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Monoclonal Antibodies

REGN5093 for Lung Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed NSCLC that is at advanced stage. Advanced is defined as unresectable or metastatic disease
Patients must have exhausted all approved available therapies appropriate for the patient
Must not have
Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease or spinal cord compression as defined in the protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 12 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, REGN5093, to see if it is safe and effective for patients with MET-altered Non-small cell lung cancer (NSCLC).

Who is the study for?
This trial is for patients with advanced Non-Small Cell Lung Cancer who have MET alterations and have tried all other approved treatments. They must provide tumor tissue samples, not have had recent radiation or major surgery, and should not be recovering from severe side effects of previous therapies.
What is being tested?
REGN5093 is being tested to determine its safety (phase 1) and how well it works against lung cancer (phase 2). The study will find the highest dose patients can take without serious side effects and measure the drug's effect on tumor size.
What are the potential side effects?
Possible side effects of REGN5093 may include reactions at the infusion site, general discomfort, changes in blood tests reflecting organ function, but specific side effects will be determined during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung cancer is at an advanced stage and cannot be removed by surgery.
Select...
I have tried all approved treatments for my condition.
Select...
My cancer has a specific genetic change related to the MET gene.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have an active brain tumor or cancer spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 12 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 12 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence and severity of adverse events of special interest (AESIs)
Incidence and severity of serious adverse events (SAEs)
Incidence and severity of treatment-emergent adverse events (TEAEs)
+2 more
Secondary study objectives
Disease control rate (DCR) per RECIST 1.1.
Duration of response (DOR) per RECIST 1.1.
Incidence and severity of AESIs
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: REGN5093Experimental Treatment1 Intervention
Monotherapy in dose escalation cohorts (phase 1) followed by an expansion phase (phase 2)

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
671 Previous Clinical Trials
385,593 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
284 Previous Clinical Trials
254,686 Total Patients Enrolled

Media Library

REGN5093 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04077099 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: REGN5093
Non-Small Cell Lung Cancer Clinical Trial 2023: REGN5093 Highlights & Side Effects. Trial Name: NCT04077099 — Phase 1 & 2
REGN5093 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04077099 — Phase 1 & 2
~134 spots leftby Jan 2032
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