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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 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 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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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)

Interventions

  • DRUG fianlimab
  • DRUG cemiplimab
  • DRUG Platinum Doublet

Study Locations (1)

New York

  • Icahn School of Medicine at Mount Sinai - New York

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2019-07-23
Est. Completion 2030-05-14
Phase Phase 2

Sponsor

Regeneron Pharmaceuticals

280 total trials

What the Registry Record Tells You About NCT03916627

The ClinicalTrials.gov registry entry for NCT03916627 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (90% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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

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.