NCT04351555: Phase 3: (NeoADAURA): Osimertinib VS Osimertinib + Chemo VS Chemo Alone - Neoadjuvant Therapy - EGFRm Positive Resectable Non-Small Cell Lung Cancer

First Posted	2020-04-17
Trial status	Active, not recruiting
Sponsor	AstraZeneca
Abstract Presentation Peer-reviewed journal publication	Neoadjuvant Osimertinib for Resectable EGFR-Mutated Non-Small Cell Lung Cancer J Clin Oncol Sep 2025 PUBMED JCO
NCCN
FDA

NCT04351555: Phase 3: (NeoADAURA): Osimertinib VS Osimertinib + Chemo VS Chemo Alone - Neoadjuvant Therapy - EGFRm Positive Resectable Non-Small Cell Lung Cancer

(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))

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

Intervention / Treatment:

Drug: Osimertinib

Drug: Cisplatin

Drug: Carboplatin

Drug: Placebo

Drug: Pemetrexed

Other Study ID Numbers:

D516AC00001

2022-502606-33-00 ( Registry Identifier ) (REGISTRY: CTIS (EU))

2020-000058-89 ( EudraCT Number )

ClinicalTrials.gov Link: https://clinicaltrials.gov/study/NCT04351555