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NCT05553834 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Duke University.

Active
Registry status
Phase 2
Development phase
60
Enrollment target
2
Study locations

NCT05553834 is a Phase 2 study of Non-small Cell Lung Cancer (NSCLC) that is active but no longer recruiting, run by Duke University. The registered enrollment target is 60 participants, below the 288-participant average among 58 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (79% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT05553834, a Phase 2 study of Non-small Cell Lung Cancer (NSCLC), is active but no longer recruiting, sponsored by Duke University.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target
2
Study locations

Study Summary

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.

Conditions Studied

Non-small Cell Lung Cancer (NSCLC)

Interventions

  • COMBINATION_PRODUCT Alirocumab and Cemiplimab

Study Locations (2)

Florida

  • Moffitt Cancer Center - Tampa

North Carolina

  • Duke University - Durham

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2023-05-16
Est. Completion 2026-03-01
Phase Phase 2

Sponsor

Duke University

1,725 total trials

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What the Registry Record Tells You About NCT05553834

The ClinicalTrials.gov registry entry for NCT05553834 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 288-participant average among 58 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (79% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 1 intervention - of which Alirocumab and Cemiplimab is the first listed.

NCT05553834 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, North Carolina.

Frequently Asked Questions

What is clinical trial NCT05553834 about?

NCT05553834 is a clinical study titled "PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung". 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 me...

What is the current status of trial NCT05553834?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2023-05-16. Estimated completion is 2026-03-01.

What conditions does trial NCT05553834 study?

This clinical trial studies the following conditions: Non-small Cell Lung Cancer (NSCLC).

What interventions are being tested in trial NCT05553834?

The interventions under investigation include: Alirocumab and Cemiplimab (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT05553834?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05553834 being conducted?

This trial has 2 study locations across Florida, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.