Aumolertinib with or Without Chemotherapy As 1st Line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Sensitizing EGFR Mutations

Phase 3 Active not recruiting 624 enrolled Jiangsu Hansoh Pharmaceutical Co., Ltd.

RandomizedParallel-groupOpen-labelTreatment

Summary

To assess the efficacy and safety of Aumolertinib plus chemotherapy versus Aumolertinib alone as first-line treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC) with sensitizing epidermal growth factor receptor mutations (EGFRm+).

Timeline

Start: 2021-08-11
Primary completion: 2024-06-18
Completion: 2026-01-31

Outcome

Met primary endpoint

paper Aumolertinib in combination with chemotherapy significantly improved progression-free survival. PMID 42296979 ↗

paper combination therapy versus 18·9 months (17·8-21·1) in the monotherapy (hazard ratio [HR] 0·47, 95% CI 0·37-0·60; log-rank p<0·0001). PMID 42296979 ↗

release “data from AENEAS2 phase III demonstrate a statistically significant risk reduction over 50% in disease progression or death” hspharm.com ↗

Publications

Li Z, Hu J, Chen J, Yu Y, Meng X, Dong X, Hu Y, Ji Y, Liu H, Wang W, Ning F, Zhang Z, Liu C, Zhang Z, Wang Q, Zheng W, Wang H, Qu X, Chen Z, Fan S, Zhang X, Lu S. Aumolertinib with or without chemotherapy in EGFR-mutated advanced non-small-cell lung cancer (AENEAS2): an open-label, multicentre, randomised, controlled, phase 3 trial. Lancet Oncol. 2026 Jul;27(7):785-794. doi: 10.1016/S1470-2045(26)00090-2. Epub 2026 Jun 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Almonertinib	Small molecule	100 mg	Oral
Subject	Carboplatin	Small molecule	5 unknown	Intravenous
Subject	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Subject	Pemetrexed	Small molecule	500 mg/m2	Intravenous