A Phase IIII Study of AL8326 in Small Cell Lung Cancer

Description

This is a multicenter, randomized, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of AL8326 tablets in small cell lung cancer (SCLC) patients with disease progression or recurrence after receiving at least second-line treatment regimens.

There are 2 treatment groups in this trial, and the study population, sample size and basic design of each group are:

Patients with pathologically confirmed small cell lung cancer at baseline and need = or >3rd line treatment : the sample size was expected to be 243 cases, 162 in the active group and 81 in the control group.

Subjects will be randomized in a 2:1 ratio under double-blind conditions into two groups, with the active group receiving the trial drug AL8326 tablets and the control group receiving placebo. AL8326 tablets and placebo are administered as follows: oral administration, once daily for 28 days per cycle until intolerable toxicity or established disease progression or death or voluntary withdrawal or up to 12 months ( approximately 13 cycles) of treatment. Subjects will have a final visit, followed by a long-term follow-up period, and the tumor disease status will be determined according to RECIST 1.1.