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NOT YET RECRUITING
NCT07836543
PHASE2

Trastuzumab Rezetecan and Adebrelimab, Alone or in Combination, After Chemoradiotherapy for HER2-Altered Unresectable Stage III Lung Cancer

Sponsor: Ming Chen

View on ClinicalTrials.gov

Summary

A randomized phase II study to assess the efficacy and safety of Trastuzumab Rezetecan and/or Adebrelimab as consolidation therapy following chemoradiotherapy in patients with unresectable stage III HER2-altered NSCLC.

Official title: A Randomized, Open-label, Multicenter, Phase II Study of Trastuzumab Rezetecan With Adebrelimab, Trastuzumab Rezetecan Alone and Adebrelimab Alone as Consolidation Therapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer Harboring HER2 Alterations Without Progression After Definitive Chemoradiotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2026-09

Completion Date

2031-12

Last Updated

2026-09-23

Healthy Volunteers

No

Interventions

DRUG

Trastuzumab Rezetecan (SHR-A1811) + Adebrelimab

Trastuzumab Rezetecan (4.8mg/kg, iv, d1, Q3W) and Adebrelimab (1200mg, iv, d1, Q3W). Treatment will continue for up to 12 months or until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation are met.

DRUG

Trastuzumab Rezetecan (SHR-A1811)

Trastuzumab Rezetecan (4.8mg/kg, iv, d1, Q3W). Treatment will continue for up to 12 months or until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation are met.

DRUG

Adebrelimab

Adebrelimab (1200mg, iv, d1, Q3W). Treatment will continue for up to 12 months or until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation are met.