Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305754
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-03-05
Brief Title:
Sacituzumab Tirumotecan MK-2870 Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor EGFR-Mutated Advanced Nonsquamous Non-small Cell Lung Cancer NSCLC and Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors MK-2870-009
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Randomized Open-label Phase 3 Study of MK-2870 vs Platinum Doublets in Participants With EGFR-mutated Advanced Nonsquamous Non-small Cell Lung Cancer NSCLC Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors
Status:
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:
The purpose of this study is to evaluate sacituzumab tirumotecan versus pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor EGFR-mutated advanced non-squamous non-small cell lung cancer NSCLC Participants in this study have NSCLC that has continued to progress on prior treatment with EGFR tyrosine kinase inhibitors TKIs
The primary hypotheses of this study are that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy pemetrexed and carboplatin in regard to progression-free survival PFS and overall survival OS
The primary hypotheses of this study are that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy pemetrexed and carboplatin in regard to progression-free survival PFS and overall survival OS
Detailed Description:
Participants will be randomized 11 into two arms
Sacituzumab tirumotecan
Pemetrexed plus Carboplatin
Participants will receive treatment until any of the criteria for discontinuation of study intervention are met
Sacituzumab tirumotecan
Pemetrexed plus Carboplatin
Participants will receive treatment until any of the criteria for discontinuation of study intervention are met
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-2870-009 | OTHER | Merck | None |
| 2023-504910-31 | REGISTRY | None | None |
| U1111-1288-3804 | OTHER | None | None |