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
Sites (30)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| Centre Francois Baclesse Coordinator of this site? Confirm its status | Caen Cedex 5 | France | Completed |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Completed |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Completed |
| Centre Hospitalier Universitaire de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Completed |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Completed |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| National Cancer Center Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun | South Korea | Unknown status |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Haeundae Paik Hospital Coordinator of this site? Confirm its status | Pusan | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seol St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Boramae Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| The Catholic University of Korea St. Vincent's Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| Dana Farber Harvard Cancer Center Consortium Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of California Irvine Medical Center - Bldg 56, RT81, Rm 241 Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| University of Pittsburgh UPMC - Clinical Research Services Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Moffitt Cancer Center - McKinley Drive Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Georgetown University Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.