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.
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. .
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.