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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%

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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%

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 09 Mar 2025

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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

    • 24 Oct 2023 Trial design presented at the 48th European Society for Medical Oncology Congress
    • 16 Oct 2023 According to a BioNTech media release, trial in progress data will be presented at the European Society for Molecular Oncology Congress 2023 in Madrid, Spain from October 20-24, 2023.
    • 15 Oct 2023 According to a Regeneron Pharmaceuticals media release, clinical data from this study will be presented at the European Society for Medical Oncology (ESMO) Congress 2023 from October 20 to 24 in Madrid, Spain.

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