Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment
NCT06841055
This study is recruiting at 4 US sites in 4 states, according to its ClinicalTrials.gov record last updated .
Summary
This is a Phase II, multisite, open-label study consisting of two parts in participants with advanced/metastatic Non-small Cell Lung Cancer (NSCLC) which progressed after a first-line chemoimmunotherapy to evaluate the combination of pumitamig (also known as BNT327, BMS-986545 or PM8002) with standard of care. Part 1 is a safety run-in with pumitamig (Dose 1 or Dose 2) plus docetaxel and will include up to 12 participants in total to be treated in Part 1A and 1B sequentially. Part 2 is a dose expansion at the deemed safe dose of pumitamig plus docetaxel and will include up to 54 participants.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Non-small Cell Lung Cancer
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- BioNTech SE
- Last updated on ClinicalTrials.gov
- April 24, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Alabama · 1
- The University of Alabama at Birmingham Hospital · Birmingham, AL
Florida · 1
- Moffitt Cancer Center · Tampa, FL
Kentucky · 1
- Baptist Health Hardin · Elizabethtown, KY
New York · 1
- NYU Langone - NYU Grossman School of Medicine · New York, NY
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.