At a glance

ClinicalIndex Comparison Record

Phase 3Active· 682 enrolled

Drug / intervention

AZD9291 80 mg/40 mg +2 moredrug

Likely dose

AZD9291 80 mg/40 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02511106

NCT02511106Phase 3Active

Compare CT.gov

A Phase III, Double-blind, Randomized, Placebo-controlled Multi-centre, Study to Assess the Efficacy and Safety of AZD9291 Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy (ADAURA).

AstraZeneca·interventional·Posted Jul 29, 2015·Updated Mar 30, 2026

In Brief

A Phase 3 clinical trial evaluating AZD9291 80 mg/40 mg, Placebo AZD9291 80 mg/40 mg, and 1 other intervention for Stage IB-IIIA Non-small Cell Lung Carcinoma. Active but no longer recruiting, targeting 682 participants across 238 sites in 25 countries.

Detailed Summary

To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsStage IB-IIIA Non-small Cell Lung Carcinoma

CountriesAustralia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Netherlands, Poland, Romania, Russia, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United States, Vietnam

Collaborators--

Timeline

Phase 3Active

20162017201820192020202120222023202420252026202720282029

First PostedJul 2015

Enrollment StartOct 2015

Primary CompletionApr 2022

TodayJul 2026

Study CompletionJan 2029

First PostedJul 29, 2015

Enrollment StartOct 21, 2015

Primary CompletionApr 11, 2022

Study CompletionJan 31, 2029

TodayJul 2, 2026

Enrollment to primary: 6.5 yearsPosted 10.9 years ago

Interventions

AZD9291 80 mg/40 mgdrug

The initial dose of AZD9291 80 mg once daily can be reduced to 40 mg once daily.

Placebo AZD9291 80 mg/40 mgdrug

The initial dose of Placebo AZD9291 80 mg once daily can be reduced to 40 mg once daily.

Open-label AZD9291 80 mg/40 mgdrug

Eligible patients will be offered open-label osimertinib upon recurrence and in the absence of intervening systemic anti-cancer therapy.