Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422143
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-05-15
Brief Title:
Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan Sac-TMT MK-2870 in Metastatic Squamous Non-small Cell Lung Cancer NSCLC MK-2870-023
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Phase 3 Study of Pembrolizumab in Combination With CarboplatinTaxane Paclitaxel or Nab-paclitaxel Followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer
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 phase 3 study of pembrolizumab in combination with carboplatintaxane paclitaxel or nab-paclitaxel followed by pembrolizumab with or without maintenance sacituzumab tirumotecan sac-TMT MK-2870 in first-line treatment of metastatic squamous non-small cell lung cancer It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival OS
Detailed Description:
All participants undergo an initial induction phase of four cycles each cycle consisting of a once every 3 weeks q3w cycle of pembrolizumab q3w carboplatin q3w paclitaxel q3w or nabpaclitaxel weekly Participants are then randomly assigned to pembrolizumab maintenance vs pembrolizumab sac-TMT maintenance
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 |
|---|---|---|---|
| U1111-1301-2790 | OTHER | UTN | None |
| 2023-510128-66 | OTHER | None | None |
| jRCT2021240015 | REGISTRY | None | None |