Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04624204
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2020-11-05
Brief Title:
Placebo-controlled Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer LS-SCLC MK 7339-013KEYLYNK-013
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase 3 Study of Pembrolizumab MK-3475 in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib MK-7339 Compared to Concurrent Chemoradiation Therapy Alone in Participants With Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer LS-SCLC
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:
Researchers are looking for new ways to treat Limited-Stage Small Cell Lung Cancer LS-SCLC a type of lung cancer that has not spread from the lung to other parts of the body The purpose of this study is to learn if pembrolizumab and olaparib when given with chemotherapy and radiation treatment CRT can be effective in treating LS-SCLC The researchers want to know if participants who receive CRT and pembrolizumab with or without olaparib have a longer overall survival compared to participants who only receive CRT
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-7339-013 | OTHER | None | None |
| jRCT2031200296 | REGISTRY | None | None |
| 2019-003616-31 | EUDRACT_NUMBER | jRCT | None |