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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: Active Phase 2 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Duke University.
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 284-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (79% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Ascertain the response rate associated with alirocumab and cemiplimab, with 95% confidence intervals. Response rate is defined as the proportion of treated subjects with a complete or partial response per RECIST 1.1 criteria. All patients who receive at least one dose of alirocumab and cemiplimab will be considered for the primary outcome analysis
Conditions Studied
Interventions
- COMBINATION_PRODUCT Alirocumab and Cemiplimab
Study Locations (2)
Florida
- Moffitt Cancer Center - Tampa
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-05-16 |
| Est. Completion | 2026-03-01 |
| Phase | Phase 2 |
What the registry record for NCT05553834 still lists
NCT05553834 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 284-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (79% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05553834's enrollment target sits among peer trials
60 42nd of 59 higher than 18 of 59 other Non-small Cell Lung Cancer (NSCLC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-small Cell Lung Cancer (NSCLC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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