Ignite Creation Date:
2024-05-06 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03425643
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-13
First Post:
2018-02-02
Brief Title:
Efficacy and Safety of Pembrolizumab MK-3475 With Platinum Doublet Chemotherapy as NeoadjuvantAdjuvant Therapy for Participants With Resectable Stage II IIIA and Resectable IIIB T3-4N2 Non-small Cell Lung Cancer MK-3475-671KEYNOTE-671
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase III Randomized Double-blind Trial of Platinum Doublet Chemotherapy -Pembrolizumab MK-3475 as NeoadjuvantAdjuvant Therapy for Participants With Resectable Stage II IIIA and Resectable IIIB T3-4N2 Non-small Cell Lung Cancer NSCLC KEYNOTE-671
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
This trial will evaluate the safety and efficacy of pembrolizumab MK-3475 in combination with platinum doublet neoadjuvant chemotherapy NAC before surgery neoadjuvant phase followed by pembrolizumab alone after surgery adjuvant phase in participants with resectable stage II IIIA and resectable IIIB T3-4N2 non-small cell lung cancer NSCLC The primary hypotheses of this study are that neoadjuvant pembrolizumab vs placebo in combination with NAC followed by surgery and adjuvant pembrolizumab vs placebo will improve 1 event free survival EFS by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 11 RECIST 11 and 2 overall survival OS
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 |
|---|---|---|---|
| 2017-001832-21 | EUDRACT_NUMBER | JAPIC-CTI | None |
| MK-3475-671 | OTHER | None | None |
| 183970 | OTHER | None | None |