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

NCT05351320 | Recruiting Phase 2

• 1 other identifier: FL006-IIT-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

NSCLC, Unresectable , Radiochemotherapy, WX-0593

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Develop Grade 3 or Higher drug-related Pneumonitis

  within 90 days after radiation therapy

Secondary Outcomes (5)

• Progression Free Survival (PFS)

  24 months

• Overall Survival (OS)

  24 months

• Adverse Events (AEs)

  24 months

• Disease control rate (DCR)

  24 months

• Objective response rate (ORR)

  24 months

Study Arms (1)

WX-0593 single arm

EXPERIMENTAL

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; Drug: chemotherapy; Radiation: Thoracic Radiation Therapy（TRT）

Interventions

WX-0593 Tablets DRUG

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

Also known as: Iruplinalkib

WX-0593 single arm

chemotherapy DRUG

Platinum-based chemotherapy

WX-0593 single arm

Thoracic Radiation Therapy（TRT） RADIATION

Five days a week to accept chest radiotherapy, once per day, every time 1.8-2.0 Gy, total dose 54-66 Gy

WX-0593 single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinming Yu: lead

Study Sites (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Jinming Yu, PhD

CONTACT

8613806406293; jn7984729@public.jn.sd.cn

Linlin Wang, PhD

CONTACT

8613793187739; wanglinlinatjn@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the hospital

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: April 28, 2022
• Study Start: April 30, 2022
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: April 28, 2022

Record last verified: 2022-04

Locations

CN (1)