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Study Comparing Amivantamab and Chemotherapy Versus Cetuximab and Chemotherapy for Patients with Advanced Colorectal 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 cancer known as colorectal cancer, specifically when it is located on the left side of the colon and cannot be surgically removed or has spread to other parts of the body. The study is particularly interested in cases where the cancer does not have certain genetic mutations, specifically KRAS, NRAS, and BRAF mutations. The trial will compare two different treatment approaches to see which is more effective as a first-line treatment for this type of cancer.

Participants in the study will receive one of two treatment combinations. The first group will receive a medication called Amivantamab along with chemotherapy drugs known as mFOLFOX6 or FOLFIRI. The second group will receive a medication called Cetuximab along with the same chemotherapy options, mFOLFOX6 or FOLFIRI. Amivantamab is given as a solution for injection under the skin, while Cetuximab is administered as a solution for infusion into a vein. Some participants may receive a placebo, which looks like the real treatment but does not contain the active medication.

The purpose of the study is to compare the effectiveness of these treatments in terms of how long they can prevent the cancer from getting worse. Participants will be randomly assigned to one of the treatment groups and will receive their assigned treatment over a period of time. The study will monitor the progress of the cancer using standard medical assessments to determine which treatment combination is more effective. The trial is expected to continue until 2028, with recruitment starting in 2025.

The research process

The trial runs in 5 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, you will be randomly assigned to one of two treatment groups. This means you will either receive amivantamab with chemotherapy or cetuximab with chemotherapy.

    The study aims to compare the effectiveness of these treatments in patients with a specific type of colorectal cancer.

  2. Step 2

    Treatment administration

    If you are in the amivantamab group, you will receive this medication through an injection under the skin. The exact dosage and frequency will be explained to you by the medical team.

    If you are in the cetuximab group, you will receive this medication through an infusion into a vein. The dosage is 5 mg/mL, and the frequency and duration will be provided by the medical team.

  3. Step 3

    Chemotherapy

    Both groups will receive chemotherapy, which may include mFOLFOX6 or FOLFIRI. These are combinations of drugs used to treat cancer, and the medical team will provide specific details about the dosage and schedule.

  4. Step 4

    Monitoring and assessments

    Throughout the study, regular monitoring and assessments will be conducted to evaluate your health and the effectiveness of the treatment. This includes scans and tests to measure the size of the tumor.

    The study will use a standard method called RECIST v1.1 to assess the tumor's response to treatment.

  5. Step 5

    End of study participation

    Your participation in the study will continue until the study's estimated end date in December 2028, or until the medical team decides it is appropriate for you to stop.

    At the end of your participation, a final assessment will be conducted to gather information about your health and the treatment's impact.

Who can join the trial?

8 criteria

  • Have a confirmed diagnosis of adenocarcinoma, a type of cancer, in the left side of the colon that cannot be removed by surgery or has spread to other parts of the body.
  • Have a tumor that is **KRAS, NRAS, and BRAF Wild-type (WT)**, meaning it does not have certain genetic mutations. This must be confirmed by a test on tissue or blood.
  • Agree to provide a new sample of the tumor tissue for testing.
  • Have a tumor that can be measured using a standard method called **RECIST v1.1**. If there is only one tumor that can be measured, it can be used for a biopsy, but scans to assess the tumor must be done at least 7 days after the biopsy.
  • Have an **ECOG Performance Status (PS)** of 0 or 1, which means you are fully active or have some symptoms but can still carry out light work.
  • Have not received any previous treatment with drugs for colorectal cancer that cannot be removed by surgery or has spread.
  • Be within the age range of 18 to 64 years old.
  • Both males and females can participate.

Who cannot join the trial?

3 criteria

  • Patients with a type of cancer that is not KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer 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

  • Amivantamab

    is a medication used in this clinical trial to treat certain types of colorectal cancer. It works by targeting specific proteins on cancer cells, which can help slow down or stop the growth of the cancer. This medication is being tested to see if it can be an effective first-line treatment for patients with a specific type of colorectal cancer that cannot be removed by surgery or has spread to other parts of the body.

  • mFOLFOX6

    is a combination of chemotherapy drugs used to treat colorectal cancer. It includes several medications that work together to kill cancer cells or stop them from growing. This therapy is often used as a standard treatment for colorectal cancer and is being tested in this trial to see how well it works in combination with other treatments.

  • FOLFIRI

    is another combination of chemotherapy drugs used to treat colorectal cancer. Like mFOLFOX6, it includes multiple medications that work together to attack cancer cells. This therapy is also a standard treatment option for colorectal cancer and is being evaluated in this trial to determine its effectiveness when used with other therapies.

  • Cetuximab

    is a medication that targets specific proteins on the surface of cancer cells. By binding to these proteins, it can help slow down or stop the growth of the cancer. Cetuximab is used in this trial to see if it can be an effective treatment option for patients with a certain type of colorectal cancer, either alone or in combination with other therapies.

What is already known about the treatment

Amivantamab – Amivantamab is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials as a potential treatment for certain types of colorectal cancer that cannot be surgically removed or have spread to other parts of the body. The medication works by targeting specific proteins on the surface of cancer cells, helping the immune system to recognize and attack these cells. Amivantamab is classified as a monoclonal antibody, a type of drug designed to bind to specific targets in the body.

Investigated diseases

KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer – This type of colorectal cancer occurs in the left side of the colon and is characterized by the absence of mutations in the KRAS, NRAS, and BRAF genes. It is considered unresectable, meaning it cannot be removed surgically, or metastatic, indicating that it has spread to other parts of the body. The disease typically begins in the cells lining the colon and can progress to invade nearby tissues and organs. As the cancer advances, it may cause symptoms such as changes in bowel habits, abdominal pain, and weight loss. The progression of the disease can vary, with some cases remaining localized while others spread more extensively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513852-13-00Protocol code61186372COR3001Estimated enrolment1 000 patientsSponsorJanssen Cilag International

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