AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

NCT02296125 · FLAURA Phase 3Completed

Lead sponsor: AstraZeneca (Industry)
Enrollment: 674 (actual)
Start date: 3 Dec 2014
Primary completion: 19 Jun 2017 (actual)
Study completion: 20 Nov 2025
Last update posted: 21 Apr 2026

Design

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

Interventions

AZD9291 80 mg/40 mg + placebo Drug
Placebo Erlotinib 150/100mg Drug
Placebo Gefitinib 250 mg Drug
Erlotinib 150/100 mg Drug
Gefitinib 250 mg Drug
Placebo AZD9291 80 mg/ 40 mg Drug

Conditions and primary outcome

Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non Small Cell Lung Cancer

Primary outcome

Median Progression Free Survival (PFS) (Months) (At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression); Percentage of Participants in Progression Free Survival at 6, 12, and 18 Months (At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT02296125 (opens in a new tab)· Licence: public-domain

First posted 6 Nov 2018 · Last update posted 21 Apr 2026 · Imported 26 Oct 2026 from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

Median Progression Free Survival (PFS) (Months)
Time frame
At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression
Measure
Median
Unit
Months
- Osimertinib 80 mg (Global Cohort) vs SoC EGFR-TKI (Global Cohort)Superiority
  Estimate
  0.46Hazard Ratio (HR)
  95% CI, two-sided
  0.37 to 0.57
  p-value
  <0.0001
  Method
  Log Rank
- Osimertinib 80 mg (China Cohort) vs SoC EGFR-TKI (China Cohort)Other
  Estimate
  0.56Hazard Ratio (HR)
  95% CI, two-sided
  0.37 to 0.85
  p-value
  0.0065
  Method
  Log Rank

Serious adverse events

Time frame: All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued

Participants with serious adverse events per group for FLAURA, as posted
Group	Affected	At risk
Osimertinib 80 mg (Global Cohort)	74	279
SoC EGFR-TKI (Global Cohort)	76	277
Osimertinib 80 mg (China Cohort)	25	71
SoC EGFR-TKI (China Cohort)	12	65

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

15 on PubMed

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)
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)
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)
A Real-World Study of Patient Characteristics and Clinical Outcomes in EGFR Mutated Lung Cancer Treated with First-Line Osimertinib: Expanding the FLAURA Trial Results into Routine Clinical Practice.
Cancers · 2024 Mar 7
PubMed 38539415 (opens in a new tab)DOI 10.3390/cancers16061079 (opens in a new tab)
Longitudinal Circulating Tumor DNA Modeling to Predict Disease Progression in First-Line Mutant Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer.
Clinical pharmacology and therapeutics · 2024 Feb
PubMed 38010260 (opens in a new tab)DOI 10.1002/cpt.3113 (opens in a new tab)
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)
Time to deterioration of patient-reported outcomes in non-small cell lung cancer: exploring different definitions.
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022 Aug
PubMed 35099678 (opens in a new tab)DOI 10.1007/s11136-022-03088-0 (opens in a new tab)
Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study.
Targeted oncology · 2021 Mar
PubMed 33544337 (opens in a new tab)DOI 10.1007/s11523-021-00794-6 (opens in a new tab)
Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC.
The New England journal of medicine · 2020 Jan 2
PubMed 31751012 (opens in a new tab)DOI 10.1056/NEJMoa1913662 (opens in a new tab)
Patient-reported outcomes from FLAURA: Osimertinib versus erlotinib or gefitinib in patients with EGFR-mutated advanced non-small-cell lung cancer.
European journal of cancer (Oxford, England : 1990) · 2020 Jan
PubMed 31838405 (opens in a new tab)DOI 10.1016/j.ejca.2019.11.006 (opens in a new tab)
Programmed Cell Death Ligand 1 Expression in Untreated EGFR Mutated Advanced NSCLC and Response to Osimertinib Versus Comparator in FLAURA.
Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2020 Jan
PubMed 31605792 (opens in a new tab)DOI 10.1016/j.jtho.2019.09.009 (opens in a new tab)
Tissue and Plasma EGFR Mutation Analysis in the FLAURA Trial: Osimertinib versus Comparator EGFR Tyrosine Kinase Inhibitor as First-Line Treatment in Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer.
Clinical cancer research : an official journal of the American Association for Cancer Research · 2019 Nov 15
PubMed 31439584 (opens in a new tab)DOI 10.1158/1078-0432.CCR-19-1126 (opens in a new tab)
Postprogression Outcomes for Osimertinib versus Standard-of-Care EGFR-TKI in Patients with Previously Untreated EGFR-mutated Advanced Non-Small Cell Lung Cancer.
Clinical cancer research : an official journal of the American Association for Cancer Research · 2019 Apr 1
PubMed 30659024 (opens in a new tab)DOI 10.1158/1078-0432.CCR-18-3325 (opens in a new tab)
Osimertinib versus standard-of-care EGFR-TKI as first-line treatment for EGFRm advanced NSCLC: FLAURA Japanese subset.
Japanese journal of clinical oncology · 2019 Jan 1
PubMed 30508196 (opens in a new tab)DOI 10.1093/jjco/hyy179 (opens in a new tab)
Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer.
The New England journal of medicine · 2018 Jan 11
PubMed 29151359 (opens in a new tab)DOI 10.1056/NEJMoa1713137 (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.

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Data integrity

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Drugs on HealthTrade

AZD9291

Source

NCT02296125 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.