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.
Who Can Participate?
Eligibility
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. .
For more information about who can be in this study, please contact the study team at (919) 681-4768. .
Age Range
18-100
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
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.
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.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
Scott
Antonia
Protocol Number
PRO00109594
NCT ID
NCT05144529
Phase
Pilot
Enrollment Status
OPEN TO ACCRUAL