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AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT02151981 · AURA3 Phase 3Completed

Lead sponsor
AstraZeneca (Industry)
Enrollment
421 (actual)
Start date
4 Aug 2014
Primary completion
15 Apr 2016 (actual)
Study completion
15 Dec 2023
Last update posted
7 Jan 2025

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
None
Arms
2

Interventions

  • Chemotherapy Drug
  • Cross-over to Osimertinib Drug

Conditions and primary outcome

  • Anticancer Treatment

Primary outcome

Progression Free Survival (PFS) by Investigator Assessment (RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT02151981 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Progression Free Survival (PFS) by Investigator Assessment

    Time frame
    RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
    Measure
    Median
    Unit
    Months

    • Osimertinib 80mg vs ChemotherapySuperiority or other

      Estimate
      0.30Hazard Ratio (HR)
      95% CI, two-sided
      0.23 to 0.41
      p-value
      <0.001
      Method
      Log Rank

Serious adverse events

Time frame: AEs from start of study drug until 28 days post treatment discontinuation up to 4 years and 7 months (at the time of analysis)

Participants with serious adverse events per group for AURA3, as posted
GroupAffectedAt risk
Osimertinib 80 mg84279
Chemotherapy36136

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

13 on PubMed

  1. Variability of Circulating Tumor DNA Levels in Plasma Samples From Patients With Advanced Non-Small-Cell Lung Cancer in the Absence of Treatment.

    JCO precision oncology · 2025 Oct

    PubMed 41166679 (opens in a new tab)DOI 10.1200/PO-25-00287 (opens in a new tab)

  2. EGFR mutation testing across the osimertinib clinical program.

    Lung cancer (Amsterdam, Netherlands) · 2025 Jun

    PubMed 40311309 (opens in a new tab)DOI 10.1016/j.lungcan.2025.108549 (opens in a new tab)

  3. Longitudinal Analyses of Circulating Tumor DNA for the Detection of EGFR Mutation-Positive Advanced NSCLC Progression During Treatment: Data From FLAURA and AURA3.

    Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2024 Nov

    PubMed 39029876 (opens in a new tab)DOI 10.1016/j.jtho.2024.07.008 (opens in a new tab)

  4. Early Clearance of Plasma Epidermal Growth Factor Receptor Mutations as a Predictor of Outcome on Osimertinib in Advanced Non-Small Cell Lung Cancer; Exploratory Analysis from AURA3 and FLAURA.

    Clinical cancer research : an official journal of the American Association for Cancer Research · 2023 Sep 1

    PubMed 37379430 (opens in a new tab)DOI 10.1158/1078-0432.CCR-22-3146 (opens in a new tab)

  5. An Analysis of 5-Level Version of EQ-5D Adjusting for Treatment Switching: The Case of Patients With Epidermal Growth Factor Receptor T790M-Positive Nonsmall Cell Lung Cancer Treated With Osimertinib.

    Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2022 Jul

    PubMed 35379563 (opens in a new tab)DOI 10.1016/j.jval.2022.01.022 (opens in a new tab)

  6. Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events.

    Clinical trials (London, England) · 2022 Jun

    PubMed 35575012 (opens in a new tab)DOI 10.1177/17407745221093935 (opens in a new tab)

  7. Osimertinib versus platinum-pemetrexed for patients with EGFR T790M advanced NSCLC and progression on a prior EGFR-tyrosine kinase inhibitor: AURA3 overall survival analysis.

    Annals of oncology : official journal of the European Society for Medical Oncology · 2020 Nov

    PubMed 32861806 (opens in a new tab)DOI 10.1016/j.annonc.2020.08.2100 (opens in a new tab)

  8. Epidermal growth factor receptor mutation analysis in tissue and plasma from the AURA3 trial: Osimertinib versus platinum-pemetrexed for T790M mutation-positive advanced non-small cell lung cancer.

    Cancer · 2020 Jan 15

    PubMed 31769875 (opens in a new tab)DOI 10.1002/cncr.32503 (opens in a new tab)

  9. CNS Efficacy of Osimertinib in Patients With T790M-Positive Advanced Non-Small-Cell Lung Cancer: Data From a Randomized Phase III Trial (AURA3).

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2018 Sep 10

    PubMed 30059262 (opens in a new tab)DOI 10.1200/JCO.2018.77.9363 (opens in a new tab)

  10. Patient-Reported Symptoms and Impact of Treatment With Osimertinib Versus Chemotherapy in Advanced Non-Small-Cell Lung Cancer: The AURA3 Trial.

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2018 Jun 20

    PubMed 29733770 (opens in a new tab)DOI 10.1200/JCO.2017.77.2293 (opens in a new tab)

  11. Osimertinib in Japanese patients with EGFR T790M mutation-positive advanced non-small-cell lung cancer: AURA3 trial.

    Cancer science · 2018 Jun

    PubMed 29697876 (opens in a new tab)DOI 10.1111/cas.13623 (opens in a new tab)

  12. Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer.

    The New England journal of medicine · 2017 Feb 16

    PubMed 27959700 (opens in a new tab)DOI 10.1056/NEJMoa1612674 (opens in a new tab)

  13. Gefitinib plus chemotherapy versus placebo plus chemotherapy in EGFR-mutation-positive non-small-cell lung cancer after progression on first-line gefitinib (IMPRESS): a phase 3 randomised trial.

    The Lancet. Oncology · 2015 Aug

    PubMed 26159065 (opens in a new tab)DOI 10.1016/S1470-2045(15)00121-7 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.