Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06074588
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-10-03
Brief Title:
Sacituzumab Tirumotecan MK-2870 Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer NSCLC With EGFR Mutations or Other Genomic Alterations MK-2870-004
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 Chemotherapy Docetaxel or Pemetrexed in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer NSCLC With EGFR Mutations or Other Genomic Alterations
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:
The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy docetaxel or pemetrexed for the treatment of previously-treated non-small cell lung cancer NSCLC with exon 19del or exon 21 L858R EGFR mutations hereafter referred to as EGFR mutations or EGFR-mutated or any of the follow genomic alterations ALK gene rearrangements ROS1 rearrangements BRAF V600E mutations NTRK gene fusions MET exon 14 skipping mutations RET rearrangements or less common EGFR point mutations of exon 20 S768I exon 21 L861Q or exon 18 G719X mutations The primary hypotheses are that sacituzumab tirumotecan is 1 superior to chemotherapy with respect to progression-free survival PFS per RECIST 11 as assessed by BICR in NSCLC with EGFR mutations and 2 superior to chemotherapy with respect to overall survival OS in NSCLC with EGFR mutations
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 |
|---|---|---|---|
| 2023-503539-16 | OTHER | None | None |
| jRCT2031240108 | REGISTRY | Japan Registry of Clinical Trials jRCT | None |