Non-small Cell Lung Cancer (NSCLC)
Conditions
Keywords
NSCLC, Unresectable , Radiochemotherapy, WX-0593
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.
Interventions
DRUGWX-0593 Tablets
WX-0593 60 mg, tablets, orally, once daily for 7 days, followed by WX-0593 180 mg, tablets, orally, once daily
DRUGchemotherapy
Platinum-based chemotherapy
RADIATIONThoracic 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
Sponsors
Jinming Yu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Develop Grade 3 or Higher drug-related Pneumonitis | within 90 days after radiation therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | 24 months | 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 |
| Overall Survival (OS) | 24 months | OS is defined as the time from the first dose of study drug to death due to any cause. |
| Adverse Events (AEs) | 24 months | Percentage of participants who experienced one or more AEs. |
| Disease control rate (DCR) | 24 months | — |
| Objective response rate (ORR) | 24 months | — |
Countries
China
Contacts
Primary ContactJinming Yu, PhD
Backup ContactLinlin Wang, PhD
Outcome results
None listed