AZD9291 versus gefitinib or erlotinib in patients with locally advanced or metastatic non-small cell lung cancer - FLAURA

Study identifier:D5160C00007

ClinicalTrials.gov identifier:NCT02296125

EudraCT identifier:2014-002694-11

CTIS identifier:N/A

Recruitment Complete

Official Title

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.

Medical condition

Locally advanced or metastatic EGFR sensitising mutation positive Non Small Cell Lung Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

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

Sex

All

Actual Enrollment

674

Study type

Interventional

Age

18 Years - 100 Years

Date

Study Start Date: 03 Dec 2014
Primary Completion Date: 19 Jun 2017
Estimated Study Completion Date: 31 Jan 2025

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria