Clinical Trial

Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer

Recruiting Phase 2/3
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Summary
This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC). This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.
Protocol Amendment History 8 changes
critical Primary endpoint(s) modified 2026-08-14
notable Enrollment increased: 1260 -> 1580 participants 2026-08-14
minor Trial arms changed: 8 -> 10 2026-08-14
notable Primary completion moved earlier: 2029-02 -> 2029-01 2026-08-14
minor Completion pushed: 2030-03 -> 2031-12 2026-08-14
notable Trial sites expanded: 225 -> 261 locations 2026-07-02
notable Trial sites expanded: 206 -> 225 locations 2026-05-23
notable Trial sites expanded: 184 -> 206 locations 2026-04-16
Trial Details
NCT Number NCT06712316
Lead Sponsor BioNTech SE
Collaborators: Bristol-Myers Squibb
Conditions Non-small Cell Lung Cancer
Enrollment 1,580 participants
Start Date 2025-01-07
Primary Completion 2029-01 (estimated)
Study Completion 2031-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-13