A Phase III, Open Label, Randomized Study of AZD9291 Versus Platinum-Based Doublet Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Whose Disease Has Progressed With Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Whose Tumours Harbour a T790M Mutation Within the Epidermal Growth Factor Receptor Gene (AURA3)

Trial Profile

A Phase III, Open Label, Randomized Study of AZD9291 Versus Platinum-Based Doublet Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Whose Disease Has Progressed With Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Whose Tumours Harbour a T790M Mutation Within the Epidermal Growth Factor Receptor Gene (AURA3)

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Mar 2018

At a glance

  • Drugs Osimertinib (Primary) ; Carboplatin; Cisplatin; Pemetrexed
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms AURA3
  • Sponsors AstraZeneca
  • Most Recent Events

    • 31 Jan 2018 Results presened in an AstraZeneca Media Release.
    • 31 Jan 2018 According to an AstraZeneca media release, based on the data from this trial Health Canada has granted full approval (Notice of Compliance) for Tagrisso (osimertinib) for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
    • 18 Oct 2017 Results assessing concordance between plasma circulating tumor DNA (ctDNA) and tissue for the detection of EGFR mutations using three distinct plasma detection technologies in the Osimertinib Phase III Trial, presented at the 18th World Conference on Lung Cancer.
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