Clinical Trial

A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer

Recruiting Phase 1/2
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Summary
This study aims to investigate the combination of BNT324, a B7-H3 antibody-drug conjugate (ADC) with BNT327, a programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF) bispecific antibody, in participants with advanced/metastatic or relapsed/progressive small cell lung cancer (SCLC) and non small cell lung cancer (NSCLC).
Protocol Amendment History 5 changes
notable Trial sites expanded: 76 -> 86 locations 2026-06-25
notable Primary completion pushed: 2027-08 -> 2028-09 2026-06-25
minor Completion pushed: 2031-06 -> 2032-05 2026-06-25
notable Trial sites expanded: 58 -> 76 locations 2026-05-20
notable Trial sites expanded: 52 -> 58 locations 2026-04-16
Trial Details
NCT Number NCT06892548
Lead Sponsor BioNTech SE
Collaborators: DualityBio Inc., Biotheus Inc.
Conditions Advanced Lung Cancer
Enrollment 594 participants
Start Date 2025-05-02
Primary Completion 2028-09 (estimated)
Study Completion 2032-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-16