Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569420
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Study Of Comparing SAF-189s With Crizotinib In First Line ALK-Positive Advanced and Metastatic NSCLC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Multicenter Phase III Open-label Study Efficacy and Safety of Comparing SAF-189s With Crizotinib in First-line Anaplastic Lymphoma Kinase-positive Advanced and Metastatic NSCLC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized multicenter Phase III open-label study will evaluate the efficacy and safety of SAF-189s versus crizotinib treatment in participants with treatment-naive ALK-positive advanced NSCLC Participants will be randomized 11 into one of the two treatment groups to receive either SAF-189s 160 milligrams mg once daily QD or crizotinib 250 mg BID orally respectively
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None