NCT06712316

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

A Phase II/III, Multisite, Randomized Master Protocol for a Global Trial of BNT327 in Combination With Chemotherapy and Other Investigational Agents in First-line Non-small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,260 (estimated)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Each substudy contains a Phase 2 part followed by a Phase 3 part. Participants will be randomized to one of two dose levels of pumitamig (BNT327) plus chemotherapy for the Phase 2 part of each substudy. For the Phase 3 part of both substudies, an independent data monitoring committee (IDMC) and a blinded Independent Central Review (BICR) will be established. The IDMC will provide independent review of the data during the study as needed and the BICR will review all available tumor assessment scans for all treated participants. The planned study duration per study participant is up to 64 months.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pumitamig	Intravenous infusion
DRUG	Pembrolizumab	Intravenous infusion
DRUG	Carboplatin	Intravenous infusion
DRUG	Pemetrexed	Intravenous infusion
DRUG	Paclitaxel	Intravenous infusion

Timeline

• Start date: 2025-01-07
• Primary completion: 2029-02-01
• Completion: 2030-03-01
• First posted: 2024-12-02
• Last updated: 2026-04-15

Locations

206 sites across 15 countries: United States, Australia, Belgium, China, France, Germany, Italy, Japan, Poland, Romania, South Korea, Spain, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study