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Study of Amivantamab and Cetrelimab for Patients with 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 clinical trial is focused on studying a type of lung cancer known as Metastatic Non-small Cell Lung Cancer (NSCLC). This is a condition where cancer cells from the lungs have spread to other parts of the body. The study is testing a combination of two treatments: Amivantamab and Cetrelimab. These treatments are given as a solution through a vein, which is known as an infusion. The purpose of the study is to find the best dose of these treatments and to see how well they work together in fighting this type of lung cancer.

Participants in the study will receive the combination of Amivantamab and Cetrelimab. The study will be conducted in two phases. In the first phase, researchers will determine the most suitable dose of the combination treatment. In the second phase, they will evaluate how effective the treatment is in reducing the size of the cancer or stopping its growth. The study will also look at the safety of the treatment and any side effects that may occur.

This trial is designed to help understand how the combination of these two treatments can benefit people with NSCLC, especially those whose cancer has specific characteristics related to EGFR and PD-L1 status. The study aims to provide valuable information that could lead to better treatment options 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

    Joining the study

    Upon joining the study, the participant is confirmed to have metastatic non-small cell lung cancer (NSCLC).

    The participant must have at least one measurable lesion and a performance status indicating they are able to carry out daily activities with minimal assistance.

  2. Step 2

    Phase 1: combination dose selection

    The participant receives a combination of two medications: amivantamab and cetrelimab. Both are administered through an intravenous infusion.

    The goal is to determine the recommended dose for further study. The participant's response to the treatment and any side effects are closely monitored.

  3. Step 3

    Phase 2: expansion

    In this phase, the participant continues to receive the combination therapy at the dose determined in phase 1.

    The focus is on evaluating the effect of the treatment on the cancer, particularly in relation to specific genetic markers and protein expressions in the cancer cells.

  4. Step 4

    Monitoring and evaluation

    Throughout the study, the participant undergoes regular assessments to monitor the cancer's response to the treatment.

    The assessments include imaging tests and evaluations of any side effects experienced by the participant.

  5. Step 5

    Completion of the study

    The study is expected to conclude by September 28, 2025.

    Upon completion, the participant's overall response to the treatment and any long-term effects are evaluated.

Who can join the trial?

9 criteria

  • The participant must have a confirmed diagnosis of **non-small cell lung cancer (NSCLC)**, which is a type of lung cancer, and it must have spread to other parts of the body (metastatic).
  • The participant must have tried standard treatments for their cancer, and the cancer must have worsened or they cannot tolerate these treatments. This includes:
    • For those without specific genetic changes in their cancer, they must have tried chemotherapy with a drug called platinum and a type of treatment called **PD-(L)1-targeted immunotherapy**.
    • For those with specific genetic changes, they must have tried treatments that target these changes.
    • Participants may have previously received a treatment called **amivantamab**, as long as they did not stop it due to side effects.
    • Participants with a specific genetic change called **EGFR mutation** must not have received a type of treatment called **anti-PD-1/PD-L1 therapy**.
    • Participants must have at least one tumor that can be measured and has not been treated with radiation.
    • Participants must be able to perform daily activities with little or no assistance, as measured by a scale called the **Eastern Cooperative Oncology Group (ECOG) performance status**, with a score of 0 or 1.
    • Both men and women can participate in the study.
    • Participants must be adults, which means they are 18 years or older.
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Investigated drugs

  • Amivantamab

    is a medication being studied for its potential to treat metastatic non-small cell lung cancer (NSCLC). It works by targeting specific proteins on cancer cells, which may help to slow down or stop the growth of the cancer.

  • Cetrelimab

    is another medication involved in the study, used in combination with amivantamab. It is designed to help the immune system recognize and attack cancer cells, potentially improving the body's ability to fight the cancer.

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 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 markers.

  • Cetrelimab

    This medication is also administered intravenously and is under investigation in clinical trials for its use in metastatic non-small cell lung cancer. It works by blocking a protein that inhibits the immune system, thereby enhancing the body's ability to fight cancer cells. Cetrelimab is classified as an immune checkpoint inhibitor and is being studied for its role in combination therapies to enhance antitumor effects.

Investigated diseases

Metastatic Non-small Cell Lung Cancer – This is a type of lung cancer that begins in the cells lining the lungs and has spread to other parts of the body. It is the most common form of lung cancer, accounting for about 85% of cases. The disease progresses as cancer cells grow and form tumors in the lungs, which can then metastasize to other organs such as the brain, bones, or liver. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the cancer spreads, it can lead to more severe symptoms and complications. The progression of the disease varies depending on factors like the cancer's genetic characteristics and the patient's overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-501452-29-00Protocol code61186372PANSC2002Estimated enrolment60 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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