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
Recruiting now · Phase 2
Conditions studied: Non-small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT06841055
- Run by
- BioNTech SE
- People needed
- 60
- Starts
- 2025-03-03
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2026-04-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The Christie NHS Foundation Trust — Manchester, United Kingdom (enrolling)
- Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
- Baptist Health Hardin — Elizabethtown, Kentucky, United States (enrolling)
- NYU Langone - NYU Grossman School of Medicine — New York, New York, United States (enrolling)
- The University of Alabama at Birmingham Hospital — Birmingham, Alabama, United States (enrolling)
- Liverpool Cancer Therapy Centre — Liverpool, New South Wales, Australia (enrolling)
- Metro South Health - Princess Alexandra Hospital (PAH) — Woolloongabba, Queensland, Australia (enrolling)
- Cancer Research SA (CRSA) — Adelaide, South Austraila, Australia (enrolling)
- Hobart Hospital-Royal Hobart Hospital — Hobart, Tasmania, Australia (enrolling)
- One Clinical Research - Hollywood Private Hospital — Nedlands, Western Australia, Australia (enrolling)
- Gyeongsang National University Hospital (GNUH) — Jinju, Gyeongsangnam-do, South Korea (enrolling)
- Chungbuk National University Hospital — Cheongju-si, South Korea (enrolling)
- Gachon University Gil Medical Center — Incheon, South Korea (enrolling)
- Severance Hospital, Yonsei University Health System — Seoul, South Korea (enrolling)
- Samsung Medical Center — Seoul, South Korea (enrolling)
- Institut dInvestigacio Biomedica de Bellvitge (IDIBELL) — Barcelona, Spain (enrolling)
- Hospital Universitario Ramón y Cajal — Madrid, Spain (enrolling)
- Hospital Universitario Fundacion Jimenez Diaz — Madrid, Spain (enrolling)
- Hospital Universitario Virgen del Rocio — Seville, Spain (enrolling)
- Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur) — Valencia, Spain (enrolling)
- Baskent University Adana Turgut Noyan Application and Research Center Kisla Health Campus — Adana, Turkey (Türkiye) (enrolling)
- Memorial Ankara Hospital — Ankara, Turkey (Türkiye) (enrolling)
- Ankara Bilkent City Hospital — Ankara, Turkey (Türkiye) (enrolling)
- Memorial Antalya Hospital — Antalya, Turkey (Türkiye) (enrolling)
- Yeditepe University Hospital — Istanbul, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
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