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Study of Encorafenib and Binimetinib for Patients with BRAF V600-Mutant 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 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.

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Netherlands Cancer Institute Amsterdam The Netherlands
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Ucxfmmsflcck Mmdjddt Cjxymyt Gisgdwvja Groningen The Netherlands
Ioebkvgk Cbwwdx Dodmirucjnekqctdt L'hospitalet De Llobregat Spain
Hxqxoaaf Ufznxkugeageo Rhoeirny Dt Mqqhwl Malaga Spain
Agfbcmo Unufn Sxztksizb Lspjje Dk Buemdlj Bologna Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
15.04.2019
Spain Spain
Not recruiting
15.04.2019
The Netherlands The Netherlands
Not recruiting
15.04.2019

Trial locations

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.

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 ID:
2024-515929-28-00
Protocol code:
C4221008
NCT ID:
NCT03915951
Trial Phase:
Therapeutic exploratory (Phase II)

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