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A Study of Amivantamab and Lazertinib for Adults with EGFR-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at a type of lung cancer called Non-Small Cell Lung Cancer that has spread to other parts of the body or has grown in a way that cannot be cured with surgery or radiation. Specifically, this study focuses on lung cancer that has certain changes in a gene called EGFR, which stands for epidermal growth factor receptor. These changes are known as EGFR mutations and include specific types called Ex19del and Ex21 L858R. The study will test two different treatment combinations. One group of patients will receive JNJ-61186372, which contains the active substance amivantamab, given as an injection under the skin, together with JNJ-73841937, which contains the active substance lazertinib, taken as a tablet by mouth. This combination will be used as a first treatment for patients who have not yet received other treatments for their advanced lung cancer. The other group of patients will receive JNJ-61186372 combined with platinum-based chemotherapy, which are drugs that contain platinum and are commonly used to treat cancer, and this will be given as a second treatment for patients who have already received one previous treatment.

The purpose of this study is to see how well these treatment combinations work against the lung cancer in patients who have the specific EGFR mutations. The study will look at whether the treatments can slow down or stop the cancer from growing or spreading. Patients in the study will receive their assigned treatment combination and will be monitored regularly by the doctors to check how the cancer is responding and to watch for any side effects. The study is designed as an open-label trial, which means that both the patients and the doctors will know which treatment is being given.

During the study, patients will have regular visits where doctors will perform tests and examinations to measure the size of the cancer and see if it is getting smaller, staying the same, or growing. The study will follow patients for several years to gather information about how long the treatment keeps the cancer under control and how patients feel while taking the medications. This information will help doctors understand whether these treatment combinations could be useful options for patients with this type of lung cancer in the future.

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

    Treatment initiation

    Upon joining the study, treatment will begin based on the assigned group. There are two treatment approaches in this study.

    The first treatment option involves receiving amivantamab in combination with lazertinib as initial treatment. The second treatment option involves receiving amivantamab in combination with platinum-based chemotherapy as second-line treatment.

    Amivantamab is administered as an injection under the skin (subcutaneous injection). Lazertinib is taken by mouth in tablet form.

  2. Step 2

    Ongoing treatment administration

    Treatment will continue according to the prescribed schedule determined by the study protocol.

    If assigned to receive amivantamab with lazertinib, the subcutaneous injections of amivantamab will be administered at specified intervals, while lazertinib tablets will be taken orally as directed.

    If assigned to receive amivantamab with platinum-based chemotherapy, the subcutaneous injections of amivantamab will be combined with chemotherapy treatment according to the established schedule.

  3. Step 3

    Regular monitoring and assessments

    Throughout the study, regular assessments will be conducted to monitor the response to treatment.

    These assessments will include imaging scans to measure any changes in tumor size according to RECIST v1.1 criteria, which is a standardized method for evaluating whether tumors are shrinking, staying the same, or growing.

    The treating physician will review these results to determine how the treatment is working.

  4. Step 4

    Continuation of treatment

    Treatment will continue as long as it remains beneficial and tolerable.

    Any side effects experienced will be monitored and managed according to standard medical practice.

    The study is designed to run until November 2030, though individual participation duration may vary based on treatment response and tolerability.

Who can join the trial?

7 criteria

  • You must have advanced or metastatic non-small cell lung cancer confirmed by tissue examination under a microscope or cell analysis. Advanced means the cancer has grown extensively in your body, and metastatic means it has spread to other parts of your body. This cancer cannot be treated with the goal of curing it completely.
  • Your cancer must have a specific change in a gene called EGFR mutation. This must be either an Ex19del type or Ex21 L858R type. This change must be confirmed by an approved test performed in a certified laboratory.
  • You must have at least one tumor that can be measured by imaging scans, according to standard measurement rules called RECIST version 1.1. This tumor must not have been previously treated with radiation therapy.
  • Any side effects from previous cancer treatments must have improved to a mild level or returned to your baseline condition. Exceptions include hair loss of any severity, mild nerve damage in arms or legs, or mild underactive thyroid that is controlled with medication.
  • You must have an ECOG performance status of 0 to 1. This is a scale that measures how well you can perform daily activities. A score of 0 means you are fully active, and a score of 1 means you have some restrictions but can still do light work.
  • You can be male or female.
  • You must be an adult.

Who cannot join the trial?

7 criteria

  • The specific exclusion criteria (reasons why a patient cannot participate in this study) have not been provided in the available information.
  • Generally, clinical trials have rules about who cannot join to ensure patient safety and reliable results.
  • Common reasons patients may not be able to participate in cancer treatment studies include having other serious medical conditions, taking certain medications that could interfere with the study treatment, or having abnormal results in blood tests or heart function tests.
  • Some studies exclude patients who have received specific types of cancer treatment recently or who have cancer that has spread to the brain.
  • Pregnant or breastfeeding women (nursing mothers) are typically not allowed to participate in cancer drug studies because the treatment could harm the baby.
  • Patients with severe problems in major organs like the heart, liver, or kidneys may not be eligible.
  • Those who have had severe allergic reactions (bad responses by the body's defense system) to similar medications in the past may be excluded.
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Investigated drugs

  • Amivantamab

    is a medication given as an injection under the skin. It is being tested as a treatment for a type of lung cancer called non-small cell lung cancer that has specific changes in a gene called EGFR. In this study, it is being given together with other medications to see if it can help stop the cancer from growing.

  • Lazertinib

    is a medication being tested in combination with amivantamab for patients who are receiving their first treatment for lung cancer with EGFR gene changes. It works by targeting the abnormal proteins that help cancer cells grow.

  • Platinum-based chemotherapy

    refers to a group of cancer-fighting medications that contain platinum. In this study, these medications are being given together with amivantamab to patients who are receiving their second treatment for lung cancer after their first treatment has stopped working.

What is already known about the treatment

  • Amivantamab

    Amivantamab is a medication given as an injection under the skin (subcutaneous administration) that is used to treat a specific type of lung cancer called non-small cell lung cancer with EGFR mutations, which has spread to other parts of the body or is in an advanced stage. This drug works by targeting two proteins on cancer cells called EGFR and MET, blocking their signals that help cancer cells grow and survive, which helps slow down or stop the cancer from spreading. It is currently being studied in clinical trials as a treatment option, either combined with another medication called lazertinib as a first treatment choice, or combined with chemotherapy drugs as a second treatment option for patients whose cancer has specific genetic changes. Amivantamab belongs to a class of medications called bispecific antibodies, which are designed to attach to two different targets on cancer cells at the same time.

  • Lazertinib

    Lazertinib is a medication taken by mouth (oral administration) that is used in combination with amivantamab to treat lung cancer with specific genetic mutations in the EGFR gene. This drug works by blocking the activity of the mutated EGFR protein inside cancer cells, which prevents the cells from receiving growth signals and helps stop the cancer from growing. It is currently being evaluated in clinical trials as a first-line treatment option for patients with advanced or metastatic non-small cell lung cancer who have common EGFR mutations. Lazertinib belongs to a class of medications called tyrosine kinase inhibitors, which are targeted therapies that specifically interfere with proteins that promote cancer cell growth.

Investigated diseases

Non-Small Cell Lung Cancer – Non-small cell lung cancer is a type of cancer that begins in the lungs and accounts for the majority of all lung cancer cases. The disease develops when cells in the lung tissue begin to grow abnormally and uncontrollably. In this study, the focus is on cases with specific EGFR mutations, which are changes in a gene that can cause cells to grow and divide more rapidly. The cancer can be locally advanced, meaning it has spread to nearby tissues or lymph nodes, or metastatic, meaning it has spread to distant parts of the body. As the disease progresses, the abnormal cells continue to multiply and can form tumors that interfere with normal lung function. The presence of EGFR mutations makes this a distinct subtype of non-small cell lung cancer with particular growth patterns.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520730-28-00Protocol code61186372NSC2012Estimated enrolment472 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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