Clinical Trial

A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC

Recruiting Phase 3
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Summary
This trial is a registrational phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with first-line treatment of HER2-mutant advanced or metastatic non-squamous non-small cell lung cancer.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-11.
Status change: Not Yet Recruiting → Recruiting 2025-11-13
Trial Details
NCT Number NCT07178795
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions Non-squamous Non-small Cell Lung Cancer
Enrollment 440 participants
Start Date 2025-09-29
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-11-17