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NCT05144529 · ClinicalTrials.gov registry record · Phase 2
A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC
A Phase 2 study of Lung Cancer Metastatic, sponsored by Scott Antonia.
- Active
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT05144529: Active Phase 2 study of Lung Cancer Metastatic, sponsored by Scott Antonia.
NCT05144529 is a Phase 2 study of Lung Cancer Metastatic that is active but no longer recruiting, run by Scott Antonia. The registered enrollment target is 38 participants, below the 364-participant average among 8 other Lung Cancer Metastatic trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05144529, a Phase 2 study of Lung Cancer Metastatic, is active but no longer recruiting, sponsored by Scott Antonia.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a research study to find out the safety and tolerability of combining the drug evolucumab with standard immunotherapy in people with advanced lung cancer (a type called non-small cell lung cancer). Nivolumab (Opdivo™) and ipilimumab (Yervoy™) are immunotherapy-type drugs which are approved for the treatment of advanced lung cancer that has expression of PD-L1 greater than or equal to 1%. Evolucumab is being combined with nivolumab and ipilimumab to see if it will improve the anti-tumor capabilities of the immunotherapy. Adding evolocumab to the combination of nivolumab and ipilimumab has not been tested in people before and is considered investigational.
Primary Outcome
Safety is defined as the incidence of DLTs assessed in the first 6 evaluable subjects treated with nivolumab, ipilimumab, and evolocumab, including those that cross over to receive evolocumab.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Evolocumab
Study Locations (1)
North Carolina
- Duke Univ. Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2022-03-22 |
| Est. Completion | 2027-06 |
| Phase | Phase 2 |
What the registry record for NCT05144529 still lists
NCT05144529 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 364-participant average among 8 other Lung Cancer Metastatic trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Lung Cancer Metastatic appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT05144529 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05144529 about?
NCT05144529 is a clinical study titled "A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC". This is a research study to find out the safety and tolerability of combining the drug evolucumab with standard immunotherapy in people with advanced lung cancer (a type called non-small cell lung cancer). Nivolumab (Opdivo™) and ipilimumab (Yervoy™) are immunotherapy-type drugs which are approved ...
What is the current status of trial NCT05144529?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2022-03-22. Estimated completion is 2027-06.
What conditions does trial NCT05144529 study?
This clinical trial studies the following conditions: Lung Cancer Metastatic.
What interventions are being tested in trial NCT05144529?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Evolocumab (DRUG).
Who is sponsoring clinical trial NCT05144529?
This trial is sponsored by Scott Antonia, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05144529 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lung Cancer Metastatic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05144529's enrollment target sits among peer trials
38 5th of 8 higher than 3 of 8 other Lung Cancer Metastatic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Cancer Metastatic 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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