Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05722015
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-01-27
Brief Title:
A Study of Subcutaneous SC Pembrolizumab Coformulated With Hyaluronidase MK-3475A vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer NSCLC MK-3475A-D77
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 3 Randomized Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase MK-3475A Versus Intravenous Pembrolizumab Administered With Chemotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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 study is to assess the pharmacokinetics PK and safety of SC MK-3475A vs intravenous IV pembrolizumab administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer The primary hypotheses of this study are MK-3475A subcutaneous SC is noninferior to pembrolizumab IV with respect to PK parameters
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 |
|---|---|---|---|
| 2022-501506-36-00 | OTHER | None | None |
| MK-3475A-D77 | OTHER | None | None |
| jRCT2031230049 | REGISTRY | Japan Registry of Clinical Trials jRCT | None |