RecruitingPhase 2NCT05351320

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


Sponsor

Jinming Yu

Enrollment

40 participants

Start Date

Apr 30, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a targeted drug called WX-0593 (an ALK/ROS1 inhibitor) given alongside standard chemoradiation for people with inoperable, locally advanced non-small cell lung cancer (NSCLC) whose tumors have specific gene mutations (ALK or ROS1). **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of locally advanced, inoperable NSCLC (stage II–III) - Your tumor has an active ALK or ROS1 mutation - You have not received any prior treatment for this cancer - Your lung function, organ function, and performance status are within acceptable limits **You may NOT be eligible if...** - You have another cancer diagnosed within the past 5 years - Your tumor has mixed small cell and non-small cell features - You have previously received ALK-targeted therapy - You have significant interstitial lung disease or active tuberculosis - You have an active autoimmune disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGWX-0593 Tablets

WX-0593 60 mg, tablets, orally, once daily for 7 days, followed by WX-0593 180 mg, tablets, orally, once daily

DRUGchemotherapy

Platinum-based chemotherapy

RADIATIONThoracic 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


Locations(1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

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NCT05351320


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