Safety and Efficacy of Intravenous Cemiplimab Plus BNT116 Versus Cemiplimab Alone in Advanced Non-Small Cell Lung Cancer in Adult Participants With PD-L1 ≥ 50%

• Status: Not yet recruiting
• Trial end date: 2027-07-21

Summary

Primary objective of phase 1:

1. To assess the safety and tolerability of BNT116 alone and in combination with cemiplimab in first-line treatment of participants with advanced non-small cell lung cancer (NSCLC) whose tumors express programmed cell death ligand-1 (PD-L1) in ≥ 50% of tumor cells.

Primary objectives of phase 2:

1. To assess the objective response rate (ORR) per independent review committee (IRC) of combination of cemiplimab and BNT116 and cemiplimab monotherapy in the first-line treatment of participants with advanced NSCLC whose tumors express PD-L1 in ≥ 50% of tumor cells.

2. To assess the tumor burden reduction at week 27 per IRC of combination of cemiplimab and BNT116 and cemiplimab monotherapy in the first-line treatment of participants with advanced NSCLC whose tumors express PD-L1 in ≥ 50% of tumor cells.

Secondary objective of phase 1:

To assess anti-tumor activities as measured by ORR, tumor burden reduction at week 27, duration of response (DOR), progression free survival (PFS), and overall survival (OS).

Secondary objectives of phase 2:

1. To assess other anti-tumor activities of combination of cemiplimab and BNT116 and cemiplimab monotherapy, as measured by tumor burden reduction at week 27 and ORR per investigator assessment, DOR, PFS, and OS.

2. To assess the safety and tolerability of combination of cemiplimab and BNT116 and cemiplimab monotherapy.

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Collaborator: BioNTech SE
• Treatments: Cemiplimab