[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yayi He\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":92},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"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",false,"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).","ALL","18 Years","75 Years",{"count":21,"type":22},46,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","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.",[28],"SCLC, Extensive Stage","NOT_YET_RECRUITING","2026-06-02",{"date":32,"type":33},"2026-06-08","ACTUAL",{"date":35,"type":22},"2026-06",{"date":37,"type":22},"2028-12",{"name":39,"class":40},"Yayi He","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100634328","phase-2-benmelstobart-plus-anlotinib-chemotherapy-and-thoracic-radiation-for-limited-stage-small-cell-lung-cancer-100634328","NCT07538258","Benmelstobart Plus Anlotinib, Chemotherapy and Thoracic Radiation for Limited-Stage Small Cell Lung Cancer","A Single-Arm, Exploratory Clinical Study of Benmelstobart Combined With Anlotinib and Chemotherapy Concurrent With Thoracic Radiotherapy as First-Line Treatment in Limited-Stage Small Cell Lung Cancer (LS-SCLC)","Aurora004","Inclusion Criteria:\n\n* 1: Histologically or cytologically confirmed inoperable limited-stage small cell lung cancer (LS-SCLC) (per VALG staging).\n\n  2: No prior systemic therapy for limited-stage small cell lung cancer\n\n  3: Presence of measurable lesions as defined by RECIST 1.1. A previously irradiated lesion may be considered measurable only if it has demonstrated clear progression after radiotherapy and is not the sole lesion\n\n  4: Age ≥ 18 and ≤ 75 years\n\n  5: ECOG performance status: 0-1\n\n  6: Expected survival ≥ 3 months\n\n  7: Adequate hematologic and organ function, defined as meeting the following criteria: a) Hematologic function (no transfusion of blood or blood products, no G-CSF or other hematopoietic growth factors within 14 days): 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 (CrCl) ≥ 50 mL\u002Fmin; ii. Urine protein \\\u003C 2+ or 24-hour urine protein quantification \\\u003C 1.0 g. c) Hepatic function: i. Serum total bilirubin (TBil) ≤ 1.5 × ULN; ii. AST and ALT ≤ 2.5 × 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%.\n\n  8: Subjects voluntarily participate in this study, provide written informed consent, demonstrate good compliance, and agree to comply with follow-up procedures.\n\nExclusion Criteria:\n\n* 1: Prior use of anti-angiogenic agents such as anlotinib, apatinib, bevacizumab, or related immunotherapeutic agents targeting PD-1, PD-L1, etc\n\n  2: Presence of multiple factors affecting oral medication absorption (e.g., inability to swallow, status post gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.).\n\n  3: Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n\n  4: Patients with imaging evidence of tumor invasion adjacent to major blood vessels, or judged by the investigator to have a high risk of fatal massive hemorrhage due to tumor invasion of major blood vessels during the subsequent study period.\n\n  5: History of severe bleeding tendency or coagulopathy, including but not limited to: clinically significant hemoptysis (more than one tablespoon per day) within 3 months prior to enrollment; or clinically significant bleeding symptoms or bleeding diathesis within 4 weeks prior to randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer (including gastrointestinal perforation and\u002For fistula; however, patients with surgically repaired gastrointestinal perforation or fistula may be eligible), unhealed wounds, ulcers, or fractures, etc.\n\n  6: Undergoing major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to randomization.\n\n  7: History of arterial\u002Fvenous thrombotic events within 6 months prior to randomization, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism.\n\n  8: Development of active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose.\n\n  9: Any other conditions that, in the judgment of the investigator, would render the patient ineligible for study enrollment.",{"count":50,"type":22},27,[25],"This is a single-arm, single-center, exploratory clinical study conducted at Shanghai Pulmonary Hospital, Tongji University. The study evaluates the effectiveness and safety of first-line treatment with benmelstobart (an immunotherapy), anlotinib (an anti-angiogenic drug), platinum-etoposide chemotherapy, and concurrent thoracic radiotherapy in participants with previously untreated, unresectable limited-stage small cell lung cancer (LS-SCLC).\n\nEligible participants are aged 18 to 75 years, with histologically or cytologically confirmed limited-stage SCLC (VALG staging), no prior systemic treatment for lung cancer, measurable lesions by RECIST 1.1, ECOG performance status 0-1, and adequate organ function.\n\nParticipants receive 4 cycles of induction therapy (21 days per cycle), including benmelstobart intravenously every 3 weeks, anlotinib orally for 2 weeks on \u002F 1 week off, and chemotherapy with carboplatin or cisplatin plus etoposide. Thoracic radiotherapy (60-70 Gy in 30-35 fractions) is given concurrently with chemotherapy cycles 1-3. After induction, participants receive maintenance therapy with benmelstobart plus anlotinib for up to 2 years or until disease progression or unacceptable side effects.\n\nThe primary objective is to assess the Objective Response Rate (ORR) as evaluated by investigators using RECIST 1.1. Secondary objectives include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety assessments of adverse events graded by CTCAE 5.0.\n\nA total of 27 participants will be enrolled. The study is expected to start in March 2026, complete enrollment by September 2027, and end in March 2029. All participants will be regularly followed for efficacy and safety.",[54],"Limited-stage Small Cell Lung Cancer (LS-SCLC)",[56,57,58,59],"Limited-stage small cell lung cancer","benmelstobart","anlotinib","chemotherapy","2026-04-12",{"date":62,"type":33},"2026-04-20",{"date":62,"type":22},{"date":65,"type":22},"2029-03-31",{"name":39,"class":40},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":91,"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":76,"type":22},33,[25],"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.",[28],[81,82,83,84,85,86,87],"Small Cell Lung Cancer","Extensive-Stage","Benmelstobart","Anlotinib","Chemotherapy","Thoracic Radiotherapy","First-Line",{"date":62,"type":33},{"date":62,"type":22},{"date":65,"type":22},{"name":39,"class":40},""]