MedTrace Logo

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

NCT06082635 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2025-05-18

No results posted yet for this study

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

Conditions

  • Non Small Cell Lung Cancer

Interventions

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

Sponsors & Collaborators

  • Sun Yat-sen University

    collaborator OTHER

  • Shenzhen TargetRx, Inc.

    lead INDUSTRY

Principal Investigators

  • Li Zhang, MD · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-14
Primary Completion
2026-04-30
Completion
2028-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06082635 on ClinicalTrials.gov