NCT05120349: ADAURA2

A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection

Active, enrolled Phase 3 Last updated 12 January 2026

What this trial tests

Phase 3 trial testing Osimertinib in Non-Small Cell Lung Cancer in 390 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 February 2022

Primary endpoint
2 August 2027

1 November 2032

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	390
Start date	21 February 2022
Primary completion	2 August 2027
Estimated completion	1 November 2032
Sites	139 locations across Italy, Japan, Malaysia, Taiwan, Vietnam, Poland, South Korea, Russia

Drugs / interventions tested

• Osimertinib (osimertinib) — full drug profile →
• Placebo

Conditions studied

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

Sponsor

AstraZeneca — full company profile →

Who can join

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

Sponsor's own description

This is a global study to assess the effects of osimertinib in participants with EGFRm stage IA2-IA3 non-small cell lung cancer following complete tumour resection.

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. 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
3. Targeted Therapy and Immunotherapy in Early-Stage Non-Small Cell Lung Cancer: Current Evidence and Ongoing Trials.
   de Scordilli M, Michelotti A, Bertoli E, De Carlo E, et al · · 2022 · cited 57× · PMID 35806230 · DOI 10.3390/ijms23137222
4. Adjuvant Osimertinib vs. Placebo in Completely Resected Stage IA2-IA3 EGFR-Mutated NSCLC: ADAURA2.
   Tsutani Y, Goldman JW, Dacic S, Yatabe Y, et al · · 2023 · cited 48× · PMID 36872181 · DOI 10.1016/j.cllc.2023.02.002
5. Adjuvant icotinib versus observation in patients with completely resected EGFR-mutated stage IB NSCLC (GASTO1003, CORIN): a randomised, open-label, phase 2 trial.
   Ou W, Li N, Wang BX, Zhu TF, et al · · 2023 · cited 27× · PMID 36816343 · DOI 10.1016/j.eclinm.2023.101839
6. High-risk features associated with recurrence in stage I lung adenocarcinoma.
   Fick CN, Dunne EG, Vanstraelen S, Toumbacaris N, et al · · 2025 · cited 25× · PMID 38788834 · DOI 10.1016/j.jtcvs.2024.05.009
7. New systemic treatment paradigms in resectable non-small cell lung cancer and variations in patient access across Europe.
   Houda I, Dickhoff C, Uyl-de Groot CA, Reguart N, et al · · 2024 · cited 22× · PMID 38476748 · DOI 10.1016/j.lanepe.2024.100840
8. Personalized care for patients with EGFR-mutant nonsmall cell lung cancer: Navigating early to advanced disease management.
   Borgeaud M, Olivier T, Bar J, Saw SPL, et al · · 2025 · cited 16× · PMID 40673977 · DOI 10.3322/caac.70024