Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-29 @ 12:06 PM
Study NCT ID:
NCT02492568
Status:
COMPLETED
Last Update Posted:
2020-08-17
First Post:
2015-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pembrolizumab After SBRT Versus Pembrolizumab Alone in Advanced NSCLC
Sponsor:
The Netherlands Cancer Institute
Organization:
Study Overview
Official Title:
Randomized Phase II, 2-arm Study of Pembrolizumab After High Dose Radiation (SBRT) Versus Pembrolizumab Alone in Patients With Advanced Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2020-08
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:
PEMBRO-RT
Brief Summary:
To evaluate the increase in Overall Response Rate (ORR) in the pembrolizumab alone arm compared to the pembrolizumab after SBRT arm at 12 weeks
Detailed Description:
The investigators hypothesize that in a significant subset of patients with recurrent NSCLC immunotherapy after SBRT will be superior to treatment with immunotherapy alone and that SBRT, given to a single metastatic site of the tumor, will augment the immune response to the tumor. Objectives: Disease Control Rate (DCR), defined as the percentage of patients having a complete response, partial response or stable disease at 12 weeks, PFS, defined as time from randomization to disease progression or death, OS, defined as time from randomization to death (of any cause). Toxicity.
Study Oversight
Has Oversight DMC:
True
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?: