AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.

NCT02511106 · ADAURA Phase 3Active, not recruiting

Lead sponsor: AstraZeneca (Industry)
Enrollment: 682 (actual)
Start date: 21 Oct 2015
Primary completion: 11 Apr 2022 (actual)
Study completion: 31 Jan 2029
Last update posted: 11 Sep 2026

Design

Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel
Masking: Triple
Arms: 2

Interventions

AZD9291 80 mg/40 mg Drug
Placebo AZD9291 80 mg/40 mg Drug
Open-label AZD9291 80 mg/40 mg Drug

Conditions and primary outcome

Stage IB-IIIA Non-small Cell Lung Carcinoma

Primary outcome

Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS). (Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months))

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT02511106 (opens in a new tab)· Licence: public-domain

First posted 27 Jul 2021 · Last update posted 11 Sep 2026 · Imported 26 Oct 2026 from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).
Time frame
Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months)
Measure
Median
Unit
Months
- AZD9291 80mg Tablet vs Placebo TabletSuperiority
  Estimate
  0.23Hazard Ratio (HR)
  95% CI, two-sided
  0.18 to 0.30
  p-value
  <0.0001
  Method
  Log Rank
Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).
Time frame
Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months)
Measure
Median
Unit
Months
- AZD9291 80mg Tablet vs Placebo TabletSuperiority
  Estimate
  0.27Hazard Ratio (HR)
  95% CI, two-sided
  0.21 to 0.34
  p-value
  <0.0001
  Method
  Log Rank

Serious adverse events

Time frame: Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.

Participants with serious adverse events per group for ADAURA, as posted
Group	Affected	At risk
AZD9291	68	337
Placebo	47	343

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

14 on PubMed

Adjuvant Osimertinib in Resected EGFR-Mutated Stage IB-IIIA NSCLC: Exploratory 8-Year Overall Survival Landmark Update from the ADAURA Trial.
Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2026 Sep 13
PubMed 42732874 (opens in a new tab)DOI 10.1016/j.jtho.2026.104179 (opens in a new tab)
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)
Molecular residual disease analysis of adjuvant osimertinib in resected EGFR-mutated stage IB-IIIA non-small-cell lung cancer.
Nature medicine · 2025 Jun
PubMed 40097663 (opens in a new tab)DOI 10.1038/s41591-025-03577-y (opens in a new tab)
Successful Osimertinib Rechallenge After Relapse Following Adjuvant Osimertinib: A Case Report.
Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2024 Apr
PubMed 38340108 (opens in a new tab)DOI 10.1016/j.jtho.2024.01.001 (opens in a new tab)
Improving Report of the ADAURA Trial by Distinguishing Treatment-Related Adverse Events From Treatment-Emergent Adverse Events and Assessing Independence of Censoring in Final Disease-Free Survival Analyses.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023 Sep 10
PubMed 37390376 (opens in a new tab)DOI 10.1200/JCO.23.00604 (opens in a new tab)
Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC: Updated Analysis From the Phase 3 ADAURA Trial.
Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2023 Sep
PubMed 37236398 (opens in a new tab)DOI 10.1016/j.jtho.2023.05.015 (opens in a new tab)
Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC.
The New England journal of medicine · 2023 Jul 13
PubMed 37272535 (opens in a new tab)DOI 10.1056/NEJMoa2304594 (opens in a new tab)
Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non-Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023 Apr 1
PubMed 36720083 (opens in a new tab)DOI 10.1200/JCO.22.02186 (opens in a new tab)
Current and Future Perspectives of Health-Related Quality of Life in Resectable EGFR-Mutated Non-Small Cell Lung Cancer: A Podcast.
Targeted oncology · 2023 Jan
PubMed 36534268 (opens in a new tab)DOI 10.1007/s11523-022-00927-5 (opens in a new tab)
Health-Related Quality of Life Outcomes in Patients with Resected Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer Who Received Adjuvant Osimertinib in the Phase III ADAURA Trial.
Clinical cancer research : an official journal of the American Association for Cancer Research · 2022 Jun 1
PubMed 35012927 (opens in a new tab)DOI 10.1158/1078-0432.CCR-21-3530 (opens in a new tab)
Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC.
Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2022 Mar
PubMed 34740861 (opens in a new tab)DOI 10.1016/j.jtho.2021.10.014 (opens in a new tab)
A plain language summary of results from the ADAURA study: osimertinib after surgery for patients who have early-stage EGFR-mutated non-small cell lung cancer.
Future oncology (London, England) · 2021 Dec 1
PubMed 34723634 (opens in a new tab)DOI 10.2217/fon-2021-0752 (opens in a new tab)
Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer.
The New England journal of medicine · 2020 Oct 29
PubMed 32955177 (opens in a new tab)DOI 10.1056/NEJMoa2027071 (opens in a new tab)
ADAURA: Phase III, Double-blind, Randomized Study of Osimertinib Versus Placebo in EGFR Mutation-positive Early-stage NSCLC After Complete Surgical Resection.
Clinical lung cancer · 2018 Jul
PubMed 29789220 (opens in a new tab)DOI 10.1016/j.cllc.2018.04.004 (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

AZD9291

Source

NCT02511106 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read 25 Oct 2026

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.