Hangzhou Edcheng Pharmaceutical Technology Co., Ltd.

Primary objective To evaluate the overall survival (OS) efficacy of AL8326 tablets as a single agent in patients with small cell lung cancer who have relapsed or progressed after second-line or higher systemic treatment. Secondary objective To evaluate the progression-free survival (PFS) and other efficacy indicators of AL8326 tablets as a single agent in patients with small cell lung cancer who have relapsed or progressed after second-line or higher systemic treatment.

Primary study objective: Effect of a high-fat diet on the pharmacokinetics of AL8326 after oral administration of AL8326 tablets in healthy Chinese adult subjects. Secondary study objective: Safety and tolerability of a single oral dose of AL8326 tablets in healthy subjects.

Primary purpose To evaluate the efficacy of AL8326 monotherapy in the treatment of small cell lung cancer (SCLC) based on the progression-free survival rate of patients with small cell lung cancer (SCLC) who have not progressed after first-line platinum-containing chemotherapy, the objective response rate (ORR) of patients with SCLC who have relapsed or progressed after first-line platinum-containing chemotherapy, and the ORR of patients with SCLC who have relapsed or progressed after second-line or higher treatment. Secondary purpose To evaluate the safety and tolerability of AL8326 monotherapy in patients with small cell lung cancer who have not progressed after first-line platinum-containing chemotherapy; To evaluate the safety and tolerability of AL8326 monotherapy in patients with small cell lung cancer who have relapsed or progressed after first-line platinum-containing chemotherapy; To evaluate the safety and tolerability of AL8326 monotherapy in patients with small cell lung cancer who have relapsed or progressed after at least two lines of treatment. Exploratory purpose (optional) To explore the effect of AL8326 on immune cells in patients with SCLC.