NCT06082635

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

A Multi-centered, Randomized, Open-label Phase III Study to Evaluate the Efficacy and Safety of TGRX-326 Comparing With Crizotinib in Patients of Advanced ALK-positive or Metastatic Non-Small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 321 (actual)
• Sponsor: Shenzhen TargetRx Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, open-label, Phase III clinical trial which compares the safety and efficacy of TGRX-326 with crizotinib in patients with ALK-positive advanced or metastatic NSCLC

Detailed description

This Phase III study aims to evaluate the safety profile and efficacy profile in patients with ALK-positive advanced or metastatic NSCLC and to compare the efficacy and safety of TGRX-326 with that of crizotinib. The primary purpose of this study is to evaluate and compare the efficacy profile of TGRX-326 with crizotinib, with progression-free survival (PFS) as evaluated by independent review committee (IRC) as end point. Secondary objectives include comparing efficacy profile of other endpoints and safety profiles of the investigational drug with crizotinib. Exploratory objective includes the evaluation of population pharmacokinetic (PK) profile of TGRX-326 and efficacy of TGRX-326 in ALK-positive advanced NSCLC patients determined as progressive disease after crizotinib treatment.

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 a day in 28-day cycles
DRUG	Crizotinib	Subjects will be treated with the control drug crizotinib at 250 mg twice a day in 28-day cycles

Timeline

• Start date: 2023-12-14
• Primary completion: 2026-04-30
• Completion: 2028-11-30
• First posted: 2023-10-13
• Last updated: 2025-05-18

Locations

1 site across 1 country: China