NCT04351555: NeoADAURA

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

Active, enrolled Phase 3 Last updated 23 May 2025

What this trial tests

Phase 3 trial testing Osimertinib in Non-Small Cell Lung Cancer in 358 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

16 December 2020

Primary endpoint
15 October 2024

13 June 2029

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	358
Start date	16 December 2020
Primary completion	15 October 2024
Estimated completion	13 June 2029
Sites	158 locations across Italy, Japan, Taiwan, Vietnam, Poland, South Korea, Russia, Mexico

Drugs / interventions tested

• Osimertinib (osimertinib) — full drug profile →
• Cisplatin (cisplatin) — full drug profile →
• Carboplatin
• Placebo
• Pemetrexed — full drug profile →

Conditions studied

• Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 100, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy alone, for the treatment of patients with resectable EGFRm Non-Small Cell Lung Cancer

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non-Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial.
   Herbst RS, Wu YL, John T, Grohe C, et al · · 2023 · cited 301× · PMID 36720083 · DOI 10.1200/jco.22.02186
2. Evolution of systemic therapy for stages I-III non-metastatic non-small-cell lung cancer.
   Chaft JE, Rimner A, Weder W, Azzoli CG, et al · · 2021 · cited 275× · PMID 33911215 · DOI 10.1038/s41571-021-00501-4
3. Preoperative and Postoperative Systemic Therapy for Operable Non-Small-Cell Lung Cancer.
   Chaft JE, Shyr Y, Sepesi B, Forde PM. · · 2022 · cited 159× · PMID 34985966 · DOI 10.1200/jco.21.01589
4. Neoadjuvant osimertinib with/without chemotherapy versus chemotherapy alone for <i>EGFR</i>-mutated resectable non-small-cell lung cancer: NeoADAURA.
   Tsuboi M, Weder W, Escriu C, Blakely C, et al · · 2021 · cited 150× · PMID 34278827 · DOI 10.2217/fon-2021-0549
5. Targeted Therapies in Early Stage NSCLC: Hype or Hope?
   Friedlaender A, Addeo A, Russo A, Gregorc V, et al · · 2020 · cited 75× · PMID 32878298 · DOI 10.3390/ijms21176329
6. Emerging evidence and treatment paradigm of non-small cell lung cancer.
   Liu SM, Zheng MM, Pan Y, Liu SY, et al · · 2023 · cited 70× · PMID 37069698 · DOI 10.1186/s13045-023-01436-2
7. Erlotinib versus gemcitabine plus cisplatin as neoadjuvant treatment of stage IIIA-N2 EGFR-mutant non-small-cell lung cancer: final overall survival analysis of the EMERGING-CTONG 1103 randomised phase II trial.
   Zhong WZ, Yan HH, Chen KN, Chen C, et al · · 2023 · cited 65× · PMID 36823150 · DOI 10.1038/s41392-022-01286-3
8. Neoadjuvant Targeted Therapy in Resectable NSCLC: Current and Future Perspectives.
   Lee JM, McNamee CJ, Toloza E, Negrao MV, et al · · 2023 · cited 59× · PMID 37451404 · DOI 10.1016/j.jtho.2023.07.006