NCT05351320

WX-0593 Combined With Concurrent Chemoradiotherapy in Unresectable Locally Advanced NSCLC

A Phase II Study of WX-0593 Combined With Concurrent Chemoradiotherapy in the Treatment of Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutation of ALK or ROS1

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Jinming Yu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this trial is to evaluate the safety of WX-0593 combined with concurrent chemoradiotherapy in unresectable, locally advanced non-small cell lung cancer (NSCLC) with activating mutation of ALK or ROS1. This trial consists of two parts. In Part 1, approximately 8 patients will be included and receive WX-0593 maintenance until disease progression or unacceptable toxicity. In Part 2, approximately 32 patients will be included and receive WX-0593 monotherapy for 1-2 cycles and subsequently with concurrent chemoradiation, followed by WX-0593 maintenance until disease progression or unacceptable toxicity.

Conditions

• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	WX-0593 Tablets	WX-0593 60 mg, tablets, orally, once daily for 7 days, followed by WX-0593 180 mg, tablets, orally, once daily
DRUG	chemotherapy	Platinum-based chemotherapy
RADIATION	Thoracic Radiation Therapy（TRT）	Five days a week to accept chest radiotherapy, once per day, every time 1.8-2.0 Gy, total dose 54-66 Gy

Timeline

• Start date: 2022-04-30
• Primary completion: 2026-04-30
• Completion: 2026-05-30
• First posted: 2022-04-28
• Last updated: 2022-04-28

Locations

1 site across 1 country: China