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

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

Trial Details

NCT ID
NCT06841055
Phase
PHASE2
Sponsor
BioNTech SE
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Pumitamig
  • Docetaxel
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Tampa, Florida, United States|27.94752,-82.45843
  • Elizabethtown, Kentucky, United States|37.69395,-85.85913
  • New York, New York, United States|40.71427,-74.00597
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Have histologically or cytologically confirmed diagnosis of Stage IV NSCLC that has documented radiographic progression on one or after one prior l…
  • Participants must have received minimum two cycles of immunotherapy in first-line treatment to be eligible to this study.
  • Only one prior line of immunotherapy containing regimen is allowed in an advanced/metastatic setting. If participant had received adjuvant immunoth…
  • Historical PD-L1 results must be available.

For full eligibility, visit ClinicalTrials.gov.

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