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ACTIVE NOT RECRUITING 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)

NCT05557591 · View on ClinicalTrials.gov ↗

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

290 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05557591

The ClinicalTrials.gov registry entry for NCT05557591 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05557591 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05557591?

The interventions under investigation include: Cemiplimab (DRUG), BNT116 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05557591?

This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial