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

BioNTech SE

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.

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 month…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Key Inclusion Criteria: * Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 9th edition. * Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the…

Interventions

Drug
Pumitamig
Intravenous infusion
Drug
Pembrolizumab
Intravenous infusion
Drug
Carboplatin
Intravenous infusion
Drug
Pemetrexed
Intravenous infusion
Drug
Paclitaxel
Intravenous infusion

Locations (206)

Alaska Oncology and Hematology, LLC
Anchorage, Alaska
John Muir Clinical Research Center
Concord, California
University Of California - San Diego Moores Cancer Center
La Jolla, California
Clermont Oncology Center
Clermont, Florida
Cleveland Clinic Florida - Martin North Hospital
Stuart, Florida
H. Lee Moffit Cancer center and research institute
Tampa, Florida