Ignite Creation Date:
2024-05-06 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03631706
Status:
COMPLETED
Last Update Posted:
2024-02-26
First Post:
2018-08-09
Brief Title:
M7824 Versus Pembrolizumab as a First-line 1L Treatment in Participants With Programmed Death-ligand 1 PD-L1 Expressing Advanced Non-small Cell Lung Cancer NSCLC
Sponsor:
EMD Serono Research Development Institute Inc
Organization:
EMD Serono
Study Overview
Official Title:
An Adaptive Phase III Multicenter Randomized Open-Label Controlled Study of M7824 Bintrafusp Alfa Versus Pembrolizumab as a First-line Treatment in Patients With PD-L1 Expressing Advanced Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2024-07
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 the study is to evaluate the efficacy and safety of bintrafusp alfa M7824 compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression with no epidermal growth factor receptor EGFR mutation or anaplastic lymphoma kinase ALK translocation The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules
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 |
|---|---|---|---|
| 2018-001517-32 | EUDRACT_NUMBER | None | None |