Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04632758
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-24
First Post:
2020-09-05
Brief Title:
Study Comparing WX-0593 to Crizotinib in ALK Positive Non-Small Cell Lung Cancer NSCLC Patients
Sponsor:
Qilu Pharmaceutical Co Ltd
Organization:
Qilu Pharmaceutical Co Ltd
Study Overview
Official Title:
An Open-label Randomized Multicenter Phase 3 Study Comparing WX-0593 to Crizotinib in Anaplastic Lymphoma Kinase ALK Positive Non-Small Cell Lung Cancer NSCLC Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 tolerabilitysafety or exposure are identified
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None