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

Jinming Yu

Status and phase: Enrolling; Phase 2

Conditions: Non-small Cell Lung Cancer (NSCLC)

Treatments: Drug: WX-0593 Tablets; Radiation: Thoracic Radiation Therapy（TRT）; Drug: chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05351320

FL006-IIT-002

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

WX-0593 single arm

Experimental group

Description:

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.

Treatment:

Drug: chemotherapy

Radiation: Thoracic Radiation Therapy（TRT）

Drug: WX-0593 Tablets