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

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05351320
• Other study ID #: FL006-IIT-002
• Status: Recruiting
• Phase: Phase 2
• Start date: April 30, 2022
• Est. completion date: May 30, 2026

Study information

• Verified date: April 2022
• Source: Shandong Cancer Hospital and Institute
• Contact: Jinming Yu, PhD
• Phone: 8613806406293
• Email: jn7984729[@]public.jn.sd.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer (NSCLC)

Intervention

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
• 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

Locations

Country	Name	City	State
China	Shandong Cancer Hospital and Institute	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Jinming Yu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Develop Grade 3 or Higher drug-related Pneumonitis		within 90 days after radiation therapy
Secondary	Progression Free Survival (PFS)	PFS is defined as the time from the first dose of study drug to the first documented disease progression or death due to any cause, whichever occurs first	24 months
Secondary	Overall Survival (OS)	OS is defined as the time from the first dose of study drug to death due to any cause.	24 months
Secondary	Adverse Events (AEs)	Percentage of participants who experienced one or more AEs.	24 months
Secondary	Disease control rate (DCR)		24 months
Secondary	Objective response rate (ORR)		24 months