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NCT04077099Active, not recruitingPhase 1/2

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

A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 16 Sept 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
95 (actual)
First submitted
13 Aug 2019
Start date
7 Jan 2020
Primary completion date
6 Jul 2027
Lead sponsor
Regeneron Pharmaceuticals
Diseases
Lung cancer
NCT number
NCT04077099
EU CT number
2023-506248-18-00
EudraCT number
2019-001908-38

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 95
  • From 7 Jan 2020 to the primary completion date, 6 Jul 2027
  • 30 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Has not yet recovered from any acute toxicities resulting from prior therapy with certain exceptions as described in the protocol
  • Has received radiation therapy or major surgery within 14 days as described in the protocol

Other illness

  • 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
    • Note: Other protocol defined Inclusion/Exclusion criteria apply

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Institut Bergonie
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BordeauxFranceCompleted
Centre Francois Baclesse
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Caen Cedex 5FranceCompleted
Centr Georges Francois Leclerc
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DijonFranceCompleted
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceCompleted
Centre Hospitalier Universitaire de Montpellier
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MontpellierFranceCompleted
Centre Hospitalier Universitaire de Rennes
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RennesFranceCompleted
Pusan National University Hospital
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BusanSouth KoreaUnknown status
Chungbuk National University Hospital
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Cheongju-siSouth KoreaUnknown status
National Cancer Center
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Gyeonggi-doSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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HwasunSouth KoreaUnknown status
Gachon University Gil Medical Center
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IncheonSouth KoreaUnknown status
Haeundae Paik Hospital
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PusanSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Seol St. Mary's Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Boramae Medical Center
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SeoulSouth KoreaUnknown status
Korea University Guro Hospital
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Ajou University Hospital
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SuwonSouth KoreaUnknown status
The Catholic University of Korea St. Vincent's Hospital
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SuwonSouth KoreaUnknown status
Dana Farber Harvard Cancer Center Consortium
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BostonUnited StatesUnknown status
The University of Texas MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesUnknown status
University of California Irvine Medical Center - Bldg 56, RT81, Rm 241
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OrangeUnited StatesUnknown status
University of Pittsburgh UPMC - Clinical Research Services
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PittsburghUnited StatesUnknown status
Moffitt Cancer Center - McKinley Drive
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TampaUnited StatesUnknown status
Georgetown University Medical Center
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Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.