Not recruiting

Study on Methotrexate, Dexamethasone, and Montelukast to Prevent Infusion Reactions in Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer

Verified siteRegistered drugNo 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 EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC). The study aims to evaluate the effectiveness of different medications in reducing reactions that may occur during the infusion of a treatment called Amivantamab. Amivantamab is a special type of medication known as an EGFR-MET bispecific antibody, which targets specific proteins involved in the growth of cancer cells. The trial will test three different medications: Methotrexate, Dexamethasone, and Montelukast, to see if they can help prevent these infusion-related reactions.

The purpose of the study is to assess whether taking Methotrexate, Dexamethasone, or Montelukast before receiving Amivantamab can reduce the frequency or severity of these reactions. Methotrexate is given as a solution for injection, Dexamethasone is taken as a tablet, and Montelukast is also taken as a tablet. Participants in the study will receive one of these medications before their Amivantamab infusion. The study will monitor the participants to see how well these medications work in preventing reactions during the first dose of Amivantamab.

The study will involve participants who have previously been treated with a medication called Osimertinib and chemotherapy. The trial will take place over a period of time, with participants receiving the study medications and being observed for any reactions. The goal is to find out if these medications can make the infusion process safer and more comfortable for patients with this 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 participant must have advanced or metastatic non-small cell lung cancer (NSCLC) and meet specific health criteria, including a performance status grade of 0 or 1.
Participants must have progressed on or after prior treatment with osimertinib and platinum-based chemotherapy.
Step 2
Preparation for treatment
Before starting the main treatment, participants will receive medications to help prevent reactions to the infusion of amivantamab.
These medications include subcutaneous methotrexate, oral dexamethasone, and oral montelukast.
Step 3
Main treatment
The main treatment involves the administration of intravenous amivantamab.
Participants will also receive oral lazertinib as part of the combination therapy.
Step 4
Monitoring and follow-up
Participants will be monitored for any infusion-related reactions (IRRs) during the first cycle of treatment, particularly on Day 1.
The study aims to assess the rate of IRRs occurring within 24 hours of the first amivantamab infusion.
Step 5
Completion of the study
The study is estimated to end by December 16, 2025.
Participants will continue to be monitored and may receive follow-up care as needed.

Who can join the trial?

7 criteria

The participant must have advanced or metastatic non-small cell lung cancer (NSCLC). This means the cancer has spread beyond the lungs.
The participant must have an Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1. This is a scale that measures how well a person can perform daily activities. A grade of 0 means fully active, and 1 means some symptoms but still able to do light work.
If the participant is a female using oral contraceptives, she must also use an additional barrier contraceptive method, like a condom, to prevent pregnancy during the study.
If the participant is a male, he must wear a condom during any activity that could pass ejaculate to another person during the study and for 3 months after the last dose of the study treatment.
Each participant, or their legally authorized representative, must sign an informed consent form (ICF). This form shows that the participant understands the study's purpose and procedures and agrees to take part.
The participant must have had their cancer progress after treatment with osimertinib and platinum-based chemotherapy. They may have used a first-or-second generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) before osimertinib.
The participant must have previously identified EGFR-mutated non-small cell lung cancer (NSCLC). This means the cancer has specific changes in the EGFR gene, such as EGFR Exon19 deletion or L858R, confirmed by a certified laboratory.

Who cannot join the trial?

6 criteria

Patients who do not have EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer cannot participate. This means the study is only for those with a specific type of lung cancer that has certain genetic changes.
Patients who are not within the specified age range cannot participate. The study is for certain age groups, so if you are too young or too old, you may not be eligible.
Patients who are not willing or able to follow the study procedures cannot participate. This means you need to be able to attend appointments and follow instructions given by the study team.
Patients who have other medical conditions that might interfere with the study cannot participate. This means if you have other health issues that could affect the study results, you may not be eligible.
Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
Patients who are currently participating in another clinical trial cannot participate. This is to avoid any interference between different study treatments.

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Verified sites

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

Centre Hospitalier Regional Et Universitaire De Brest
Verified
Brest, France
Centre Hospitalier Universitaire Rouen
Verified
Rouen, France
Centre Leon Berard
Verified
Lyon, France

Trial locations

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Investigated drugs

Methotrexate
is a medication that is given as an injection under the skin. In this trial, it is being tested to see if it can help prevent reactions that some people have when they receive their first dose of a specific cancer treatment called amivantamab.
Dexamethasone
is a medication taken by mouth. It is a type of steroid that is being studied to find out if it can reduce the chance or severity of reactions to the first dose of amivantamab, which is used to treat certain types of lung cancer.
Montelukast
is a medication also taken by mouth. It is commonly used to manage allergies and asthma. In this trial, it is being evaluated to determine if it can help prevent infusion-related reactions when patients receive their first dose of amivantamab.

What is already known about the treatment

Methotrexate
Methotrexate is administered subcutaneously and is currently being studied for its potential to prevent infusion-related reactions in patients receiving amivantamab for EGFR-mutated advanced or metastatic non-small cell lung cancer. It is well-documented in medical literature as a treatment for various conditions, including cancer and autoimmune diseases. Methotrexate works by inhibiting the enzyme dihydrofolate reductase, which is crucial for DNA synthesis, thus slowing the growth of rapidly dividing cells. It is classified as an antimetabolite and antifolate drug.
Dexamethasone
Dexamethasone is taken orally and is being evaluated for its ability to reduce infusion-related reactions in patients treated with amivantamab. It is a well-established medication in the medical field, commonly used for its anti-inflammatory and immunosuppressant properties. Dexamethasone works by mimicking the effects of cortisol, a natural hormone, to reduce inflammation and suppress the immune response. It belongs to the class of corticosteroids.
Montelukast
Montelukast is administered orally and is under investigation for its role in preventing infusion-related reactions in patients receiving amivantamab. It is widely recognized in medical literature for managing asthma and allergic rhinitis. Montelukast functions by blocking leukotriene receptors, which helps reduce inflammation and constriction in the airways. It is classified as a leukotriene receptor antagonist.

Investigated diseases

EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer – This is a type of lung cancer characterized by mutations in the epidermal growth factor receptor (EGFR) gene. These mutations lead to uncontrolled cell growth and division, contributing to the development and progression of cancer. The disease is classified as advanced or metastatic when it has spread beyond the lungs to other parts of the body. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some patients experiencing rapid worsening of symptoms. Understanding the specific genetic mutations involved is crucial for determining appropriate treatment strategies.