Phase II, Open Label, Single-arm Study to Assess Safety and Efficacy of AZD9291 in Patients With Locally Advanced/Metastatic NSCLC Whose Disease Has Progressed With Previous EGFR TKI and Whose Tumours Are EGFR and T790M Mutation Positive

Trial Profile

Phase II, Open Label, Single-arm Study to Assess Safety and Efficacy of AZD9291 in Patients With Locally Advanced/Metastatic NSCLC Whose Disease Has Progressed With Previous EGFR TKI and Whose Tumours Are EGFR and T790M Mutation Positive

Completed
Phase of Trial: Phase II

Latest Information Update: 27 Jul 2017

At a glance

  • Drugs Osimertinib (Primary)
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms AURA2
  • Sponsors AstraZeneca
  • Most Recent Events

    • 06 Jun 2017 Results of population pharmacokinetic and pharmacodynamic analysis using data from three AURA studies (AURA, AURA 2 and AURA 3) presented at the 53rd Annual Meeting of the American Society of Clinical Oncology
    • 23 Dec 2016 Results of population pharmacokinetics (popPK) analysis and exposure-response (ER) analysis (n=780) using data from two patient studies (AURA- NCT01802632, AURA2- NCT02094261) and one healthy volunteer study (Study 5, NCT01951599), published in the British Journal of Clinical Pharmacology.
    • 14 Oct 2016 Results of this study (data cut-off 1 Nov 2015), published in the Lancet Oncology Journal.
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