Nanjing Galaxy Biotechnology Co Ltd

Primary: To evaluate the safety and tolerability of C-005 in patients with advanced NSCLC who have developed T790M mutations after previous resistance to first- or second-generation EGFR-TKIs; To determine the MTD (dose escalation phase) of C-005 in patients with locally advanced or metastatic NSCLC carrying EGFR mutations, and the efficacy at the recommended dose level (expanded enrollment phase), to provide a basis for subsequent clinical trial dosing. Secondary: To investigate the PK characteristics of C-005 and its possible major metabolites in NSCLC patients.