Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT04077099

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

Led by Regeneron Pharmaceuticals · Updated on 2026-03-18

231

Participants Needed

40

Research Sites

641 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed advanced NSCLC that is unresectable or metastatic as described in the protocol
  • Willing to provide tumor tissue as described in the protocol
  • Documented presence of MET alteration as described in the protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ and bone marrow function as described in the protocol
Not Eligible

You will not qualify if you...

  • Received treatment with an approved systemic therapy or participated in a study of an investigational agent or device within 2 weeks as described in the protocol
  • Not recovered from acute toxicities from prior therapy with certain exceptions as described in the protocol
  • Received radiation therapy or major surgery within 14 days as described in the protocol
  • Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol
  • Uncontrolled infection as described in the protocol
  • Other protocol defined inclusion/exclusion criteria apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 40 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Withdrawn

2

University of California Irvine Medical Center - Bldg 56, RT81, Rm 241

Orange, California, United States, 92868

Completed

3

Georgetown University Medical Center

Washington D.C., District of Columbia, United States, 20007

Completed

4

Moffitt Cancer Center - McKinley Drive

Tampa, Florida, United States, 33612

Actively Recruiting

5

University of Kentucky, Markey Cancer Center Clinical Research Organization

Lexington, Kentucky, United States, 40536

Withdrawn

6

DNU_Massachusetts General Hospital_DNU

Boston, Massachusetts, United States, 02114

Withdrawn

7

Dana Farber Harvard Cancer Center Consortium

Boston, Massachusetts, United States, 02215

Completed

8

Henry Ford Health System

Detroit, Michigan, United States, 48202

Withdrawn

9

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Withdrawn

10

NYU Cancer Institute

New York, New York, United States, 10016

Withdrawn

11

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Completed

12

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Completed

13

Duke Cancer Center

Durham, North Carolina, United States, 27710

Withdrawn

14

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States, 73104

Withdrawn

15

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

Withdrawn

16

University of Pittsburgh UPMC - Clinical Research Services

Pittsburgh, Pennsylvania, United States, 15232

Completed

17

Harold C. Simmons Comprehensive Cancer Center

Dallas, Texas, United States, 75235

Withdrawn

18

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

19

Centre Georges Francois Leclerc

Dijon, Bourgogne-Franche-Comté, France, 21034

Withdrawn

20

Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

Rennes, Bretange, France, 35033

Completed

21

Institut Bergonie

Bordeaux, New Aquitaine, France, 33076

Completed

22

Centre Francois Baclesse (CFB)

Caen, Normandy, France, 14076

Completed

23

Centre Hospitalier Universitaire de Grenoble

Grenoble, France, 38043

Completed

24

Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve

Montpellier, France, 34295

Completed

25

National Cancer Center

Gyeonggi-do, Gyeonggi-do, South Korea, 10408

Actively Recruiting

26

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea, 13620

Actively Recruiting

27

The Catholic University Of Korea St. Vincent's Hospital

Suwon, Gyeonggi-do, South Korea, 16247

Actively Recruiting

28

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea, 16499

Actively Recruiting

29

Haeundae Paik Hospital

Pusan, Gyeongsangnam-do, South Korea, 48108

Actively Recruiting

30

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea, 58128

Actively Recruiting

31

Gachon University Gil Medical Center

Incheon, Namdong-gu, South Korea, 21565

Actively Recruiting

32

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea, 28644

Actively Recruiting

33

Pusan National University Hospital

Busan, South Korea, 49241

Actively Recruiting

34

Asan Medical Center

Seoul, South Korea, 05505

Actively Recruiting

35

Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

36

Seol St. Mary's Hospital

Seoul, South Korea, 06591

Completed

37

Boramae Medical Center

Seoul, South Korea, 07061

Actively Recruiting

38

Korea University Guro Hospital

Seoul, South Korea, 08308

Actively Recruiting

39

Seoul National University Hospital

Seoul, South Korea, 3080

Actively Recruiting

40

Severance Hospital

Seoul, South Korea, 3722

Actively Recruiting

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Research Team

C

Clinical Trials Administrator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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