Phase II AZD9291 open label study in NSCLC after previous EGFR TKI therapy in EGFR and T790M mutation positive tumours - AURA2

Study identifier:D5160C00002

ClinicalTrials.gov identifier:NCT02094261

EudraCT identifier:2014-000531-17

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Non Small Cell Lung Cancer

Phase

Phase 2

Healthy volunteers

No

Study drug

AZD9291

Sex

All

Actual Enrollment

210

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 20 May 2014
Primary Completion Date: 01 May 2015
Study Completion Date: 07 Nov 2023

Study design

Allocation: N/A
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria