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

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

DRUG

TGRX-326

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

Sponsors & Collaborators

• Sun Yat-sen University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Sichuan Cancer Hospital and Research Institute

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Zhejiang University

  collaborator OTHER

• Jilin Provincial Tumor Hospital

  collaborator OTHER

• Hunan Cancer Hospital

  collaborator OTHER

• Shandong Cancer Hospital and Institute

  collaborator OTHER

• Jiangxi Provincial Cancer Hospital

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Liaoning Cancer Hospital & Institute

  collaborator OTHER

• Haerbin Medical University Cancer Hospital

  collaborator UNKNOWN

• Xinxiang Central Hospital

  collaborator OTHER

• Xiangyang Central Hospital

  collaborator OTHER

• Mianyang Central Hospital

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• First Affiliated Hospital of Bengbu Medical College

  collaborator UNKNOWN

• Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

  collaborator OTHER

• Bingzhou Medical University Affiliated Hospital

  collaborator UNKNOWN

• Fujian Cancer Hospital

  collaborator OTHER_GOV

• Ningbo No. 1 Hospital

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• The Second Affiliated Hospital of AFMU

  collaborator UNKNOWN

• Yunnan Cancer Hospital

  collaborator OTHER

• Capital Medical School Beijing Chest Hospital

  collaborator UNKNOWN

• Shijiazhuang People's Hospital

  collaborator OTHER

• Tianjin Cancer Hospital

  collaborator UNKNOWN

• Affiliated Cancer Hospital of Guizhou Medical University

  collaborator UNKNOWN

• Nanchang University First Affiliated Hospital

  collaborator UNKNOWN

• Jingzhou First People's Hospital

  collaborator UNKNOWN

• Shanghai Chest Hospital

  collaborator OTHER

• Shenzhen TargetRx, Inc.

  lead INDUSTRY

Principal Investigators

• Li Zhang, MD · Study Principal Investigator

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-18

Primary Completion

2024-12-29

Completion

2025-12-31

Countries

• China

Study Locations