X-396 (Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases

Exclusion Criteria

• •1. Currently under treatment of other systemic anti-cancer therapies.
• •2. Evidence of active malignancy within last 5 years.
• •3. Patients who participated in other clinical trials within last 4 weeks before the initiation of study treatment.
• •4. Patients who received surgery or immunotherapy within last 4 weeks before the initiation of study treatment.
• •5. Patients who need to receive drugs which are potent CYP3A4 inhibitors or inducers within last 2 weeks before the initiation of study treatment and during the study.
• •6. Patients who previously received organ transplantation or stem cell transplantation.
• •7. Patients with clinically significant cardiovascular diseases.
• •8. Patients with active gastrointestinal diseases or other conditions that will interfere significantly with the absorption, distribution, metabolism or excretion of study medication.
• •9. Patients with interstitial lung disease history or signs of active interstitial lung disease.
• •10. Patients with known allergy or delayed hypersensitivity reaction to study drug or its excipients.
• •11. Pregnant and lactating women.
• •12. Patients with other illness or medical conditions potentially interfering with the study treatment.