Ignite Creation Date:
2024-07-17 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465329
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-13
Brief Title:
A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer NSCLC
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Randomized Phase 2 Platform Study to Evaluate Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for the Perioperative Treatment of Patients With Resectable 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 study will enroll adult participants with early-stage stage II-IIIB non-small cell lung cancer for whom surgery is planned
The aim is to find out whether an investigational treatment consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug works better than cemiplimab plus chemotherapy without the additional drug
The study is also looking at several other research questions including
What are the side effects associated with the investigational treatments in comparison to the control treatment
Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed
How much of the study drugs are in the blood at a given time
Does the body make antibodies against the study drugs which could make the drugs less effective or could lead to side effects
The aim is to find out whether an investigational treatment consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug works better than cemiplimab plus chemotherapy without the additional drug
The study is also looking at several other research questions including
What are the side effects associated with the investigational treatments in comparison to the control treatment
Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed
How much of the study drugs are in the blood at a given time
Does the body make antibodies against the study drugs which could make the drugs less effective or could lead to side effects
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 |
|---|---|---|---|
| 2023-509806-31-00 | REGISTRY | None | None |