A Phase III, Double-blind, Randomised Study to Assess the Safety and Efficacy of AZD9291 Versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non Small Cell Lung Cancer

Trial Profile

A Phase III, Double-blind, Randomised Study to Assess the Safety and Efficacy of AZD9291 Versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non Small Cell Lung Cancer

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 28 Nov 2017

At a glance

  • Drugs Osimertinib (Primary) ; Erlotinib; Gefitinib
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms FLAURA
  • Sponsors AstraZeneca
  • Most Recent Events

    • 28 Nov 2017 According to an AstraZeneca media release, the European Medicines Agency has accepted a variation to the Marketing Authorisation Application (MAAv) for Tagrisso (osimertinib) for the 1st-line treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) based on data from this trial.
    • 27 Nov 2017 According to a company media release, AstraZeneca has submitted a supplemental new drug application (sNDA) to Japan's Pharmaceuticals and Medical Devices Agency for the use of Tagrisso (osimertinib) based on data from the Phase III FLAURA trial.
    • 18 Nov 2017 Results published in the New England Journal of Medicine.
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