biostudies-literatureShi YChina National Major Project for New Drug InnovationQilu Pharmaceutical Co., Ltd.72https://www.ebi.ac.uk/biostudies/studies/S-EPMC9960473biostudies-literatureUnknown21(1)<h4>Background</h4>Iruplinalkib (WX-0593) is an anaplastic lymphoma kinase (ALK)/c-ros oncogene 1 (ROS1) tyrosine kinase inhibitor. Here we reported the single-arm, phase II study (INTELLECT) results of the efficacy and safety of iruplinalkib for ALK-positive crizotinib-resistant advanced non-small cell lung cancer (NSCLC) patients.<h4>Methods</h4>ALK-positive crizotinib-resistant advanced NSCLC patients aged ≥18 years, with Eastern Cooperative Oncology Group performance status of 0-2 were eligible. Patients received iruplinalkib 180 mg orally once daily for a 21-day cycle with a 7-day lead-in phase at 60 mg orally once daily. The primary endpoint was the independent review committee (IRC)-assessed objective response rate (ORR).<h4>Results</h4>From August 7, 2019, to October 30, 2020, 146 BMC medicineEfficacy and safety of iruplinalkib (WX-0593) in ALK-positive crizotinib-resistant advanced non-small cell lung cancer patients: a single-arm, multicenter phase II study (INTELLECT).PMC99604732017ZX09304015Hu YSi MShan JZhang HHao XZhang LZhang SZhao YShi YWang LWang MLiu YSun SWang XGu KWang ZZhao JYu YLi HKang XYang LChen JHang XTan BYang WHu CZhang ZGeng HZhang YYang RLiu CfalseEfficacy and safety of iruplinalkib (WX-0593) in ALK-positive crizotinib-resistant advanced non-small cell lung cancer patients: a single-arm, multicenter phase II study (INTELLECT).<h4>Background</h4>Iruplinalkib (WX-0593) is an anaplastic lymphoma kinase (ALK)/c-ros oncogene 1 (ROS1) tyrosine kinase inhibitor. Here we reported the single-arm, phase II study (INTELLECT) results of the efficacy and safety of iruplinalkib for ALK-positive crizotinib-resistant advanced non-small cell lung cancer (NSCLC) patients.<h4>Methods</h4>ALK-positive crizotinib-resistant advanced NSCLC patients aged ≥18 years, with Eastern Cooperative Oncology Group performance status of 0-2 were eligible. Patients received iruplinalkib 180 mg orally once daily for a 21-day cycle with a 7-day lead-in phase at 60 mg orally once daily. The primary endpoint was the independent review committee (IRC)-assessed objective response rate (ORR).<h4>Results</h4>From August 7, 2019, to October 30, 2020, 146 2023-01-01T00:00:00Z2023 Feb2026-07-14T22:31:02.081Z2025-02-19T00:13:59.354ZS-EPMC99604733682915410.1186/s12916-023-02738-5