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NCT05557591 · ClinicalTrials.gov registry record · Phase 2

A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1)

A Phase 2 study of Advanced Non-Small-Cell Lung Cancer, sponsored by Regeneron Pharmaceuticals.

Active
Registry status
Phase 2
Development phase
51
Enrollment target
20
Study locations

NCT05557591 is a Phase 2 study of Advanced Non-Small-Cell Lung Cancer that is active but no longer recruiting, run by Regeneron Pharmaceuticals. The registered enrollment target is 51 participants, below the 380-participant average among 22 other Advanced Non-Small-Cell Lung Cancer trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT05557591, a Phase 2 study of Advanced Non-Small-Cell Lung Cancer, is active but no longer recruiting, sponsored by Regeneron Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
51 participants
Enrollment target
20
Study locations

Study Summary

This study is researching an investigational drug, called BNT116, in combination with cemiplimab. BNT116 and cemiplimab will each be called a "study drug", and together be called "study drugs". The study is focused on patients who have advanced non-small cell lung cancer (NSCLC). The aims of this study are to see how safe and tolerable BNT116 is in combination with cemiplimab and to see how effective BNT116 in combination with cemiplimab is compared to cemiplimab by itself at treating cancer. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drugs * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the drug less effective or could lead to side effects)

Interventions

  • DRUG Cemiplimab
  • DRUG BNT116

Study Locations (20)

Other

  • LTD High Technology Hospital Medcenter - Batumi
  • LLC Todua Clinic - Tbilisi
  • LTD New Hospitals - Tbilisi
  • LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic - Tbilisi
  • LTD Cancer Research Centre - Tbilisi
  • Caucasus Medical Centre - Tbilisi
  • Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt - Frankfurt
  • Universitaetsklinikum Giessen Und Marburg Gmbh Standort Giessen - Giessen
  • Krankenhaus Martha-Maria Halle-Doelau gGmbH - Halle
  • Klinikverbund Kempten-Oberallgäu - Kempten

California

  • The Oncology Institute of Hope and Innovation - Los Angeles
  • UCLA Medical Center - Santa Monica

Kentucky

  • Norton Cancer Institute, Downtown - Louisville

New Mexico

  • San Juan Oncology Associates - Farmington

New York

  • Weill Cornell Medicine - New York

North Carolina

  • FirstHealth of the Carolinas Outpatient Cancer Center - Pinehurst

Texas

  • Millenium Research & Clinical Development - Houston

Virginia

  • Virginia Cancer Specialists - Fairfax

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2023-04-21
Est. Completion 2028-05-16
Phase Phase 2

Sponsor

Regeneron Pharmaceuticals

280 total trials

What the Registry Record Tells You About NCT05557591

The ClinicalTrials.gov registry entry for NCT05557591 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 380-participant average among 22 other Advanced Non-Small-Cell Lung Cancer trials with a reported enrollment target (87% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Non-Small-Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Cemiplimab is the first listed.

NCT05557591 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Kentucky.

Frequently Asked Questions

What is clinical trial NCT05557591 about?

NCT05557591 is a clinical study titled "A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1)". This study is researching an investigational drug, called BNT116, in combination with cemiplimab. BNT116 and cemiplimab will each be called a "study drug", and together be called "study drugs". The study is focused on patients who have advanced non-small cell lung cancer (NSCLC). The aims of this s...

What is the current status of trial NCT05557591?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2023-04-21. Estimated completion is 2028-05-16.

What conditions does trial NCT05557591 study?

This clinical trial studies the following conditions: Advanced Non-Small-Cell Lung Cancer.

What interventions are being tested in trial NCT05557591?

The interventions under investigation include: Cemiplimab (DRUG), BNT116 (DRUG).

Who is sponsoring clinical trial NCT05557591?

This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05557591 being conducted?

This trial has 20 study locations across California, Kentucky, New Mexico, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.

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.