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

NCT ID: NCT05351320

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2026-05-30

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

WX-0593 Tablets

Intervention Type: DRUG

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

chemotherapy

Intervention Type: DRUG

Platinum-based chemotherapy

Thoracic Radiation Therapy（TRT）

Intervention Type: RADIATION

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

Interventions

WX-0593 Tablets

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

Intervention Type: DRUG

chemotherapy

Platinum-based chemotherapy

Intervention Type: DRUG

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

Intervention Type: RADIATION

Other Intervention Names

Iruplinalkib

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinming Yu

OTHER

Sponsor Role: lead

Responsible Party

Jinming Yu

Director of the hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jinming Yu, PhD

Role: CONTACT

jn7984729@public.jn.sd.cn

8613806406293

Linlin Wang, PhD

Role: CONTACT

wanglinlinatjn@163.com

8613793187739

Facility Contacts

Jinming Yu, PhD

Role: primary

Other Identifiers

FL006-IIT-002

Identifier Type: -

Identifier Source: org_study_id