RecruitingPhase 3NCT06247605

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


Sponsor

Advenchen Laboratories Nanjing Ltd.

Enrollment

243 participants

Start Date

Oct 26, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called AL8326 for people with small cell lung cancer that has returned or spread after previous treatments. Small cell lung cancer is an aggressive form of lung cancer, and this trial is for patients whose cancer has not responded to at least two prior treatment regimens. **You may be eligible if...** - You are 18 or older - You have small cell lung cancer that has come back or progressed after at least two prior treatments, including a platinum-based chemotherapy - Your cancer can be measured on scans - You are expected to live at least 12 weeks - You are in reasonably good physical condition (able to carry out light activities) - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have not yet tried at least two prior treatments - Your organ function is significantly impaired - You have uncontrolled serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAL8326 tablets

10mg/tablet, Oral administration, once daily.

DRUGplacebo

Oral administration, once daily.


Locations(1)

JILIN Cancer Hospital

Changchun, Jilin, China

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NCT06247605


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