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NCT03916627 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients
A Phase 2 study of Non-Small Cell Lung Cancer and Hepatocellular Carcinoma, sponsored by Regeneron Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT03916627: Active Phase 2 study of Non-Small Cell Lung Cancer and Hepatocellular Carcinoma, sponsored by Regeneron Pharmaceuticals.
NCT03916627 is a Phase 2 study of Non-Small Cell Lung Cancer and Hepatocellular Carcinoma that is active but no longer recruiting, run by Regeneron Pharmaceuticals. The registered enrollment target is 65 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer 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
NCT03916627, a Phase 2 study of Non-Small Cell Lung Cancer and Hepatocellular Carcinoma, is active but no longer recruiting, sponsored by Regeneron Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being done to better understand whether or not cemiplimab by itself and in combination with other treatments given prior to surgery will cause your tumor to respond in a beneficial way; whether the drug(s) are safe and what side effects they cause; and other details about how they function in the body. One of the treatments that will be combined cemiplimab is another experimental drug called fianlimab. In this form, cemiplimab and fianlimab will each individually be called "study drug" or "study drugs" when combined. Cemiplimab (also known as REGN2810) and fianlimab (also known as REGN3767) are both a type of drug called a monoclonal antibody. Antibodies are proteins naturally found in your blood that fight infections. A monoclonal antibody is a special kind of antibody that is manufactured as a medication to target specific proteins in the body that may be involved in your cancer. * Cemiplimab is a drug that blocks the programmed death receptor 1 (PD-1), a cell receptor on immune cells * Fianlimab is a drug that blocks the action of a protein called lymphocyte activation gene (LAG)-33 (LAG-3)
Primary Outcome
Cohorts A1, A2, A3
Conditions Studied
Interventions
- DRUG fianlimab
- DRUG cemiplimab
- DRUG Platinum Doublet
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2019-07-23 |
| Est. Completion | 2030-05-14 |
| Phase | Phase 2 |
What the registry record for NCT03916627 still lists
NCT03916627 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (90% lower).
The record links to 3 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which fianlimab is the first listed.
NCT03916627 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03916627 about?
NCT03916627 is a clinical study titled "Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients". This study is being done to better understand whether or not cemiplimab by itself and in combination with other treatments given prior to surgery will cause your tumor to respond in a beneficial way; whether the drug(s) are safe and what side effects they cause; and other details about how they func...
What is the current status of trial NCT03916627?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2019-07-23. Estimated completion is 2030-05-14.
What conditions does trial NCT03916627 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Hepatocellular Carcinoma, Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT03916627?
The interventions under investigation include: fianlimab (DRUG), cemiplimab (DRUG), Platinum Doublet (DRUG).
Who is sponsoring clinical trial NCT03916627?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03916627 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03916627's enrollment target sits among peer trials
65 305th of 454 higher than 149 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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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