AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.
Summary
To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy
Timeline
- Start
- 2015-10-21
- Primary completion
- 2022-04-11
- Completion
- 2029-01-31
Outcome
Met primary endpoint
registry analysis (superiority test); AZD9291 80mg Tablet vs Placebo Tablet; p <0.0001; Hazard Ratio (HR) 0.23 (95% CI 0.18 to 0.30); Log Rank NCT02511106 ↗
registry analysis (superiority test); AZD9291 80mg Tablet vs Placebo Tablet; p <0.0001; Hazard Ratio (HR) 0.27 (95% CI 0.21 to 0.34); Log Rank NCT02511106 ↗
release “ADAURA Phase III trial showing Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the primary analysis population” astrazeneca.com ↗
release “reduced the risk of disease recurrence or death by 83% in the primary endpoint of DFS in patients with Stage II and IIIA disease” astrazeneca.com ↗
release “Approval based on unprecedented results from the ADAURA Phase III trial where Tagrisso reduced the risk of disease recurrence or death by 80%” astrazeneca.com ↗
release “Updated results from the pivotal ADAURA Phase III trial showed that AstraZeneca’s Tagrisso (osimertinib) demonstrated a sustained, clinically meaningful improvement in disease-free survival (DFS)” astrazeneca.com ↗
Publications
- Results Herbst RS, Wu YL, Tsuboi M. Osimertinib in EGFR-Mutated Lung Cancer. Reply. N Engl J Med. 2021 Feb 18;384(7):675-676. doi: 10.1056/NEJMc2033951. No abstract available.
- Murat-Onana ML, Ramalingam SS, Janne PA, Gray JE, Ahn MJ, John T, Yatabe Y, Huang X, Rukazenkov Y, Javey M, Brown H, Li-Sucholeiki X. EGFR mutation testing across the osimertinib clinical program. Lung Cancer. 2025 Jun;204:108549. doi: 10.1016/j.lungcan.2025.108549. Epub 2025 Apr 18.
- Herbst RS, John T, Grohe C, Goldman JW, Kato T, Laktionov K, Bonanno L, Tiseo M, Majem M, Domine M, Ahn MJ, Kowalski DM, Perol M, Sriuranpong V, Ozguroglu M, Bhetariya P, Markovets A, Rukazenkov Y, Muldoon C, Robichaux J, Hartmaier R, Tsuboi M, Wu YL. Molecular residual disease analysis of adjuvant osimertinib in resected EGFR-mutated stage IB-IIIA non-small-cell lung cancer. Nat Med. 2025 Jun;31(6):1958-1968. doi: 10.1038/s41591-025-03577-y. Epub 2025 Mar 17.
- Dwyer LJ, Singhal N, Yu B, Kao S. Successful Osimertinib Rechallenge After Relapse Following Adjuvant Osimertinib: A Case Report. J Thorac Oncol. 2024 Apr;19(4):650-652. doi: 10.1016/j.jtho.2024.01.001. Epub 2024 Feb 9.
- Wu D, Li GF. Improving Report of the ADAURA Trial by Distinguishing Treatment-Related Adverse Events From Treatment-Emergent Adverse Events and Assessing Independence of Censoring in Final Disease-Free Survival Analyses. J Clin Oncol. 2023 Sep 10;41(26):4317-4318. doi: 10.1200/JCO.23.00604. Epub 2023 Jun 30. No abstract available.
- Tsuboi M, Herbst RS, John T, Kato T, Majem M, Grohe C, Wang J, Goldman JW, Lu S, Su WC, de Marinis F, Shepherd FA, Lee KH, Le NT, Dechaphunkul A, Kowalski D, Poole L, Bolanos A, Rukazenkov Y, Wu YL; ADAURA Investigators. Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. N Engl J Med. 2023 Jul 13;389(2):137-147. doi: 10.1056/NEJMoa2304594. Epub 2023 Jun 4.
- John T, Grohe C, Goldman JW, Shepherd FA, de Marinis F, Kato T, Wang Q, Su WC, Choi JH, Sriuranpong V, Melotti B, Fidler MJ, Chen J, Albayaty M, Stachowiak M, Taggart S, Wu YL, Tsuboi M, Herbst RS, Majem M. Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC: Updated Analysis From the Phase 3 ADAURA Trial. J Thorac Oncol. 2023 Sep;18(9):1209-1221. doi: 10.1016/j.jtho.2023.05.015. Epub 2023 May 24.
- Herbst RS, Wu YL, John T, Grohe C, Majem M, Wang J, Kato T, Goldman JW, Laktionov K, Kim SW, Yu CJ, Vu HV, Lu S, Lee KY, Mukhametshina G, Akewanlop C, de Marinis F, Bonanno L, Domine M, Shepherd FA, Urban D, Huang X, Bolanos A, Stachowiak M, Tsuboi M. Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non-Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial. J Clin Oncol. 2023 Apr 1;41(10):1830-1840. doi: 10.1200/JCO.22.02186. Epub 2023 Jan 31.
- John T, Majem M, Legg D, Goldman J. Current and Future Perspectives of Health-Related Quality of Life in Resectable EGFR-Mutated Non-Small Cell Lung Cancer: A Podcast. Target Oncol. 2023 Jan;18(1):1-8. doi: 10.1007/s11523-022-00927-5. Epub 2022 Dec 19. No abstract available.
- Majem M, Goldman JW, John T, Grohe C, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Li S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Atagi S, Zeng L, Kulkarni D, Medic N, Tsuboi M, Herbst RS, Wu YL. Health-Related Quality of Life Outcomes in Patients with Resected Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer Who Received Adjuvant Osimertinib in the Phase III ADAURA Trial. Clin Cancer Res. 2022 Jun 1;28(11):2286-2296. doi: 10.1158/1078-0432.CCR-21-3530.
- Wu YL, John T, Grohe C, Majem M, Goldman JW, Kim SW, Kato T, Laktionov K, Vu HV, Wang Z, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Atasoy A, Herbst RS, Tsuboi M. Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC. J Thorac Oncol. 2022 Mar;17(3):423-433. doi: 10.1016/j.jtho.2021.10.014. Epub 2021 Nov 2.
- Wu YL, Tsuboi M, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS. A plain language summary of results from the ADAURA study: osimertinib after surgery for patients who have early-stage EGFR-mutated non-small cell lung cancer. Future Oncol. 2021 Dec 1;17(35):4827-4835. doi: 10.2217/fon-2021-0752. Epub 2021 Nov 1.
- Wu YL, Tsuboi M, He J, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS; ADAURA Investigators. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Oct 29;383(18):1711-1723. doi: 10.1056/NEJMoa2027071. Epub 2020 Sep 19.
- Wu YL, Herbst RS, Mann H, Rukazenkov Y, Marotti M, Tsuboi M. ADAURA: Phase III, Double-blind, Randomized Study of Osimertinib Versus Placebo in EGFR Mutation-positive Early-stage NSCLC After Complete Surgical Resection. Clin Lung Cancer. 2018 Jul;19(4):e533-e536. doi: 10.1016/j.cllc.2018.04.004. Epub 2018 May 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Osimertinib | Small molecule | 80 mg | Oral |