Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623656
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multicenter Randomized Phase II Trial of Neoadjuvant Radioimmunotherapy Versus Chemoimmunotherapy in Patients With Clinical Stages IB-III N2 Non-small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if Cemiplimab with chemotherapy or Cemiplimab with stereotactic body radiation therapy SBRT works as treatment for stages IB II and III N2 Non-Small Cell Lung Cancer NSCLC
Before surgery to remove their lung cancer participants will take
1 Cemiplimab with chemotherapy Arm A every 3 weeks for up to 3 doses OR
2 Cemiplimab every 3 weeks for up to 3 doses with SBRT Arm B SBRT will be given on day 1 before taking cemiplimab then SBRT alone on day 2 and day 3
Four to 12 weeks following surgery participants in both Arm A and Arm B will receive treatment with cemiplimab for one year
Before surgery to remove their lung cancer participants will take
1 Cemiplimab with chemotherapy Arm A every 3 weeks for up to 3 doses OR
2 Cemiplimab every 3 weeks for up to 3 doses with SBRT Arm B SBRT will be given on day 1 before taking cemiplimab then SBRT alone on day 2 and day 3
Four to 12 weeks following surgery participants in both Arm A and Arm B will receive treatment with cemiplimab for one year
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None