Study design and participants
heart failure, cardiovascular or cerebrovascular disease
MENINGEAL METASTASES, HEART FAILURE, MYOCARDIAL INFARCTION, INTERSTITIAL FIBROSIS
This study was conducted at 41 hospitals in China, in accordance with the Declaration of Helsinki and the International Council for Harmonisation guidelines for Good Clinical Practice. The study protocol was approved by the ethics committees of each participating hospital and registered on the Center for Drug Evaluation of National Medical Products Administration of China (CTR20190789) and ClinicalTrials.gov (NCT04641754). All patients provided written informed consent before participating in the study.Eligible patients were ≥ 18 years old; with Key exclusion criteria included previous ALK inhibitors other than crizotinib; continuous steroids > 30 days; planned to receive drugs that prolong QTc interval such as azithromycin or previously treated with those drugs within 14 days before iruplinalkib treatment initiation; or planned to receive strong inducer or inhibitor of CYP3A4 such as phenobarbital or previously treated with those drugs within seven days before iruplinalkib treatment initiation; with meningeal metastases; any clinically relevant cardiovascular or cerebrovascular disease such as myocardial infarction, heart failure within six months before iruplinalkib treatment initiation; or previous history of diffuse or bilateral lung interstitial fibrosis.