PCSK9 + PD-1 Inhibitors for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG Performance Status 0 or 1

If molecularly altered NSCLC including EGFR, ALK, ROS1, MET exon 14, RET, BRAF, NTRK, progression on prior targeted therapy is required

Must not have

Prior treatment with PCSK9 inhibitors

Cardiac issues including MI, uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia, or cardiac failure not controlled by medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 of treatment until the date of first documented progression or date of death, whichever comes first, assessed up to 110 weeks per recist 1.1

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if combining 2 drugs can help with lung cancer not responding to current treatments.

Who is the study for?

This trial is for adults with advanced lung cancer that has worsened despite previous PD-1 inhibitor therapy. Participants must be in good physical condition, not have had major surgery recently, and their blood tests need to meet specific criteria. They can't join if they've used PCSK9 inhibitors before or have serious heart problems, uncontrolled diabetes, HIV/AIDS, another recent cancer diagnosis, or severe reactions to prior immunotherapy.

What is being tested?

The study is testing the combination of two drugs: Alirocumab (a cholesterol-lowering medication) and Cemiplimab (an immune system booster), to see if they work together against lung cancer that hasn't responded well to standard treatments. The goal is to find out whether this combo can shrink tumors in patients who haven't had luck with other therapies.

What are the potential side effects?

Possible side effects include allergic reactions at the injection site, fatigue, skin rash or itching. There's also a risk of inflammation in various organs like the liver or intestines and changes in hormone levels which could affect thyroid function or cause diabetes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or can carry out light work.

Select...

My NSCLC has specific genetic changes and has worsened despite targeted treatment.

Select...

My lung cancer has returned or spread and is confirmed by a biopsy.

Select...

My cancer progressed after treatment with PD-1 inhibitors.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been treated with PCSK9 inhibitors before.

Select...

I do not have uncontrolled heart problems.

Select...

I had a bad reaction to previous PD-1/L1 cancer treatment.

Select...

I have not had major surgery in the last 4 weeks.

Select...

I have been diagnosed with HIV/AIDS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 of treatment until the date of first documented progression or date of death, whichever comes first, assessed up to 110 weeks per recist 1.1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 of treatment until the date of first documented progression or date of death, whichever comes first, assessed up to 110 weeks per recist 1.1

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of treatment until the date of first documented progression or date of death, whichever comes first, assessed up to 110 weeks per recist 1.1 for reporting.