Experimental drug targets Hard-to-Treat lung cancer
NCT ID NCT04982224
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested an experimental drug called REGN5093-M114, alone or with another drug, in people with advanced non-small cell lung cancer that has too much MET protein. The goal was to find a safe dose and see if it could shrink tumors. The study was stopped early, but the results help researchers understand how to treat this type of cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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30 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Oct 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: 1. Histologically confirmed NSCLC that is at advanced stage for which there are no approved therapies available expected to confer clinical benefit as defined in the protocol 2. Willing to provide tumor tissue from newly obtained biopsy from tumor site. Newly obtained biopsies at tissue screening are required. An archival sample can be accepted only after discussion with the medical monitor and if the sample is not more than 6 months old and was obtained on the treatment regimen prior to study screening or after completion of the last therapy. The enrollment of patients will be based on an immunohistochemistry (IHC)-based assay using freshly obtained tumor biopsies or an archival biopsy as described above. Only patients with MET overexpressing tumors by central IHC analysis will be enrolled. For expansion cohorts only: tumor site for biopsy must not have been irradiated previously and must not be the only measurable lesion. 3. Tumor must overexpress MET protein as defined in the protocol 4. For expansion only: At least one lesion that is measurable by RECIST 1.1. Tumor lesions in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions after radiation. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Adequate organ and bone marrow function as defined in the protocol Key Exclusion 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 or 5 half-lives of the prior treatment, whichever is shorter with a minimum of 7 days from the first dose of study therapy 2. Has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities resulting from prior therapy except as described in the protocol 3. Has received radiation therapy or major surgery within 14 days of first administration of study drug or has not recovered from adverse events as defined in the protocol 4. Another malignancy that is progressing or requires active treatment except as noted in the protocol 5. Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol 6. Encephalitis, meningitis, organic brain disease (eg Parkinson's disease) or uncontrolled seizures in the year prior to first dose of study therapy 7. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency as defined in the protocol NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Henry Ford Hospital, Henry Ford Cancer Institute
Detroit, Michigan, 48202, United States
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Johns Hopkins Hospital - Clinical Study Location - Skip Viragh Outpatient Cancer Building
Baltimore, Maryland, 21231, United States
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MUSC Hollings Cancer Center
Charleston, South Carolina, 29425, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Next Virginia
Fairfax, Virginia, 22031, United States
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Sidney Kimmel Comprehensive Cancer Center - 4F Second Medical Building
Baltimore, Maryland, 21231, United States
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The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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University of California Irvine School of Medicine - Suite 400, Room 407
Orange, California, 92868, United States
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University of Colorado Hospital Anshutz Outpatient Pavillion
Denver, Colorado, 80045, United States
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University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Lung cancer drug trial pulled before it even started
- Could your own tumor cells beat lung cancer? new trial tests it
- New hope for tough lung cancers: dual-antibody combo targets tumors from two angles
- Lung cancer gene map after drug failure could guide next steps