Clinical Trial

Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy

Active, Not Recruiting Phase 2
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Summary
This is a Phase II, multi-site, open-label, parallel group study in participants with untreated extended-stage small-cell lung cancer (ES-SCLC) (Cohort 1) or small-cell lung cancer (SCLC) which has progressed on first- or second-line treatment (Cohort 2 and Cohort 3). This study will assess the safety, efficacy, and pharmacokinetics (PK) of BNT327.
Protocol Amendment History 17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2024-06-03; most recent amendment 2026-04-16.
Status change: Recruiting → Active, Not Recruiting 2025-02-24
Status change: Not Yet Recruiting → Recruiting 2024-08-26
Trial Details
NCT Number NCT06449209
Lead Sponsor BioNTech SE
Conditions Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
Enrollment 110 participants
Start Date 2024-08-05
Primary Completion 2027-06 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2026-04-17