Almonertinib Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB Non-Small Cell Lung Cancer With EGFR-sensitive Mutations

Phase 3 Active not recruiting 192 enrolled Jiangsu Hansoh Pharmaceutical Co., Ltd.

RandomizedParallel-groupTriple-blindTreatment

Summary

To assess the efficacy and safety of Almonertinib versus placebo in patients with epidermal growth factor receptor mutation-positive (EGFRm+) stage II-IIIB non-small cell lung cancer (NSCLC), following complete tumor resection with or without adjuvant chemotherapy.

Timeline

Start: 2021-04-30
Primary completion: 2024-07-08
Completion: 2029-01-01

Outcome

Met primary endpoint

paper The BICR-assessed disease-free survival was significantly improved in the aumolertinib group compared with the placebo group PMID 41539318 ↗

paper with an HR of 0·17 (95% CI 0·09-0·29, p<0·0001). PMID 41539318 ↗

Publications

Zhang L, Zhang X, Wu L, Xing W, Liu C, Zhang P, Chen K, Shi J, Xu S, Zhang X, Dong X, Fang H, Yu X, Gao Y, Li G, Chen Z, Fan S, Zhang X, Cheng Y. Aumolertinib as adjuvant therapy in resected EGFR-mutated non-small-cell lung cancer (ARTS): a double-blind, multicentre, randomised, controlled, phase 3 trial. Lancet Oncol. 2026 Feb;27(2):159-168. doi: 10.1016/S1470-2045(25)00643-6. Epub 2026 Jan 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Almonertinib	Small molecule	110 mg	Oral