NCT06794957

A Study of AL8326 in Non-Small Cell Lung Cancer

A Single-Arm, Open, Phase Ib Study Evaluating the Safety, Preliminary Efficacy of AL8326 in the Treatment of Non-Small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Advenchen Laboratories, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is a multicenter, single arm, open, phase IB clinical trial, designed to evaluate the preliminary efficacy and safety of AL8326 in patients with non-small cell lung cancer (NSCLC) who relapsed or progressed after multi line treatment and failed standard treatment.

Detailed description

The subjects received the test drug al8326 tablets in the order of enrollment (oral administration, once a day, one cycle every 28 days) until intolerable toxicity or disease progression or death or voluntary withdrawal or the end of this study. The subjects will conduct anti-tumor efficacy evaluation and corresponding safety inspection every 2 cycles, and determine the tumor disease status according to the solid tumor efficacy evaluation criteria (RECIST 1.1). Subjects requiring pharmacokinetic analysis will be randomly treated with trial drug AL8326 tablets 60mg QD or 40mg QD (oral administration, once a day, one cycle every 28 days) in a 1:1 ratio.

Conditions

• Non-small Cell Lung Cancer

Interventions

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

Timeline

• Start date: 2022-05-19
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-01-27
• Last updated: 2025-01-27

Locations

10 sites across 1 country: China