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

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07778745
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Adebrelimab — DRUG
    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.
  • Trastuzumab rezetecan — DRUG
    3.2mg/kg 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.

Study Details

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.

Key Dates

First listed
Aug 21, 2026
Start date
Aug 20, 2026
Status verified
Aug 2026
Primary completion
Aug 30, 2027
Completion
Aug 30, 2029

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Adebrelimab + Trastuzumab rezetecan Induction Therapy

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: End of Cycle 3/Cycle 4 induction (each cycle 21 days). Surgery-eligible patients assess tumor 6-8 weeks after Cycle3 last dose; others evaluate at Cycle4 end, ±7-day imaging window. ]

Central Contacts

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