Clinical Trial

Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

Recruiting Phase 3
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Summary
This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (BNT327) combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy (etoposide/carboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).
Protocol Amendment History 3 changes
notable Trial sites expanded: 211 -> 221 locations 2026-07-25
notable Trial sites expanded: 202 -> 211 locations 2026-07-02
notable Trial sites expanded: 138 -> 202 locations 2026-06-02
Trial Details
NCT Number NCT06712355
Lead Sponsor BioNTech SE
Collaborators: Bristol-Myers Squibb
Conditions Extensive-stage Small-cell Lung Cancer
Enrollment 621 participants
Start Date 2025-02-03
Primary Completion 2028-12 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-24