A Phase I Study of CFT8919 in Patients With Advanced NSCLC

This is a Phase I clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of CFT8919 capsules in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who carry EGFR mutations. The study includes three parts: dose-escalation, dose-expansion, and cohort-expansion. The primary objectives are to determine the maximum tolerated dose (MTD) in the dose-escalation phase and to assess the antitumor efficacy in the cohort-expansion phase. Secondary objectives include assessing pharmacokinetic parameters, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Exploratory objectives will evaluate biomarkers and the relationship between drug exposure and treatment outcomes.