JS111 in Patients With Advanced NSCLC Harboring EGFR Mutations

In Phase I, approximately 3-12 subjects will be enrolled in each dose group (160 mg QD or 240 mg QD) and receive oral JS111 capsules once daily until any treatment discontinuation criteria are met. After all subjects have completed at least 21 days observation following the first dose, the Safety Monitoring Committee (SMC) will review safety and pharmacokinetic data to make decisions. Phase II will continue enrollment at the RP2D dose level until approximately 30 subjects have been treated at that dose.