At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 210 enrolled
Drug / intervention
AZD9291drug
Likely dose
AZD9291 80 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.
Phase II, Open Label, Single-arm Study to Assess Safety and Efficacy of AZD9291 in Patients With Locally Advanced/Metastatic NSCLC Whose Disease Has Progressed With Previous EGFR TKI and Whose Tumours Are EGFR and T790M Mutation Positive
In Brief
A Phase 2 clinical trial evaluating AZD9291 for Non Small Cell Lung Cancer. Completed, enrolled 210 participants across 44 sites in 8 countries.
Detailed Summary
A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours are Epidermal Growth Factor Receptor Mutation and T790M Mutation Positive
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon Small Cell Lung Cancer
CountriesCanada, Hong Kong, Italy, Japan, South Korea, Spain, Taiwan, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartMay 2014
Primary CompletionMay 2015
Study CompletionNov 2023
TodayJul 2026
First PostedMar 21, 2014
Enrollment StartMay 20, 2014
Primary CompletionMay 1, 2015
Study CompletionNov 7, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.3 years ago
Interventions
AZD9291drug
Once daily tablet 80 mg