Status:
RECRUITING
A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 effectivenes...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- 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
- 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
Key Trial Info
Start Date :
January 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 22 2032
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT04077099
Start Date
January 7 2020
End Date
April 22 2032
Last Update
December 18 2025
Active Locations (33)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of California Irvine Medical Center - Bldg 56, RT81, Rm 241
Orange, California, United States, 92868
3
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
4
Moffitt Cancer Center - McKinley Drive
Tampa, Florida, United States, 33612