Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-27 @ 1:45 AM
Study NCT ID:
NCT03884192
Status:
UNKNOWN
Last Update Posted:
2019-03-21
First Post:
2019-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Consolidation Sintilimab After Concurrent Chemoradiation in Patients With Unresectable Stage III NSCLC
Sponsor:
Shandong Cancer Hospital and Institute
Organization:
Study Overview
Official Title:
CONSIST: A Phase III Randomized Control Study of Consolidation Sintilimab (IBI308) After Concurrent Chemoradiation Versus Chemoradiation Alone in Patients With Unresectable Local Advanced Stage III NSCLC
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
RECRUITING
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:
CONSIST
Brief Summary:
This is an open label, multi-center, randomized, control phase III trial, to compare the efficacy and safety of consolidation therapy with sintilimab (IBI308) versus best supported care (BSC), in unresectable stage III NSCLC patients who do not experience disease progression after initial concurrent chemoradiation.
Detailed Description:
This is an open label, multi-center, randomized, control study of sintilimab versus BSC in unresectable local advanced stage III NSCLC patients without disease progression after concurrent chemoradiation.
Study Oversight
Has Oversight DMC:
True
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?: