Study of Encorafenib and Binimetinib for Patients with BRAFV600E-Mutant Metastatic Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as BRAFV600E-mutant metastatic Non-small Cell Lung Cancer. The study is testing a combination of two medications: Encorafenib, which is a BRAF inhibitor, and Binimetinib, a MEK inhibitor. These medications are being used together to see how effective they are in treating this specific type of lung cancer.

The purpose of the study is to evaluate how well the combination of encorafenib and binimetinib works in patients with this type of lung cancer. Participants in the study will take these medications orally, meaning they will swallow them in the form of capsules and tablets. The study will last for a period of up to 60 days, during which the effects of the treatment will be closely monitored.

Throughout the study, researchers will assess the response of the cancer to the treatment, looking for any signs of improvement or progression. The study aims to provide valuable information on the potential benefits of using these medications together for patients with BRAFV600E-mutant metastatic Non-small Cell Lung Cancer.

1 joining the study

Upon joining the study, the patient will have signed a consent form. This form confirms understanding of the study and agreement to participate.

The patient must be able to attend scheduled visits and comply with the treatment and testing schedule.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes checking bone marrow, liver, and kidney function.

A test will confirm the presence of a BRAFV600E mutation in lung cancer tissue.

3 treatment initiation

The patient will begin treatment with two medications: Braftovi (encorafenib) and Mektovi (binimetinib).

Braftovi is taken as 75 mg hard capsules, and Mektovi is taken as 15 mg film-coated tablets. Both are administered orally.

4 treatment schedule

The patient will take the medications daily as prescribed. The exact dosage and frequency will be determined by the healthcare provider.

Regular monitoring will occur to assess the response to treatment and any side effects.

5 ongoing assessments

Throughout the study, the patient will undergo regular assessments to monitor the effectiveness of the treatment.

These assessments will include imaging tests to evaluate the size and progression of the cancer.

6 completion of treatment

The study is expected to continue until May 2025, or until the patient completes the treatment protocol.

Upon completion, a final assessment will be conducted to evaluate the overall response to the treatment.

Who Can Join the Study?

Must have signed a written consent form agreeing to participate in the study.
Must be willing and able to attend scheduled visits, follow the treatment plan, and undergo lab tests.
Must have adequate bone marrow function, which means having enough healthy blood cells.
Must have adequate liver and kidney function, which means the liver and kidneys are working well enough.
Female patients who can have children must have a negative pregnancy test.
Female patients who can have children must agree to use effective birth control and not donate eggs during the study and for 30 days after the last treatment.
Male patients must agree to use effective birth control and not donate sperm during the study and for 90 days after the last treatment.
Must have national health insurance coverage.
Must be at least 18 years old.
Must have a confirmed diagnosis of Stage IV Non-Small Cell Lung Cancer (NSCLC).
Must have an ECOG performance status of 0-1, which means being fully active or having some symptoms but being able to carry out light work.
Must be able to swallow and keep down oral medication.
Must have a specific genetic change called a BRAFV600E mutation in lung cancer tissue.
Must have enough tumor tissue available for testing to confirm the BRAFV600E mutation.
Must be either new to treatment for advanced/metastatic disease or have progressed after certain previous treatments.
Must have measurable disease based on specific criteria used to assess cancer.

Who Cannot Join the Study?

Patients who do not have the specific type of lung cancer called BRAFV600E-mutant metastatic Non-small Cell Lung Cancer cannot participate.
Patients who have a different type of BRAF mutation that is not V600E in the second or third line of treatment cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Centre Hospitalier Intercommunal Creteil	Creteil	France
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier De Colmar	Colmar	France
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Hospital Foch	Suresnes	France
Centre Hospitalier Alpes Leman	74130	France
Centre Hospitalier Le Mans	Le Mans	France
Hopital Ambroise Pare	Boulogne-Billancourt	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier De Saint-Quentin	Saint Quentin	France
Hopital Prive D Antony	Antony	France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace	Mulhouse	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Institut Sainte Catherine	Avignon	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Centre Hospitalier De Pau	Pau	France
Les Hopitaux Nord-Ouest	Villefranche sur Saône	France
Cvwzxc Lflz Bpyfkj	Lyon	France
Cvpjgc Hjmcijsacby Ec Urziklcrhgdsx Dm Lsjyrmu	Limoges	France
Auxdmtymxv Pmpfzzgy Hlbenqac Dt Muohwovlt	Marseille	France
Cfpvdu Hvivhlaibes Ropdhytc Ubiqqsjbgmutb Dr Tpxrh	Tours	France
Csqvic Hjyhifdrpbj Rrqohxss Dodwcmhtlcplhb	Angers	France
Icslvvbx Plzwjccliivblvd Cmludr Cpafgp	Marseille	France
Hoinblvh Uamrrnuqcxvmhf Sziihfhcuy &cfnzik Hrpfkvh de Hozsqiqzcpr	STRASBOURG, Alsace	France
Ixkgpvwr Czegc	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	04.01.2021

Trial locations

Encorafenib is a medication used in this trial to target and inhibit the activity of a specific protein called BRAF, which is involved in cell growth. This medication is being tested for its effectiveness in treating patients with a specific type of lung cancer that has a mutation known as BRAFV600E.

Binimetinib is another medication used in combination with Encorafenib in this trial. It works by inhibiting a protein called MEK, which is part of a pathway that helps cancer cells grow and survive. The combination of Binimetinib with Encorafenib aims to enhance the treatment’s effectiveness against the cancer cells with the BRAFV600E mutation.

Investigated diseases:

Non-small cell lung cancer stage IV

BRAFV600E-mutant metastatic Non-small Cell Lung Cancer – This is a type of lung cancer characterized by the presence of a specific genetic mutation known as BRAFV600E. It is a form of non-small cell lung cancer (NSCLC), which is the most common type of lung cancer. The disease begins in the tissues of the lung and can spread to other parts of the body. The BRAFV600E mutation leads to abnormal cell growth and division, contributing to cancer progression. As the cancer advances, it may cause symptoms such as persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some patients experiencing rapid growth and others having a slower course.

Trial ID:

2024-515944-22-00

Protocol code:

IFCT-1904

NCT ID:

NCT04526782

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Encorafenib and Binimetinib for Patients with BRAFV600E-Mutant Metastatic Non-Small Cell Lung Cancer

What is this study about?

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