Not recruiting

Study of Davutamig (REGN5093) for Patients with Advanced Non-Small Cell Lung Cancer with MET Alterations

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC) that has specific changes in a gene called MET. The treatment being tested is a new medication called REGN5093, which is a type of medicine known as a bispecific antibody. This medication is designed to target and bind to specific proteins in the body, potentially helping to treat the cancer.

The purpose of the study is to evaluate the safety and effectiveness of REGN5093 in patients with MET-altered advanced non-small cell lung cancer. The study is divided into two phases. In the first phase, the focus is on determining the safest dose of REGN5093 that patients can tolerate. In the second phase, the study will look at how well the medication works in reducing the size of the tumors.

Participants in the study will receive REGN5093 through an IV infusion, which means the medication is given directly into a vein. The study will monitor patients for any side effects and measure how the medication is processed in the body. The overall goal is to find out if REGN5093 can be a safe and effective treatment option for patients with this specific type of lung cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be required to provide a sample of tumor tissue. This may involve a biopsy, which is a procedure to remove a small piece of tissue for examination.
The patient must have a confirmed diagnosis of advanced non-small cell lung cancer (NSCLC) with specific changes in the MET gene.
Step 2
Phase 1 treatment
The patient will receive the medication REGN5093, which is a powder that is mixed into a solution and given through an intravenous (IV) infusion.
The main goal of this phase is to determine the safest dose of REGN5093 and to observe how the body processes the medication.
Step 3
Monitoring and assessments
Throughout the study, the patient will undergo regular monitoring to check for any side effects and to measure the levels of REGN5093 in the blood.
The patient will also have regular scans to assess the response of the cancer to the treatment.
Step 4
Phase 2 treatment
If the patient continues to the second phase, the focus will shift to evaluating the effectiveness of REGN5093 in reducing the size of the cancer.
The patient will continue to receive REGN5093 through IV infusion, with the dose determined from phase 1.
Step 5
Completion of the study
The study is expected to conclude by October 2024. At the end of the study, the patient will have a final assessment to evaluate the overall impact of the treatment on their cancer.

Who can join the trial?

5 criteria

The patient must have a type of lung cancer called non-small cell lung cancer (NSCLC) that is at an advanced stage. This means the cancer cannot be removed by surgery or has spread to other parts of the body. The patient should have tried all other approved treatments that are suitable for them.
The patient should have a sample of their tumor tissue available, unless discussed with the medical team.
The patient must be willing to provide a sample of their tumor tissue from a new biopsy. This means taking a small piece of the tumor for testing. This is required unless it is not safe for medical reasons and discussed with the medical team. For certain groups in the study, the biopsy should be from a tumor area that has not been treated with radiation before and is not the only area that can be measured for the study.
The patient must have a previously confirmed change in the MET gene. This could be a specific change called MET-exon14 gene mutation, an increase in the number of MET genes called MET gene amplification, or higher levels of MET protein, as defined in the study protocol.
Other criteria defined in the study protocol may also apply.

Who cannot join the trial?

4 criteria

Patients who have a different type of cancer than MET-altered non-small cell lung cancer (NSCLC) cannot participate. This means the study is only for those with a specific change in their lung cancer.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who do not meet the safety and health requirements set by the study cannot participate. This ensures the study is safe for all participants.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

CHU Grenoble Alpes
Verified
La Tronche, France
Centr Georges Francois Leclerc
Verified
Dijon, France
Centre Francois Baclesse
Verified
Caen, France

Trial locations

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Investigated drugs

REGN5093 is an investigational medication being studied for its potential use in treating patients with advanced non-small cell lung cancer that has alterations in the MET gene. The trial aims to evaluate the safety and tolerability of this medication, as well as how the body processes it. The study also seeks to determine the most effective dose for future research phases. Additionally, the trial will assess the medication's ability to reduce tumor size in patients.

Davutamig

What is already known about the treatment

REGN5093 – This medication is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its potential use in treating MET-altered non-small cell lung cancer (NSCLC). The main therapeutic indication is for patients with this specific type of lung cancer. REGN5093 works by targeting and inhibiting the MET protein, which is involved in the growth and spread of cancer cells. It is classified as a targeted therapy, focusing on specific molecular targets associated with cancer.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) – Non-small cell lung cancer is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. The disease often begins in the cells lining the air passages and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. The progression of NSCLC can vary, with some cases remaining localized while others may spread to lymph nodes or distant organs.