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)

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT07640789
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Non-small Cell Lung Cancer Stage III

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BL-B01D1 — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Osimertinib — DRUG
    Oral administration for a cycle of 3 weeks.

Study Details

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.

Key Dates

First listed
Jun 11, 2026
Start date
Aug 28, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
418 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BL-B01D1+Osimertinib
    Participants receive BL-B01D1+Osimertinib in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
  • Active Comparator: Osimertinib
    Participants receive Osimertinib in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to approximately 24 months ]

Central Contacts

Related Studies