[Translation] Clinical study of cnetinib in patients with advanced non-small cell lung cancer with brain metastases or progression of brain metastases after EGFR inhibitor therapy
主要目的: 评价克耐替尼胶囊对经EGFR抑制剂治疗后脑转移或脑转移进展的晚期非小细胞肺癌(NSCLC)患者的安全性和有效性。 次要目的: 评价克耐替尼在经EGFR抑制剂治疗后脑转移或脑转移进展的晚期NSCLC患者中血脑屏障(BBB)的穿透率及脑脊液(CSF)中的PK特征。 评估克耐替尼的暴露水平与疗效和安全性的关系。
[Translation] Main objective: To evaluate the safety and efficacy of crnetinib capsules in patients with advanced non-small cell lung cancer (NSCLC) with brain metastases or progression of brain metastases after EGFR inhibitor therapy. Secondary objectives: To evaluate the blood-brain barrier (BBB) penetration and PK profile of cerebrospinal fluid (CSF) of crnetinib in advanced NSCLC patients with brain metastases or progression of brain metastases after EGFR inhibitor therapy. To assess the relationship between the exposure level of cnetinib and efficacy and safety.