TOP 2201 (Non-Small Cell Lung Cancer) - Clinical Trial
What is the 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.
Metastatic Non-Small Cell Lung Cancer (NSCLC)
Who Can Participate in the Study?
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
For more information about who can be in this study, please contact the study team at 919-681-4768.
What is Involved?
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
If you are eligible, you will go on to the dosing period. During this period, you will:
- 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
You will get the study drugs for up to 2 years unless you and/or the study doctor decide to stop using them because they are not helping you. We will follow up with you every 3 months to see how you are doing after you stop the study drugs.
Study Details
