A Study Comparing BL-B01D1 Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer(PANKU-Lung07)
NCT07502300 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 562
Last updated 2026-04-20
Summary
This trial is a registrational Phase III, randomized, open-label, multicenter study to compare the efficacy and safety of BL-B01D1 in combination with tislelizumab versus platinum-based chemotherapy in combination with tislelizumab in first-line patients with extensive-stage small cell lung cancer.
Conditions
- Extensive-stage Small-cell Lung Cancer
Interventions
- DRUG
-
BL-B01D1
Administration by intravenous infusion for a cycle of 3 weeks.
- DRUG
-
Tislelizumab
Administration by intravenous infusion for a cycle of 3 weeks.
- DRUG
-
Administration by intravenous infusion for a cycle of 3 weeks.
- DRUG
-
Etoposide
Administration by intravenous infusion for a cycle of 3 weeks.
Sponsors & Collaborators
-
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
collaborator INDUSTRY -
Sichuan Baili Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2029-12-31
- Completion
- 2029-12-31
Countries
- China
Study Locations
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