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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

NCT07778745 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-08-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

DRUG

Trastuzumab rezetecan

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.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-20
Primary Completion
2027-08-30
Completion
2029-08-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07778745 on ClinicalTrials.gov