REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis

Exclusion criteria

• . Major surgery within four weeks of the start of treatment.
• . Type I leptomeningeal disease per ESMO-EANO guidelines.
• . Have received prior radiotherapy within two weeks before the first dose of Study treatment (four weeks in case of radiation therapy of the central nervous system). Participants must have recovered from all radiation-related toxicities, not require steroids, and not have had radiation pneumonitis.
• . Treatment with approved or investigational cancer therapy within14 days prior to initiation of Study treatment.
• . Any of the following cardiac criteria:
• . Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment): myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Classification Class ≥ II), cerebrovascular accident or transient ischemic attack, symptomatic bradycardia, requirement for anti-arrhythmic medication. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2.
• . Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity).
• . Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.