BNT327-06

This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC).

This study includes two sub-studies (sub-study A and sub-study B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.

Each sub-study contains a Phase 2 part followed by a Phase 3 part. Participants will be randomized to one of two dose levels of BNT327 plus chemotherapy for the Phase 2 part of each sub-study. After the analysis of the Phase 2 data (efficacy, safety, and exposure-response), an internal review committee (IRC) will decide whether participants will be treated with BNT327 at dose level 1 or 2 in the Phase 3 part of the sub-studies. After dose selection, the selected dose will be used for all participants in the study. For the Phase 3 parts of both sub-studies, an independent data monitoring committee (IDMC) will be established as needed to provide independent review of the data during the study.

The sponsor may decide not to perform or stop recruiting participants in the Phase 2 part of the study depending on data generated in the BNT327-01 (NCT06449209) and BNT327-02 (NCT06449222) studies. The sponsor may also choose not to continue all sub-studies.