TerminatedPhase 2

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

Stopped: Slow enrollment.

United States19 participantsStarted 2022-03-22

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. All patients must have histologically documented or suspected recurrent incurable and/or stage 4 squamous or non-squamous NSCLC.
✓. NO prior chemotherapy, radiation therapy or biologic/targeted therapy for current diagnosis recurrent/metastatic NSCLC. Medical therapy (including adjuvant or maintenance immune therapy) for early stage NSCLC allowed if completed \> 6 months prior to study enrollment.
✓. TPS PD-L1 \< 50%
✓. Performance Status ECOG 0-1 (Appendix B).
✓. Age \>18 years old.
✓. No active invasive malignancy in the past 2 years other than non-melanoma skin cancer. Cancers that are in-situ are not considered invasive.
✓. No autoimmune disease that would constitute contraindication to receive nivolumab
✓. Patients must have core needle biopsy tissue that is available and adequate for dedicated research purposes.

What they're measuring

Number of Participants With DLT (Dose-limiting Toxicity)

Timeframe: Up to 30 days after first study dose

Change in CD3+ Tumor Infiltrating Lymphocytes

Timeframe: Baseline and day 29

Trial details

NCT IDNCT05144529

SponsorEziafa Oduah, MD, PhD, MPH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-27

Results submitted2025-09-26

View on ClinicalTrials.gov More Lung Cancer Metastatic trials