NCT05955391

TGRX-326 Chinese Phase II for Advanced Non-small Cell Lung Cancer (NSCLC)

A Multi-centered, Open-label, Single-arm Phase II Study to Evaluate the Safety and Efficacy of TGRX-326 Monotherapy in Patients of Advanced ALK-positiveNon-Small Cell Lung Cancer Who Failed 2nd-Generation ALK Inhibitor Therapies

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Shenzhen TargetRx Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, single-arm, open-label, Phase II clinical trial which explores the safety and efficacy of TGRX-326 in patients with ALK-positive advanced NSCLC who have failed prior 2nd-generation ALK treatments due to progressive disease or intolerance.

Detailed description

This Phase II studyaims to evaluate the safety profile and efficacy profile in patients with ALK-positive advanced NSCLC. The primary purpose of this study is to evaluate the efficacy profile of TGRX-326, with the objective response rate (ORR) as end point. Secondary objectives include evaluating efficacy profile of other endpoints and safety profiles of the investigational drug. Exploratory objective includes the evaluation of population pharmacokinetic (PK) profile of TGRX-326.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	TGRX-326	Subjects will be treated with the investigational drug TGRX-326 at 60 mg once day in 21-day cycles

Timeline

• Start date: 2023-01-18
• Primary completion: 2024-12-29
• Completion: 2025-12-31
• First posted: 2023-07-21
• Last updated: 2025-05-18

Locations

1 site across 1 country: China