Clinical Trial

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(PANKU-Lung04)

Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-02-16; most recent amendment 2026-04-15.
Status change: Not Yet Recruiting → Recruiting 2025-03-03
Trial Details
NCT Number NCT06838273
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions Non-small Cell Lung Cancer
Enrollment 720 participants
Start Date 2025-02-24
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-20