Neoadjuvant Aumolertinib for unresectable stage III EGFR-mutant non-small cell lung cancer: a single-arm phase II trial

Dongliang Bian, Shuyu Ji, Yue Liu, Zhida Huang, Lei Jiang, Ming Liu, Xiao Bao, Jie Yang, Yirui Zhou, Junjie Hu, Liangdong Sun, Yingzhi Zheng, Jie Huang, Jing Liu, Xinsheng Zhu, Jing Zhang, Lele Zhang, Xiaogang Liu, Wenxin He, Dong Xie, Yuming Zhu, Chunyan Wu (), Deping Zhao (), Liang Duan (), Gening Jiang () and Peng Zhang ()
Additional contact information
Dongliang Bian: Tongji University
Shuyu Ji: Tongji University
Yue Liu: Tongji University
Zhida Huang: Fujian Medical University Union Hospital
Lei Jiang: Tongji University
Ming Liu: Tongji University
Xiao Bao: Tongji University
Jie Yang: Tongji University
Yirui Zhou: Tongji University
Junjie Hu: Tongji University
Liangdong Sun: Tongji University
Yingzhi Zheng: Tongji University
Jie Huang: Tongji University
Jing Liu: Tongji University
Xinsheng Zhu: Tongji University
Jing Zhang: Tongji University
Lele Zhang: Tongji University
Xiaogang Liu: Tongji University
Wenxin He: Tongji University
Dong Xie: Tongji University
Yuming Zhu: Tongji University
Chunyan Wu: Tongji University
Deping Zhao: Tongji University
Liang Duan: Tongji University
Gening Jiang: Tongji University
Peng Zhang: Tongji University

Nature Communications, 2025, vol. 16, issue 1, 1-13

Abstract: Abstract Aumolertinib, a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), is widely utilized for advanced EGFR-mutant non-small cell lung cancer patients (NSCLCm). This single-arm, phase II trial (NCT04685070) assessed the feasibility of neoadjuvant Aumolertinib for unresectable stage III NSCLCm. Fifty-six patients were enrolled, with 51 participants receiving neoadjuvant Aumolertinib (110 mg/day, orally) and forming the intention-to-treat population. The primary endpoint was objective response rate (ORR). Secondary endpoints included major pathological response (MPR) rate, pathological complete response (pCR) rate, complete (R0) resection rate, event-free survival (EFS), overall survival (OS), and treatment-related adverse events (TRAEs). The ORR was 70.6% (95% confidence interval: 58%-84%), meeting the pre-specified primary endpoint. Additionally, twenty-three (45.1%) participants converted into resectable disease and underwent surgery. Among them, R0 resection, MPR and pCR rates were 100%, 21.7%, and 13.0%, respectively. The median EFS and OS were not reached. While, the 1- and 2-year EFS rates were 88.2% and 58.8%, respectively. Fatigue (49.0%), alanine aminotransferase concentration elevation (39.2%), and rash (35.3%) were the most common treatment-related adverse events (TRAEs). Grade 3/4 TRAEs occurred in 5 patients (9.8%), and no grade 5 TRAE was recorded. RNA-sequencing based analysis revealed increased infiltration of CD8 + T-cells in post-treatment tumors compared to baseline, particularly in responsive and Ex19-Del mutation tumors. Collectively, neoadjuvant Aumolertinib showed promising efficacy and a surgical conversion rate with a tolerable safety profile for unresecable NSCLCm in stage III, potentially involved in the remodeling of tumor microenvironment.

Date: 2025
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DOI: 10.1038/s41467-025-58435-9

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