First-in-Human Phase I/II Study of FHND-9041 in Patients With EGFR Mutated Advanced Non-Small Cell Lung Cancer

"In Phase I, using a 3+3 design, dose escalation and expansion studies were conducted at doses of 40, 80, 120 and 180 mg/day. At least 3 patients were enrolled in each dose arm, and no dose-limiting toxicities were observed. With a plateau observed at 120 mg/day, the 80 mg/d and 120mg/d groups were selected for dose expansion. The 80mg/d queue has expanded by 36 patients, and the 120mg/d queue has expanded by 39 patients. In Phase Ⅱ, after comprehensive analysis and consultation, at least 30 patients were enrolled according to the inclusion and exclusion criteria. 37 patients with locally advanced or metastatic EGFR-mutated NSCLC receiving first-line treatment were enrolled."