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REGN5093 for adults with 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

PHASE1; PHASE2 · Regeneron Pharmaceuticals · NCT04077099

This will test whether REGN5093 can shrink tumors and determine safe dose(s) in adults with unresectable or metastatic NSCLC whose tumors have MET alterations.

Quick facts

PhasePHASE1; PHASE2
Study typeInterventional
Enrollment231 (estimated)
Ages18 Years and up
SexAll
SponsorRegeneron Pharmaceuticals (industry)
Drugs / interventionsradiation
Locations40 sites (Birmingham, Alabama and 39 other locations)
Trial IDNCT04077099 on ClinicalTrials.gov

What this trial studies

The first phase is a dose-finding phase to identify safe and tolerable dose(s) of the investigational antibody REGN5093. The second phase uses the selected dose(s) to see how well REGN5093 works to shrink tumors and delay disease progression in patients with MET-altered advanced NSCLC. The trial will monitor side effects, measure how the drug behaves in the body (pharmacokinetics), and collect tumor tissue and other biomarkers. Safety, tumor response, and time-to-progression endpoints will guide further development.

Who should consider this trial

Good fit: Adults with unresectable or metastatic NSCLC with a documented MET alteration, ECOG performance status 0–1, adequate organ and marrow function, and willingness to provide tumor tissue are ideal candidates.

Not a fit: Patients without MET alterations, with ECOG >1, untreated active CNS metastases or leptomeningeal disease, recent major surgery or radiation, or recent investigational therapy are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, REGN5093 could offer a targeted treatment option that shrinks tumors and delays progression for patients with MET-altered NSCLC.

How similar studies have performed: MET-targeted therapies such as MET tyrosine kinase inhibitors have shown benefit for certain MET-altered NSCLC patients, but REGN5093 is a newer antibody approach with limited prior clinical data.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Histologically confirmed advanced NSCLC that is unresectable or metastatic as described in the protocol
2. Willing to provide tumor tissue as described in the protocol
3. Documented presence of MET alteration as described in the protocol.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Adequate organ and bone marrow function as described 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 as described in the protocol
2. Has not yet recovered from any acute toxicities resulting from prior therapy with certain exceptions as described in the protocol
3. Has received radiation therapy or major surgery within 14 days as described in the protocol
4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease or spinal cord compression as defined in the protocol
5. Uncontrolled infection as described in the protocol

Note: Other protocol defined Inclusion/Exclusion criteria apply

Where this trial is running

Birmingham, Alabama and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: NSCLC, MET, HGF, MET-altered advanced, Unresectable, Metastatic disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.