ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

PCSK9 mediates immune checkpoint blockade resistance by downregulating tumor cell surface MHC class 1 molecules. This study will evaluate if combining the anti-PCSK9 antibody alirocumab with the anti-PD-1 antibody cemiplimab can generate anti-tumor activity and clinical responses in patients with metastatic lung cancer who have progressed on first line immune checkpoint blockade therapy.

Official Title

A Phase II Study of PCSK9 Inhibitor Alirocumab and PD-1 Inhibitor Cemiplimab in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung Cancer: TOP2201

Quick Facts

Study Start:2023-05-16

Study Completion:2027-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05553834

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Histologically documented recurrent and/or metastatic non-small cell lung cancer * Progression after prior PD-1 directed therapy (as monotherapy or in combination with chemotherapy and/or anti-CTLA4, or anti-VEGF agents) - defined as investigator assessed progression from prior treatment * If molecularly altered NSCLC including EGFR, ALK, ROS1, MET exon 14, RET, BRAF, NTRK, progression on prior targeted therapy is required * Measurable disease by RECIST 1.1 * ECOG Performance Status 0 or 1 * Signed written informed consent * Minimum of 4 weeks from any other experimental anti-cancer therapies or prior PD-1 treatment * Meet all the laboratory criteria per protocol	* Prior treatment with PCSK9 inhibitors * Cardiac issues including MI, uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia, or cardiac failure not controlled by medications. * Uncontrolled diabetes mellitus, defined as HbA1c \> 10 * Major surgery less than 4 weeks prior to study enrollment * Another malignant condition diagnosed within 3 years of study enrollment * Intolerance to prior PD-1/L1 treatment including discontinuation for severe or recurrent severe toxicity (including myocarditis or other myocardiotoxity, encephalitis, colitis, diarrhea, pancreatitis, hypo/hyperthyroidism, hypopituitarism, adrenal insufficiency, rash, autonomic neuropathy, myasthenia gravis, Guillain-Barre, myositis/polymyositis, hepatitis, Type 1 Diabetes, thrombocytopenia) or developed an immune checkpoint blockade related immune adverse event that was refractory to steroids and required additional systemic immunosuppressive medication. * Known history of HIV seropositivity or known acquired immunodeficiency syndrome (AIDS) * Additional exclusion criterion as per listed in the protocol

Inclusion Criteria

Exclusion Criteria

* Histologically documented recurrent and/or metastatic non-small cell lung cancer
* Progression after prior PD-1 directed therapy (as monotherapy or in combination with chemotherapy and/or anti-CTLA4, or anti-VEGF agents) - defined as investigator assessed progression from prior treatment
* If molecularly altered NSCLC including EGFR, ALK, ROS1, MET exon 14, RET, BRAF, NTRK, progression on prior targeted therapy is required
* Measurable disease by RECIST 1.1
* ECOG Performance Status 0 or 1
* Signed written informed consent
* Minimum of 4 weeks from any other experimental anti-cancer therapies or prior PD-1 treatment
* Meet all the laboratory criteria per protocol

* Prior treatment with PCSK9 inhibitors
* Cardiac issues including MI, uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia, or cardiac failure not controlled by medications.
* Uncontrolled diabetes mellitus, defined as HbA1c \> 10
* Major surgery less than 4 weeks prior to study enrollment
* Another malignant condition diagnosed within 3 years of study enrollment
* Intolerance to prior PD-1/L1 treatment including discontinuation for severe or recurrent severe toxicity (including myocarditis or other myocardiotoxity, encephalitis, colitis, diarrhea, pancreatitis, hypo/hyperthyroidism, hypopituitarism, adrenal insufficiency, rash, autonomic neuropathy, myasthenia gravis, Guillain-Barre, myositis/polymyositis, hepatitis, Type 1 Diabetes, thrombocytopenia) or developed an immune checkpoint blockade related immune adverse event that was refractory to steroids and required additional systemic immunosuppressive medication.
* Known history of HIV seropositivity or known acquired immunodeficiency syndrome (AIDS)
* Additional exclusion criterion as per listed in the protocol

Contacts and Locations

Study Locations (Sites)

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Duke University

Durham, North Carolina, 27705

United States

Collaborators and Investigators

Sponsor: Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-16

Study Completion Date2027-01-01

Study Record Updates

Study Start Date2023-05-16

Study Completion Date2027-01-01

Terms related to this study

Additional Relevant MeSH Terms

Non-small Cell Lung Cancer (NSCLC)