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A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)

StatusRecruiting
PhasePhase 3
Started2026-08-28
View on ClinicalTrials.gov ↗

Amendment history

2026-09-08
Study Status, Contacts/Locations v1
Recruitment opened
Start dateestimated 2026-06→confirmed 2026-08-28
Study sitesdetails revised at 1 of 1 site
2026-06-07
Original filing
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in patients with unresectable EGFR-mutated Stage III non-small cell lung cancer who have not progressed following platinum-based chemoradiotherapy.
Trial Details
NCT Number NCT07640789
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions Non-small Cell Lung Cancer Stage III
Enrollment 418 participants
Start Date 2026-08-28
Primary Completion 2030-12 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-10