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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 4 years
Awards & highlights
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 4 years
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
+2 moreSecondary study objectives
Disease control rate (DCR) per RECIST 1.1.
Duration of response (DOR) per RECIST 1.1.
Immunogenicity as measured by Anti-drug antibodies (ADA) to REGN5093
+9 moreTrial 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
647 Previous Clinical Trials
384,136 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
276 Previous Clinical Trials
254,135 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously received MET-targeted therapy.My lung cancer is at an advanced stage and cannot be removed by surgery.I have previously been treated with a MET-targeted agent, except if I'm in cohort 1A.I still have side effects from previous treatments, but they are mild.I haven't had any cancer treatment or been in a trial for at least 2 weeks.I have tried all approved treatments for my condition.I am willing to provide a new biopsy sample for the study.I haven't had major surgery or radiation within the last 14 days and have recovered from any side effects.I do not have an active brain tumor or cancer spread to my brain or spinal cord.I have tumor tissue samples available for testing.My cancer has a specific genetic change related to the MET gene.
Research Study Groups:
This trial has the following groups:- Group 1: REGN5093
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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