Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345729
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-03-28
Brief Title:
A Study of MK-1084 Plus Pembrolizumab MK-3475 in Participants With KRAS G12C Mutant Metastatic Non-small Cell Lung Cancer NSCLC With Programmed Cell Death Ligand 1 PD-L1 Tumor Proportion Score TPS 50 MK-1084-004
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant Metastatic NSCLC With PD-L1 TPS 50
Status:
RECRUITING
Status Verified Date:
2024-10
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 is a study evaluating the efficacy and safety of MK-1084 with pembrolizumab as first-line treatment in participants with metastatic non-small cell lung cancer NSCLC with identified Kirsten rat sarcoma viral oncogene homolog G12C KRAS G12C mutation and programmed cell death ligand 1 PD-L1 tumor proportion score TPS 50 There are two primary study hypotheses
Hypothesis 1 Combination of MK-1084 and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival PFS per Response Evaluation Criteria in Solid Tumors Version 11 RECIST 11 by blinded independent central review BICR
Hypothesis 2 Combination of MK-1084 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival OS
Hypothesis 1 Combination of MK-1084 and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival PFS per Response Evaluation Criteria in Solid Tumors Version 11 RECIST 11 by blinded independent central review BICR
Hypothesis 2 Combination of MK-1084 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to 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 |
|---|---|---|---|
| MK-1084-004 | OTHER | None | None |
| U1111-1296-8093 | OTHER | None | None |
| 2023-507776-42 | REGISTRY | EU CT | None |