This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with BNT327 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).
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Part 1 - Occurrence of dose limiting toxicities (DLTs) within a participant
Timeframe: 21 days starting on Day 1 of Cycle 1
Part 1 and Part 2a - Occurrence of treatment emergent adverse events (TEAEs), treatment-related adverse events (TRAE), treatment emergent serious adverse events (TESAE), treatment-related serious adverse events (TRSAE)
Timeframe: from the first dose of investigational medicinal product (IMP) up to 90 days after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to a maximum of 27 months)
Part 1 and Part 2a - Occurrence of dose interruption, reduction, and discontinuation due to TEAEs
Timeframe: from the first dose of IMP up to 90 days after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to a maximum of 27 months)
Part 2a and Part 2b - Objective response rate (ORR)
Timeframe: from the time of initiation of the first dose of IMP to approximately 36 months
BioNTech clinical trials patient information