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Study identifier: NCT06841055 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Non-small Cell Lung Cancer  ·  Sponsor: BioNTech SE

PhasePhase 2
Planned participants60
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

BioNTech clinical trials patient information  ·  +49 6131 9084  ·  patients@biontech.de

Always discuss trial participation with your own doctor first.

Locations (30)

The University of Alabama at Birmingham HospitalBirmingham, Alabama, United StatesRecruiting
Moffitt Cancer CenterTampa, Florida, United StatesRecruiting
Baptist Health HardinElizabethtown, Kentucky, United StatesRecruiting
NYU Langone - NYU Grossman School of MedicineNew York, New York, United StatesRecruiting
Texas Oncology, P.A.Houston, Texas, United StatesCompleted
Liverpool Cancer Therapy CentreLiverpool, New South Wales, AustraliaRecruiting
Metro South Health - Princess Alexandra Hospital (PAH)Woolloongabba, Queensland, AustraliaRecruiting
Cancer Research SA (CRSA)Adelaide, South Austraila, AustraliaRecruiting
Hobart Hospital-Royal Hobart HospitalHobart, Tasmania, AustraliaRecruiting
One Clinical Research - Hollywood Private HospitalNedlands, Western Australia, AustraliaRecruiting
Gyeongsang National University Hospital (GNUH)Jinju, Gyeongsangnam-do, South KoreaRecruiting
Chungbuk National University HospitalCheongju-si, South KoreaRecruiting

+ 18 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06841055