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A Phase II Single-arm Trial to Investigate Tepotinib in Advanced (Locally Advanced or Metastatic) Non-small Cell Lung Cancer With METex14 Skipping Alterations or MET Amplification (VISION)

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Trial Profile

A Phase II Single-arm Trial to Investigate Tepotinib in Advanced (Locally Advanced or Metastatic) Non-small Cell Lung Cancer With METex14 Skipping Alterations or MET Amplification (VISION)

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

Latest Information Update: 21 Feb 2024

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At a glance

  • Drugs Tepotinib (Primary)
  • Indications Adenocarcinoma; Non-small cell lung cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms VISION
  • Sponsors EMD Serono; EMD Serono Research & Development Institute; Merck KGaA

    • Most Recent Events

    • 16 Feb 2024 According to a Food and Drug Administration media release, the Food and Drug Administration granted traditional approval to tepotinib (Tepmetko, EMD Serono, Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. The approval is based on results from this VISION trial and conversion of approval is based on an additional 161 patients and an added 28 months of follow-up time to assess DOR.
    • 24 Oct 2023 Results (n=313; data cutoff date: 20 Nov 2022) of analysis assessing patient characteristics and outcomes according to METex14 positivity in LBx and/or TBx presented at the 48th European Society for Medical Oncology Congress
    • 24 Oct 2023 Results (n=313) reporting long-term efficacy in previously treated patients and prior/post-tepotinib Treatment presented at the 48th European Society for Medical Oncology Congress
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