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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 4 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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My lung cancer is at an advanced stage and cannot be removed by surgery.

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I have tried all approved treatments for my condition.

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My cancer has a specific genetic change related to the MET gene.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 more

Secondary outcome measures

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 more

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)

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

619 Previous Clinical Trials

380,173 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

261 Previous Clinical Trials

250,982 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aim of this experiment?

"The main result of this clinical trial to be monitored over a period of four years is the quantity of patients with Dose Limiting Toxicities. Researchers will also assess other outcomes such as Phase 1 and 2 Disease Control Rates (DCRs) per RECIST 1.1, Phase 2/Dose Expansion-related Adverse Event Severity Indexes(AESIs), and laboratory abnormalities graded 3 or higher during Phase 2/Dose Expansion."

Answered by AI

What is the geographic scope of this clinical investigation?

"This research is enrolling from 6 distinct medical centres, three of which are in Philadelphia, Houston and Tampa. To reduce the burden of transportation for participants, it may be prudent to opt for a clinic closest to you."

Answered by AI

What is the upper limit of persons enrolled in this research project?

"Indeed, clinicaltrials.gov conveys that this experiment is actively enlisting participants; it was initially posted on the 7th of January 2020 and most recently updated on the 22nd of September 2022. The trial seeks to recruit 111 people from 6 distinct medical centres."

Answered by AI

Is the research actively recruiting participants at this time?

"According to the records held on clinicaltrials.gov, enrollment for this medical study is ongoing. It was originally created in July 2020 and modified most recently in September 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer

2020. "REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04077099.

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