Abstract CT126: Aumolertinib as adjuvant therapy in patients with stage II-IIIB EGFR-mutated NSCLC after complete tumor resection: A randomized, double-blind, placebo-controlled, phase 3 trial (ARTS)

作者：Ying Cheng, Xiqin Zhang, Lin Wu, Wenxiang Wang, Wenqun Xing, Chunling Liu, Caigang Liu, Kai Chen, Jianhua Shi, Peng Zhang, Shidong Xu, Xiaodong Zhang, Xiaorong Dong, Haohui Fang, Xinmin Yu, Yang Gao, Gaofeng Li, Liang Chen, Huiyuan Gong, Renhua Guo, Zhenyuan Gao, Yinghua Ji, Lunxu Liu, Xianling Liu, Hui Tian, Fei Xiong, Xin Zhao, Lejie Cao, Qing Geng, Hongxu Liu, Jixian Liu, Yang Li, Zhenfa Zhang, Di Ge, Xingya Li, Minghui Wang, Yan Xu, Zhi Xu, Jun Chen, Zhaoxia Dai, Jian Hu, Juan Li, Shujun Li, Min Ye, Aimin Zang, Chanjuan Xie, Zhenzhong Su, Zhenmin Chen, Shaonan Fan · 发表于：Cancer Research · 年份：2025 · DOI：10.1158/1538-7445.am2025-ct126 · 被引用次数：3 · 研究领域：Lung Cancer Treatments and Mutations、Lung Cancer Diagnosis and Treatment、Gastric Cancer Management and Outcomes

Abstract Background: Lung cancer is the primary cause of cancer-related morbidity and mortality globally. Approximately 30% of patients with EGFR mutation (EGFRm) in NSCLC are diagnosed at an early stage and are candidates for curative-intent surgical resection; however, disease recurrence remains a substantial clinical challenge. Aumolertinib is a third-generation EGFR TKI that potently inhibits both sensitizing EGFR mutations (ex19del/L858R) and the resistance mutation T790M. ARTS (NCT04687241) is a randomized, double-blind, placebo-controlled, multicenter, phase 3 trial designed to evaluate the efficacy and safety of adjuvant aumolertinib versus placebo in patients with stage II-IIIB EGFRm NSCLC after complete resection, with or without adjuvant chemotherapy. Methods: Inclusion criteria included patients aged ≥18 years, ECOG PS 0-1, primary non-squamous stage II/IIIA/IIIB (T3N2M0) NSCLC, confirmed EGFRm (ex19del or L858R), complete resection with full postsurgical recovery, with or without postoperative adjuvant chemotherapy. Patients were randomized in a 1:1 ratio to receive aumolertinib (110 mg orally, once daily) or matched placebo for a planned treatment duration of 3 years. Stratification was based on stage (II, IIIA N2-, IIIA/B N2+) and mutation type (ex19del, L858R). The primary endpoint was disease-free survival (DFS), assessed by blinded independent central review (BICR). Secondary endpoints included investigator-assessed DFS, overall survival (OS), and safety pro...