NCT06838273

A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase III Randomized Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib versus osimertinib as first-Line treatment in patients with EGFR-mutated locally advanced or metastatic Non-small Cell Lung Cancer.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	BL-B01D1	Administration by intravenous infusion for a cycle of 3 weeks.
DRUG	Osimertinib	Oral administration, 80mg daily for a cycle of 3 weeks.
DRUG	Osimertinib	Oral administration, 80mg daily for a cycle of 3 weeks.

Timeline

• Start date: 2025-02-24
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-02-20
• Last updated: 2025-09-24

Locations

1 site across 1 country: China