Purpose of this Study
We are doing this study to find out if 2 investigational drugs called aliocumab and cemiplimab (the study drugs) are a safe and effective option to treat NSCLC that has spread to other organs in the body and help patients live disease free for a longer period of time.
Who Can Participate?
Eligibility
Adults who:
- Are diagnosed with NSCLC that has spread to other parts of the body
- Are not benefitting from standard treatments, like immunotherapy
- Have stopped treatment for their cancer, including radiation or surgery
- Are not pregnant or breast feeding
- Do not have any major complications related to the heart, lungs, liver, or kidneys
What is Involved?
Description
The study is divided into two periods, a screening period and a dosing period.
If you choose to join the study, during the screening period you will:
- Visit our clinic 1 or 2 times
- Have a physical exam
- Have imaging scans (MRI and CT)
- Have a heart scan (EKG)
- Have blood draws
- Begin receiving the study drugs - you will get an injection of aliocumab at home every 2 weeks *AND* you will get an infusion (IV) of cemiplimab in our clinic every 3 weeks
- Have blood draws
- Have a CT scan 6 weeks after you start the study drugs, and then every 3 months while you are getting the study drugs
Study Details
Full Title
A Phase II of Study of PCSK9 Inhibitor Alirocumab and PD-1 Inhibitor Cemiplimab in Patients with Metastatic, Refactory To Prior Anti PD-1 Non-small Cell Lung Cancer: TOP 2201 (PO# 1017893 and Protocol # R2810-ONC-21117)
Principal Investigator
Scott
Antonia
Protocol Number
PRO00111111
NCT ID
NCT05553834
Phase
II
Enrollment Status
Open to Enrollment