AZD9291 versus Placebo in patients with stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy. - ADAURA

Study identifier:D5164C00001

ClinicalTrials.gov identifier:NCT02511106

EudraCT identifier:2015-000662-65

CTIS identifier:2023-506524-82-00

Recruitment Complete

Official Title

A Phase III, double-blind, randomized, placebo-controlled multi-centre, study to assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy (ADAURA).

Medical condition

Stage IB-IIIA non-small cell lung carcinoma

Phase

Phase 3

Healthy volunteers

No

Study drug

AZD9291 80 mg/40 mg, Placebo AZD9291 80 mg/40 mg, Open-label AZD9291 80 mg/40 mg

Sex

All

Actual Enrollment

682

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 21 Oct 2015
Primary Completion Date: 11 Apr 2022
Estimated Study Completion Date: 31 Jan 2029

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

-

Inclusion and exclusion criteria