CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 674 enrolled
Drug / intervention
AZD9291 80 mg/40 mg + placebo +5 moredrug
Likely dose
AZD9291 80 mg/40 mg + placebofrom 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/NCT02296125
NCT02296125Phase 3Completed
CompareCT.gov

A Phase III, Double-blind, Randomised Study to Assess the Safety and Efficacy of AZD9291 Versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non Small Cell Lung Cancer.

AstraZeneca·interventional·Posted Nov 20, 2014·Updated Apr 21, 2026

In Brief

A Phase 3 clinical trial evaluating AZD9291 80 mg/40 mg + placebo, Placebo Erlotinib 150/100mg, and 4 other interventions for Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non Small Cell Lung Cancer. Completed, enrolled 674 participants across 170 sites in 30 countries.

Detailed Summary

To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non Small Cell Lung Cancer

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLocally Advanced or Metastatic EGFR Sensitising Mutation Positive Non Small Cell Lung Cancer
CountriesAustralia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Malaysia, Philippines, Poland, Portugal, Romania, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States, Vietnam
CollaboratorsParexel

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 20, 2014
Enrollment StartDec 3, 2014
Primary CompletionJun 19, 2017
Study CompletionNov 20, 2025
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.6 years ago

Interventions

AZD9291 80 mg/40 mg + placebodrug

The initial dose of AZD9291 80 mg once daily can be reduced to 40 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

Placebo Erlotinib 150/100mgdrug

The initial dose of Placebo Erlotinib 150 mg once daily can be reduced to Placebo 100 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

Placebo Gefitinib 250 mgdrug

The initial dose of Placebo Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

Erlotinib 150/100 mgdrug

The initial dose of Erlotinib 150mg once daily can be reduced to 10 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria. Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were randomized to Standard of Care arm may have the option to receive open-label AZD9291 (crossover to active AZD9291).

Gefitinib 250 mgdrug

The initial dose of Gefitinib 250mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria. Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were randomized to Standard of Care arm may have the option to receive open-label AZD9291 (crossover to active AZD9291).

Placebo AZD9291 80 mg/ 40 mgdrug

The initial dose of Placebo AZD9291 80 mg once daily can be reduced to Placebo AZD9291 40 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.