 140mmHg and\u002For diastolic blood pressure ≥ 90mmHg) or pulmonary hypertension that has not been controlled after standardized treatment; Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months before the first administration; valvular disease with clinical significance; There are serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias that require clinical intervention, II-III degree atrioventricular block, etc.\n* Patients with tumor involving the atrium or ventricle during screening.\n* When screening, there are clinical emergencies that require urgent treatment due to tumor obstruction or compression (such as intestinal obstruction or vascular compression).\n* Individuals with active bleeding during screening.\n* Those with a history of deep vein thrombosis or pulmonary embolism within 6 months before screening.\n* Individuals who have received live vaccines within 6 weeks before screening.\n* Subjects with uncontrolled systemic bacterial, viral, or fungal infections after optimal treatment.\n* Participated in other interventional clinical studies within 4 weeks before the first administration.\n* Individuals with poor adherence or those who are deemed unsuitable for clinical trials by researchers due to other reasons.","75 Years",{"count":126,"type":21},165,[24],"This is an open-label umbrella study conducted in first treatment ES-SCLC patients, employing a novel umbrella trial design (biomarker-integrated multi-arm trial with a shared ICI+chemotherapy control arm). Eligible patients were assigned to trial arms based on biomarker expression levels. Biomarker subgroups were defined as: (1) High ASCL1\u002FNEUROD1\u002FDLL3 expression: DLL3-CAR-NK cells combined with ICI + etoposide + carboplatin (DLL3 group); (2) Myc overexpression: XPO1 inhibitor selinexor combined with ICI + etoposide + carboplatin (XPO1 group); (3) VIM\u002FAXL high expression group treated with anlotinib combined with ICI + etoposide + carboplatin (anlotinib group).",[27],"NOT_YET_RECRUITING","2025-09-24",{"date":133,"type":38},"2025-09-30",{"date":135,"type":21},"2025-11",{"date":137,"type":21},"2028-12",{"name":139,"class":45},"Tianjin Medical University Cancer Institute and Hospital",1]