A Study of Osimertinib with or without Chemotherapy versus Chemotherapy alone as neoadjuvant therapy for Patients with EGFRm positive resectable Non-Small Cell Lung Cancer - NeoADAURA

Study identifier:D516AC00001

ClinicalTrials.gov identifier:NCT04351555

EudraCT identifier:2020-000058-89

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase III, Randomised, Controlled, Multi-center, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination with Chemotherapy versus Standard of Care Chemotherapy Alone for the Treatment of Patients with Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer

Medical condition

Non-small Cell Lung Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Osimertinib, Cisplatin, Carboplatin, Placebo, Pemetrexed

Sex

All

Actual Enrollment

358

Study type

Interventional

Age

18 Years - 100 Years

Date

Study Start Date: 16 Dec 2020
Estimated Primary Completion Date: 15 Oct 2024
Estimated Study Completion Date: 13 Jun 2029

Study design

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

Verification:

Verified 01 Jul 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria