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A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody), Cemiplimab (Anti-PD-1 Antibody), and Chemotherapy Versus Cemiplimab and Chemotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Irrespective of PD-L1 Expression Levels

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Trial Profile

A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody), Cemiplimab (Anti-PD-1 Antibody), and Chemotherapy Versus Cemiplimab and Chemotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Irrespective of PD-L1 Expression Levels

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 27 Jan 2026

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At a glance

  • Drugs Cemiplimab (Primary) ; Fianlimab (Primary) ; Carboplatin; Cisplatin; Paclitaxel; Pemetrexed
  • Indications Non-small cell lung cancer; Squamous cell cancer
  • Focus Therapeutic Use
  • Sponsors Regeneron Pharmaceuticals

Most Recent Events

  • 22 Jan 2026 Status changed from recruiting to active, no longer recruiting.
  • 09 Sep 2024 According to a Regeneron Pharmaceuticals media release, trial update was presented in an poster presentation session at the IASLC 2024 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer.
  • 04 Jun 2024 Trial design presented at the 60th Annual Meeting of the American Society of Clinical Oncology

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