[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652885":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":11,"centralContacts":25,"locations":11,"responsibleParty":31,"collaborators":11,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":37,"acronym":11,"eligibilityCriteria":38,"healthyVolunteers":35,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":11,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":11,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":11},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Adebrelimab + Trastuzumab rezetecan Induction Therapy","EXPERIMENTAL",null,[13,14],"Drug: Adebrelimab","Drug: Trastuzumab rezetecan",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"DRUG","Adebrelimab","1200mg intravenous infusion on Day 1 of every 21-day cycle for 3-4 induction cycles; consolidation therapy after local treatment as physician discretion. Infusion duration 30-60 minutes.",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"Trastuzumab rezetecan","3.2mg\u002Fkg intravenous infusion on Day 1 of every 21-day cycle for 3-4 induction cycles; fixed dose 408mg if body weight ≥85kg. First infusion over 90 mins, subsequent cycles 60 mins if well tolerated.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Meng Wang Meng Wang","CONTACT","18622221623","18622221623@pm.com",{"type":32,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100652885","phase-2-a-prospective-phase-ii-clinical-trial-evaluating-the-efficacy-and-safety-of-adebrelimab-in-combination-with-trastuzumab-rezetecan-for-patients-with-stage-iii-unresectable-her2-positive-nsclc-100652885",false,"NCT07778745","A Prospective Phase II Clinical Trial Evaluating the Efficacy and Safety of Adebrelimab in Combination With Trastuzumab Rezetecan for Patients With Stage III Unresectable HER2-Positive NSCLC","Inclusion Criteria:\n\n* Aged 18-75 years, male or female.\n* Histologically or cytologically confirmed stage III unresectable NSCLC per AJCC 9th edition, judged unresectable by institutional MDT team.\n* Confirmed HER2 alteration: HER2 mutation\u002Famplification detected by tissue NGS, or HER2 protein overexpression (IHC 2+ or 3+).\n* No prior systemic anti-tumor therapy for NSCLC; prior anti-tumor Chinese herbal medicine allowed if ≥2 weeks washout before first dose.\n* At least 1 measurable target lesion per RECIST v1.1.\n* ECOG performance status 0 or 1.\n* Able to provide tumor tissue specimen (archival ≤6 months or newly biopsied non-irradiated lesion).\n* FEV1 \\>1.0 L and FEV1% predicted \\>40% within past 3 months.\n* Adequate organ function within 7 days before first dose (no blood product\u002FG-CSF support within 14 days):\n\n  * Hematology: WBC ≥3.0×10⁹\u002FL, ANC ≥1.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL, Hb ≥90g\u002FL\n  * Liver: AST\u002FALT ≤2.5×ULN (≤5×ULN for liver metastasis), TBIL ≤1.5×ULN\n  * Renal: Serum Cr ≤1.5×ULN or CrCl ≥50 mL\u002Fmin\n  * Cardiac: LVEF ≥50% by echocardiogram\n* Fertile male\u002Ffemale participants must use effective contraception during treatment and 6 months after last dose; female participants non-lactating, negative serum HCG within 14 days pre-first dose.\n* Voluntarily sign written informed consent, good compliance for follow-up.\n\nExclusion Criteria:\n\n* Mixed small cell\u002Flarge cell neuroendocrine\u002Fsarcomatoid NSCLC histology.\n* Concurrent other actionable driver gene alterations (EGFR, ALK, MET, BRAF, RET etc.) besides HER2.\n* Past or concurrent other malignant tumor (except fully resected cancer ≥5 years without active treatment).\n* Prior thoracic radiotherapy.\n* Major surgery within 28 days or minor invasive surgery within 7 days before first dose.\n* HIV infection, active hepatitis B\u002FC, organ transplant history, congenital\u002Facquired immunodeficiency.\n* Systemic immune modulators (thymosin, interferon, IL-2) within 4 weeks pre-enrollment.\n* Uncontrolled severe cardiovascular disease, unstable angina or intervention-required ventricular arrhythmia within 1 month.\n* Confirmed or suspected interstitial lung disease, severe baseline pulmonary dysfunction interfering with lung toxicity monitoring.\n* Active uncontrolled ≥2 grade infection within 2 weeks before enrollment.\n* Active tuberculosis under treatment.\n* Known hypersensitivity to any component of study drugs or other monoclonal antibodies\u002Ffusion proteins.\n* Any condition judged by investigator to compromise participant safety or trial compliance.","ALL","18 Years","75 Years",{"count":43,"type":44},37,"ESTIMATED","INTERVENTIONAL",[47],"PHASE2","This is a single-arm, open-label, multicenter phase II investigator-initiated trial. The study aims to explore the efficacy and safety of Adebrelimab plus Trastuzumab rezetecan induction therapy in patients with stage III unresectable HER2-altered non-small cell lung cancer (NSCLC). Eligible patients receive 3-4 cycles Q3W induction combination therapy. After induction, patients will receive radical surgery or concurrent chemoradiotherapy via MDT evaluation, followed by consolidation therapy and long-term survival follow-up. The primary endpoint is objective response rate (ORR) assessed per RECIST v1.1. Secondary endpoints include surgical conversion rate, major pathological response (MPR), event-free survival (EFS), overall survival (OS), and safety profiles.",[50],"NSCLC","NOT_YET_RECRUITING","2026-08-19",{"date":54,"type":55},"2026-08-21","ACTUAL",{"date":57,"type":44},"2026-08-20",{"date":59,"type":44},"2029-08-30",{"name":5,"class":6}]