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

Name: A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC — clinical trial record (NCT07178795)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 3

SponsorSichuan Baili Pharmaceutical Co., Ltd.

Started2025-09-29

View on ClinicalTrials.gov ↗

Amendment history

2025-11-13

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2025-09→confirmed 2025-09-29

2025-09-11

Original filing

Sichuan Baili Pharmaceutical Co., Ltd.

135 trials monitored

See 14 trials at risk

Lung Cancer

4,033 trials monitored

See 210 trials at risk

Non-Small Cell Lung Cancer (NSCLC)

2,914 trials monitored

See 156 trials at risk

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.

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