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: 09 Oct 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

    • 09 Oct 2017 According to an AstraZeneca media release, based on the results from this study, the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for TAGRISSO (osimertinib) for the 1st-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
    • 10 Sep 2017 According to an AstraZeneca media release, a final overall survival (OS) analysis is planned at a later maturity.
    • 10 Sep 2017 Results presented in an AstraZeneca media release.
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