A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA)
Summary
A global study to assess the efficacy and safety of osimertinib following chemoradiation in patients with stage III unresectable Epidermal Growth Factor Receptor Mutation Positive non-small cell lung cancer
Timeline
- Start
- 2018-07-19
- Primary completion
- 2024-01-05
- Completion
- 2027-10-29
Outcome
Met primary endpoint
registry analysis (superiority test); Osimertinib vs Placebo; p <0.001; Hazard Ratio (HR) 0.16 (95% CI 0.10 to 0.24); Log Rank NCT03521154 ↗
paper Osimertinib resulted in a significant progression-free survival benefit as compared with placebo PMID 38828946 ↗
release “LAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival” astrazeneca.com ↗
release “LAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS)” astrazeneca.com ↗
release “Tagrisso continues to serve patients as a backbone therapy in EGFR-mutated lung cancer, extending progression-free survival in the LAURA trial by more than three years.” astrazeneca.com ↗
release “Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years” astrazeneca.com ↗
Publications
- Kato T, Dong X, Takahashi T, Soparattanapaisarn N, Geater SL, Wang CL, Arriola E, Moiseenko F, Thompson L, Grainger E, Armenteros-Monterroso E, Evans A, Bolanos A, Ramalingam SS, Lu S. Osimertinib after definitive CRT in unresectable stage III EGFR-mutated NSCLC: safety outcomes from the phase III LAURA study. Lung Cancer. 2026 Jun 6;218:109486. doi: 10.1016/j.lungcan.2026.109486. Online ahead of print.
- Lu S, Kato T, Dong X, Ahn MJ, Quang LV, Soparattanapaisarn N, Inoue T, Wang CL, Huang M, Yang JC, Cobo M, Ozguroglu M, Casarini I, Sriuranpong V, Cronemberger E, Takahashi T, Runglodvatana Y, Chen M, Huang X, Grainger E, Ghiorghiu D, van der Gronde T, Ramalingam SS. A plain language review of results from the LAURA study: osimertinib after chemoradiotherapy for patients with EGFR-mutated non-small cell lung cancer that cannot be removed by surgery. Future Oncol. 2026 May;22(11):1247-1262. doi: 10.1080/14796694.2026.2652543. Epub 2026 Apr 27.
- Arriola E, Casarini I, Ozguroglu M, Huang M, Takahashi T, Lai X, Goto K, Maneenil K, Lee KH, Cobo M, Valdiviezo N, Evans A, Bolanos A, Huang X, Lai R, Ramalingam SS. Patient-reported outcomes from the LAURA study: osimertinib in patients with unresectable stage III EGFR-mutated non-small cell lung cancer after definitive chemoradiotherapy. Eur J Cancer. 2026 Jun 3;240:116744. doi: 10.1016/j.ejca.2026.116744. Epub 2026 Apr 12.
- 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.
- Lu S, Ahn MJ, Reungwetwattana T, Ozguroglu M, Kato T, Yang JC, Huang M, Fujiki F, Inoue T, Quang LV, Sriuranpong V, Vicente D, Fuentes C, Chaudhry AA, Poole L, Armenteros Monterroso E, Rukazenkov Y, van der Gronde T, Ramalingam SS. Osimertinib after definitive chemoradiotherapy in unresectable stage III epidermal growth factor receptor-mutated non-small-cell lung cancer: analyses of central nervous system efficacy and distant progression from the phase III LAURA study. Ann Oncol. 2024 Dec;35(12):1116-1125. doi: 10.1016/j.annonc.2024.08.2243. Epub 2024 Sep 16.
- Lu S, Kato T, Dong X, Ahn MJ, Quang LV, Soparattanapaisarn N, Inoue T, Wang CL, Huang M, Yang JC, Cobo M, Ozguroglu M, Casarini I, Khiem DV, Sriuranpong V, Cronemberger E, Takahashi T, Runglodvatana Y, Chen M, Huang X, Grainger E, Ghiorghiu D, van der Gronde T, Ramalingam SS; LAURA Trial Investigators. Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. N Engl J Med. 2024 Aug 15;391(7):585-597. doi: 10.1056/NEJMoa2402614. Epub 2024 Jun 2.
- Tu CY, Hsia TC, Lin YC, Liang JA, Li CC, Chien CR. Efficacy of Definitive Radiotherapy for Patients with Clinical Stage IIIB or IIIC Lung Adenocarcinoma and Epidermal Growth Factor Receptor (EGFR) Mutations Treated Using First- or Second-Generation EGFR Tyrosine Kinase Inhibitors. Can Respir J. 2024 Mar 5;2024:8889536. doi: 10.1155/2024/8889536. eCollection 2024.
- Lu S, Casarini I, Kato T, Cobo M, Ozguroglu M, Hodge R, van der Gronde T, Saggese M, Ramalingam SS. Osimertinib Maintenance After Definitive Chemoradiation in Patients With Unresectable EGFR Mutation Positive Stage III Non-small-cell Lung Cancer: LAURA Trial in Progress. Clin Lung Cancer. 2021 Jul;22(4):371-375. doi: 10.1016/j.cllc.2020.11.004. Epub 2021 Jan 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Osimertinib | Small molecule | 80 mg | Oral |