Study Comparing WX-0593 to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients

Summary

The primary purpose of this study is to evaluate the efficacy and safety of WX-0593 vs. crizotinib in patients with ALK-positive non-small cell lung cancer who had not received prior systemic therapy

Timeline

Start

2019-06-01

Primary completion

2024-12-01

Completion

2024-12-01

Outcome

Met primary endpoint

paper The PFS assessed by IRC was significantly longer among patients in the iruplinalkib group PMID 38280448 ↗

paper hazard ratio, 0.34 [98.02% CI: 0.23-0.52], p < 0.0001 PMID 38280448 ↗

release “一线治疗ALK阳性晚期NSCLC疗效和安全性的Ⅲ期头对头随机对照临床试验（INSPIRE研究）——结果显示：独立评审委员会（IRC）评估，伊鲁阿克组和克唑替尼组的中位无进展生存期（mPFS）分别为27.7个月和14.6个月，PFS 风险比（HR）为0.34（P<0.0001）。” qilu-pharma.com ↗

Publications

• Shi Y, Chen J, Yang R, Wu H, Wang Z, Yang W, Cui J, Zhang Y, Liu C, Cheng Y, Liu Y, Shan J, Wang D, Yang L, Hu C, Zhao J, Cao R, Tan B, Xu K, Si M, Li H, Mao R, Li L, Kang X, Wang L. Iruplinalkib (WX-0593) Versus Crizotinib in ALK TKI-Naive Locally Advanced or Metastatic ALK-Positive NSCLC: Interim Analysis of a Randomized, Open-Label, Phase 3 Study (INSPIRE). J Thorac Oncol. 2024 Jun;19(6):912-927. doi: 10.1016/j.jtho.2024.01.013. Epub 2024 Jan 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Crizotinib	Small molecule	250 mg	Oral
Subject	Iruplinalkib	Unknown	180 mg	—

Indications