drugset / Trial / NCT06449209

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

NCT06449209

Phase 2 Active not recruiting 110 enrolled BioNTech SE
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-08-05
Primary completion
2027-06
Completion
2028-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Pumitamig Protein / enzyme biologic Intravenous
Background Carboplatin Small molecule Intravenous
Background Etoposide Small molecule Intravenous
Background Paclitaxel Small molecule Intravenous
Background Topotecan Small molecule Intravenous