OncRef

Clinical Trial: NCT02296125

AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:AstraZeneca
Information Provided By:AstraZeneca
Last Update Posted:2026-04-21

Study Overview

Brief 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

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.

Conditions

Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non Small Cell Lung Cancer

Intervention / Treatment

  • Drug: AZD9291 80 mg/40 mg + placebo
  • Drug: Placebo Erlotinib 150/100mg
  • Drug: Placebo Gefitinib 250 mg
  • Drug: Erlotinib 150/100 mg
  • Drug: Gefitinib 250 mg
  • Drug: Placebo AZD9291 80 mg/ 40 mg

Other Study ID Numbers

  • D5160C00007
  • U1111-1160-2242
  • 2014-002694-11
  • 2014

Start Date (Actual)

2014-12-03

Primary Completion Date (Actual)

2017-06-19

Study Completion Date (Actual)

2025-11-20

Enrollment (Actual)

674

Study Type

Interventional

Phase

Phase 3