RecruitingPhase 3NCT07178795

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


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

440 participants

Start Date

Sep 29, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new targeted treatment — BL-M07D1, an antibody-drug conjugate that delivers chemotherapy directly to cancer cells with HER2 mutations — versus standard pembrolizumab immunotherapy plus platinum chemotherapy, as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) with HER2 mutations. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with advanced or metastatic non-squamous NSCLC - Your tumor has a confirmed HER2 functional (activating) mutation, verified by a central lab - You have not received prior systemic treatment for advanced or metastatic NSCLC - You have good overall health, adequate organ function, and at least one measurable tumor lesion - You have a life expectancy of at least 12 weeks **You may NOT be eligible if...** - Your tumor does not have a HER2 mutation - You have already received systemic treatment for advanced NSCLC - You have significant health conditions that would make treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBL-M07D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUGPembrolizumab

Administration by intravenous infusion for a cycle of 3 weeks.

DRUGPemetrexed

Administration by intravenous infusion for a cycle of 3 weeks.

DRUGCarboplatin

Administration by intravenous infusion for a cycle of 3 weeks.

DRUGCisplatin

Administration by intravenous infusion for a cycle of 3 weeks.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07178795


Related Trials