To evaluate the efficacy, safety, pharmacokinetic characteristics, exposure level, relationship between efficacy and safety, penetration rate of blood-brain barrier, cerebrospinal fluid PK characteristics and receptor occupancy in relation to efficacy.
[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
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.
To evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy of single and subsequent multiple oral administration of Cnetinib Capsules in patients with advanced non-small cell lung cancer with EGFR gene T790M mutation, so as to provide suggestions for the design of late-stage clinical trials. in accordance with.
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