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A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody) in Combination With Cemiplimab (Anti-PD-1 Antibody) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50%

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Trial Profile

A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody) in Combination With Cemiplimab (Anti-PD-1 Antibody) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50%

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 23 May 2025

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At a glance

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

Most Recent Events

  • 04 Jun 2024 Trial design presented at the 60th Annual Meeting of the American Society of Clinical Oncology.
  • 02 Feb 2024 According to a Regeneron Pharmaceuticals media release, the company to report potentially pivotal initial results form this trial in second half of 2024.
  • 14 Nov 2023 Planned End Date changed from 15 Dec 2031 to 5 Feb 2032.

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