Ignite Creation Date:
2024-05-06 @ 1:05 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03924869
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-15
First Post:
2019-04-22
Brief Title:
Efficacy and Safety Study of Stereotactic Body Radiotherapy SBRT With or Without Pembrolizumab MK-3475 in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer NSCLC MK-3475-867KEYNOTE-867
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 3 Randomized Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy SBRT With or Without Pembrolizumab MK-3475 in Participants With Unresected Stages I or II Non Small Cell Lung Cancer NSCLC KEYNOTE-867
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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 purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy SBRT plus pembrolizumab MK-3475 in the treatment of adult participants with unresected stage I or II Stage IIB N0 M0 non-small cell lung cancer NSCLC
The primary study hypothesis is SBRT plus pembrolizumab prolongs Event-free Survival EFS compared to SBRT plus placebo normal saline solution
The primary study hypothesis is SBRT plus pembrolizumab prolongs Event-free Survival EFS compared to SBRT plus placebo normal saline solution
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MK-3475-867 | OTHER | None | None |
| KEYNOTE-867 | OTHER | None | None |
| 194909 | REGISTRY | None | None |
| 2022-500413-11-00 | REGISTRY | None | None |
| 2018-004320-11 | EUDRACT_NUMBER | EU CT | None |