Jiangsu Maidu Pharmaceutical Research and Development Co., Ltd.

This trial is a single-center, open-label, single-dose clinical pharmacokinetic study. It aims to evaluate the in vivo absorption, material balance and biotransformation pathways of a single oral dose of 80 mg/100 μCi [14C] sutetinib maleate suspension in healthy Chinese male subjects, so as to reveal the overall pharmacokinetics and safety of sutetinib maleate in humans and provide a reference for the rational use of the drug in clinical practice.

Primary objective: To evaluate the efficacy of sutetinib maleate capsules in the treatment of patients with locally advanced or metastatic NSCLC who are EGFR mutation-positive. Secondary objective: To evaluate the safety of sutetinib maleate capsules in the treatment of patients with locally advanced or metastatic NSCLC who are EGFR mutation-positive.

Primary objective: To evaluate the efficacy of sutetinib maleate capsules in the treatment of patients with locally advanced or metastatic NSCLC (limited to non-resistant rare EGFR mutations, including L861Q, G719X and/or S768I). Secondary objective: To evaluate the safety of sutetinib maleate capsules in the treatment of patients with locally advanced or metastatic NSCLC (limited to non-resistant rare EGFR mutations, including L861Q, G719X and/or S768I). To evaluate the population pharmacokinetic (PPK) characteristics of sutetinib maleate capsules in the treatment of patients with locally advanced or metastatic NSCLC (limited to non-resistant rare EGFR mutations, including L861Q, G719X and/or S768I).