Zorifertinib Plus Intra-Ommaya CSF Chemotherapy for Leptomeningeal Progression in NSCLC After Third-Generation EGFR-TKI

Exclusion criteria

• ✕. Myocardial infarction within 6 months prior to screening;
• ✕. Documented history of heart failure (NYHA Class III-IV);
• ✕. Uncontrolled hypertension: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg, regardless of antihypertensive medication use (adjustment of antihypertensive drugs prior to screening is permitted);
• ✕. Drug-refractory arrhythmias;
• ✕. Screening QTcF \>470 ms;
• ✕. Left ventricular ejection fraction (LVEF) \<50%. 5. Subjects with gastrointestinal diseases or severe impairment of gastrointestinal function that may significantly affect drug absorption (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
• ✕. Strong inducers or strong inhibitors of CYP3A4;
• ✕. Drugs that may prolong the QT interval or induce torsades de pointes. 7. Subjects with prior or current HIV infection are excluded. HCV antibody-positive subjects may be enrolled if HCV RNA is undetectable (with the lower limit of detection defined per each center's standards) and there is no concurrent hepatitis B virus (HBV) infection. HBV-infected subjects may be enrolled if they meet the following conditions: