[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sclc-extensive-stage\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sclc-extensive-stage":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,41,72,106,128,155,190,215,235,258,283,308,332,353,371,395,417,438],{"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":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100053538","phase-2-toripalimab-combined-with-beat-chemotherapy-in-the-treatment-of-advanced-back-line-small-cell-lung-cancer-100053538",false,"NCT07698054","Toripalimab Combined With Beat Chemotherapy in the Treatment of Advanced Back-line Small Cell Lung Cancer","A Prospective, Open-label, Bayesian Adaptive Randomized Phase II Clinical Study of Toripalimab Combined With Beat Chemotherapy in the Treatment of Advanced Back-line Small Cell Lung Cancer","Inclusion Criteria:\n\n* 1.Age ≥18 years old, both male and female are acceptable.\n* 2\\. Histology and pathology diagnosis of extensive stage small cell lung cancer, and must meet the following standards:\n\n  1. always has not received the immune therapy,\n  2. Previously received immunotherapy, with the number of treatment lines ≥2 and the immunotherapy being effective(immunotherapy PFS \\> 3 months, withdrawal time \\> 3 months)\n  3. never used anlotinib,\n* 3\\. ECOG: 0 \\~ 2;\n* 4 . The expected lifetime 12 weeks or more;\n* 5\\. Major organs function normal\n\nExclusion Criteria:\n\n* 1.Those who are allergic to toripalimab or etoposide or have metabolic disorders;\n* 2.With known the special ripley sheet resistance, etoposide contraindication;\n* 3.Other circumstances that the researcher assessed as unsuitable for participation in this clinical study.","ALL","18 Years",{"count":19,"type":20},130,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is a randomized, open-label, multi-center investigator-initiated clinical trial. Patients who meet the inclusion criteria receive the treatment plan stipulated in the protocol. A Bayesian design is used to explore the efficacy and safety of teprotumumab combined with pulse chemotherapy in the treatment of advanced second-line extensive-stage small cell lung cancer.",[26,27,28],"SCLC, Extensive Stage","Bayesian","Metronomic Chemotherapy","NOT_YET_RECRUITING","2026-07-09",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":20},"2026-08-01",{"date":37,"type":20},"2030-12-31",{"name":39,"class":40},"Henan Cancer Hospital","OTHER_GOV",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100621133","phase-1-safety-tolerability-and-preliminary-efficacy-of-neuk203-13-in-refractory-neuroendocrine-tumor-patients-100621133","NCT07366658","Safety, Tolerability and Preliminary Efficacy of NEUK203-13 in Refractory Neuroendocrine Tumor Patients","A Study to Explore the Safety, Tolerability, and Preliminary Efficacy of NEUK203-13 Injection in Patients With Neuroendocrine Tumors Who Have Failed Systemic Therapy","NEUK203-13","Inclusion Criteria:\n\n* 1\\. Understand and voluntarily sign the Informed Consent Form (ICF);\n* 2\\. Aged ≥ 18 years and \\\u003C 75 years at the time of signing the ICF, regardless of gender;\n* 3\\. Pathologically confirmed neuroendocrine tumors, including small cell lung cancer (SCLC), etc.;\n* 4\\. Previous failure or intolerance to systemic therapy, or recurrence after remission: among them, patients with small cell lung cancer must have received at least platinum-based chemotherapy with or without PD-1\u002FPD-L1 inhibitors in previous treatments, with imaging evidence of disease progression after treatment;\n* 5\\. Must provide tissue samples for biomarker analysis, preferably newly obtained tissues. For patients unable to provide newly obtained tissues, 4 unstained sections of archived formalin-fixed, paraffin-embedded (FFPE) tissues can be provided (at least 1 patient with high DLL3 expression shall be enrolled in each dose group: high expression is defined as positive staining in ≥ 50% of tumor cells; preference is given to enrolling DLL3-positive patients);\n* 6\\. Have at least one measurable lesion as the target lesion (per RECIST v1.1 criteria);\n* 7\\. Expected survival ≥ 3 months;\n* 8\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n* 9\\. Have adequate bone marrow reserve and organ function within 7 days before the first administration of NEUK203-13 Injection:\n* 10\\. Sufficient bone marrow function (no supportive therapy within 14 days before the first administration): hemoglobin (Hb) ≥ 90 g\u002FL, platelets (PLT) ≥ 75 × 10⁹\u002FL, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL;\n* 11\\. Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), total bilirubin (TBIL) \\\u003C 1.5 × ULN;\n* 12\\. Renal function: serum creatinine (Scr) ≤ 1.5 × ULN and creatinine clearance rate (Ccr) ≥ 60 mL\u002Fmin (calculated according to the Cockcroft-Gault formula); Coagulation function: prothrombin time (PT) ≤ 1.5 × ULN, international normalized ratio (INR) ≤ 2.0;\n* 13\\. Female patients of childbearing potential or male patients whose partners are of childbearing potential agree to use highly effective contraceptive measures from any dose administration in the study until 6 months after the last dose of the study.\n\nExclusion Criteria:\n\n* 1\\. Mixed carcinoma with non-neuroendocrine tumor components;\n* 2\\. Active brain metastases (patients with stable disease for 3 months after treatment without the need for continued glucocorticoid therapy are eligible for enrollment); known leptomeningeal metastases; isolated central nervous system (CNS) disease progression without evidence of progression outside the CNS;\n* 3\\. A history of hypersensitivity to interleukin-2 (IL-2), fludarabine, cyclophosphamide, tocilizumab, or any component of the infusion product formulation; or patients with a history of specific allergic disorders (asthma, rubella, eczematous dermatitis);\n* 4\\. Prior receipt of any of the following treatments:\n* 5\\. Any systemic antineoplastic therapy within 4 weeks or 5 half-lives prior to the first administration of NEUK203-13 Injection, whichever is shorter;\n* 6\\. Radiotherapy not involving the thoracic cavity within 2 weeks prior to the first administration of NEUK203-13 Injection, or radiotherapy involving the thoracic cavity within 4 weeks prior to the first administration of the study drug, whichever is longer;\n* 7\\. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study;\n* 8\\. Prior vaccination with an antineoplastic vaccine, or receipt of a live vaccine within 4 weeks prior to the first administration of NEUK203-13 Injection;\n* 9\\. Major surgery or severe trauma within 4 weeks prior to the first administration of NEUK203-13 Injection;\n* 10\\. Failure of toxicities from prior antineoplastic therapy to resolve to ≤ Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) (except alopecia) or to the level specified in the inclusion\u002Fexclusion criteria, whichever is more stringent;\n* 11\\. Active autoimmune disease or a history of autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); exceptions include patients with vitiligo, patients with a history of childhood asthma\u002Fallergies that have resolved completely and require no intervention in adulthood, patients with autoimmune-mediated hypothyroidism receiving a stable dose of thyroid replacement hormone, and patients with type 1 diabetes receiving a stable dose of insulin;\n* 12\\. A history of immunodeficiency, including positive HIV test results, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;\n* 13\\. Severe infection (CTCAE \\> Grade 2) within 4 weeks prior to the first administration of NEUK203-13 Injection, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging indicating active pulmonary inflammation; or presence of signs and symptoms of infection requiring oral or intravenous antibiotic therapy within 2 weeks prior to the first administration of the study drug (except for prophylactic antibiotic use);\n* 14\\. Tuberculosis infection identified by medical history or CT examination; Active hepatitis B (HBV DNA ≥ 500 IU\u002FmL), hepatitis C (positive anti-HCV antibodies and HCV-RNA above the lower limit of detection of the assay), or positive syphilis test results (including positive RPR or TPPA);\n* 15\\. Prior diagnosis of any other malignant tumor, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or breast cancer, or adequately treated localized prostate cancer;\n* 16\\. Pregnant or lactating women;\n* 17\\. Uncontrolled concurrent diseases, including but not limited to: documented cerebrovascular events (stroke or transient ischemic attack) within 6 months prior to the first administration of the study drug, symptomatic congestive heart failure, left ventricular ejection fraction (LVEF) \\\u003C 50%, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmias, severe chronic gastrointestinal disease with diarrhea, or severe dyspnea requiring oxygen therapy;\n* 18\\. A definite history of neurological or psychiatric disorders that, in the investigator's judgment, may affect the patient's cognitive function or compliance, including unstable epilepsy, dementia, schizophrenia, etc.; or psychiatric illnesses\u002Fsocial conditions that may affect study compliance, significantly increase the risk of adverse events, or impair the patient's ability to provide written informed consent;\n* 19\\. Other factors judged by the investigator that may force the patient to terminate the study prematurely, such as severely abnormal laboratory test results, and\u002For family or social factors that may affect patient safety or the collection of trial data.","75 Years",{"count":51,"type":20},9,[53],"PHASE1","This is a Phase I clinical trial being conducted in humans for the first time, aiming to evaluate a novel cell therapy called NEUK203-13 Injection for the treatment of patients with advanced small cell lung cancer (SCLC) who have failed systematic therapy or late stage neuroendocrine tumors(NETs). The primary goal of the study is to determine the safety and tolerability of this new therapy and to preliminarily observe its anti-tumor effects.\n\nNEUK203-13 Injection is an \"off-the-shelf\" CAR-NK cell therapy developed based on induced pluripotent stem cell (iPSC) technology, targeting the DLL3 protein highly expressed in SCLC or other neuroendocrine tumors(NETs) .\n\nPrimary Objective Primary Endpoint aims to evaluate safety and tolerability Secondary Endpoints aim to preliminarily observe efficacy and investigate the pharmacokinetics of the drug in the body.\n\nTwo pre-set dose levels are planned, with an enrollment of 7-9 patients. Treatment Regimen\n\n1. Lymphodepletion Conditioning: Chemotherapy (Cyclophosphamide + Fludarabine) before cell infusion to clear lymphocytes in the body.\n2. Cell Infusion: NEUK203-13 is administered via intravenous infusion, d1，d4 and d7 for three doses.\n3. Supportive Medication: Concurrent use of IL-2 (Interleukin-2) d1, d4, d7 and d10 to support NK cell persistence.\n\nTarget Patient Population Patients with advanced SCLC who have progressed after prior platinum-based chemotherapy or late stage neuroendocrine tumors(NETs) and have a relatively good performance status.\n\nKey Monitoring Focus Close monitoring of risks specific to cell therapy, such as Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).\n\nIn short, this study represents the first clinical exploration of NEUK203-13 Injection in patients with advanced small cell lung cancer or other neuroendocrine tumors(NETs). Its primary focus is on safety, while simultaneously gathering preliminary signals on whether the therapy can control tumors, thereby laying the foundation for subsequent clinical development.",[26,56],"Neuroendocrine Tumors",[58,59],"Car-NK cells","iPSC","RECRUITING","2026-06-23",{"date":63,"type":33},"2026-06-25",{"date":65,"type":33},"2026-02-20",{"date":67,"type":20},"2027-01-20",{"name":69,"class":70},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":71},"100632066","phase-1-68ga-pfd3-pet-imaging-for-the-diagnosis-and-evaluation-of-small-cell-lung-cancer-100632066","NCT07508852","68Ga-PFD3 PET Imaging for the Diagnosis and Evaluation of Small Cell Lung Cancer","Targeting Delta-like Ligand 3 (DLL3) With 68Ga-PFD3 PET\u002FCT for the Diagnosis and Assessment of Small Cell Lung Cancer (SCLC)","Inclusion Criteria:\n\n* Adults.\n* Histologically confirmed small cell lung cancer (SCLC).\n* At least one measurable lesion ≥1 cm in diameter (primary tumor, metastatic lesion, or involved lymph node) confirmed by standard imaging modalities.\n* Laboratory tests (complete blood count and biochemical analysis) completed within 4 weeks prior to enrollment.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Breastfeeding.\n* Acute psychiatric disorders.\n* Inability to undergo PET scanning (e.g., due to claustrophobia, weight limits, or other medical contraindications).\n* Inability to complete the study procedures as anticipated.\n* Prior therapy targeting DLL3.",{"count":80,"type":20},30,[53,23],"This study aims to investigate and evaluate the safety and performance of a novel probe, PFD3, for the diagnosis and assessment of patients with small cell lung cancer (SCLC).",[84,26,85,86,87],"SCLC","SCLC, Limited Stage","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )",[84,89,90,91,92,93,94,95,96],"small cell lung cancer","PET\u002FCT","PET","DLL3","Delta-like ligand 3","imaging","diagnosis","evaluation","2026-06-16",{"date":99,"type":33},"2026-06-18",{"date":101,"type":33},"2025-10-22",{"date":103,"type":20},"2027-12-31",{"name":105,"class":70},"Peking University First Hospital",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":4},"100643270","phase-2-lomustine-combined-with-anlotinib-as-interventional-therapy-for-extensive-stage-small-cell-lung-cancer-resistant-to-second-line-and-above-treatment-100643270","NCT07632209","Lomustine Combined With Anlotinib as Interventional Therapy for Extensive-stage Small Cell Lung Cancer Resistant to Second-line and Above Treatment","A Single-arm, Phase II Interventional Study to Evaluate the Efficacy and Safety of Lomustine Combined With Anlotinib in Patients With Extensive-stage Small Cell Lung Cancer Resistant to Second-line and Further Lines of Treatment","Aurora003","Inclusion Criteria:\n\n* 1: Aged 18-75 years, without gender restriction.\n\n  2: Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC), classified as extensive-stage disease according to the Veterans Administration Lung Study Group (VALSG) staging system.\n\n  3: Has received at least two lines of prior systemic antitumor therapy.\n\n  4: Has at least one measurable lesion as defined by RECIST 1.1 criteria.\n\n  5: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n\n  6: Adequate organ function meeting the following criteria: Hematological function: Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL; platelet count (PLT) ≥ 100×10⁹\u002FL; hemoglobin (Hb) ≥ 90 g\u002FL. Hepatic and renal function: Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5×ULN (≤ 5×ULN for patients with liver metastases); serum creatinine (Cr) ≤ 1.5×ULN; estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73m². Coagulation function: International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (APTT) ≤ 1.5×ULN.\n\n  7: Expected survival time ≥ 3 months.\n\n  8: Voluntarily signs the informed consent form and is willing and able to comply with the study protocol and follow-up requirements.\n\nExclusion Criteria:\n\n* 1: Previous treatment with lomustine, anlotinib, or other similar anti-angiogenic TKIs.\n\n  2: Uncontrolled central nervous system (CNS) metastases (e.g., unstable or symptomatic brain metastases, or those requiring ongoing glucocorticoid therapy).\n\n  3: Active bleeding or high bleeding risk (e.g., history of massive gastrointestinal hemorrhage or cerebral hemorrhage within the past 6 months, or presence of unhealed wounds or ulcers).\n\n  4: Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg) or severe cardiovascular diseases (e.g., myocardial infarction, severe arrhythmia, heart failure within the past 6 months).\n\n  5: Active infection (such as pneumonia, sepsis) or uncontrolled systemic diseases (such as uncontrolled diabetes, autoimmune diseases).\n\n  6: Pregnant or lactating females. Female participants must use effective contraception during treatment and for 6 months after the last dose of study treatment; male participants must use effective contraception during treatment and for 3 months after the last dose of study treatment.\n\n  7: History of other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and other cured malignancies.\n\n  8: Known hypersensitivity to lomustine, anlotinib, or any excipient in their formulations.\n\n  9: Any other condition deemed inappropriate for participation in this study by the investigator (e.g., mental disorders, inability to comply with follow-up procedures).",{"count":115,"type":20},46,[23],"This single-arm phase II study aims to evaluate the efficacy and safety of lomustine combined with anlotinib in patients with extensive-stage small cell lung cancer resistant to second-line and above systemic treatment.",[26],"2026-06-02",{"date":121,"type":33},"2026-06-08",{"date":123,"type":20},"2026-06",{"date":125,"type":20},"2028-12",{"name":127,"class":70},"Yayi He",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":152,"leadSponsor":154,"locationsCount":4},"100634329","phase-2-a-study-of-benmelstobart-anlotinib-chemotherapy-and-thoracic-radiotherapy-for-people-with-extensive-stage-small-cell-lung-cancer-100634329","NCT07538271","A Study of Benmelstobart, Anlotinib, Chemotherapy and Thoracic Radiotherapy for People With Extensive-stage Small Cell Lung Cancer","A Single-arm, Exploratory Clinical Study of Benmelstobart Combined With Anlotinib and Chemotherapy Followed by Thoracic Radiotherapy as First-line Treatment for Extensive-stage Small Cell Lung Cancer (ES-SCLC)","Aurora 005","Inclusion Criteria:\n\n* 1: Histologically or cytologically confirmed inoperable extensive-stage small cell lung cancer (ES-SCLC) according to the VALG staging system\n\n  2: No prior systemic therapy for extensive-stage small cell lung cancer (ES-SCLC)\n\n  3: Presence of measurable lesions as defined by the RECIST 1.1 criteria. A previously irradiated lesion can be considered measurable only if there is clear progression after radiotherapy and it is not the sole lesion\n\n  4: Aged 18 to 75 years\n\n  5: ECOG performance status score of 0 to 1\n\n  6: Expected survival time ≥ 3 months\n\n  7: Number of tumor metastases ≤ 3. Brain metastases must be asymptomatic or treated and stable for at least 1 month prior to the initiation of study treatment, with no use of steroids or anticonvulsants during this period\n\n  8: Adequate hematological and organ function, meeting the following criteria: a) Hematology (no blood transfusion or blood products within 14 days; no correction with G-CSF or other hematopoietic stimulants): i. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL (1,500\u002Fmm³); ii. Platelet Count (PLT) ≥ 100 × 10⁹\u002FL (100,000\u002Fmm³); iii. Hemoglobin (HB) ≥ 80 g\u002FL. b) Renal function: i. Calculated Creatinine Clearance Rate (CrCl) ≥ 50 mL\u002Fmin; ii. Urine protein \\\u003C 2+ or 24-hour urinary protein quantitation \\\u003C 1.0 g. c) Hepatic function: i. Serum Total Bilirubin (TBil) ≤ 1.5 × ULN (for patients with liver metastases, TBil ≤ 3 × ULN); ii. AST and ALT ≤ 2.5 × ULN (for patients with liver metastases, ≤ 5 × ULN); iii. Serum Albumin (ALB) ≥ 28 g\u002FL. d) Coagulation function: i. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN. e) Cardiac function: i. Left Ventricular Ejection Fraction (LVEF) ≥ 50%. f) Other: i. Lipase ≤ 1.5 × ULN; patients with lipase \\> 1.5 × ULN may be enrolled if there is no clinical or radiological evidence of pancreatitis; ii. Amylase ≤ 1.5 × ULN; patients with amylase \\> 1.5 × ULN may be enrolled if there is no clinical or radiological evidence of pancreatitis; iii. Alkaline Phosphatase (ALP) ≤ 2.5 × ULN (for patients with bone metastases, ALP ≤ 5 × ULN\n\n  9: The subject voluntarily agrees to participate in the study, signs the informed consent form, has good compliance, and is willing to cooperate with follow-up\n\nExclusion Criteria:\n\n* 1: Patients with symptomatic brain metastases. Patients whose brain metastases have been treated and remain clinically stable for at least 1 month, with no use of steroids or anticonvulsants for at least 1 month prior to study enrollment, are eligible\n\n  2: Prior use of anti-angiogenic agents such as anlotinib, apatinib, bevacizumab, or immune checkpoint inhibitors targeting PD-1, PD-L1, etc\n\n  3: Patients with conditions that affect oral drug administration (e.g., dysphagia, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.)\n\n  4: Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage\n\n  5: Patients with radiological evidence of tumor invasion around major blood vessels, or those judged by the investigator to be at high risk of fatal massive hemorrhage due to potential tumor invasion of major blood vessels during the study\n\n  6: History of severe bleeding tendency or coagulation disorders, including but not limited to: clinically significant hemoptysis (≥ 1 tablespoon per day) within 3 months prior to enrollment; or clinically significant bleeding symptoms or tendency within 4 weeks prior to group assignment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer (including gastrointestinal perforation and\u002For fistula; patients with gastrointestinal perforation or fistula that has been surgically resected are eligible), unhealed wounds, ulcers, or fractures, etc\n\n  7: Receipt of major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to group assignment\n\n  8: History of arterial\u002Fvenous thrombotic events (e.g., cerebrovascular accident including transient ischemic attack, deep vein thrombosis, pulmonary embolism) within 6 months prior to group assignment\n\n  9: Active autoimmune disease requiring systemic treatment (e.g., disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose of study drug\n\n  10: Other conditions that increase the risk associated with study participation or study drugs and, in the investigator's judgment, render the patient unsuitable for enrollment",{"count":137,"type":20},33,[23],"This is a single-center, single-arm, exploratory clinical study conducted at Shanghai Pulmonary Hospital, Tongji University. It aims to evaluate the efficacy and safety of first-line treatment with benmelstobart plus anlotinib and chemotherapy (carboplatin\u002Fcisplatin plus etoposide), followed by sequential thoracic radiotherapy, in patients with previously untreated extensive-stage small cell lung cancer (ES-SCLC).\n\nEligible participants will be adults aged 18-75 years with histologically or cytologically confirmed ES-SCLC, measurable lesions per RECIST 1.1, ECOG performance status 0-1, and adequate organ function. Patients will receive 4 cycles of induction therapy (benmelstobart, anlotinib, platinum-etoposide chemotherapy). Those without disease progression will receive consolidative thoracic radiotherapy, followed by maintenance therapy with benmelstobart plus anlotinib until disease progression or unacceptable toxicity.\n\nThe primary endpoint is objective response rate (ORR) assessed by investigators. Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety parameters including adverse events graded by CTCAE 5.0. A total of 33 subjects will be enrolled. This study uses a non-randomized, open-label design without a control group.",[26],[86,142,143,144,145,146,147],"Extensive-Stage","Benmelstobart","Anlotinib","Chemotherapy","Thoracic Radiotherapy","First-Line","2026-04-12",{"date":150,"type":33},"2026-04-20",{"date":150,"type":20},{"date":153,"type":20},"2029-03-31",{"name":127,"class":70},{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":165,"briefSummary":166,"conditions":167,"keywords":170,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":71},"100629864","phase-1-adaptive-phase-12-study-of-dual-target-car-nk-cells-in-relapsedrefractory-small-cell-lung-cancer-sclc-100629864","NCT07480213","Adaptive Phase 1\u002F2 Study of Dual-Target CAR-NK Cells in Relapsed\u002FRefractory Small Cell Lung Cancer (SCLC)","A Phase 1\u002F2 Adaptive Dose-Escalation and Expansion Study of Dual-Targeting Chimeric Antigen Receptor Natural Killer (CAR-NK) Cells Directed Against DLL3, CD56 (NCAM1), and\u002For GD2 in Adults With Relapsed\u002FRefractory Small Cell Lung Cancer","DART-NK-SCLC","Inclusion Criteria:\n\n* Age 18 to 75 years at the time of consent.\n* Histologically or cytologically confirmed small cell lung cancer (SCLC) that is metastatic, extensive-stage, or unresectable, and relapsed or refractory after at least 1 prior systemic regimen (must include a platinum-based regimen unless contraindicated).\n* At least one measurable lesion per RECIST v1.1.\n* ECOG performance status 0 to 1.\n* Adequate organ function (hematologic, renal, hepatic, and cardiac) as defined in the protocol (examples: ANC \\>= 1.0 x10\\^9\u002FL, platelets \\>= 75 x10\\^9\u002FL, creatinine clearance \\>= 50 mL\u002Fmin, AST\u002FALT \\\u003C= 3 x ULN, total bilirubin \\\u003C= 1.5 x ULN).\n* Life expectancy \\>= 12 weeks.\n* Tumor tissue available (archival or fresh) for antigen profiling (DLL3, CD56\u002FNCAM1, GD2).\n* Negative pregnancy test for persons of childbearing potential; agreement to use effective contraception for the protocol-defined duration.\n\nExclusion Criteria:\n\n* Active or uncontrolled CNS metastases or leptomeningeal disease (treated\u002Fstable CNS metastases may be allowed per protocol).\n* Prior treatment with CAR-T, CAR-NK, or other gene-modified cellular therapy within 6 months (or any prior therapy directed against the investigational target antigens if it would confound safety\u002Fefficacy assessment).\n* Allogeneic hematopoietic stem cell transplant within 6 months or active graft-versus-host disease.\n* Active uncontrolled infection, including uncontrolled HIV, active hepatitis B or C with viremia, or active tuberculosis.\n* Clinically significant cardiovascular disease (e.g., recent myocardial infarction within 6 months, uncontrolled arrhythmia, LVEF \\\u003C 45%).\n* Active autoimmune disease requiring systemic immunosuppression; chronic systemic corticosteroid use \\> 10 mg\u002Fday prednisone equivalent (unless for physiologic replacement).\n* Concurrent malignancy requiring active treatment (exceptions may apply for certain non-melanoma skin cancers or in situ cancers).\n* Pregnant or breastfeeding.\n* Any condition that, in the investigator's opinion, would make participation unsafe or interfere with compliance.",{"count":164,"type":20},60,[53,23],"This study is an open-label, multi-center, adaptive Phase 1\u002F2 trial evaluating the safety, feasibility, and preliminary antitumor activity of allogeneic dual-target CAR-NK cell products in adults with relapsed or refractory small cell lung cancer (SCLC). Three candidate dual-target constructs (DLL3\u002FCD56, DLL3\u002FGD2, and CD56\u002FGD2) will be assessed during dose escalation; a pre-specified interim assessment will select the most suitable construct to proceed into an expansion cohort at the recommended Phase 2 dose (RP2D).",[168,169,26],"Small Cell Lung Cancer (SCLC)","Relapsed\u002FRefractory SCLC",[171,172,92,173,174,175,176,177,178,179],"CAR-NK","dual-target","CD56","NCAM1","GD2","adoptive cell therapy","mmunotherapy","solid tumor","small cell lung cance","2026-03-14",{"date":182,"type":33},"2026-03-18",{"date":184,"type":33},"2026-02-02",{"date":186,"type":20},"2028-04-17",{"name":188,"class":189},"Beijing Biotech","INDUSTRY",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":200,"briefSummary":201,"conditions":202,"keywords":203,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},"100601408","phase-2-golidocitinib-with-pd-1-inhibitors-as-maintenance-treatment-for-previously-untreated-es-sclc-100601408","NCT07110103","Golidocitinib With PD-1 Inhibitors as Maintenance Treatment for Previously Untreated ES-SCLC","Golidocitinib With PD-1 Inhibitors as Maintenance Treatment in Patients With Previously Untreated Extensive-stage Small Cell Lung Cancer: an Open-label, Single-arm, Phase 2 Study","JACKPOT38","Inclusion Criteria:\n\n1. Able to provide a signed and dated informed consent form, including compliance with the requirements and restrictions listed in the ICF and this protocol;\n2. Subjects are ≥ 18 years old when signing the ICF;\n3. Subjects have an ECOG performance status score of 0 or 1 and have not deteriorated in the past 2 weeks;\n4. Life expectancy ≥ 3 months;\n5. Histologically or cytologically confirmed ES-SCLC (stage IV \\[any T stage, any N stage, M1 a\u002Fb\u002Fc stage\\] according to the 8th edition of the AJCC TNM staging system for lung cancer, or T3-4 stage disease caused by multiple lung nodules and the disease is too diffuse, or the tumor\u002Fnodule volume is too large to be tolerated by a tolerable radiotherapy plan);\n6. The presence of at least one measurable lesion (based on RECIST 1.1): with a long diameter ≥ 10 mm (lymph node lesions require a short diameter of ≥15 mm) that can be accurately and repeatedly measured at baseline under CT or MRI; and there are measurable lesions outside the central nervous system;\n7. SCLC patients who have not received any systemic anti-tumor treatment for advanced disease; if the patient has received neoadjuvant\u002Fadjuvant therapy in the past, the interval between the diagnosis of ES-SCLC and the completion of the last treatment must be at least 6 months;\n8. Patients must be suitable for platinum (cisplatin or carboplatin)-based chemotherapy as the first-line treatment for ES-SCLC;\n9. Adequate bone marrow reserve and organ system function reserve, summarized as follows:\n\n   * Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL without growth factor support;\n   * Platelet ≥ 100×109\u002FL without growth factor support or blood transfusion;\n   * Hemoglobin ≥ 9 g\u002FdL or 90 g\u002FL without erythropoietin or blood transfusion;\n   * Total bilirubin ≤ 1.5 × ULN; if suffering from Gilbert syndrome (unconjugated hyperbilirubinemia), total bilirubin should be ≤ 3 × ULN;\n   * ALT and AST ≤ 2.5 × ULN. For patients with documented liver metastases, AST and ALT levels ≤ 5 × ULN;\n   * Creatinine clearance calculated by the Cockcroft-Gault method, \\>60 ml\u002Fmin for patients receiving cisplatin and \\>45 ml\u002Fmin for patients receiving carboplatin;\n   * Urine routine examination shows less than 2+ protein in urine, or 24-hour urine protein quantitative \\\u003C1 g;\n   * Good coagulation function, defined as international normalized ratio (INR) and\u002For prothrombin time (PT) ≤1.5 times ULN and\u002For activated partial thromboplastin time (APTT) ≤1.5 upper limit of normal; if the subject is receiving anticoagulant therapy, as long as the PT is within the intended use range of the anticoagulant drug;\n   * Serum amylase ≤1.5 times ULN and\u002For serum lipase ≤1.5 times ULN;\n   * Left ventricular ejection fraction (LVEF) ≥ 55%;\n10. For patients with central nervous system metastases, the following conditions must be met before they can be included:\n\n    * No neurological symptoms or symptoms are stable for at least 2 weeks after local treatment, no need to use corticosteroids or anti-epileptic drugs, and hormonal treatment has been stopped within 3 days before the first dose of study drug;\n    * If brain metastases have been treated locally (radiotherapy or surgery), there should be a time window of ≥ 2 weeks before the first dose of study treatment to ensure that local treatment-related adverse events have been reduced to CTCAE ≤ 1 grade;\n11. Women of childbearing potential must undergo a urine and\u002For serum pregnancy test (if the urine test cannot be confirmed as negative) within 7 days before the first medication, and the result must be negative; WOCBP or men and their WOCBP partners should agree to take effective contraceptive measures from the signing of the ICF until 6 months after the last dose of the study drug;\n12. The subjects should be able to understand the study protocol and voluntarily comply with the study and follow-up;\n13. For patients who are about to enter the maintenance period, the investigator shall determine whether they are suitable for starting treatment with golidocitinib combined with PD-1 inhibitors (generally all previous toxicities must be alleviated to CTCAE ≤ 1 level, excluding hair loss, fatigue or other conditions that are judged by the investigator to be clinically insignificant).\n\nExclusion Criteria:\n\n1. Histopathological confirmation of the presence of mixed NSCLC and SCLC components;\n2. The presence of spinal cord compression or meningeal metastasis;\n3. Any of the following medical histories:\n\n   * Systemic treatment with Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs (including thymosin, interferon, interleukin, excluding local use for the control of pleural effusion) within 2 weeks before the first dose;\n   * Currently participating in interventional clinical research treatment, or receiving other research drugs or using research devices within 4 weeks before the first dose; any drug still in the development stage needs to be washed out for 5 half-lives (or discussed with the research team);\n   * Other major surgeries other than diagnosis or biopsy (excluding vascular access) within 4 weeks before the first dose, or major surgery is expected during the study;\n   * Palliative radiotherapy within 2 weeks before the first dose;\n   * Serious arterial\u002Fvenous thrombotic events, including cerebrovascular accident (e.g., history of stroke or intracranial hemorrhage), deep vein thrombosis, and pulmonary embolism, occurred within 6 months before the first dose;\n   * Currently receiving (or unable to stop taking at least 1 week before the first dose) drugs, herbal supplements, and foods that are known to be strong inducers or inhibitors of CYP3A;\n   * Prior to the first dose, there was a CTCAE caused by previous treatment \\> Grade 1 adverse events (except alopecia of any degree);\n4. Receiving solid organ or blood system transplantation (such as previous allogeneic bone marrow transplantation or whole blood transfusion within 120 days of sample collection during the study);\n5. Previous interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid hormone treatment, or current clinically active interstitial lung disease (including interstitial lung changes), immune pneumonitis caused by immunotherapy;\n6. Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids or immunosuppressants) within 2 years before the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment;\n7. Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of the study. Physiological doses of glucocorticoids (≤10 mg\u002Fday of prednisone or equivalent) are allowed;\n8. Diagnosed with other malignancies within 5 years before the first dose, excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ that has been evaluated to be clinically cured;\n9. Vaccinated with live vaccines within 30 days before the first dose (cycle 1, day 1), including live attenuated vaccines, excluding inactivated vaccines;\n10. Known active tuberculosis, such as positive tuberculin (PPD) test (nodule diameter \\> 10 mm), positive T-SPOT test, chest X-ray\u002FCT Tuberculosis lesions are found, or other positive results are found based on routine clinical screening (except for those who have been cured after standardized anti-tuberculosis treatment as assessed by the researchers);\n11. Subjects currently have severe infectious diseases that are difficult to control and must be excluded. After the recent infectious diseases are under control, the research team must determine whether they can be included in the group;\n12. Subjects with active infections, including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) and COVID-19 active infections (determined by the researchers to be clinically significant, with signs or symptoms, etc.). Testing for COVID-19 will be based on local practice;\n13. Meet any of the following cardiac criteria:\n\n    * Congestive heart failure (CHF) classified as class II by the New York Heart Association (NYHA);\n    * Clinically significant valvular heart disease, hypertrophic or constrictive cardiomyopathy;\n    * Any clinically significant abnormalities on resting ECG, such as complete left bundle branch block, 2\u002F3 degree atrioventricular block, PR interval \\> 250 msec;\n    * Average calibrated QTcF \\> 470 msec of 3 resting ECGs during the screening period;\n    * Subjects with any factors that may cause QT prolongation or increased risk of arrhythmic events (e.g., heart failure, hypokalemia, congenital long QT syndrome or a first-degree relative with long QT syndrome or a family history of unexplained sudden death under the age of 40, or any concomitant medication known to cause QT prolongation);\n    * Ventricular arrhythmias requiring treatment;\n    * Acute myocardial infarction (AMI), unstable angina or new angina within 6 months before the administration of this study;\n14. Allergy to the drugs used in the study or their ingredients;\n15. Intractable nausea and vomiting, chronic gastrointestinal diseases, difficulty swallowing drugs, intestinal obstruction or previous intestinal resection, which may lead to inability to fully absorb the study drugs;\n16. Pregnant or lactating women;\n17. Known bleeding diathesis, that is, hemophilia, von Willebrand disease;\n18. The investigators assess that there are severe or uncontrollable systemic diseases (including poorly controlled hypertension and bleeding diseases) that cannot be carried out in clinical studies or may lead to poor compliance with clinical studies.",{"count":199,"type":20},20,[23],"This is an open-label, single-arm, phase 2 study to evaluate the safety and efficacy of golidocitinib with PD-1 inhibitors as maintenance treatment in patients with previously untreated extensive-stage small cell lung cancer.",[84,26],[204,205],"golidocitinib","ES-SCLC","2026-02-25",{"date":208,"type":33},"2026-02-27",{"date":210,"type":33},"2025-10-31",{"date":212,"type":20},"2028-06-30",{"name":69,"class":70},2,{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":21,"phases":224,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":233,"locationsCount":71},"100624700","phase-1-a-phase-i-study-to-evaluate-the-safety-and-preliminary-efficacy-of-225acac-dotatate-injection-combined-with-tislelizumab-in-the-maintenance-treatment-period-for-patients-of-extensive-stage-small-cell-lung-cancer-es-sclc-with-somatostatin-receptors-sstr-as-first-line-treatment-100624700","NCT07413042","A Phase I Study to Evaluate the Safety and Preliminary Efficacy of [225Ac]Ac-DOTATATE Injection Combined With Tislelizumab in the Maintenance Treatment Period for Patients of Extensive-stage Small Cell Lung Cancer (ES-SCLC) With Somatostatin Receptors (SSTR)+ as First-line Treatment","Inclusion Criteria:\n\n1. Patients must have the ability to understand and sign an approved informed consent form (ICF).\n2. Patients must be \\>= 18 and \\\u003C＝80 years of age.\n3. Extensive-stage small cell lung cancer that requires histopathological or cytological confirmation.\n4. Presence of at least 1 measurable site of disease (based on RECIST 1.1).\n5. ECOG score of 0 or 1.\n6. SSTR-PET positive.\n7. Sufficient bone marrow capacity and organ function:\n\n   Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 ml\u002Fmin (Cockcroft Gault formula).\n\n   Hemoglobin≥90g\u002FL, neutrophil count ≥1.5×10\\^9\u002FL, platelets≥100×10\\^9\u002FL. Serum total bilirubin ≤1.5×ULN. Serum albumin ≥30g\u002FL. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN，or ALT\u002FAST≤5×ULN with liver metastases.\n\n   Partially activated prothrombin time (APTT) ≤1.5 x ULN.\n8. Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, IUDs, etc., during treatment and within 6 months of the last use of the trial drug.\n\nExclusion Criteria:\n\n1. Pregnant or lactating females.\n2. Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to initiation of study treatment.\n3. Uncontrolled congestive heart failure.\n4. uncontrolled diabetes mellitus, including baseline fasting glucose \\> 2 x ULN.\n5. Known hypersensitivity to Lutetium\\[177Lu\\] Oxodotreotide Injection or \\[225Ac\\]Ac-DOTATATE Injection and their excipients.\n6. Other treatment options (e.g., chemotherapy, targeted therapy) that, in the opinion of the investigator, are more appropriate for the patient than the treatment provided in the study based on the patient's disease characteristics.\n7. Unsuitable for the study for any reason, in the opinion of the investigator.","80 Years",{"count":223,"type":20},24,[53],"This is a phase I study to evaluate the safety and preliminary efficacy of \\[225Ac\\]Ac-DOTATATE injection combined with tislelizumab in the maintenance treatment period for patients of extensive-stage small cell lung cancer (ES-SCLC) with somatostatin receptors (SSTR)+ as first-line treatment.Patients with ES-SCLC who have completed the induction therapy of first-line standard treatment and are yet to enter the maintenance treatment period are planned to be enrolled.",[26],"2026-02-09",{"date":229,"type":33},"2026-02-17",{"date":231,"type":33},"2026-01-20",{"date":212,"type":20},{"name":234,"class":70},"Peking University Cancer Hospital & Institute",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":245,"phases":4,"briefSummary":246,"conditions":247,"keywords":249,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":257,"locationsCount":4},"100623741","anlotinib-in-cross-line-treatment-of-nsclc-and-sclc-100623741","NCT07400575","Anlotinib in Cross-line Treatment of NSCLC and SCLC","Multicenter, Retrospective, Real World Study of Anlotinib in Cross-line Treatment of NSCLC and SCLC","NSCLC SCLC","Inclusion Criteria:\n\nFrom October 1, 2018 to April 30, 2025, patients meeting all the following criteria will be included in this study:\n\n* Patients must be diagnosed with advanced metastatic non-small cell lung cancer (including squamous cell carcinoma, adenocarcinoma, etc.) or extensive-stage small cell lung cancer during the period from October 1, 2018 to April 30, 2025.\n* Patients clinically documented as having driver gene-negative advanced metastatic non-small cell lung cancer or extensive-stage small cell lung cancer, who were treated with anlotinib during the treatment period and continued using anlotinib after disease progression (with at least 4 months of continuous medication records in the medical records), or other immune or chemotherapy drugs.\n* Patients who underwent at least one imaging examination within 90 days before reapplication of anlotinib or other immune or chemotherapy drugs after progression during anlotinib treatment, and subsequently had at least two imaging examinations.\n\nExclusion Criteria:\n\nFrom October 1, 2018 to April 30, 2025, patients meeting any of the following criteria will be excluded from this study:\n\n* Patients who received other TKI-class anti-angiogenic drugs (including but not limited to bevacizumab, recombinant human endostatin, pazopanib, regorafenib, cabozantinib, sunitinib, sorafenib, apatinib, axitinib, lenvatinib, fruquintinib, vandetanib, cediranib, nintedanib, pralsetinib, selpercatinib, alectinib, ponatinib) before the first application of anlotinib treatment.\n* Patients who received other anti-angiogenic drugs (including but not limited to bevacizumab, recombinant human endostatin, pazopanib, regorafenib, cabozantinib, sunitinib, sorafenib, apatinib, axitinib, lenvatinib, fruquintinib, vandetanib, cediranib, nintedanib, pralsetinib, selpercatinib, alectinib, ponatinib) after progression.\n* Patients who underwent surgical treatment during anlotinib therapy. - Patients with driver gene positivity.\n* Patients with concurrent other malignant tumors. - Pathological subtypes: advanced metastatic non-small cell lung cancer, including but not limited to large cell carcinoma, adenosquamous carcinoma, carcinoid, pulmonary sarcomatoid carcinoma; extensive-stage small cell lung cancer, including but not limited to oat cell type, mixed type, etc.",{"count":244,"type":20},350,"OBSERVATIONAL","Previous studies on bevacizumab in colorectal and ovarian cancers have demonstrated that continued anti-angiogenic therapy after disease progression can still provide clinical benefits. As a typical multi-targeted anti-angiogenic tyrosine kinase inhibitor, anlotinib hydrochloride has been approved in China for second-line or later treatment of advanced soft tissue sarcoma, where it has also shown significant potential. Retrospective studies have indicated the effectiveness of anlotinib in cross-line treatment for sarcoma. However, there is a lack of multi-center real-world studies evaluating the clinical efficacy of anlotinib in cross-line treatment for driver gene-negative advanced metastatic non-small cell lung cancer and extensive-stage small cell lung cancer.\n\nThis study aims to evaluate, through a retrospective multi-center study, the efficacy and safety of anlotinib monotherapy or combination regimens in the later-line treatment of driver gene-negative advanced metastatic non-small cell lung cancer and extensive-stage small cell lung cancer after anlotinib treatment failure, providing clinical evidence for cross-line therapy.",[248,26],"NSCLC (Advanced Non-small Cell Lung Cancer)",[144,250,205],"mNSCLC","2026-02-03",{"date":253,"type":33},"2026-02-10",{"date":255,"type":20},"2026-02-01",{"date":103,"type":20},{"name":39,"class":40},{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":265,"targetDuration":4,"studyType":21,"phases":267,"briefSummary":268,"conditions":269,"keywords":270,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":279,"leadSponsor":281,"locationsCount":71},"100620519","phase-2-a-study-of-bemotuzumab-plus-chemotherapy-and-anlotinib-induction-followed-by-bemotuzumab-anlotinib-and-consolidative-thoracic-radiotherapy-in-extensive-stage-small-cell-lung-cancer-100620519","NCT07358676","A Study of Bemotuzumab Plus Chemotherapy and Anlotinib Induction Followed by Bemotuzumab, Anlotinib and Consolidative Thoracic Radiotherapy in Extensive-Stage Small Cell Lung Cancer","An Exploratory Phase II Study of Bemotuzumab Combined With Chemotherapy and Anlotinib as Induction Therapy, Followed by Bemotuzumab, Anlotinib, and Consolidative Thoracic Radiotherapy in Patients With Extensive-Stage Small Cell Lung Cancer","\\*\\*Inclusion Criteria:\\*\\*\n\n1. Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) per VALG staging.\n2. No prior systemic therapy for ES-SCLC.\n3. At least one measurable lesion as defined by RECIST 1.1 criteria.\n4. Age 18-75 years.\n5. ECOG performance status of 0-2.\n6. Life expectancy of ≥3 months.\n7. Adequate hematologic and organ function:\n\n   * Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL.\n   * Platelet count ≥ 100 × 10\\^9\u002FL.\n   * Hemoglobin ≥ 80 g\u002FL.\n   * Creatinine clearance ≥ 50 mL\u002Fmin.\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN).\n   * AST and ALT ≤ 2.5 × ULN.\n   * Albumin ≥ 28 g\u002FL.\n   * INR and APTT ≤ 1.5 × ULN.\n   * Left ventricular ejection fraction (LVEF) ≥ 50%.\n8. For females of childbearing potential: negative serum pregnancy test within 3 days prior to dosing and agreement to use highly effective contraception.\n9. For males: agreement to use barrier contraception.\n10. Willing and able to provide written informed consent and comply with study procedures.\n\n\\*\\*Exclusion Criteria:\\*\\*\n\n1. Symptomatic brain metastases. (Asymptomatic, treated, and stable brain metastases for ≥1 month without steroids are allowed).\n2. Prior thoracic radiotherapy for SCLC.\n3. Prior treatment with anti-angiogenic agents (e.g., anlotinib, bevacizumab) or anti-PD-1\u002FPD-L1 therapies.\n4. Factors affecting oral medication intake (e.g., inability to swallow, major gastrointestinal resection).\n5. Uncontrolled effusions requiring repeated drainage (pleural, pericardial, or ascites).\n6. Imaging evidence of tumor invasion of major blood vessels or high risk of fatal hemorrhage as judged by the investigator.\n7. History of significant bleeding tendency or coagulopathy, including clinically significant hemoptysis (\\>1 tablespoon daily within 3 months) or significant bleeding within 4 weeks prior to enrollment.\n8. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment.\n9. Arterial\u002Fvenous thrombotic events within 6 months prior to enrollment (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism).\n10. Active autoimmune disease requiring systemic treatment within 2 years prior to first dose.\n11. Any other condition that, in the investigator's judgment, increases risk or renders the patient unsuitable for the study.",{"count":266,"type":20},25,[23],"This is a phase II study evaluating a new combination therapy for untreated extensive-stage small cell lung cancer. The treatment involves an initial phase with the drug Bemotuzumab plus standard chemotherapy and anlotinib, followed by a phase combining Bemotuzumab, anlotinib, and chest radiation. The primary objectives are to assess the efficacy of this approach in delaying cancer growth (progression-free survival) and to evaluate its safety in approximately 25 patients.",[168,26],[168,271,272,273,274],"bemotuzumab","anlotinib","hypofractionated radiotherapy","Induction therapy","2026-01-14",{"date":277,"type":33},"2026-01-22",{"date":255,"type":20},{"date":280,"type":20},"2028-01-01",{"name":282,"class":70},"Tianjin Medical University Cancer Institute and Hospital",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":291,"targetDuration":4,"studyType":21,"phases":293,"briefSummary":294,"conditions":295,"keywords":297,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":305,"locationsCount":307},"100617665","phase-2-a-study-evaluating-the-efficacy-and-safety-of-abp1011t-tablets-in-patients-with-advanced-solid-tumors-100617665","NCT07321574","A Study Evaluating the Efficacy and Safety of ABP1011T Tablets in Patients With Advanced Solid Tumors","An Open-Label, Multi-Cohort Phase IIb Clinical Study Evaluating the Efficacy and Safety of ABP1011T Tablets in Patients With Advanced Solid Tumors","ABP1011T-03","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with protocol requirements;\n2. Age 18 \\\u003C= age \\\u003C= 75 years, male or female;\n3. Expected survival \\>= 12 weeks;\n4. ECOG performance status \\\u003C= 1 point;\n5. Patients with advanced solid tumors who have experienced disease progression on standard therapy, intolerance to standard therapy, or lack of effective standard therapy, with histopathological or cytopathological confirmation (priority enrollment for small cell lung cancer, esophageal cancer, cervical cancer, bladder cancer, renal cell carcinoma, or other potentially sensitive tumor types. Cohort A is the small cell lung cancer cohort: includes patients who have failed at least two prior systemic therapies; Cohort B includes patients with other advanced solid tumors); At least one measurable lesion meeting RECIST v1.1 criteria;\n6. Recovery from toxic effects of the last prior treatment (CTCAE \\\u003C= Grade 1, except for specific conditions such as \"alopecia\" or \"hyperpigmentation\"), and the investigator determines that the corresponding AE poses no safety risk;\n7. Systolic blood pressure \\\u003C= 140 mmHg, diastolic blood pressure \\\u003C= 90 mmHg, with no changes in antihypertensive medications or dosages within 7 days prior to the first dose.\n8. Organ and bone marrow function levels must meet the following requirements: Bone marrow: Absolute neutrophil count (ANC) \\>= 1.5 × 10\\^9\u002FL, platelet count \\>= 75 × 10\\^9\u002FL, Hemoglobin \\>=90 g\u002FL, with no transfusion of platelets or red blood cells within 14 days prior to the first dose, and no transfusion or treatment with biological response modifiers (e.g., granulocyte colony-stimulating factor, erythropoietin, interleukin-11) within 14 days prior to the first dose; Liver function: No history of liver cirrhosis (decompensated cirrhosis Child-Pugh B or C). For patients without liver metastases: serum total bilirubin (TBIL) \\\u003C= 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C= 2.5 × ULN. Patients with liver metastases must have TBIL \\\u003C= 2.5×ULN, ALT and AST \\\u003C= 5×ULN. Renal function: Serum creatinine \\\u003C= 1.5×ULN, or creatinine clearance \\> 60 mL\u002Fmin (Cockcroft-Gault formula); Urine protein qualitative \\\u003C= 1+; If urine protein qualitative \\>= 2+, 24-hour urine protein quantification is required. The investigator will determine eligibility based on test results. Coagulation function: Prothrombin time (PT) \\\u003C= 1.5 × ULN; International Normalized Ratio (INR) \\\u003C= 1.5 × ULN, and activated partial thromboplastin time (APTT) \\\u003C= 1.5 × ULN.\n9. Female subjects of childbearing potential must undergo a serum pregnancy test within 3 days prior to initiating study medication, with negative results, and must agree to use a medically approved highly effective contraceptive method (e.g., intrauterine device, oral contraceptive, or condom) during the study period and for 6 months after the last study dose. Male subjects with female partners of childbearing potential must agree to use effective contraception during the study period and for 6 months after the last study dose.\n\nExclusion Criteria:\n\n1\\. History of or current presence of other malignant tumors, except for the following:\n\n1\\) Completely resected basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical carcinoma in situ; 2) Completely resected secondary primary cancer with no recurrence within five years; 2. Patients with known hypersensitivity to any component of the study drug or similar agents, or with a history of severe allergic reactions; 3. Patients who have received any of the following treatments or medications prior to the first study treatment: 1) Major surgery or severe trauma within 4 weeks before the first study drug administration (Major surgery is defined as any invasive procedure involving extensive excision or breaching of the mesothelial barrier, such as the pleural cavity, peritoneum, or meninges. However, diagnostic tissue biopsies are permitted). Severe trauma refers to unhealed wounds, ulcers, or fractures; 2) Received Chinese herbal medicine or traditional Chinese medicine for antitumor indications within 2 weeks prior to the first study drug dose.\n\n3\\) Received antitumor therapy (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, biologic therapy, or tumor embolization) within 4 weeks prior to the first study drug dose; For oral fluoropyrimidine drugs and endocrine therapy, discontinuation \\\u003C= 2 weeks or 5 half-lives; for nitrosoureas and mitomycin, discontinuation \\\u003C= 6 weeks. If washout time is inadequate due to scheduling or drug PK characteristics, discussion with the sponsor is required; 4) Wthin 1 week prior to first dose, received potent CYP3A4 or CYP2C9 inhibitors or inducers; 5) Within 1 week prior to first dose, received drugs known to significantly prolong the QT interval (e.g., Class Ia and Class III antiarrhythmics); 6) Concurrent use of antiplatelet agents or anticoagulants during the screening period that cannot be discontinued; 4. Patients with known brain metastases, brainstem metastases, spinal cord metastases, and\u002For compression, or unstable central nervous system metastases. (However, the following situations may be determined through discussion between the investigator and sponsor: If asymptomatic, or with stable brain metastasis symptoms, and if steroids, anticonvulsants, or mannitol therapy has not been used or has been discontinued for \\>=4 weeks prior to the first study dose, and the investigator determines the benefits outweigh the risks, the subject may be considered for screening and enrollment); 5. Patients with symptomatic, disseminated visceral disease at an advanced stage who are at risk of life-threatening complications in the short term, or patients with pleural effusion, ascites, or pericardial effusion who underwent paracentesis or thoracentesis within three weeks prior to the first study dose; 6. Patients with imaging evidence of tumor encasement or infiltration of major vessels (e.g., pulmonary artery, pulmonary vein, superior vena cava, inferior vena cava), or significant tumor invasion into adjacent organs (aorta, trachea, gastrointestinal tract) adjacent to esophageal or gastrointestinal lesions, resulting in high risk of hemorrhage or fistula formation; and patients who have undergone tracheal stent placement.\n\n7\\. Within 6 months prior to screening, presence of cardiovascular disease meeting any of the following criteria: 1) Congestive heart failure with cardiac function \\>= New York Heart Association (NYHA) Class II; left ventricular ejection fraction (LVEF) \\\u003C 50%; 2) Severe arrhythmia requiring medication; 3) QTcF (Fridericia formula) \\> 450 msec in males or \\> 470 msec in females, or presence of risk factors for torsades de pointes, such as clinically significant hypokalemia as determined by the investigator, history of familial long QT syndrome, or familial arrhythmia history (e.g., Wolff-Parkinson-White syndrome); and abnormal troponin levels; 4) Myocardial infarction, severe\u002Funstable angina, cardiac revascularization, cerebrovascular accident, or similar events within six months prior to dosing; 5) History of \\>= Grade 3 thromboembolic events within the past 2 years, or currently receiving thrombolytic or anticoagulant therapy due to high thrombotic risk; 8. Electrolite disturbances during screening; 9. Uncontrolled systemic diseases despite treatment, such as diabetes; 10. Current acute pulmonary disease, interstitial lung disease or pneumonia, pulmonary fibrosis, acute pulmonary disease, or treatable reflex interstitial pneumonia; 11. Patients with a clear tendency toward gastrointestinal bleeding, including the following conditions: presence of locally active ulcerative lesions with fecal occult blood test (\\>=2+); history of melena or hematemesis within the past 2 months; patients deemed by the investigator to be at risk for major gastrointestinal hemorrhage; 12. History of or current unhealed gastrointestinal perforation or visceral fistula; 13. Evidence of active infection:\n\n1. Hepatitis B (HBV) (requiring both positive hepatitis B surface antigen (HBsAg) and HBV-DNA levels exceeding the center's specified detection limit);\n2. Hepatitis C (requiring both HCV antibody \\[HCV-Ab\\] positivity and HCV-RNA levels exceeding the lower limit of detection for the analytical method);\n3. Active local or systemic infection requiring systemic antimicrobial therapy within 4 weeks prior to first dosing, or unexplained fever \\>38.5°C during screening\u002Fprior to first dosing;\n4. Active pulmonary tuberculosis infection identified through medical history or CT examination, or history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or history of active pulmonary tuberculosis infection more than 1 year prior without formal treatment; 14. Individuals with positive human immunodeficiency virus (HIV RNA) or Treponema pallidum antibody status; 15. Presence of multiple factors affecting oral medication administration (e.g., inability to swallow, chronic diarrhea, intestinal obstruction), or conditions judged by the investigator to severely impair gastrointestinal absorption; 16. History of confirmed neurological or psychiatric disorders, including epilepsy, dementia, depression, etc.; 17. Patients with alcohol or drug dependence, a history of needle phobia or blood phobia, or inability to tolerate venous blood collection; 18. Habitual consumption of grapefruit juice or excessive amounts of tea, coffee, and\u002For caffeinated beverages, with inability to discontinue during the trial period; 19. Received any investigational drug within 4 weeks prior to first dosing, or concurrent participation in another clinical study (except: participation in an observational, non-interventional clinical study; being in the follow-up period of an interventional clinical study; or completion of the previous study drug administration more than 5 half-lives ago); 20. Female patients who are pregnant or breastfeeding; 21. Patients deemed unsuitable for inclusion in this study by the investigator.",{"count":292,"type":20},110,[23],"This study is a multicenter, open-label, multi-cohort investigation exploring the efficacy and safety of ABP1011T tablets in participants with specific target solid tumors, providing a foundation for subsequent clinical research.\n\nBased on safety and efficacy data from the prior Phase I\u002FIIa clinical trial (Protocol Number: ABP1011T-I\u002FII-01), priority enrollment is given to participants with advanced solid tumors including small cell lung cancer, esophageal cancer, cervical cancer, bladder cancer, and renal cell carcinoma (excluding osteosarcoma). Cohort A (Cohort A1, Cohort A2, Cohort A3) comprises the small cell lung cancer cohort: Participants must have failed at least two prior systemic therapies. Cohort B enrolls participants with other advanced solid tumors (excluding osteosarcoma).\n\nABP1011T tablets are administered as continuous therapy in clinical studies, with a 21-day treatment cycle. Participants take one tablet orally once daily on an empty stomach (with water, avoiding food for at least 1 hour before and after each dose).",[26,296],"Advanced Solid Tumors",[298,296],"SLCL","2026-01-06",{"date":301,"type":33},"2026-01-07",{"date":303,"type":33},"2025-12-30",{"date":125,"type":20},{"name":306,"class":189},"Shanghai AB PharmaTech Ltd.",8,{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":245,"phases":4,"briefSummary":317,"conditions":318,"keywords":320,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":4},"100616651","real-world-study-of-toripalimab-in-extensive-stage-small-cell-lung-cancer-100616651","NCT07308379","Real-World Study of Toripalimab in Extensive-Stage Small Cell Lung Cancer","A Prospective, Observational, Multi-Center, Real-World Study of Toripalimab Injection in First-Line Treatment of Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Voluntarily participate and sign the informed consent form.\n* Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC);\n* Scheduled to receive Toripalimab as first-line treatment;\n* Availability of traceable medical history records during the treatment period.\n\nExclusion Criteria:\n\n* Pregnant or lactating women;\n* Known allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs or their components；\n* Any other condition deemed by the investigator as unsuitable for inclusion in the study.",{"count":316,"type":20},1200,"This is a prospective, observational, multi-center, real-world study evaluating the effectiveness and safety of Toripalimab (a PD-1 inhibitor) as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). The primary objective is to assess real-world progression-free survival (rwPFS). Secondary objectives include evaluating real-world objective response rate (rwORR), disease control rate (rwDCR), overall survival (rwOS), and safety. Approximately 1200 patients from multiple centers in China will be enrolled and followed according to routine clinical practice. Data will be collected from medical records and follow-up visits.",[26,319],"Toripalimab",[321,319,322],"Extensive stage SCLC","Real-World Study","2025-12-15",{"date":325,"type":33},"2025-12-29",{"date":327,"type":20},"2026-02",{"date":329,"type":20},"2028-08",{"name":331,"class":70},"Fudan University",{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":21,"phases":341,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":214},"100603420","phase-1-olvi-vec-combined-with-platinum-plus-etoposide-therapy-in-patients-with-late-phase-sclc-100603420","NCT07136285","Olvi-Vec Combined With Platinum Plus Etoposide Therapy in Patients With Late Phase SCLC","PIb\u002FII, Open-label, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of I.V. Olvi-Vec Combined With Platinum Plus Etoposide in Patients With Advanced SCLC Who Are Platinum-recurrent or Platinum-refractory","Inclusion Criteria:\n\n* Able to understand and voluntarily sign an informed consent form.\n* Age ≥ 18 years old, gender not limited.\n* Small cell lung cancer confirmed by organization or cytology.\n* After receiving platinum based chemotherapy regimens and\u002For immunotherapy, platinum based chemotherapy regimens and\u002For anlotinib, and other recommended treatments according to guidelines, disease progression or recurrence has occurred.\n* There should be at least one measurable target lesion during the baseline period, according to RECIST 1.1 (if a lesion that has received radiation therapy has obvious evidence of disease progression after radiation therapy, it can be used as a target lesion).\n* ECOG physical condition score 0 or 1.\n* Have sufficient bone marrow, liver and kidney organ function-\n\nExclusion Criteria:\n\n* Compound small cell lung cancer and transformed small cell lung cancer.\n* Patients with brain metastases and neurological symptoms; Note: Subjects with previous imaging evidence of brain metastases who have undergone local treatment (such as radiotherapy or surgery) for intracranial metastases and have stable lesions for more than 28 days without symptoms can be enrolled.\n* Other primary malignant tumors other than small cell lung cancer (excluding non melanoma skin cancer, breast cancer in situ, cervical cancer in situ, and superficial bladder cancer, or other cancers that have been effectively controlled in the past three years and have no evidence of disease recurrence) were previously or currently combined.\n* Clinically significant cardiovascular diseases At the beginning of the study treatment, the toxicity associated with previous anti-tumor treatments did not recover to ≤ CTCAE grade 1, except for hair loss and peripheral neurotoxicity of CTCAE grade 2.\n* Known HIV infection (HIV antibody positive), active hepatitis B and C patients.\n* Receive chemotherapy, targeted therapy, radiotherapy, and biological therapy, with less than 4 weeks since the first administration in this study; Or have received local radiotherapy within 2 weeks.\n* Having undergone major surgery or significant traumatic injury within 28 days prior to the first administration of the investigational drug -",{"count":340,"type":20},27,[53,23],"Oncolytic virus product named Olvi-Vec combined with Platinum plus Etoposide in patients with late phase SCLC",[26],"2025-11-25",{"date":346,"type":33},"2025-12-03",{"date":348,"type":33},"2023-07-24",{"date":350,"type":20},"2026-12",{"name":352,"class":189},"Newsoara HYK Biopharmaceutical (Shanghai) Co., Ltd.",{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":21,"phases":361,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":370,"locationsCount":4},"100603842","phase-1-an-umbrella-study-of-recurrent-extensive-stage-small-cell-lung-cancer-based-on-molecular-typing-100603842","NCT07141771","An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing","Inclusion Criteria:\n\n1\\. Be able to fully understand and sign the informed consent form, including compliance with the requirements and restrictions listed in the ICF and this protocol. A legally authorized representative may sign off on behalf of the subject.\n\n2\\. Subject age must be 18 years (including 18 years). 3. Participants must have stage IV metastatic small cell lung cancer confirmed by histology or cytology, not suitable for radical surgery or radiotherapy, and have disease progression after first-line standard platinum-containing regimen.\n\n4\\. The ECOG \u002F WHO fitness status score is 0 to 1. 5. Expected survival time must be at least 12 weeks. 6. Participants agreed to perform the biopsy and could obtain enough tissue specimens for whole-exon sequencing, transcriptome sequencing, and multiplex fluorescent immunohistochemical detection.\n\n7.The patient has sufficient important organ functions during screening (requiring no blood transfusion, no use of hematopoietic stimulating factors or human albumin preparations within 14 days prior to screening), and the specific definition is as follows:\n\n1. Blood routine: Absolute neutrophil count (Absolute neutrophil count, ANC) 1.5109 \u002F L; Platelet Count (Platelet, PLT)≥100×109\u002FL; Hemoglobin content (Hemoglobin, HGB) 90 g \u002F L;\n2. liver function: serum total bilirubin (Total bilirubin, TBIL) 1.5 Upper Normal Value (Upper limit of normal value, ULN), Patients with liver metastasis or with proven Gilbert syndrome, TBIL≤3×ULN. For subjects without liver metastases, Alanine aminotransferase (Alanine aminotransferase, ALT) and aspartate aminotransferase (Aspartate transferase, AST) ≤2.5×ULN, Subjects with liver metastases, ALT or AST 5 ULN;\n3. Renal function: creatinine clearance calculated according to the Cockcroft-Gault method (Clearance of creatinine, CCr) 60 mL\u002Fmin;\n4. Coagulation: activated partial thromboplastin time (Activated partial thromboplastin time, APTT) and the international standardized ratio (International normalized ratio, INR) 1.5 ULN (subjects receiving anticoagulation are within treatment range);\n5. cardiac function criteria: echocardiogram (Echocardiography, ECHO) showed a left ventricular ejection fraction (LVEF) greater than 50%.\n\n   8\\. The blood pregnancy test must be negative within 7 days before the first use of the test drug; fertile qualified patients (male and female) must agree to use reliable contraceptive methods (hormone or barrier method or abstinence) with their partner during the trial and at least 6 months after the last dose. Ferproductive patients were defined as sexually mature and with biologically underlying fertility.\n\n   9\\. Crias for molecular typing selection:\n   1. characteristics of transcription factor subtypes:\n   2. (1) SCLC-A and N types belong to neuroendocrine types, and SCLC-P and-I are cells with non-neuroendocrine subtypes. SCLC-A and N had significantly higher expression of neuroendocrine markers (chromaffin A (CgA) and synaptic vesicle protein (Syn)), while SCLC-P and I highly expressed the neuroendocrine inhibitory gene RE1 silent transcription factor (REST).\n   3. (2) SCLC-I is the most characteristic of stromal cells, while SCLC-A has the most characteristic of epithelial cells. High expression markers of SCLC-I of stromal cells: VIM and AXL. Most of the SCLC cells expressing the thyroid transcription factor (TTF 1) belong to the SCLC-A type.\n   4. (3) The vast majority of TP 53 and RB 1 mutations do not differ in subtype classification, and the classification of subtypes is not associated with specific gene mutations.\n   5. In conclusion, SCLC-A is neuroendocrine with epithelial cells, expressing TTF 1; SCLC-N, also neuroendocrine, but not TTF 1; SCLC-P and SCLC-I are non-neuroendocrine, while SCLC-I has a subtype characterized by mesenchymal cells.\n   6. H-score method (integral system): IHC test of tissue specimens to calculate the product of the percentage of positive tumor cell nuclear staining (0-100%) observed under the optical microscope and its staining intensity (intensity, 0,1 +, 2 +, 3 +), to obtain H-score (range 0-300) 13.\n   7. SLFN11:1 + under IHC score is positive 13, and the cut-off value is usually selected 10,10, which is defined as high expression 28.\n   8. BCL-2: The average copy number per spot was calculated based on the minimum and maximum number of Bcl-2 FISH signal from each nucleus in each tissue site. Copy arrays were constructed based on the absolute gene copy number using the following criteria: 1 to 2 signals with average copy number \\\u003C2.5; 3 to 4 signals, average copy number 2.5 and \\\u003C4.5; 5 to 6 signals, average copy number 4.5 and \\\u003C6.5; and 7 to 10 signals, with average copy number 6.5 29.\n   9. c-Myc: IHC 1 +, 2 + and 3 + were positive; 0 was negative.\n   10. If two or more markers in the same class have an H score of more than 10, then multiple markers in the tumor may be positive. The predominant marker was defined as the marker with the highest H-Score.\n   11. TROP-2: IHC stains at least 10% of tumor cells with an intensity score of 1 + (weak), and 2 + (moderate) and 3 + (strong) are defined as positive 22. At the same time, ANPY will be tested simultaneously (before the start of treatment) and submitted for transcriptomic testing.\n\n   10, with at least 1 measurable lesion according to RECIST 1.1.\n\n   Exclusion Criteria:\n   1. Acute toxicity associated with prior anti-tumor therapy for 4 weeks prior to the first dose did not return to grade NCI CTCAE v5.0 1 or the baseline level specified by the entry criteria (excluding alopecia or fatigue).\n   2. The following drugs or herbal supplements cannot be stopped within 3 weeks before and during the study: (1) strong inducers or inhibitors of CYP3A4; (2) drugs mainly metabolized by CYP3A4;\n   3. The subject does not agree to secondary biopsy or cannot obtain enough tissue specimens for full exon sequencing, transcriptome sequencing, and multiple fluorescent immunohistochemical testing.\n   4. Mean corrected QT interval (Corrected QT interval, QTc, Fridericia's correction) from 12-lead ECG (12-Electrocardiograph, ECG)\\> 470 ms (3 repeats). Various clinically significant cardiac rhythm, conduction, and resting ECG morphology abnormalities, such as complete left bundle branch block, degree III conduction block, degree II conduction block, and PR interval\\> 250 ms. Various factors that may increase the risk of QTc extension or arrhythmic events, such as cardiac failure, hypokalemia, congenital long QT syndrome, long QT syndrome in immediate family history or unexplained sudden death under 40 years of age, are using any medication with known QT interval extension.\n   5. Acute or chronic active hepatitis B \\[defined as hepatitis B surface antigen (HbsAg) and\u002For hepatitis B core antibody (HbcAb) positive and hepatitis B virus (HBV) DNA copy number ≥ 1 × 10\\]3 copies per mL or ≥ 200 IU\u002FmL.\n   6. Acute or chronic active hepatitis C (HCV), or HCV antibody positive and HCV-RNA levels greater than the upper central reference limit.\n\n   7 Patients with active brain metastases are enrolled if their central nervous system (Central nervous system, CNS) tumor metastasis is limited to supratentorial or cerebellum, is adequately treated (surgery or radiotherapy), has maintained radiographic stability for at least 4 weeks, and does not require corticosteroids to control symptoms.\n\n   8 Concurrent diseases failing to control, Example: a) severe infection occurred within 4 weeks before initiation of study treatment, Including but not limited to hospitalization for infection, bacteremia or complications of severe pneumonia; Or having received therapeutic oral or intravenous antibiotics within two weeks prior to starting study treatment, Patients receiving prophylactic antibiotic therapy may be enrolled (e. g. prevention of urinary tract infection or chronic obstructive pulmonary disease); b) symptomatic congestive heart failure (New York Heart Association Grade II-IV) or symptomatic or poorly controlled arrhythmia; c) with other malignancies within 5 years prior to treatment (cutaneous carcinoma, breast \u002F cervix, and in situ, nonmelanoma with radical treatment and no evidence of disease recurrence); And d) suspected or confirmed subjects with acute promyelocytic leukemia (indicated by morphology, immunotyping, molecular testing, or chromosome karyotype); e) subjects with current cancerous meningitis, spinal cord compression, etc.; f) a history of poorly controlled hypertension and diabetes; g) symptomatic endogenous lung disease; h) any arterial thromboembolic event within 6 months prior to inclusion, Including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack; i) significant malnutrition, If intravenous nutrition solution is needed. Stable for more than 4 weeks after correction of malnutrition before the first dose of study drug can be enrolled; j) tumor invasion of important surrounding organs or blood vessels (such as mediastinal macrovessels, superior vena cava, trachea, esophagus, etc.), Or at risk of oesophageal tracheal fistula or oesophageal pleural fistula; k) after esophageal or endotracheal cavity stenting; l) other acute or chronic diseases or abnormal laboratory test values that may lead to the following results: increase the risk associated with study participation or study drug administration, Or to interfere with the interpretation of the study findings, And listed the subject as ineligible for the study at the discretion of the investigator; m) a history of gastrointestinal perforation and \u002F or fistula within 6 months prior to study inclusion. N) with an uncontrolled third-space effusion requiring repeated drainage, such as pleural fluid, ascites, and pericardial effusion.(Patients who do not require drainage or have no significant increase for 3 days can be enrolled).\n\n   9\\. Patients with active gastrointestinal or other diseases, as well as factors such as surgical resection that may significantly affect drug absorption, metabolism, or excretion. Including but not limited to the following situations: malabsorption syndrome, inflammatory bowel disease, partial or complete intestinal obstruction, gastric or small intestine resection surgery.\n\n   10\\. Patients had a history of severe underlying pulmonary disease or medical conditions, such as moderate to severe chronic obstructive pulmonary disease (COPD), interstitial pulmonary disease (ILD), drug-induced ILD, acute or chronic infectious pneumonia, lung transplantation, etc.; 11. Pregnant or lactating women. 12 is participating in another interventional clinical study and has not completed study treatment.\n\n   13 A known history of allogeneic organ transplantation and allogeneic HSCT. 14. Major surgical procedure (craniotomy, thoracotomy, laparotomy, vascular intervention, otherwise defined by the investigator) within 4 weeks of the first administration of the study drug, or the presence of an unhealed wound, ulcer, or fracture. Note: Local surgical treatment of isolated lesions is acceptable for the purpose of palliative treatment.\n\n   15\\. HIV-infected persons (HIV 1 \u002F 2 antibody-positive). 16 Known active syphilis infection, active pulmonary tuberculosis. 17 Patients with a clear history of mental disorders and medication for treatment.\n\n   18\\. People with a history of drug abuse or drug use. 19. The investigator considers that the patient has other factors that may affect the study results and interfere with the entire study process, including previous, or existing physical conditions, treatment or laboratory abnormalities, and the subject's unwillingness to comply with the procedures, limitations and requirements of the study.",{"count":360,"type":20},100,[53,23],"Small-cell lung cancer (SCLC) has a high degree of malignancy and extremely poor prognosis, slow progress in the treatment of ES-SCLC, and a more ideal posterior therapy needs to be explored. This is an I \u002F II, phase umbrella study to explore afterline treatment options following progression of frontline platinum-containing therapy for small cell lung cancer.\n\nThis study includes 2 parts:\n\nPart 1 will enroll patients with end of first-line platinum-containing therapy and progression interval of less than 180 days or more of second-line therapy (no first-line relapse time required).\n\nPart 2 will enroll patients with end of first-line platinum-containing therapy greater than 180 days.\n\nBased on the optimal selection of patients with recurrent broad-stage small cell lung cancer with different molecular and clinical characteristics, we further explored different treatment modes suitable for different populations through umbrella cohort studies.",[26],"2025-08-25",{"date":366,"type":33},"2025-08-26",{"date":368,"type":20},"2025-12-31",{"date":37,"type":20},{"name":69,"class":70},{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":377,"targetDuration":379,"studyType":245,"phases":4,"briefSummary":380,"conditions":381,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":394},"100412731","lung-cancer-registry-100412731","NCT04654364","Lung Cancer Registry","Inclusion Criteria:\n\n* stage III A-C and IV A-B NSCLC\n* limited disease (LD) and extensive disease (ED) SCLC)\n* patients ≥ 18 years\n\nExclusion Criteria:\n\n\\- Due to the non-interventional design of the registry there are no specific exclusion criteria.",{"count":378,"type":20},500,"5 Years","Lung cancer is the second most common cancer in Austria with 2.868 men and 2.009 women diagnosed in 2016. Reflecting the high mortality of this disease, 2.415 men and 1.534 women died from lung cancer. Therefore, lung cancer is the most common reason for cancer associated death in men and second most common reason in women.\n\nThis malignant disease can be divided into two main groups: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). NSCLC is a paradigm for personalized medicine, with an increasing number of targetable gene alterations. Despite this growing diversity of molecular subtypes, in most patients no targetable mutation can be detected. For these patients check-point inhibitors with or without chemotherapy is the mainstay of the initial tumor therapy. Until recently, little progress has been made in the treatment of SCLC in last decades. Recently, an overall survival benefit by the addition of an immune-checkpoint inhibitor to first-line chemotherapy for advanced SCLC has been reported.\n\nDespite the progress in the treatment of NSCLC, the performance of predictive biomarkers is weak. Therefore, the development of more precise prediction models is of great importance for the progress of personalized treatment strategies.",[382,383,384,26,85],"Lung Cancer","NSCLC Stage IV","NSCLC, Stage III","2025-04-09",{"date":387,"type":33},"2025-04-10",{"date":389,"type":33},"2020-08-18",{"date":391,"type":20},"2030-08",{"name":393,"class":70},"Arbeitsgemeinschaft medikamentoese Tumortherapie",3,{"id":396,"slug":397,"hasResults":11,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":21,"phases":404,"briefSummary":405,"conditions":406,"keywords":407,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":416},"100577048","phase-2-nanocrystalline-megestrol--immunochemo-as-1st-line-for-es-sclc-cachexia-100577048","NCT06793228","Nanocrystalline Megestrol + Immunochemo As 1st-Line for ES-SCLC Cachexia","Nanocrystalline Megestrol Combined with Immunochemotherapy As First-Line Treatment for Cachexia in Extensive-Stage Small Cell Lung Cancer: a Patient-Centered Phase II Study","Inclusion Criteria:\n\n1. Good compliance and voluntary signing of a written informed consent form (ICF).\n2. Age at enrolment ≥18 years, ≤75 years, and gender-neutral (patients \\>75 years old will be enrolled in the RWS cohort).\n3. Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2 (patients with PS 3 and above due to oncological factors can be enrolled in the CU cohort or RWS cohort).\n4. Expected survival ≥ 6 months.\n5. Patients with histologically or cytologically confirmed small cell lung cancer (SCLC) and confirmed extensive stage small cell lung cancer based on AJCC 8th edition staging or the American Legion Lung Cancer Association (VALG) Stage II staging method (excluding mixed small cell lung cancer).\n6. Subjects have not received prior systemic systemic chemotherapy for metastatic disease. Subjects with prior adjuvant\u002Fneoadjuvant chemotherapy or radical synchronous or sequential radiotherapy for non-metastatic disease with curative intent are eligible for this study if disease progression occurred \\>6 months after the end of the last treatment.\n7. Have at least one measurable tumour lesion according to RECIST v1.1.\n8. Meet the diagnostic criteria for premalignant or malignant stage. Diagnostic criteria for pre-Cachexia stage\n\n   Referring to the 2016 ESPEN consensus on terminology, the following conditions are also met:\n   * Maximum weight loss \\\u003C5% relative to baseline 6 months ago;\n\n     * Anorexia (presence of anorexia complaints or anorexia\u002Fmalignant condition subscale FAACT-A\u002FCS score ≤37); (iii) Serum C-reactive protein CRP ≥ 5 mg\u002FL. Diagnostic criteria for cachexia Any one of the following conditions combined with loss of appetite or systemic inflammatory response.\n\n   Involuntary weight loss \\>5% in the last 6 months. ② Weight loss \\>2% when BMI \\\u003C18.5kg ③ Weight loss \\>2% with muscle loss.\n9. Determine good organ function by the following requirements:\n\n   a) Routine haematology (no supportive therapy with any blood components and cell growth factors within 7 days prior to initiation of study treatment): i. Absolute neutrophil ANC ≥ 1.5 × 10\\^9\u002FL (1,500\u002Fmm3); ii. Platelet count ≥ 100 × 10\\^9\u002FL (100,000\u002Fmm3); and iii. Haemoglobin ≥ 90 g\u002FL.\n\n   b) Renal function: i. Creatinine clearance\\* (CrCl) calculated ≥ 50 mL\u002Fmin\n\n   \\* The Cockcroft-Gault formula will be used to calculate CrCl (Cockcroft-Gault formula) CrCl (mL\u002Fmin) = (140 - age) × weight (kg) × F}\u002F (SCr (mg\u002FdL) × 72) F = 1 for males; F = 0.85 for females; SCr = serum creatinine. ii. urine protein ≤ 1+ or 24-hour (h) urine protein quantitatively \\\u003C 1.0 g. c) Liver function: i. serum total bilirubin (TBil) ≤ 1.5 × upper limit of normal (ULN); TBil ≤ 3 × ULN for patients with liver metastases or evidence of confirmed\u002Fsuspected Gilbert's disease.\n\n   ii. AST and ALT ≤ 2.5 × ULN; for patients with liver metastases, AST and ALT ≤ 5 × ULN iii. serum albumin (ALB) ≥ 28 g\u002FL d) Coagulation: International Normalised Ratio and Activated Partial Thromboplastin Time ≤ 1.5 × ULN (unless the patient is on anticoagulant therapy and the coagulation parameters (PT\u002FINR and APTT) are in the expected range for treatment with anticoagulants at screening).\n\n   e) Cardiac function: left ventricular ejection fraction (LVEF) ≥50%.\n10. Lung function indices 1st second forced expiratory volume (FEV1) \\>1L or \\>30% of predicted value, and lung carbon monoxide diffusion function (DLCO) \\>30% of predicted value;\n11. Female patients of childbearing potential must have a urine or serum pregnancy test (if the urine pregnancy test result is not confirmed negative, a serum pregnancy test is required, and the serum pregnancy result will be used as the basis for the negative result) performed within 3 days prior to the first dose of the drug, and the result is negative. If a female patient of childbearing potential engages in sexual intercourse with an unsterilised male partner, the patient must be using an acceptable method of contraception from the start of screening and must agree to continue to use the adopted method of contraception for a period of 120 days after the last dose of study drug; the decision on whether or not to discontinue contraception after this time point should be discussed with the investigator. If an unsterilised male patient has sexual intercourse with a female partner of childbearing potential, the patient must use an effective method of contraception from the start of screening until the 120th day after the last dose of study medication; discontinuation of contraception after this time point should be discussed with the investigator.\n12. The patient is willing and able to comply with the schedule of visits, treatment regimens, laboratory tests, and other requirements of the study.\n\nExclusion Criteria:\n\nSubjects meeting any of the exclusion criteria baseline will be excluded from the study:\n\nMain exclusion criteria\n\n1. Presence of malignant conditions other than those caused by oncological etiology such as chronic respiratory failure requiring home oxygen support, chronic obstructive pulmonary disease, chronic and persistent congestive heart failure, acquired immunodeficiency syndrome, uncontrollable thyroid disease.\n2. Presence of any condition that interferes with gastrointestinal absorption such as dysphagia, malabsorption, previous history of gastrectomy, or uncontrollable vomiting; being on tube feeding or parenteral nutrition; presence of anorexia nervosa, anorexia due to psychiatric disorders, or pain that makes it difficult to eat.\n3. Being on other appetite or weight-increasing medications such as: adrenocortical steroids (except for short-term use of dexamethasone during chemotherapy), androgens, progesterone analogues, thalidomide, and anamorelin or other appetite stimulants.\n4. Use of any proprietary or herbal medicine used for cancer control within 14 days prior to the first dose of study drug.\n5. Pre-existing (within 3 years) or current other malignancies, except cured localised tumours (e.g. basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.).\n6. Concurrent enrolment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study.\n7. Previous treatment with any other antibody or drug specifically targeting the T-cell co-stimulatory or checkpoint pathway such as anti-PD-1, PD-L1 or CTLA-4 therapy.\n8. Presence of esophagogastric fundal varices, severe ulcers, history of gastrointestinal perforation and\u002For fistulae, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), history of intra-abdominal abscess or acute gastrointestinal bleeding, thromboembolic disease, ascites, or lower extremity oedema in the 6 months prior to the first dose.\n9. Current uncontrolled co-morbidities including, but not limited to, decompensated cirrhosis, renal failure, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or psychiatric\u002Fsocial conditions that would limit the patient's ability to comply with the requirements of the study or affect the patient's ability to provide written informed consent.\n10. Pre-existing history of myocarditis, cardiomyopathy, or malignant arrhythmia. Unstable angina requiring hospitalisation, myocardial infarction, congestive heart failure (aortic aneurysm of grade 2 and at risk of rupture as determined by the New York Heart Association functional class), or other cardiac impairment (e.g., poorly controlled arrhythmia, myocardial ischaemia) that may interfere with the evaluation of the safety of the investigational drug, within 6 months prior to the first dose of study drug.\n11. Severe chronic or active infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 14 days prior to the first dose of study drug.\n12. Patients with active molluscum contagiosum metastases, or brain metastases that are not well controlled; Patients with stable treated brain metastases may be enrolled at the discretion of the investigator; Patients with untreated, asymptomatic brain metastases may be enrolled at the judgement of the investigator, but will require regular brain imaging of the disease site.\n13. Major surgical procedure or serious trauma within 30 days prior to the first dose of the drug or major surgical procedure planned within 30 days of the first dose of the drug.\n14. Live or live attenuated vaccine administered within 30 days prior to the first dose or planned to be administered during the study period; inactivated vaccines are permitted.\n15. Known hypersensitivity to any component of the study drug.\n16. Females who are pregnant or breastfeeding.\n17. Patients who, in the judgement of the investigator, may have poor compliance with the procedures and requirements of the study; patients who, in the judgement of the investigator, have any condition that endangers patient safety or interferes with the assessment of the study (e.g., patients treated with radiotherapy\u002Fsynchrotron radiotherapy during the immunochemotherapy phase, except during the maintenance phase).\n\nSecondary exclusion criteria (CU cohort may be included)\n\n1. Active autoimmune disease requiring systemic therapy within the last two years, active or previous history of definite inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis or chronic diarrhoea).\n2. Patients with Cushing's syndrome, adrenal or pituitary insufficiency; patients with difficult-to-control diabetes mellitus; and current hypertension with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg treated with oral antihypertensive medications.\n\n(3) Previous non-infectious pneumonia requiring systemic glucocorticoid therapy or current non-infectious pneumonia combined with mild to moderate interstitial pneumonia, inactive interstitial pneumonia.\n\n4\\) Presence of unmitigated toxicity from prior antineoplastic therapy, with unmitigated defined as failure to recover to NCI CTCAE version 5.0 grade 0 or 1 (except alopecia areata) or failure to recover to levels specified in the inclusion\u002Fexclusion criteria.\n\n5\\) History of known allogeneic organ transplantation and allogeneic haematopoietic stem cell transplantation; history of organ or haematopoietic stem cell transplantation requiring immunosuppression.\n\n6\\) Patients with chronic hepatitis B or chronic hepatitis B virus carriers with HBV DNA ≥500 IU\u002FmL (2500 copies\u002FmL), or hepatitis C patients.\n\n7\\) Other circumstances as determined by the investigator.",{"count":403,"type":20},250,[23],"This study hypothesizes that nanocrystalline megestrol acetate can improve the cachexia condition in patients and enhance the efficacy of immunochemotherapy regimens. It plans to enroll patients newly diagnosed with extensive-stage small-cell lung cancer (ES-SCLC) who are in the pre-cachexia or cachexia stage of the cachexia trajectory. These patients will receive first-line standard immunochemotherapy combined with nanocrystalline megestrol acetate intervention. Compared to the use of the first-line standard immunochemotherapy regimen alone, the study will monitor changes in body weight and body composition, which are nutritional status indicators relative to baseline, to assess whether these changes can translate into improved survival benefits and enhanced quality of life for patients.\n\nThe objective of this clinical study are：1.To assess the change in body weight relative to baseline in malignant patients with ES-SCLC treated with a first-line standard immunochemotherapy regimen during treatment with a simultaneous co-administration of nanocrystalline megestrol supportive intervention, compared to standard treatment. 2.To assess the impact of simultaneous co-administration of nanocrystalline megestrol supportive intervention during treatment with a first-line standard immunochemotherapy regimen, compared to standard treatment, on survival benefit and quality of life in patients with ES-SCLC malignancy. 3.To explore the improvement in inflammatory and nutritional markers and changes in lymphocyte subpopulations in patients with ES-SCLC malignant disease with simultaneous co-administration of nanocrystalline megestrol supportive intervention during treatment with a first-line standard immunochemotherapy regimen, compared to standard treatment.",[26],[205],"2025-01-18",{"date":410,"type":33},"2025-01-27",{"date":412,"type":20},"2025-01-15",{"date":414,"type":20},"2027-12-15",{"name":39,"class":40},4,{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":21,"phases":425,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":71},"100575132","phase-2-assessment-of-adebelizumab-combined-with-chemotherapy-in-concurrent-radiotherapy-versus-sequential-radiotherapy-as-first-line-treatment-for-extensive-stage-small-cell-lung-cancer-100575132","NCT06768307","Assessment of Adebelizumab Combined with Chemotherapy in Concurrent Radiotherapy Versus Sequential Radiotherapy As First-Line Treatment for Extensive-Stage Small Cell Lung Cancer","Exploratory Clinical Study of Adebrelimab Combined with Chemotherapy and Concurrent Radiotherapy Versus Sequential Radiotherapy As First-Line Treatment for Extensive-Stage Small Cell Lung Cancer（ES-SCLC）.","Inclusion Criteria:\n\n* Age ≥18 years, no gender restrictions;\n* Confirmed pathological diagnosis of extensive-stage small cell lung cancer (ES-SCLC), defined as disease extending beyond one hemithorax, including malignant pleural and pericardial effusions or hematogenous metastases (according to the Veterans Administration Lung Cancer Study Group, VALG staging); stage IV (any T, any N, M1a\u002Fb\u002Fc) according to the AJCC (8th edition), or T3-4 due to multiple pulmonary nodules or tumor\u002Fnodule size too large to be included in a tolerable radiation therapy plan;\n* Participants have not received systemic treatment for extensive-stage SCLC;\n* No more than 5 lesions (including metastatic foci), with at least one measurable lesion (according to RECIST v1.1);\n* ECOG performance status score of 0-2;\n* Life expectancy ≥3 months;\n* Consented and signed the informed consent form, willing and able to comply with planned visits, study treatments, laboratory tests, and other trial procedures;\n* Normal major organ function, meeting the following criteria (without symptomatic treatment within 14 days): a) Hematology:\n\nHemoglobin (Hb) ≥90g\u002FL; Platelet (PLT) ≥100×10\\^9\u002FL; Neutrophil count (ANC) ≥1.5×10\\^9\u002FL; White blood cell count (WBC) ≥3.0×10\\^9\u002FL;\n\nLymphocyte ≥0.5×10\\^9\u002FL; b) Biochemistry:\n\nAlanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤ 2.5×ULN; For those with liver metastasis, ALT, AST≤5 ULN; For those with liver or bone metastasis: ALP ≤5 ULN; Total serum bilirubin (TBIL) ≤1.5×ULN (for Gilbert's syndrome participants ≤3×ULN); Albumin (ALB) ≥3 g\u002FdL;\n\nRenal function: Serum creatinine ≤1.5 x ULN or creatinine clearance rate (CrCl) ≥50mL\u002Fminute (using Cockcroft\u002FGault formula); c) Coagulation:\n\nActivated partial thromboplastin time (APTT), International Normalized Ratio (INR), Prothrombin Time (PT) ≤1.5×ULN; d) Others: Lipase ≤1.5 x ULN. Participants with lipase \\>1.5 x ULN without clinical or radiological evidence of pancreatitis can be included; e) Doppler echocardiography: Left ventricular ejection fraction (LVEF) ≥50%;\n\n* Female participants of childbearing potential must have a negative serum HCG test within 72 hours before the first dose, not breastfeeding, and must use a medically recognized contraceptive method (such as intrauterine devices, birth control pills, or condoms) during the study treatment and for 2 months after the last dose of Adebrelimab or 6 months after the last dose of Carboplatin\u002FEtoposide (whichever is longer); male participants with partners of childbearing potential must be surgically sterilized or agree to use highly effective contraception during the trial and for 2 months after the last dose of Adebrelimab or 3 months after the last dose of Carboplatin\u002FEtoposide (whichever is longer), and no sperm donation during the study.\n\nExclusion Criteria:\n\n* Participants who have previously received any T-cell co-stimulation or immune checkpoint therapy, including but not limited to cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1\u002F2 inhibitors, CD137 agonists, or other T-cell targeted drugs.\n* Participants who have previously received chemoradiotherapy for limited-stage SCLC;\n* Participants with clinically symptomatic central nervous system metastases (such as brain, spinal cord), or leptomeningeal metastases; participants with active or new CNS metastases found on imaging during the screening period are not included. (Asymptomatic untreated CNS metastases with a lesion size \\\u003C1cm are allowed to be included);\n* Participants with multiple liver metastases (isolated liver metastasis participants with metastasis \\\u003C2cm can be included)\n* Participants with spinal cord compression;\n* Participants with active autoimmune diseases requiring systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first dose, or with a history of autoimmune diseases and expected recurrence. Replacement therapies (such as thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment;\n* Diagnosed with immune deficiency or receiving systemic glucocorticoid treatment or any other form of immunosuppressive therapy within 14 days before the first dose; the use of physiological doses of glucocorticoids (≤10 mg\u002Fday of prednisone or equivalent) is allowed;\n* Participants who have had arterial\u002Fvenous thrombotic events within 6 months before the first dose, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis, and pulmonary embolism;\n* Participants with a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as cryptogenic organizing pneumonia), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest computed tomography (CT) at screening (participants with active tuberculosis are not included);\n* Participants who have undergone major surgical treatment or significant traumatic injury within 28 days before the first dose;\n* Participants who have received or plan to receive preventive vaccines or live-attenuated vaccines within 4 weeks before the first dose;\n* Participants who have received other trial medications or participated in another interventional clinical study within 4 weeks before signing the ICF;\n* Participants with other malignancies that require active treatment within 5 years (except for those with a \\>90% 5-year survival rate such as fully treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, localized prostate cancer after radical surgery, localized bladder cancer, ductal carcinoma in situ after radical surgery, or in situ breast cancer);\n* Participants with any severe and\u002For uncontrolled diseases, including: a) Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90mmHg) participants; history of hypertensive crisis or hypertensive encephalopathy; b) Uncontrolled cardiac clinical symptoms or diseases such as ≥grade 2 myocardial ischemia or myocardial infarction, uncontrollable arrhythmias (including men QTc ≥450ms, women QTc ≥470ms), and ≥grade 2 congestive heart failure (New York Heart Association, NYHA classification), unstable angina, myocardial infarction within 24 weeks, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; c) Active or uncontrolled severe infections (≥CTC AE grade 2 infections), including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia, unexplained fever \\>38.5℃ before the first dose. d) Liver cirrhosis, active hepatitis\\*; \\*Active hepatitis - Hepatitis B reference: HBsAg positive, exceeding the upper limit of normal (1000 copies\u002Fml or 500 IU\u002Fml); participants with past Hepatitis B virus (HBV) infection or cured HBV infection (defined as the presence of hepatitis B core antibody \\[HBcAb\\] and absence of HbsAg, and normal HBV DNA values detected during the screening period can be included; \\*Hepatitis C reference: HCV antibody positive, and HCV viral load exceeds the upper limit of normal\u002FHCV RNA or HCV Ab indicates acute or chronic infection; e) HIV positive or known Acquired Immune Deficiency Syndrome (AIDS); f) Urine routine suggests urinary protein ≥++, and confirmed 24-hour urinary protein quantification \\>1.0 g;\n* Participants with clinically symptomatic third-space fluid accumulation, such as pericardial effusion, pleural effusion, and abdominal effusion requiring repeated drainage (such as once a month or more frequently) that cannot be controlled by tapping or other treatments;\n* Participants whose adverse events (except for alopecia) caused by previous treatments have not recovered to ≤CTCAE grade 1; other toxicities caused by previous antitumor treatments that are expected to be unresolved and have long-term persistent sequelae, such as neurotoxicity caused by platinum-based treatments, are allowed to be included;\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n* Known history of drug abuse that cannot be quit, mental disorders, alcoholism, drug abuse, or substance abuse;\n* Known allergy to study drugs or excipients, known severe allergic reactions to any monoclonal antibody;\n* As judged by the investigator, there are factors that seriously endanger the safety of the participants or other factors that may lead to the forced termination.",{"count":164,"type":20},[23],"Immunotherapy combined with chemotherapy has emerged as the standard of care for patients with extensive-stage small cell lung cancer (ES-SCLC). The incorporation of thoracic radiotherapy can enhance treatment efficacy. Currently, the main types of research investigating immunotherapy combined with thoracic radiotherapy for untreated ES-SCLC are concurrent radiotherapy and sequential radiotherapy. The aim of this study is to evaluate the efficacy of adebelizumab in combination with chemotherapy, when administered concurrently with radiotherapy versus sequentially with radiotherapy, as a first-line treatment for ES-SCLC.",[26,428,145,429],"Immunotherapy","Radiotherapy","2025-01-06",{"date":432,"type":33},"2025-01-10",{"date":434,"type":20},"2025-02",{"date":436,"type":20},"2028-01",{"name":234,"class":70},{"id":439,"slug":440,"hasResults":11,"nctId":441,"briefTitle":442,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":221,"enrollmentInfo":444,"targetDuration":4,"studyType":21,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":4},"100563794","phase-2-a-phase-ii-study-of-ivonescimab-combined-with-cadonilimab-and-chemotherapy-in-extensive-stage-small-cell-lung-cancer-100563794","NCT06620796","A Phase II Study of Ivonescimab Combined with Cadonilimab and Chemotherapy in Extensive-stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Written informed consent must be obtained before implementing any trial-related procedures;\n* Aged 18-80 years;\n* Expected survival of more than 3 months;\n* histologically or cytologically confirmed ES-SCLC according to the American Veterans Cancer Association VALG staging system；\n* Arm 1: subjects who have not received previous systemic therapy for extensive-stage SCLC; Or patients who had received definitive chemoradiotherapy for limited-stage small cell lung cancer but had disease progression \\> 6 months later;Arm 2：ES-SCLC patients who progressed after only one PD-1\u002FPD-L1 combination chemotherapy and had response to previous treatment (PFS ≥ 3 months), no more than two systemic chemotherapy regimens were used；\n* The investigator confirms the presence of at least one measurable lesion according to RECIST 1.1 criteria;\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n* Adequate hematologic function, defined as absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL, platelet count \\>= 100 x 10\\^9\u002FL, hemoglobin \\>= 90 g\u002FL (without transfusion history within 7 days);\n* Adequate liver function, defined as total bilirubin level \\<= 1.5 times the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels \\<= 2.5 times ULN in all patients, or \\<= 5 times ULN in patients with liver metastases;\n* Adequate renal function, defined as serum creatinine \\<= 1.5 times ULN;\n* Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) \\<= 1.5 times ULN; for subjects receiving anticoagulant therapy, INR\u002FPT should be within the range planned by the anticoagulant;\n* Women of childbearing potential must have a negative pregnancy test within 7 days before starting treatment, and must use reliable contraceptive measures (such as intrauterine device, contraceptive pills, and condoms) during the trial and for 30 days after the end of the trial; male subjects of reproductive potential must use condoms for contraception during the trial and for 30 days after the end of the trial;\n* Willingness to comply with regular follow-up visits and trial requirements.\n* Participants were required to provide 10 or more unstained FFPE pathological slides (preferably newly obtained tumor tissue) archived or freshly obtained within 3 months prior to the first dose of medication. Tumor lesions used for fresh-tissue biopsy should not be used as RECIST v1.1 target lesions unless they are the only measurable lesion. The collection of archived tumor-tissue samples beyond 3 months of age was permitted, with the consent of the medical monitor, if no samples were available within 3 months of age and biopsy, as judged by the investigator, might increase the risk to the subject. If more than 10 slides were not available, some or all of the slides could be waived with investigator approval；\n* Participants were required to provide approximately 10 unstained FFPE tumor tissue slides for efficacy biomarker exploration. If it cannot be provided, it can be exempted after approval from the investigator and will not affect the Participants participation in this study；\n\nExclusion Criteria:\n\n* Currently participating in interventional clinical research treatment;\n* For Arm 1: a) Prior immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1 \u002FL1 antibody, anti-CTLA-4 antibody, anti-TIGIT antibody, anti-LAG-3 antibody, etc.), immune checkpoint agonists (e.g. ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immune cell therapy, and any treatment targeting the tumor immune mechanism; b) previous systemic anti-angiogenic therapy, including but not limited to bevacizumab small molecule TKI, etc. For Arm 2:\n\n  a) PD-1\u002FL1 inhibitor crossover therapy: after the failure of PD-1\u002FL1 inhibitor combined with chemotherapy, the chemotherapy regimen was changed and the original PD-1\u002FL1 inhibitor was given again. b) Prior immunotherapy other than PD-1\u002FL1 inhibitors, including immune checkpoint inhibitors (e.g., anti-TIGIT antibody, anti-LAG-3 antibody, etc., anti-CTLA-4 monoclonal antibody), immune checkpoint agonists (e.g. ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immune cell therapy, and any treatment targeting the mechanism of tumor immune action. c) previous treatment with a taxol chemotherapeutic agent. d) previous systemic anti-angiogenic therapy, including but not limited to bevacizumab, small molecule TKI, etc.\n* Imaging during the screening period showed that the tumor was surrounded by important blood vessels or had obvious necrosis or cavities, and the investigator judged that the entry of the study would cause bleeding risk.\n* active autoimmune disease requiring systemic treatment within the past 2 years (e.g., with disease-modifying medications, corticosteroids, immunosuppressants). Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) is not considered a systemic treatment.\n* history of noninfectious pneumonia\u002Finterstitial lung disease requiring systemic glucocorticoid treatment or current noninfectious pneumonia.\n* History of brain stem, meningeal metastasis, spinal cord metastasis or compression.presence of active central nervous system (CNS) metastases; Participants who had previously been treated for brain metastases (e.g., surgery, radiotherapy) were allowed if they were clinically stable for at least two weeks after treatment (calculated from the time of the first administration of the study drug) and if corticosteroids were discontinued 7 days before the administration of the study drug. Participants with untreated, asymptomatic brain metastases (i.e., no neurologic symptoms, no need for corticosteroids, no brain metastases measuring \\>1.5 cm in the greatest dimension, and no substantial premetastatic edema) were eligible for enrollment\n* presence of current uncontrolled coexisting medical conditions, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorder, severe active peptic ulcer disease, or gastritis, or mental illness\u002Fsocial condition that would limit compliance with study requirements or affect the participant\\'s ability to provide written informed consent;\n* previous history of myocarditis, cardiomyopathy, and malignant arrhythmia. The presence of unstable angina, myocardial infarction, congestive heart failure (New York Heart Association functional class 2 or higher), or vascular disease (e.g., aortic aneurysm at risk for rupture) that required hospitalization within 12 months before the first dose of the study drug or other cardiac impairment (e.g., uncontrolled arrhythmias, myocardial ischemia) that could affect the safety evaluation of the study drug; The patient had a history of esophagogastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months before the first dose of medication. Any arterial thromboembolic event, venous thromboembolic event of NCI CTCAE version 5.0 or higher, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy occurred 6 months before the first dose. An acute exacerbation of chronic obstructive pulmonary disease occurred within 1 month before the first dose, except for infusion-related thrombosis that had occurred for more than 4 weeks.\n* history of severe bleeding tendency or coagulopathy; Clinically significant bleeding symptoms within 1 month before the first dose of medication, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or coughing up ≥1 teaspoon of blood or small blood clot or only coughing up blood without sputum, and those with blood in sputum were allowed), nasal bleeding (excluding epistaxis and retraction of nasal bleeding); Continuous antiplatelet or anticoagulant therapy had been administered within 10 days before the first dose.\n* lack of resolution of toxicity from prior antineoplastic therapy, defined as failure to return to NCI CTCAE version 5.0 grade 0 or 1 or levels specified in the inclusion\u002Fexclusion criteria, with the exception of alopecia. Subjects with irreversible toxicity that was not expected to worsen with study drug administration (e.g., hearing loss) may be enrolled after consultation with the medical monitor. Subjects with long-term radiation-induced toxicity that, in the judgment of the investigator, did not recover from, may be included in the study.\n* serious infection within 4 weeks before the first dose, including but not limited to coexisting conditions requiring hospitalization, sepsis, or severe pneumonia; Active infection (excluding antiviral therapy for hepatitis B or hepatitis C) that had received systemic anti-infective therapy within 2 weeks before the first dose.\n* history of immunodeficiency; HIV antibody positive; Long-term use of systemic corticosteroids or other immunosuppressive agents is ongoing.\n* Subjects with known active pulmonary tuberculosis should be excluded by clinical examination (e.g., sputum test, chest X-ray, etc.); Known active syphilis infection.\n* history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* presence of pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.\n* subjects with active hepatitis B (HBsag-positive and HBV-DNA \\> 500 copies \u002Fml or higher than the lower limit of detection); Subjects with active hepatitis C (HCV antibody-positive).\n* had a major surgical procedure or major trauma within 30 days before or within 30 days after the first dose (at the discretion of the investigator); Minor local procedures (excluding peripherally inserted central catheters and intravenous-access ports) had been performed within 3 days before the first dose.\n* received live attenuated influenza vaccine within 30 days before the first dose or plan to receive live attenuated influenza vaccine during the study and cannot receive live attenuated influenza vaccine within 90 days after treatment after the last dose of the study drug.\n* known allergy to any component of any study drug; A history of severe hypersensitivity reactions to other monoclonal antibodies was known.\n* known history of mental illness, substance abuse, alcohol or drug abuse.\n* pregnant or lactating women.\n* The presence of any past or current medical conditions, treatments, or laboratory abnormalities that may confound the results of the study, preclude full participation in the study, or participation in the study may not be in the best interest of the subject",{"count":445,"type":20},70,[23],"The goal of this clinical trial is to investigate the efficacy, safety and tolerability of Ivonescimab combined with Cadonilimab and chemotherapy in extensive-stage small cell lung cancer patients. And also explore the potential biomarkers for predicting the efficacy of Ivonescimab combined with Cadonilimab for extensive-stage small cell lung cancer.",[26],"2024-09-28",{"date":451,"type":33},"2024-10-01",{"date":453,"type":20},"2024-09-30",{"date":455,"type":20},"2027-09-30",{"name":457,"class":70},"Shanghai Pulmonary Hospital, Shanghai, China"]