A Phase IIII Study of AL8326 in Small Cell Lung Cancer

Small Cell Lung Carcinoma Clinical Trial

Official title: Phase III Clinical Study of AL8326 Tablets in Patients With Advanced or Recurrent Small Cell Lung Cancer After at Least Prior Second-line Treatment

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Small Cell Lung Carcinoma

• NCT number: NCT06247605
• Study type: Interventional
• Source: Advenchen Laboratories, LLC
• Contact: yingyin Li
• Phone: +8657188683590
• Email: anne@advenchen.com.cn
• Status: Recruiting
• Phase: Phase 3
• Start date: October 26, 2023
• Completion date: July 2029