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

Summary

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

Timeline

Start

2020-12-16

Primary completion

2024-10-15

Completion

2029-06-13

Outcome

Met primary endpoint

registry analysis (superiority test); Osimertinib + Chemo vs Placebo + Chemo; p <0.0001; Odds Ratio (OR) 19.82 NCT04351555 ↗

registry analysis (superiority test); Osimertinib vs Placebo + Chemo; p <0.0001; Odds Ratio (OR) 19.28 NCT04351555 ↗

registry analysis (superiority test); Osimertinib + Chemo vs Placebo + Chemo; p <0.0001; Odds Ratio (OR) 19.17 NCT04351555 ↗

registry analysis (superiority test); Osimertinib vs Placebo + Chemo; p <0.0001; Odds Ratio (OR) 14.68 NCT04351555 ↗

Publications

• He J, Tsuboi M, Weder W, Chen KN, Hochmair MJ, Shih JY, Lee SY, Lee KY, Nhung NV, Saeteng S, Liu L, Xing L, Gia NH, Murakami S, Han Y, Saavedra MP, Yoon SH, Teixeira CHA, Escriu C, Martinez-Marti A, Blakely CM, Yatabe Y, Dacic S, Rukazenkov Y, Huang X, Dayal A, Chaft JE; NeoADAURA Investigators. Neoadjuvant Osimertinib for Resectable EGFR-Mutated Non-Small Cell Lung Cancer. J Clin Oncol. 2025 Sep 10;43(26):2875-2887. doi: 10.1200/JCO-25-00883. Epub 2025 Jun 2.
• 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.
• Lee JB, Choi SJ, Shim HS, Park BJ, Lee CY, Sudhaman S, Velichko S, Hong MH, Cho BC, Lim SM. Neoadjuvant and Adjuvant Osimertinib in Stage IA to IIIA, EGFR-Mutant NSCLC (NORA). J Thorac Oncol. 2025 May;20(5):641-650. doi: 10.1016/j.jtho.2024.12.023. Epub 2024 Dec 26.
• Tsuboi M, Weder W, Escriu C, Blakely C, He J, Dacic S, Yatabe Y, Zeng L, Walding A, Chaft JE. Neoadjuvant osimertinib with/without chemotherapy versus chemotherapy alone for EGFR-mutated resectable non-small-cell lung cancer: NeoADAURA. Future Oncol. 2021 Nov;17(31):4045-4055. doi: 10.2217/fon-2021-0549. Epub 2021 Jul 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Osimertinib	Small molecule	40 mg	Oral
Subject	Osimertinib	Small molecule	80 mg	Oral
Background	Carboplatin	Small molecule	5 unknown	—
Background	Cisplatin	Other / unclassified	75 mg/m2	—
Background	Pemetrexed	Small molecule	500 mg/m2	—

Indications