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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
WX-0593 60 mg, tablets, orally, once daily for 7 days, followed by WX-0593 180 mg, tablets, orally, once daily
Platinum-based chemotherapy
Five days a week to accept chest radiotherapy, once per day, every time 1.8-2.0 Gy, total dose 54-66 Gy
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
RECRUITINGPercentage of Participants Who Develop Grade 3 or Higher drug-related Pneumonitis
Time frame: within 90 days after radiation therapy
Progression Free Survival (PFS)
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
Time frame: 24 months
Overall Survival (OS)
OS is defined as the time from the first dose of study drug to death due to any cause.
Time frame: 24 months
Adverse Events (AEs)
Percentage of participants who experienced one or more AEs.
Time frame: 24 months
Disease control rate (DCR)
Time frame: 24 months
Objective response rate (ORR)
Time frame: 24 months
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