A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)

This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with pumitamig (also known as BNT327 or PM8002) in participants with relapsed, progressive as well as treatment-naïve, advanced/metastatic non-small cell lung cancer (NSCLC). This study will enroll adult participants with histologically or cytologically confirmed NSCLC that is advanced (i.e., either metastatic or recurrent tumors with no known curative treatment available). The main goals of this study are: 1. To find the best dose levels (DLs) for the combination

Trial Details

NCT ID
NCT07111520
Phase
PHASE1 / PHASE2
Sponsor
BioNTech SE
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • BNT326
  • BNT327
  • Pembrolizumab
  • SoC
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Tampa, Florida, United States|27.94752,-82.45843
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Aged ≥18 years at the time of giving informed consent. Local laws will be followed if the age of consent is older.
  • Have measurable disease defined by RECIST v1.1.
  • Have Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Have adequate organ and bone marrow function within 7 days before randomization/enrollment as defined in the protocol.

For full eligibility, visit ClinicalTrials.gov.

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