This is a Phase II, multi-site, open-label, parallel group study in participants with untreated extended-stage small-cell lung cancer (ES-SCLC) (Cohort 1) or small-cell lung cancer (SCLC) which has progressed on first- or second-line treatment (Cohort 2 and Cohort 3). This study will assess the safety, efficacy, and pharmacokinetics (PK) of BNT327.
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Occurrence of treatment emergent adverse events (TEAEs), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-related serious adverse events (SAEs) and treatment-related treatment emergent SAEs
Timeframe: up to 100 days after the last dose of treatment
Occurrence of dose interruption, reduction, and discontinuation of study treatment due to TEAEs
Timeframe: up to 100 days after the last dose of treatment
Objective Response Rate
Timeframe: up to 24 months after completion of study treatment of the last participant
Best percentage change from baseline in the tumor size
Timeframe: up to 24 months after completion of study treatment of the last participant
Proportion of participants who have achieved early tumor shrinkage
Timeframe: up to 2 months after first dose of treatment