NCT07178795

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

A Randomized Controlled Phase III Clinical Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-squamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	BL-M07D1	Administration by intravenous infusion for a cycle of 3 weeks.
DRUG	Pembrolizumab	Administration by intravenous infusion for a cycle of 3 weeks.
DRUG	Pemetrexed	Administration by intravenous infusion for a cycle of 3 weeks.
DRUG	Carboplatin	Administration by intravenous infusion for a cycle of 3 weeks.
DRUG	Cisplatin	Administration by intravenous infusion for a cycle of 3 weeks.

Timeline

• Start date: 2025-09-29
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-09-17
• Last updated: 2025-11-17

Locations

1 site across 1 country: China