TOP 2101 - Metastatic Non-Small Cell Lung Cancer

What is the Purpose of this Study?

We are doing this study to see how an experimental drug called evolocumab (study drug) works in your body and against your cancer when it is given in combination with approved immunotherapy drugs.

What is the Condition Being Studied?

Non-Small Cell Lung Cancer (NSCLC )

Who Can Participate in the Study?

Adults ages 18+ who are diagnosed with or suspected to have NSCLC.

For more information about who can be in this study, please contact the study team at (919) 681-4768.

Age Group

What is Involved?

This study has 2 parts: a screening period and a study dosing period.

If you join this study, during the screening period you will:

  • Have blood draws
  • Visit the clinic for various tests to see if you're eligible for the dosing period
  • Have a new tumor biopsy

If you're eligible for the dosing period, you will:

  • Have blood draws
  • Have imaging scans (CT and MRI)
  • Receive nivolumab and chemotherapy with or without the study drug, followed by more chemotherapy
  • The immunotherapy drugs (nivolumab and ipilimumab) used in this study are given by injection into a vein (IV) every 2 weeks. The study drug (evolocumab) is given by injection under the skin.

You will be randomly assigned (fair chance) to receive nivolumab and ipilimumab with or without evolucumab. .

Treatments will continue as long as you are benefitting.

Study Details

Full Title
A Randomized Pilot Study to Investigate the Safety and Immunologic Impact of Evolocumab when Given in Combination with Ipilimumab and Nivolumab in Treatment-Naive Patients with Metastatic Non-Small Cell Lung Cancer. TOP 2101.
Principal Investigator
Professor of Medicine
Protocol Number
IRB: PRO00109594
NCT: NCT05144529
Phase Pilot
Enrollment Status