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

Lab values

• 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, or received radiotherapy within last 2 weeks before the initiation of study treatment.
  • 5\. Patients who previously received organ transplantation or stem cell transplantation.
  • 6\. Patients with clinically significant cardiovascular and cerebrovascular diseases.
  • 7\. Patients with dysphagia, active gastrointestinal diseases or other conditions that will interfere significantly with the absorption, distribution, metabolism or excretion of study medication.
  • 8\. Patients who are active carrier of hepatitis B (HBsAg positive and HBV-DNA ≥500IU/mL), hepatitis C virus antibody, treponema pallidum antibody or HIV antibody.
  • 9\. Patients with interstitial lung disease history or signs of active interstitial lung disease.
  • 10\. Pregnant and lactating women. 11. Patients with known allergy or delayed hypersensitivity reaction to study drug or its excipients.
  • 12\. Patients who need to receive drugs which could induce QT/QTc interval prolongation or torsade de pointes, or drugs which are potent CYP3A4 inhibitors or inducers within last 14 days before the initiation of study treatment and during the study.
  • 13\. Patients who are currently under treatment of warfarin or other coumarin anticoagulants.
  • 14\. Patients with other illness or medical conditions potentially interfering with the study treatment.

• 1\. Histologically or cytologically confirmed locally advance or recurrent/metastatic NSCLC that was positive for ALK mutations.
  • 2\. Contrast-enhanced MRI or CT confirmed parenchymal brain metastases with at least one measurable lesion (according to RANO and RECIST 1.1), which was not previously treated with radiotherapy.
  • 3\. At most once treated with chemotherapy, which must have been completed at least 4 weeks before the initiation of study treatment. Any adverse events related to previous chemotherapy treatment have disappeared.
  • 4\. Female or male, 18 years of age or older 5. A Karnofsky Performance Status score of at least 60. 6. An expected survival time of at least 12 weeks. 7. Adequate organ functions, defined as absolute neutrophils count ≥1.5\*10\^9/L，platelets count ≥80\*10\^9/L, hemoglobin concentration≥ 9 g/dL, total bilirubin ≤1.5 \*ULN (upper limits of normal), ALT≤2.5 \*ULN, AST≤2.5 \*ULN, creatinine≤1.5 \*ULN.
  • 8\. Drug related toxicities has been relieved to grade 1 (based on NCI CTCAE v4.03), except for hair loss.
  • 9\. Being willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
  • 10\. Signed and dated informed consent.