A Phase 2 Study of Cemiplimab (Anti-PD-1 Antibody) in Combination With BNT116 (FixVac Lung) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50%
Latest Information Update: 25 Sep 2025
At a glance
- Drugs BNT 116 (Primary) ; Cemiplimab (Primary)
- Indications Non-small cell lung cancer; Squamous cell cancer
- Focus Therapeutic Use
- Sponsors BioNTech; Regeneron Pharmaceuticals
Most Recent Events
- 21 Aug 2025 Planned End Date changed from 7 Jun 2027 to 16 May 2028.
- 21 Aug 2025 Planned primary completion date changed from 2 Mar 2027 to 26 Jan 2027.
- 21 Aug 2025 Status changed from recruiting to active, no longer recruiting.