TOP 2201 (Non-Small Cell Lung Cancer)

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)

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.

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.