Active Not RecruitingPhase 1 / Phase 2NCT04077099
Official study title

A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer

Study summary

This study will evaluate REGN5093 for the treatment of Non-Small Cell Lung Cancer (NSCLC) with MET alteration. The main purpose of this study is to determine the safety, tolerability, and effectiveness of REGN5093. The study has two phases. The main goal of Phase 1 is to determine a safe dose(s) of REGN5093. The main goal of phase 2 of the study is to use the REGN5093 drug dose(s) found in Phase 1 to see how well REGN5093 works to shrink tumors. The study is looking at several other research questions, including: * Side effects that may be experienced by people taking REGN5093 * How REGN5093 works in the body * How much REGN5093 is present in the blood * To see if REGN5093 works to reduce or delay the progression of cancer * How long it takes REGN5093 to work in the body

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedREGN5093

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · MET

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 16, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?29 U.S. locations

Locations may change over time.

Who runs it?Regeneron Pharmaceuticals

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Regeneron Pharmaceuticals
Interventions being studied
Drug: REGN5093
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Key 1. Histologically confirmed advanced NSCLC that is unresectable or metastatic as described in the protocol 2. Willing to provide tumor tissue as described in the protocol 3. Documented presence of MET alteration as described in the protocol. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Adequate organ and bone marrow function as described in the protocol Key

Reasons someone may not be able to joinExclusion criteria

1. Has received treatment with an approved systemic therapy or has participated in any study of an investigational agent or investigational device within 2 weeks as described in the protocol 2. Has not yet recovered from any acute toxicities resulting from prior therapy with certain exceptions as described in the protocol 3. Has received radiation therapy or major surgery within 14 days as described in the protocol 4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease or spinal cord compression as defined in the protocol 5. Uncontrolled infection as described in the protocol Note: Other protocol defined Inclusion/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of California Irvine Medical Center - Bldg 56, RT81, Rm 241Orange, California
  • Georgetown University Medical CenterWashington D.C., District of Columbia
  • Moffitt Cancer Center - McKinley DriveTampa, Florida
  • Dana Farber Harvard Cancer Center ConsortiumBoston, Massachusetts
  • Icahn School of Medicine at Mount SinaiNew York, New York
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • University of Pittsburgh UPMC - Clinical Research ServicesPittsburgh, Pennsylvania
  • The University of Texas MD Anderson Cancer CenterHouston, Texas
  • Centre Hospitalier Universitaire de Rennes - Hopital PontchaillouRennes, Bretange
  • Institut BergonieBordeaux, New Aquitaine
  • Centre Francois Baclesse (CFB)Caen, Normandy
  • Centre Hospitalier Universitaire de GrenobleGrenoble

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 16, 2026. Always confirm current availability with the study team.

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