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Study of Encorafenib and Binimetinib for Patients with BRAF V600-Mutant 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 Non-small Cell Lung Cancer (NSCLC) that has a specific mutation called BRAF V600. The study is testing a combination of two medications: Encorafenib and Binimetinib. Encorafenib is taken as a capsule, while Binimetinib is taken as a film-coated tablet. The purpose of the study is to evaluate how effective this combination is in treating patients who have this specific mutation in their lung cancer.

Participants in the study will take the medications by mouth. The study will observe both patients who have not received any prior treatment for their advanced or metastatic cancer and those who have already been treated with certain types of chemotherapy or immunotherapy. The study will last for a period of up to 80 weeks, during which the participants will be monitored regularly to assess the response of their cancer to the treatment.

The study aims to determine how well the combination of Encorafenib and Binimetinib works in shrinking the cancer or stopping it from growing. It will also look at how long the treatment can keep the cancer under control and how quickly the cancer responds to the treatment. The results will help understand the potential benefits of this treatment combination for patients with BRAF V600-mutant NSCLC.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure the presence of a BRAFV600E mutation in tumor tissue or blood.

    The assessment also checks for adequate liver, kidney, and bone marrow function, as well as the ability to swallow and absorb oral medications.

  2. Step 2

    Treatment initiation

    The treatment involves taking two medications: encorafenib and binimetinib. These are administered orally.

    The specific dosage and frequency are determined by the study protocol and are tailored to individual patient needs.

  3. Step 3

    Ongoing treatment and monitoring

    Regular visits are scheduled to monitor the response to treatment and manage any side effects. This includes physical examinations, blood tests, and imaging studies.

    The effectiveness of the treatment is evaluated using criteria that measure tumor response.

  4. Step 4

    Completion of treatment

    The treatment continues until the study's end date or until it is determined that the treatment is no longer beneficial.

    Upon completion, a final assessment is conducted to evaluate the overall response and any long-term effects.

Who can join the trial?

19 criteria

  • Able to provide written informed consent. If an adult patient is under guardianship, they may participate with the consent of their legally authorized guardian, if allowed by local rules.
  • Have proper liver and kidney function, which means:
    • Total bilirubin (a liver function test) should be less than or equal to 1.5 times the upper limit of normal (ULN).
    • ALT and AST (liver enzymes) should be less than or equal to 2.5 times ULN, or less than or equal to 5 times ULN if there are liver metastases (cancer spread to the liver).
    • Serum creatinine (a kidney function test) should be less than or equal to 1.5 times ULN, or creatinine clearance (a measure of kidney function) should be 50 mL/min or higher.
    • Able to swallow, keep, and absorb oral medications.
    • Willing and able to attend scheduled visits, follow the treatment plan, and undergo lab tests and other study procedures.
    • Female patients who can have children must have a negative pregnancy test and agree to use effective birth control methods and not donate eggs from the start of the study until 30 days after the last dose of the study treatment.
    • Male patients must agree to use effective birth control methods and not donate sperm from the start of the study until 90 days after the last dose of the study drug.
    • Must be 18 years or older at the time of giving informed consent.
    • Have a confirmed diagnosis of **Non-Small Cell Lung Cancer (NSCLC)** that is currently at Stage IV, which means the cancer has spread to other parts of the body.
    • Have a **BRAFV600E mutation** in the tumor tissue or blood, as determined by a local lab test. Other similar mutations may be allowed after discussion with the study sponsor.
    • The doctor must confirm that there is enough tumor tissue available for testing to confirm the **BRAFV600 mutation** status.
    • Patients can either be new to treatment (no prior treatment for advanced or metastatic disease) or have received:
      • First-line platinum-based chemotherapy.
      • First-line treatment with an anti-PD-1/PD-L1 inhibitor, which is a type of immunotherapy, with or without platinum-based chemotherapy.
      • Have measurable disease based on a standard called **RECIST v1.1**, which is a way to measure how cancer responds to treatment.
      • Have an **ECOG performance status** of 0 or 1, which means the patient is fully active or has some symptoms but can still carry out light work.
      • Have proper bone marrow function, which means:
        • **ANC** (a type of white blood cell count) should be 1.5 or higher.
        • Platelets (cells that help with blood clotting) should be 100 or higher.
        • Hemoglobin (a protein in red blood cells) should be 8.5 g/dL or higher, with or without blood transfusions.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer than Non-small Cell Lung Cancer cannot participate.
  • Patients who do not have the BRAFV600E mutation in their cancer cells are excluded. This is a specific change in the cancer's genetic material.
  • Patients who are not within the specified age range for the study cannot join. The age range is typically defined by the study.
  • Patients who are unable to follow the study procedures or take the study medications as required are not eligible.
  • Patients who have other serious health conditions that might interfere with the study treatment are excluded.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have had certain treatments for their cancer before may be excluded, depending on the study's requirements.
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Investigated drugs

  • Encorafenib

    is a medication used in this trial to treat patients with a specific type of lung cancer known as BRAFV600-mutant non-small cell lung cancer. It works by targeting and inhibiting a protein that promotes cancer cell growth, helping to slow down or stop the progression of the disease.

  • Binimetinib

    is another medication used in combination with encorafenib in this trial. It also targets proteins involved in cancer cell growth, working alongside encorafenib to enhance the treatment's effectiveness against BRAFV600-mutant non-small cell lung cancer.

What is already known about the treatment

  • Encorafenib

    Encorafenib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating non-small cell lung cancer with a specific genetic mutation known as BRAFV600E. The medication works by inhibiting a protein called BRAF, which is involved in cell growth, thereby slowing down or stopping the growth of cancer cells. It is classified as a BRAF inhibitor, a type of targeted cancer therapy.

  • Binimetinib

    Binimetinib is taken orally as tablets and is under investigation in clinical trials for its potential to treat non-small cell lung cancer with the BRAFV600E mutation. It functions by blocking a protein called MEK, which is part of a pathway that helps cancer cells grow. By inhibiting this protein, binimetinib can help reduce the proliferation of cancer cells. It belongs to the class of medications known as MEK inhibitors, which are used in targeted cancer treatments.

Investigated diseases

Non-small Cell Lung Cancer – This is the most common type of lung cancer, accounting for about 85% of all cases. It typically grows and spreads more slowly than small cell lung cancer. The disease begins in the tissues of the lungs and can spread to other parts of the body. It is often categorized into subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it can lead to more severe respiratory issues and other systemic symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515929-28-00Protocol codeC4221008Estimated enrolment117 patientsSponsorPfizer Inc.

sourced from the EU Clinical Trials Register and site verification

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