[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620519":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":25,"centralContacts":31,"locations":41,"responsibleParty":57,"collaborators":39,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":39,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":39,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":84,"whyStopped":39,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group","EXPERIMENTAL","Participants receive a multi-phase experimental regimen. Induction (4 cycles, q3w): Bemotuzumab (1200 mg IV, Day 1) combined with investigator's choice of platinum-etoposide chemotherapy (Carboplatin AUC=5 or Cisplatin 75-80 mg\u002Fm² on Day 1, plus Etoposide 100 mg\u002Fm² IV on Days 1-3) and oral Anlotinib (12 mg once daily on Days 1-14, then 7 days off).\n\nConsolidation (2 cycles, q3w): Bemotuzumab (same dose) + Anlotinib (same schedule) with concurrent hypofractionated thoracic radiotherapy (5 Gy per fraction for 5 fractions).\n\nMaintenance: Bemotuzumab (q3w) + Anlotinib (same schedule) until disease progression, unacceptable toxicity, or other withdrawal criteria. Anlotinib dose may be reduced (12mg → 10mg → 8mg) for managing toxicity.",[13],"Combination Product: Bemotuzumab + Anlotinib + Chemotherapy + Radiotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"COMBINATION_PRODUCT","Bemotuzumab + Anlotinib + Chemotherapy + Radiotherapy","This is a multi-phase combined modality regimen.\n\nInduction Phase (4 cycles): Bemotuzumab (1200mg IV, Day1 q3w) + Platinum\u002FEtoposide chemotherapy (Carboplatin \\[AUC5\\] or Cisplatin \\[75-80 mg\u002Fm²\\] on Day1, plus Etoposide \\[100 mg\u002Fm² IV, Days1-3\\]) + oral Anlotinib (12mg, Days1-14, then 7 days off).\n\nConsolidation Phase (2 cycles): Bemotuzumab (same dose) + Anlotinib (same schedule) + concurrent Thoracic Radiotherapy (5 Gy per fraction for 5 fractions).\n\nMaintenance Phase: Bemotuzumab (q3w) + Anlotinib until disease progression or unacceptable toxicity.\n\nAnlotinib Dose Modification: The dose may be increased to 12mg if well tolerated. For toxicity, it can be reduced sequentially (12mg→10mg→8mg). Treatment is discontinued if 8mg is not tolerated. For subjects at 8mg, one dose re-escalation is permitted if, in the investigator's judgement, clinical benefit is possible and safety is stable.",[9],[21,22,23,24],"Anlotinib Hydrochloride","Bemotuzumab Injection","Fucovee","Hypofractionated Radiotherapy",[26,29],{"name":27,"affiliation":5,"role":28},"Dingzhi Huang, Doctor","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":5,"role":28},"Ningbo Liu, Doctor",[32,37],{"name":27,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","86-22-23340123","3200","dingzhih72@163.com",{"name":30,"role":33,"phone":38,"phoneExt":39,"email":40},"+8615602036608",null,"liuningbo@tjmuch.com",[42],{"facility":43,"status":39,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Tianjin Medical University Cancer Institute & Hospital","Tianjin","Tianjin Municipality","300000","China","CN",{"type":50,"coordinates":51},"Point",[52,53],117.17667,39.14222,{"lat":53,"lon":52},[56],{"name":30,"role":33,"phone":38,"phoneExt":39,"email":40},{"type":58,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","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",false,"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.","ALL","18 Years","75 Years",{"count":70,"type":71},25,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","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.",[77,78],"Small Cell Lung Cancer (SCLC)","SCLC, Extensive Stage",[77,80,81,82,83],"bemotuzumab","anlotinib","hypofractionated radiotherapy","Induction therapy","NOT_YET_RECRUITING","2026-01-14",{"date":87,"type":88},"2026-01-22","ACTUAL",{"date":90,"type":71},"2026-02-01",{"date":92,"type":71},"2028-01-01",{"name":5,"class":6},1]