TOP 2101 - Metastatic Non-Small Cell Lung Cancer

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.

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:<ul>
<li>Have blood draws</li>
<li>Visit the clinic for various tests to see if you're eligible for the dosing period</li>
<li>Have a new tumor biopsy</li></ul>
If you're eligible for the dosing period, you will:<ul>
<li>Have blood draws</li>
<li>Have imaging scans (CT and MRI)</li>
<li>Receive nivolumab and chemotherapy with or without the study drug, followed by more chemotherapy</li>
<li>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.</li></ul>
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 Enrollment