Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161441
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-11-29
Brief Title:
A Trial to Learn if the Combination of Fianlimab Cemiplimab and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Phase 2 Peri-Operative Trial of Fianlimab and Cemiplimab in Combination With Chemotherapy Versus Cemiplimab in Combination With Chemotherapy in Patients With Resectable Early Stage Stage II to IIIB N2 NSCLC
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 study is researching an experimental drug called fianlimab also called REGN3767 with two other medications called cemiplimab and platinum-doublet chemotherapy individually called a study drug or collectively called study drugs when combined in this study The study is being conducted in patients who have resectable stage II to IIIB N2 non-small cell lung cancer NSCLC that can be treated with surgery
The aim of the study is to see how effective the combination of fianlimab cemiplimab and chemotherapy is in comparison with cemiplimab and chemotherapy as peri-operative therapy in participants with NSCLC
The study is looking at several other research questions including
What side effects may happen from taking the study drugs
How much of each study drug is in the blood at different times
Whether the body makes antibodies against the study drugs which could make the drugs less effective or could lead to side effects
How administering the study drugs might affect quality of life
The aim of the study is to see how effective the combination of fianlimab cemiplimab and chemotherapy is in comparison with cemiplimab and chemotherapy as peri-operative therapy in participants with NSCLC
The study is looking at several other research questions including
What side effects may happen from taking the study drugs
How much of each study drug is in the blood at different times
Whether the body makes antibodies against the study drugs which could make the drugs less effective or could lead to side effects
How administering the study drugs might affect quality of life
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 |
|---|---|---|---|
| 2023-505172-29-00 | OTHER | EU CTR Number | None |