Ignite Creation Date:
2024-05-06 @ 8:32 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02767804
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2016-04-30
Brief Title:
eXalt3 Study Comparing X-396 Ensartinib to Crizotinib in ALK Positive Non-Small Cell Lung Cancer NSCLC Patients
Sponsor:
Xcovery Holdings Inc
Organization:
Xcovery Holdings Inc
Study Overview
Official Title:
Phase 3 Randomized Study Comparing X-396 Ensartinib to Crizotinib in Anaplastic Lymphoma Kinase ALK Positive Non-Small Cell Lung Cancer NSCLC Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 X-396 ensartinib vs crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor
Detailed Description:
To evaluate the efficacy and safety of X-396 ensartinib vs crizotinib in patients with ALK-positive NSCLC that have received up to 1 prior chemotherapy regimen and no prior ALK tyrosine kinase inhibitor TKI to obtain additional pharmacokinetic PK data from sparse PK sampling to compare the quality of life QoL in patients receiving X-396 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?:
True
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