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Monoclonal Antibodies

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

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

Study 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.Check my eligibility

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.See study design

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

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I am fully active or can carry out light work.

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

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

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My cancer progressed after treatment with PD-1 inhibitors.

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Heart rate

Secondary outcome measures

Overall survival

Progression Free Survival

Safety and tolerability of the combination regimen

Trial Design

1Treatment groups

Experimental Treatment

Group I: Alirocumab and CemiplimabExperimental Treatment1 Intervention

Combination of anti-PCSK9 antibody alirocumab with the anti-PD-1 antibody cemiplimab

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,363 Previous Clinical Trials

3,420,426 Total Patients Enrolled

Regeneron PharmaceuticalsIndustry Sponsor

621 Previous Clinical Trials

380,545 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have Alirocumab and Cemiplimab been greenlit for use by the FDA?

"Our team at Power have determined that Alirocumab and Cemiplimab possess a level of safety rated 2 on our scale, as this is still in its Phase II trial stage with no evidence yet to support efficacy."

Answered by AI

Are there any vacancies left to take part in this clinical trial?

"Affirmative. Clinicaltrials.gov details this health-related study as an ongoing recruitment, first posted on May 16th 2023 and most recently revised on the 17th of the same month. 25 patients are required to partake in research across a single site."

Answered by AI

What is the upper limit of participants in this medical experiment?

"Affirmative. Information available on clinicaltrials.gov reveals that this trial, first posted in May 16th 2023, is still searching for participants. 25 people need to be enrolled from a single medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung

2023. "PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05553834.

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