Combining WX-0593 with Chemoradiotherapy for Advanced Lung Cancer

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

This study is testing if adding a new drug called WX-0593 to standard treatment can help people with advanced lung cancer who have certain genetic mutations feel better and live longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shandong Cancer Hospital and Institute (other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT05351320 on ClinicalTrials.gov

What this trial studies

This trial evaluates the safety and efficacy of WX-0593 in combination with concurrent chemoradiotherapy for patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) who have specific genetic mutations (ALK or ROS1). The study is divided into two parts: the first part includes a small group of patients receiving WX-0593 maintenance therapy, while the second part involves a larger group receiving WX-0593 followed by chemoradiation and then maintenance therapy. The goal is to assess how well this combination works and its safety profile.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unresectable, locally advanced NSCLC and active mutations of ALK or ROS1.

Not a fit: Patients with resectable NSCLC or those without the specified genetic mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced NSCLC that is currently difficult to treat.

How similar studies have performed: While this approach is novel in its specific combination, similar studies have shown promise in treating NSCLC with targeted therapies and chemoradiation.

Eligibility criteria

Inclusion Criteria:

* Male or female aged 18 years or older;
* Pathologically confirmed NSCLC who present with investigator-assessed previously untreated, unresectable, locally advanced (Stage II、III) disease (according to TMN staging of AJCC version 8);
* Has active mutation of ALK or ROS1;
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
* Has at least one evaluable lesion (according to RECIST 1.1);
* Have adequate pulmonary function test as a forced expiratory volume in 1 second (FEV1) \>50% of predicted normal volume and carbon monoxide lung diffusing capacity (DLCO) \>40% of predicted normal value;
* Have adequate organ and marrow function;
* If participant is a woman of childbearing potential (WOCBP), must agree to follow the contraceptive guidance from written informed consent until at least 180 days after the last dose of study treatment. The female participant should have negative serum pregnancy test within 7 days prior to the first dose of study drug, and not breastfeeding;
* A male participant must agree to use contraception from written informed consent until at least 180 days after the last dose of study treatment.

Exclusion Criteria:

* Diagnosed other malignant tumor besides NSCLC within 5 years prior to study entry;
* Mixed small cell and non-small cell lung cancer histology;
* Has received prior therapy with any ALK TKI;
* Has a history of extensive diffuse/bilateral interstitial fibrosis, or grade 3 or 4 pulmonary fibrosis or interstitial lung disease prior to the first dose of study drug.

Has a known history of active tuberculosis; severe infection within 4 weeks prior to study entry;

* History of primary immunodeficiency;
* Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.

Where this trial is running

Jinan, Shandong

• Shandong Cancer Hospital and Institute — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Jinming Yu, PhD

Conditions: Non-small Cell Lung Cancer, NSCLC, Unresectable , Radiochemotherapy, WX-0593