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Study on the Safety and Effectiveness of Amivantamab and Capmatinib for Patients with Unresectable Metastatic Non-Small Cell Lung Cancer

Verified siteInvestigationalNo 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 unresectable metastatic non-small cell lung cancer (NSCLC). This form of cancer is advanced and cannot be removed through surgery. The study is investigating a combination treatment using two medications: amivantamab and capmatinib. Amivantamab is given as a solution through a vein, while capmatinib is taken as a tablet by mouth.

The purpose of the study is to evaluate the safety and effectiveness of this combination therapy in patients with NSCLC. The study will be conducted in two phases. In the first phase, researchers will determine the best dose of the combination therapy. In the second phase, they will assess how well the treatment works in patients with specific genetic changes in their cancer, such as the MET exon 14 skipping mutation and MET amplification.

Participants in the study will receive the combination therapy and will be monitored for any side effects and how their cancer responds to the treatment. The study aims to provide valuable information on whether this combination therapy can be a beneficial treatment option for patients with this type of lung cancer.

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

    Initial treatment phase

    The study begins with the administration of two medications: amivantamab and capmatinib. Amivantamab is given as a solution for infusion, which means it is administered directly into a vein. Capmatinib is provided in the form of film-coated tablets, taken orally.

    The purpose of this phase is to determine the appropriate dose of the combination therapy. This involves monitoring for any side effects and adjusting the dosage as necessary to ensure safety and effectiveness.

  2. Step 2

    Dose selection and adjustment

    During this phase, the focus is on identifying the recommended dose for the combination therapy. This is referred to as the RP2CD, which stands for Recommended Phase 2 Combination Dose.

    The dosage may be adjusted based on the patient's response and any side effects experienced. The goal is to find a balance that maximizes the treatment's effectiveness while minimizing adverse effects.

  3. Step 3

    Expansion phase

    Once the appropriate dose is determined, the study moves into the expansion phase. This phase aims to evaluate the treatment's effect on the cancer, specifically looking at how well it reduces tumor size or slows its growth.

    Patients will continue to receive the combination therapy at the selected dose. Regular assessments will be conducted to monitor the cancer's response to the treatment.

  4. Step 4

    Ongoing monitoring and assessment

    Throughout the trial, patients will undergo regular health assessments. These assessments include physical exams, imaging tests, and laboratory tests to monitor the cancer's status and the patient's overall health.

    The study will also track any side effects experienced by the patient to ensure the treatment remains safe and tolerable.

  5. Step 5

    Completion of trial participation

    The trial is expected to conclude by March 26, 2025. At the end of the study, a final assessment will be conducted to evaluate the overall effectiveness and safety of the combination therapy.

    Patients will receive information about their health status and any further treatment recommendations based on the study's findings.

Who can join the trial?

5 criteria

  • Must have been previously diagnosed with **unresectable Stage IV non-small cell lung cancer (NSCLC)**. This means the lung cancer cannot be removed by surgery and has spread to other parts of the body.
  • Can have brain metastases that have been treated locally and are stable and not causing symptoms for more than 2 weeks. If taking corticosteroids, the dose should be low (10 milligrams or less of prednisone or similar) for at least 2 weeks before starting the study treatment.
  • Can have had another type of cancer in the past, as long as it does not affect the safety or effectiveness of the study treatment.
  • Must have an **ECOG performance status** of 0 or 1. This is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
  • If able to have children, must have a negative pregnancy test before starting the study and agree to have more pregnancy tests during the study.

Who cannot join the trial?

7 criteria

  • Patients who have a type of lung cancer called Unresectable Metastatic Non-small Cell Lung Cancer cannot participate. This means the cancer has spread and cannot be removed by surgery.
  • Patients who do not have a specific genetic change called MET exon 14 skipping mutation or MET amplified NSCLC are excluded. These are specific changes in the cancer cells that the study is focusing on.
  • Patients who are not within the age range specified by the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to follow the study procedures or take the study medications as required will be excluded.
  • Patients who have other serious health conditions that might interfere with the study treatment or affect their safety cannot participate.
  • Patients who are pregnant or breastfeeding are not allowed to join the study.
  • Patients who have participated in another clinical trial recently may be excluded to avoid interference with the study results.
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Investigated drugs

  • Amivantamab

    is a medication used in this trial to treat non-small cell lung cancer (NSCLC). It works by targeting specific proteins on the surface of cancer cells, helping the immune system to recognize and attack these cells. This medication is being studied to see how well it works when combined with another drug.

  • Capmatinib

    is another medication involved in this trial, also used to treat NSCLC. It targets a specific genetic mutation known as MET exon 14 skipping, which can drive cancer growth. By inhibiting this mutation, capmatinib may help slow down or stop the progression of the cancer. This trial is exploring the effectiveness of capmatinib when used together with amivantamab.

What is already known about the treatment

  • Amivantamab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating unresectable metastatic non-small cell lung cancer. It is a monoclonal antibody that targets specific proteins on cancer cells, helping the immune system to recognize and destroy them. Amivantamab is classified as an antineoplastic agent and is being evaluated for its potential to improve outcomes in patients with certain genetic mutations in their cancer cells.

  • Capmatinib

    This medication is taken orally and is also under investigation in clinical trials for the treatment of unresectable metastatic non-small cell lung cancer. It works by inhibiting a specific enzyme involved in cancer cell growth and survival, particularly in cases with MET exon 14 skipping mutations or MET amplification. Capmatinib is classified as a kinase inhibitor and is being studied for its ability to halt or slow the progression of cancer in affected patients.

Investigated diseases

Unresectable Metastatic Non-small Cell Lung Cancer – This is a type of lung cancer that cannot be removed through surgery and has spread to other parts of the body. It originates in the tissues of the lungs and is characterized by the presence of non-small cells, which grow and spread more slowly than small cell lung cancer. The disease progresses as cancer cells invade nearby tissues and organs, potentially affecting the lymph nodes and other distant sites. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the cancer advances, it can lead to complications such as fluid accumulation around the lungs and weight loss. The progression of the disease varies depending on factors like the specific genetic mutations present and the overall health of the individual.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-508256-19-00Protocol code61186372PANSC2001Estimated enrolment145 patientsSponsorJanssen Cilag International

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