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Study of Encorafenib and Binimetinib for Patients with BRAFV600E-Mutant Metastatic 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 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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

16 criteria

  • 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 trial?

4 criteria

  • 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.
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Investigated drugs

  • 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.

What is already known about the treatment

  • Encorafenib

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating BRAFV600E-mutant metastatic non-small cell lung cancer. It is a BRAF inhibitor, which means it works by blocking the activity of the BRAF protein that is involved in cell growth, thereby slowing down or stopping the growth of cancer cells. Encorafenib is classified as a targeted cancer therapy and is being evaluated for its potential to improve outcomes in patients with specific genetic mutations.

  • Binimetinib

    This medication is also taken orally and is under investigation in combination with encorafenib for treating BRAFV600E-mutant metastatic non-small cell lung cancer. Binimetinib is a MEK inhibitor, which functions by inhibiting the MEK enzymes that are part of a signaling pathway that promotes cancer cell growth. By blocking this pathway, binimetinib helps to prevent the proliferation of cancer cells. It is classified as a targeted therapy and is being studied for its ability to enhance the effectiveness of BRAF inhibitors in cancer treatment.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515944-22-00Protocol codeIFCT-1904Estimated enrolment119 patientsSponsorIntergroupe Francophone De Cancerologie Thoracique

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