Yuankai Shi, Jianhua Chen, Runxiang Yang, Hongbo Wu, Zhehai Wang, Weihua Yang, Jiuwei Cui, Yiping Zhang, Chunling Liu, Ying Cheng, Yunpeng Liu, Jinlu Shan, Donglin Wang, Lei Yang, Changlu Hu, Jian Zhao, Ranhua Cao, Bangxian Tan, Ke Xu, Meimei Si, Hui Li, Ruifeng Mao, Lingyan Li, Xiaoyan Kang, Lin Wang
BACKGROUND: Iruplinalkib (WX-0593) is a new-generation, potent anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) and has shown systemic and central nervous system (CNS) efficacy in ALK-positive non-small-cell lung cancer (NSCLC). We compared the efficacy and safety of iruplinalkib with crizotinib in ALK TKI-naïve, locally advanced or metastatic ALK-positive NSCLC patients. METHODS: In this open-label, randomized, multicenter, phase III study, patients with ALK-positive NSCLC were randomly assigned to receive iruplinalkib 180 mg once daily (7-day run-in at 60 mg once daily) or crizotinib 250 mg twice daily...
January 25, 2024: Journal of Thoracic Oncology