Status:
RECRUITING
WX-0593 Combined With Concurrent Chemoradiotherapy in Unresectable Locally Advanced NSCLC
Lead Sponsor:
Jinming Yu
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 A...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05351320
Start Date
April 30 2022
End Date
May 30 2026
Last Update
April 28 2022
Active Locations (1)
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1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 250117