Actively Recruiting
WX-0593 Combined With Concurrent Chemoradiotherapy in Unresectable Locally Advanced NSCLC
Led by Jinming Yu · Updated on 2022-04-28
40
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
WX-0593 Combined With Concurrent Chemoradiotherapy in Unresectable Locally Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Pathologically confirmed NSCLC with investigator-assessed previously untreated, unresectable, locally advanced (Stage II, III) disease
- Presence of active ALK or ROS1 mutation
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- At least one evaluable lesion according to RECIST 1.1
- Adequate pulmonary function with FEV1 >50% predicted and DLCO >40% predicted
- Adequate organ and marrow function
- Women of childbearing potential must agree to contraception and have a negative pregnancy test within 7 days before first dose, not breastfeeding
- Male participants must agree to use contraception until 180 days after last study dose
You will not qualify if you...
- Diagnosis of any other malignant tumor besides NSCLC within 5 years prior to study entry
- Mixed small cell and non-small cell lung cancer histology
- Prior therapy with any ALK tyrosine kinase inhibitor (TKI)
- History of extensive diffuse/bilateral interstitial fibrosis or grade 3 or 4 pulmonary fibrosis or interstitial lung disease before first study drug dose
- 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 past 2 years (except vitiligo, Grave's disease, or psoriasis not requiring systemic treatment)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 250117
Actively Recruiting
Research Team
J
Jinming Yu, PhD
CONTACT
L
Linlin Wang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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