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. In the Phase 2 part, participants will be randomized to one of two dose levels of pumitamig (also known as BNT327, BMS-986545, or PM8002) plus chemotherapy (Arm 1 and Arm 2). In the Phase 3 part, participants will be randomized to pumitamig plus chemotherapy (Arm 3) or pembrolizumab plus chemotherapy (Arm 4). In China, additional participants will be enrolled into the Phase 2 part of each substudy to receive pumitamig plus chemotherapy (Arm 1A) to further evaluate the selected Phase 3 dose. For the Phase 3 part of both substudi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
- DrugPumitamig
Intravenous infusion
- DrugPembrolizumab
Intravenous infusion
- DrugCarboplatin
Intravenous infusion
- DrugPemetrexed
Intravenous infusion
- DrugPaclitaxel
Intravenous infusion
Locations (261)
- Birmingham Hematology and Oncology Associates LLC d/b/a Alabama OncologyBirmingham, Alabama
- Alaska Oncology and Hematology, LLCAnchorage, Alaska
- John Muir Clinical Research CenterConcord, California
- University Of California - San Diego Moores Cancer CenterLa Jolla, California
- Clermont Oncology CenterClermont, Florida
- Mid Florida Cancer CentersOrange City, Florida