Zorifertinib With Osimertinib for NSCLC With Meningeal Progression

Exclusion criteria

• ✕. Subjects who plan to receive brain radiotherapy or intrathecal injection during the period from signing ICF to study medication.
• ✕. Radiotherapy history within 28 days before study drug administration is not allowed for enrollment, and palliative radiation to the skeleton occurring within 14 days before study drug administration is also not allowed for enrollment.
• ✕. Subjects who have undergone major surgery (e.g. intrathoracic, intraperitoneal or pelvic surgery) within 4 weeks prior to the first dose of study treatment or who have not yet recovered from the side effects associated with such surgery are not allowed to be enrolled.
• ✕. In addition to NSCLC, there are other malignant tumors, or a history of other malignant tumors within 5 years, except for the following cases: Complete resection of skin basal cell and squamous cell carcinoma and radical resection of any type of carcinoma in situ.
• ✕. Suffering from clinically significant and uncontrollable cardiac disorder and/or heart-related events within 6 months, such as:
• ✕. Strong CYP3A4 inducers or inhibitors;
• ✕. Drugs mainly metabolised by CYP3A4;
• ✕. Drugs that may cause QT interval prolongation or torsade de pointe. 8. Patients with a previous or concurrent HIV infection are not allowed to enroll. Patients who are HCV antibody positive can be enrolled if HCV-RNA is undetectable (the lower limit of normal for HCV-RNA detection is based on the test values of each site) and there is no concurrent hepatitis B virus (HBV) infection. HBV-infected individuals are allowed to be enrolled if they meet the following criteria: 1) Patients with active hepatitis B must meet the following conditions: Antiviral treatment is given for at least 6 weeks before starting study treatment, HBV DNA must be \<100 IU/mL, and ALT and AST levels must be \<ULN; 2) Patients with resolved hepatitis B or chronic hepatitis B must meet the following criteria: Patients have received prophylactic antiviral treatment for at least 2-4 weeks before the start of study treatment, transaminases have been below ULN for \>6 months, and HBV DNA is below 100 IU/mL (if in an inactive carrier state) 9. Women who are pregnant or lactating. Women of childbearing potential are required to use highly effective contraceptive methods during the dosing period and for 3 months after discontinuation of the drug. Fertile males must also use highly effective contraceptive methods during the dosing period and for 6 months after discontinuation of the drug.