deltatrials
Active Not Recruiting INTERVENTIONAL NCT05120349

A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection (ADAURA2)

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

Sponsor: AstraZeneca

Conditions Non-Small Cell Lung Cancer
Interventions Osimertinib Placebo
Updated 35 times since 2021 Last updated: Apr 22, 2026 Started: Feb 21, 2022 Primary completion: Aug 2, 2027 Completion: Nov 1, 2032
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Non-Small Cell Lung Cancer and is currently ongoing. AstraZeneca leads this study, which shows 35 recorded versions since 2022 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

This is a Phase III, double-blind, randomised, placebo-controlled, 2-arm, international study assessing the efficacy and safety of adjuvant osimertinib versus placebo in participants with stage IA2-IA3 EGFRm Non-Small Cell Lung Cancer, who have previously undergone complete tumour resection. All participants must have had a tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R). Eligible participants will be randomised in a 1:1 ratio to one of the 2 intervention arms: osimertinib 80 mg or matching placebo, once daily for 3 years unless discontinuation criteria is met.

This is a Phase III, double-blind, randomised, placebo-controlled, 2-arm, international study assessing the efficacy and safety of adjuvant osimertinib versus placebo in participants with stage IA2-IA3 EGFRm Non-Small Cell Lung Cancer, who have previously undergone complete tumour resection. All participants must have had a tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R).

Eligible participants will be randomised in a 1:1 ratio to one of the 2 intervention arms: osimertinib 80 mg or matching placebo, once daily for 3 years unless discontinuation criteria is met.

Status Flow

~Dec 2021 – ~Mar 2022 · 3 months · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~Jun 2022 · 2 months · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Oct 2022 · 30 days · monthly snapshot~Oct 2022 – ~Dec 2022 · 2 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~May 2023 · 2 months · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~Apr 2024 · 2 months · monthly snapshot~Apr 2024 – ~May 2024 · 30 days · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Jan 2025 · 3 months · monthly snapshot~Jan 2025 – ~May 2025 · 4 months · monthly snapshot~May 2025 – ~Aug 2025 · 3 months · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Nov 2025 · 2 months · monthly snapshot~Nov 2025 – ~Dec 2025 · 30 days · monthly snapshot~Dec 2025 – ~Feb 2026 · 2 months · monthly snapshot~Feb 2026 – ~Apr 2026 · 3 months · monthly snapshotApr 28, 2026 – present · 3 months · daily API

Change History

35 versions recorded

  1. Apr 28, 2026 — Present [daily]

    Active Not Recruiting

    Phase: PHASE3 → None

  2. Feb 2026 — Apr 2026 [monthly]

    Active Not Recruiting PHASE3

  3. Dec 2025 — Feb 2026 [monthly]

    Active Not Recruiting PHASE3

  4. Nov 2025 — Dec 2025 [monthly]

    Active Not Recruiting PHASE3

  5. Sep 2025 — Nov 2025 [monthly]

    Active Not Recruiting PHASE3

▶ Show 30 earlier versions

  1. Aug 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE3

  2. May 2025 — Aug 2025 [monthly]

    Active Not Recruiting PHASE3

  3. Jan 2025 — May 2025 [monthly]

    Active Not Recruiting PHASE3

  4. Oct 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  5. Sep 2024 — Oct 2024 [monthly]

    Recruiting PHASE3

  6. Aug 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

  7. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE3

  8. May 2024 — Jul 2024 [monthly]

    Recruiting PHASE3

  9. Apr 2024 — May 2024 [monthly]

    Recruiting PHASE3

  10. Feb 2024 — Apr 2024 [monthly]

    Recruiting PHASE3

  11. Jan 2024 — Feb 2024 [monthly]

    Recruiting PHASE3

  12. Dec 2023 — Jan 2024 [monthly]

    Recruiting PHASE3

  13. Nov 2023 — Dec 2023 [monthly]

    Recruiting PHASE3

  14. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE3

  15. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE3

  16. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE3

  17. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE3

  18. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE3

  19. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE3

  20. Mar 2023 — May 2023 [monthly]

    Recruiting PHASE3

  21. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE3

  22. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE3

  23. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE3

  24. Oct 2022 — Dec 2022 [monthly]

    Recruiting PHASE3

  25. Sep 2022 — Oct 2022 [monthly]

    Recruiting PHASE3

  26. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  27. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE3

  28. Apr 2022 — Jun 2022 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  29. Mar 2022 — Apr 2022 [monthly]

    Not Yet Recruiting PHASE3

  30. Dec 2021 — Mar 2022 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

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.

Contact Information

Sponsor contact:
  • AstraZeneca
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Anchorage, United States , Ankara, Turkey (Türkiye) , Atlanta, United States , Bangkok, Thailand , Bangkok, Thailand , Bangkok, Thailand , Barcelona, Spain , Bari, Italy , Barretos, Brazil , Beijing, China and 129 more locations