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
Start Date
3/3/2025
Completion Date
10/1/2028
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.
Detailed Description
If the dose level (either from Part 1A or 1B) seems tolerable, an internal review committee will decide if the study can proceed to Part 2 and enroll additional participants. In Part 2, participants who consent will be included in a separate cohort in which they will receive the same treatment as the other participants in Part 2, but in addition to a fresh baseline tumor biopsy, they will be required to provide an on-treatment tumor biopsy sample for additional analyses. Study participants will receive pumitamig in combination with docetaxel until disease progression, the occurrence of intolerable toxicity, study participant withdrawal, death, study termination or 2-year limit (whichever comes first). After completion of study treatment, except for participants who withdraw informed consent, a long-term follow-up will be conducted for all participants to record disease progression, subsequent new anticancer treatments, and survival status.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Pumitamig
Docetaxel
Conditions
Locations
The University of Alabama at Birmingham Hospital
Birmingham, Alabama 35249
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Baptist Health Hardin
Elizabethtown, Kentucky 42701
United States
NYU Langone - NYU Grossman School of Medicine
New York, New York 10016
United States
Texas Oncology, P.A.
Houston, Texas 77090
United States
Liverpool Cancer Therapy Centre
Liverpool, New South Wales 2170
Australia
Metro South Health - Princess Alexandra Hospital (PAH)
Woolloongabba, Queensland 4102
Australia
Cancer Research SA (CRSA)
Adelaide, South Austraila 5000
Australia
Hobart Hospital-Royal Hobart Hospital
Hobart, Tasmania 7000
Australia
One Clinical Research - Hollywood Private Hospital
Nedlands, Western Australia 6009
Australia
Gyeongsang National University Hospital (GNUH)
Jinju, Gyeongsangnam-do 52727
South Korea
Chungbuk National University Hospital
Cheongju-si, 28644
South Korea
Gachon University Gil Medical Center
Incheon, 21565
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Institut dInvestigacio Biomedica de Bellvitge (IDIBELL)
Barcelona, 08908
Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034
Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Spain
Hospital Universitario Virgen del Rocio
Seville, 41013
Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, 46026
Spain
Baskent University Adana Turgut Noyan Application and Research Center Kisla Health Campus
Adana, 01250
Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, 06520
Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, 06800
Turkey (Türkiye)
Memorial Antalya Hospital
Antalya, 07090
Turkey (Türkiye)
Yeditepe University Hospital
Istanbul, 34752
Turkey (Türkiye)
Koc Universitesi Hastanesi (Koc University Hospital)
Zeytinburnu, 34010
Turkey (Türkiye)
Velindre NHS Trust, Velindre Cancer Centre
Cardiff, CF14 2TL
United Kingdom
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
United Kingdom
Sarah Cannon Research Institute
London, W1G 6AD
United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX
United Kingdom