NCT05144529

A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC

A Randomized Pilot Study to Investigate the Safety and Immunologic Impact of Evolocumab When Given in Combination With Ipilimumab and Nivolumab in Treatment-Naïve Patients With Metastatic Non-Small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Scott Antonia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a research study to find out the safety and tolerability of combining the drug evolucumab with standard immunotherapy in people with advanced lung cancer (a type called non-small cell lung cancer). Nivolumab (Opdivo™) and ipilimumab (Yervoy™) are immunotherapy-type drugs which are approved for the treatment of advanced lung cancer that has expression of PD-L1 greater than or equal to 1%. Evolucumab is being combined with nivolumab and ipilimumab to see if it will improve the anti-tumor capabilities of the immunotherapy. Adding evolocumab to the combination of nivolumab and ipilimumab has not been tested in people before and is considered investigational.

Conditions

• Lung Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab IV 240 mg
DRUG	Ipilimumab	Ipilimumab IV 1 mg/kg
DRUG	Evolocumab	Evolocumab 14 mg subcutaneous injection

Timeline

• Start date: 2022-03-22
• Primary completion: 2024-09-27
• Completion: 2027-06-01
• First posted: 2021-12-03
• Last updated: 2025-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study