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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
Sponsor: BioNTech SE
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.
Official title: A Phase II, Multisite, Open-label Trial of Pumitamig (BNT327) in Combination With Standard-of-care Chemotherapy in First-line and Second-line Non-small Cell Lung Cancer (NSCLC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-03-03
Completion Date
2028-10
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Pumitamig
Intravenous infusion
Docetaxel
Intravenous infusion
Locations (30)
The University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
Moffitt Cancer Center
Tampa, Florida, United States
Baptist Health Hardin
Elizabethtown, Kentucky, United States
NYU Langone - NYU Grossman School of Medicine
New York, New York, United States
Texas Oncology, P.A.
Houston, Texas, United States
Liverpool Cancer Therapy Centre
Liverpool, New South Wales, Australia
Metro South Health - Princess Alexandra Hospital (PAH)
Woolloongabba, Queensland, Australia
Cancer Research SA (CRSA)
Adelaide, South Austraila, Australia
Hobart Hospital-Royal Hobart Hospital
Hobart, Tasmania, Australia
One Clinical Research - Hollywood Private Hospital
Nedlands, Western Australia, Australia
Gyeongsang National University Hospital (GNUH)
Jinju, Gyeongsangnam-do, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Institut dInvestigacio Biomedica de Bellvitge (IDIBELL)
Barcelona, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, Spain
Baskent University Adana Turgut Noyan Application and Research Center Kisla Health Campus
Adana, Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye)
Memorial Antalya Hospital
Antalya, Turkey (Türkiye)
Yeditepe University Hospital
Istanbul, Turkey (Türkiye)
Koc Universitesi Hastanesi (Koc University Hospital)
Zeytinburnu, Turkey (Türkiye)
Velindre NHS Trust, Velindre Cancer Centre
Cardiff, United Kingdom
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Sarah Cannon Research Institute
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom