A Global Study to assess the Effects of Osimertinib in Participants with EGFRm Stage IA2-IA3 NSCLC following Complete Tumour Resection - ADAURA2

Study identifier:D516FC00001

ClinicalTrials.gov identifier:NCT05120349

EudraCT identifier:2021-004135-89

CTIS identifier:N/A

Recruiting

Official Title

A Phase III, Double-blind, Randomised, Placebo-Controlled, International Study to assess the Efficacy and Safety of Adjuvant Osimertinib versus Placebo in Participants with EGFR mutation-positive Stage IA2-IA3 Non-small Cell Lung Cancer, following Complete Tumour Resection

Medical condition

Non-small Cell Lung Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Osimertinib, Placebo

Sex

All

Estimated Enrollment

380

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 21 Feb 2022
Estimated Primary Completion Date: 02 Aug 2027
Estimated Study Completion Date: 01 Nov 2032

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria