NCT06247605

A Phase IIII Study of AL8326 in Small Cell Lung Cancer

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 243 (estimated)
• Sponsor: Advenchen Laboratories Nanjing Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	AL8326 tablets	10mg/tablet, Oral administration, once daily.
DRUG	placebo	Oral administration, once daily.

Timeline

• Start date: 2023-10-26
• Primary completion: 2028-07-01
• Completion: 2029-07-01
• First posted: 2024-02-08
• Last updated: 2024-02-08

Locations

1 site across 1 country: China