ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC

Phase 3 Active not recruiting 337 enrolled Jiangsu Aosaikang Pharmaceutical Co., Ltd.

RandomizedParallel-groupTriple-blindTreatment

Summary

To assess the efficacy and safety of ASK120067 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor Gefitinib in patients with locally advanced or Metastatic Non Small Cell Lung Cancer

Timeline

Start: 2019-07-23
Primary completion: 2024-03-31
Completion: 2026-09-30

Outcome

Met primary endpoint

paper in the limertinib group and 9·7 months (95% CI 8·3-11·1) in the gefitinib group (hazard ratio [HR] 0·44 [95% CI 0·34-0·58]; p<0·0001). PMID 40550238 ↗

Publications

Shi Y, Wu L, Ji Y, Chen G, Li B, Bi M, Yang R, Miao L, Zhang G, Gao H, Sun L, Zhang M, Cang S, Sun M, Yao W, Pan Z, Cui J, Xiao Y, Wang Q; NCT04143607 Study Group. Efficacy and safety of limertinib versus gefitinib as first-line treatment for locally advanced or metastatic non-small-cell lung cancer with EGFR-sensitising mutation: a randomised, double-blind, double-dummy, phase 3 trial. Lancet Respir Med. 2025 Aug;13(8):677-686. doi: 10.1016/S2213-2600(25)00121-3. Epub 2025 Jun 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASK120067	Unknown	80 mg	Oral
Subject	Gefitinib	Small molecule	250 mg	Oral

Indications

No indication recorded.