The primary purpose of this study is to evaluate the efficacy and safety of WX-0593 vs. crizotinib in patients with ALK-positive non-small cell lung cancer who had not received prior systemic therapy
To evaluate the efficacy and safety of WX-0593 vs. crizotinib in patients with ALK-positive NSCLC who had not received prior systemic therapy, to obtain additional pharmacokinetic (PK) data from sparse PK sampling, to compare the quality of life (QoL) in patients receiving WX-0593 vs. crizotinib, to evaluate the status of exploratory biomarkers and correlate with clinical outcome, and to obtain germline DNA samples for possible pharmacogenetic analysis in the event that outliers with respect to efficacy, tolerability/safety, or exposure are identified.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
292
tablets, 60 mg→180mg, QD
Capsules, 250mg, BID
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Progression-free Survival (PFS)
PFS as assessed by independent radiology review based on RECIST v. 1.1 criteria
Time frame: from randomization until firstly recorded disease progression or death (whichever occurs earlier), or to the date that the last patients observed for 12 months
Progression-free survival (PFS)
PFS based on investigator assessment
Time frame: from randomization until firstly recorded disease progression or death (whichever occurs earlier), or to the date that the last patients observed for 12 months
OS
Overall survival (OS)
Time frame: from randomization until death due to any cause, withdraws informed consent, is lost to follow-up or refuses phone visits, or study completion(up to 2.5 years)
Confirmed Objective Response Rate (ORR) Assessed By independent radiology review
ORR is defined the percentage of the participants who have achieved complete response (CR) or partial response (PR) per independent radiology review using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.
Time frame: From fist administration to the date that the last patients observed for 12 months
Confirmed Objective Response Rate (ORR) Assessed By Investigators
ORR is defined the percentage of the participants who have achieved complete response (CR) or partial response (PR) per Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.
Time frame: From fist administration to the date that the last patients observed for 12 months
Time to Response (TTR) Assessed By independent radiology
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Assessed from date of the first dose until the date of progression per independent radiology review
Time frame: From fist administration to the date that the last patients observed for 12 months
Time to Response (TTR) Assessed By Investigators
Assessed from date of the first dose until the date of progression per investigator.
Time frame: From fist administration to the date that the last patients observed for 12 months
Duration of response (DOR) Assessed By independent radiology
The DOR is defined as the time from the date of the first response CR/PR (whichever is first recorded) to the date on which progressive disease (PD) is first noted or date of death.
Time frame: From fist administration to the date that the last patients observed for 12 months
Duration of response (DOR) Assessed By Investigators
The DOR is defined as the time from the date of the first response CR/PR (whichever is first recorded) to the date on which progressive disease (PD) is first noted or date of death.
Time frame: From fist administration to the date that the last patients observed for 12 months
CNS response rate based on independent radiology review
CNS response rate based on independent radiology review
Time frame: From fist administration to the date that the last patients observed for 12 months
CNS response rate based on investigator assessment
CNS response rate based on investigator assessment
Time frame: From fist administration to the date that the last patients observed for 12 months
Time to CNS progression
Time to CNS progression
Time frame: From fist administration to the date that the last patients observed for 12 months
Percentage of patients with adverse events
the incidence of adverse events, including adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs). Causality is determined by the investigator.
Time frame: from the signing of the informed consent form until at least 28 days after the last dose of study drug was administered.
Plasma concentrations (Cssmin)
Minimum value of steady plasma-drug concentration for WX-0593 at participating sites
Time frame: Cssmin before dosing on Cycle 1 Day 1, Cycle 1 Day 7, Cycle 1 Day 21, Cycle 2 Day 21, and Cycle 4 Day 21
Patient reported time to deterioration (TTD)
Patient reported time to deterioration (TTD) as measured by EORTC C30/LC13 QoL questionnaire
Time frame: From fist administration to the date that the last patients observed for 12 months
Patient reported time to deterioration (TTD)
Patient reported time to deterioration (TTD) as measured by Lung Cancer Symptom Scale (LCSS) questionnaire
Time frame: From fist administration to the date that the last patients observed for 12 months
Patient reported health-related quality of life (HRQoL)
Patient reported health-related quality of life (HRQoL) as measured by EORTC C30/LC13 QoL questionnaire
Time frame: From fist administration to the date that the last patients observed for 12 months
Patient reported health-related quality of life (HRQoL)
Patient reported health-related quality of life (HRQoL) as measured by Lung Cancer Symptom Scale (LCSS) questionnaire
Time frame: From fist administration to the date that the last patients observed for 12 months