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.

What is the Condition Being Studied?

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.

Age Group

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

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
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00111111
NCT: NCT05553834
Phase II
Enrollment Status
Open for Enrollment