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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: WX-0593 Tablets; Drug: chemotherapy; Radiation: Thoracic Radiation Therapy（TRT）

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jinming Yu, PhD; Phone Number: 8613806406293; Email: jn7984729@public.jn.sd.cn
• Study Contact Backup: Name: Linlin Wang, PhD; Phone Number: 8613793187739; Email: wanglinlinatjn@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250117
      • Recruiting
      • Shandong Cancer Hospital and Institute
      • Contact: Jinming Yu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WX-0593 single arm; Part 1: Participants will receive WX-0593 monotherapy until disease progression or unacceptable toxicity. Part 2: Participants will receive 1 or 2 cycles of WX-0593 monotherapy and subsequently with concurrent chemoradiation, followed by WX-0593 monotherapy until disease progression or unacceptable toxicity.	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; Other Names: Iruplinalkib; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Who Develop Grade 3 or Higher drug-related Pneumonitis	within 90 days after radiation therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease control rate (DCR)		24 months
Objective response rate (ORR)		24 months
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
Overall Survival (OS)	OS is defined as the time from the first dose of study drug to death due to any cause.	24 months
Adverse Events (AEs)	Percentage of participants who experienced one or more AEs.	24 months

Collaborators and Investigators

• Sponsor: Jinming Yu

Study record dates

Study Major Dates

• Study Start (Anticipated): April 30, 2022
• Primary Completion (Anticipated): April 30, 2026
• Study Completion (Anticipated): May 30, 2026

Study Registration Dates

• First Submitted: April 24, 2022
• First Submitted That Met QC Criteria: April 24, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 24, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: NSCLC, Unresectable , Radiochemotherapy, WX-0593
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: FL006-IIT-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No