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Study of Amivantamab with Carboplatin and Pemetrexed for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutation

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 lung cancer known as Non-Small Cell Lung Cancer (NSCLC) that has a specific mutation called EGFR Exon 20ins. This mutation can make the cancer more challenging to treat. The study is testing a new treatment combination to see if it is more effective than the current standard treatment. The new treatment includes a medication called Amivantamab, which is being tested in combination with two chemotherapy drugs, Carboplatin and Pemetrexed. The purpose of the study is to compare how well patients do with the combination of Amivantamab and chemotherapy versus chemotherapy alone.

Participants in the study will receive their treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will follow participants over a period to see how their cancer responds to the treatment. The main goal is to see if the new combination can help patients live longer without their cancer getting worse, which is known as progression-free survival.

This study is open-label, meaning both the researchers and participants know which treatment is being given. It is a randomized study, so participants are randomly assigned to receive either the new combination treatment or the standard chemotherapy. The study aims to provide more information on whether adding Amivantamab to the treatment plan can offer better outcomes for patients with this specific type of lung cancer.

The research process

The trial runs in 6 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, eligibility is confirmed based on specific criteria, including a confirmed diagnosis of non-small cell lung cancer with a specific genetic mutation.

    Initial assessments are conducted to ensure adequate organ and bone marrow function.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of medications through intravenous infusion.

    The medications include pemetrexed, carboplatin, and amivantamab.

  3. Step 3

    Medication administration

    Pemetrexed is administered as a 500 mg solution for infusion.

    Carboplatin is provided as a 10 mg/ml solution for infusion.

    Amivantamab is administered as part of the combination therapy.

  4. Step 4

    Treatment schedule

    The treatment is administered in cycles, with specific dosages and frequencies determined by the study protocol.

    The duration of each cycle and the overall treatment period are defined by the study's design.

  5. Step 5

    Monitoring and assessments

    Regular monitoring is conducted to assess the response to treatment and any side effects.

    Progression-free survival is evaluated using specific guidelines to determine the effectiveness of the treatment.

  6. Step 6

    Completion of treatment

    The study is estimated to conclude by January 30, 2026.

    Final assessments are conducted to evaluate the overall outcomes of the treatment.

Who can join the trial?

10 criteria

  • The participant must have a confirmed diagnosis of a specific type of lung cancer called **non-squamous non-small cell lung cancer (NSCLC)**, which has a particular genetic change known as **EGFR Exon 20ins mutation**. This must be confirmed by a certified laboratory.
  • The participant must have a disease that can be measured using a standard method called **RECIST v1.1**. If there is only one area that can be measured, it can be used for a biopsy if needed, as long as the initial scans are done at least 14 days after the biopsy.
  • The participant must have a **performance status** of 0 or 1 on the **ECOG scale**, which means they are fully active or have some symptoms but can still do light work.
  • The participant must have proper functioning of organs and bone marrow, which includes:
    • **Hemoglobin** levels of at least 10 grams per deciliter (g/dL).
    • **Absolute neutrophil count** of at least 1.5 x 109/L, without using certain medications to boost white blood cells within 10 days before the test.
    • **Platelet count** of at least 100 x 109/L.
    • **ALT and AST** levels that are no more than 3 times the upper limit of normal.
    • **Total bilirubin** levels that are no more than 1.5 times the upper limit of normal. Participants with a condition called **Gilbert's syndrome** can join if their conjugated bilirubin is normal.
    • **Creatinine clearance** greater than 50 milliliters per minute (mL/min), which is a measure of kidney function.
    • Both male and female participants are eligible.

Who cannot join the trial?

9 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not been diagnosed with **EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer**. This is a specific type of lung cancer with a particular genetic change.
  • Patients who are not within the specified age range for the study.
  • Patients who are unable to follow the study procedures or take the study medication as required.
  • Patients who have other serious health conditions that might interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who have had certain treatments for their cancer that are not allowed in this study.
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Investigated drugs

  • Amivantamab

    is a medication used in this trial to treat patients with a specific type of lung cancer. It works by targeting and blocking certain proteins on cancer cells, which may help slow down or stop the growth of the cancer.

  • Carboplatin

    is a chemotherapy drug used in this trial. It works by damaging the DNA of cancer cells, which can prevent them from dividing and growing. This helps to slow down or stop the spread of cancer.

  • Pemetrexed

    is another chemotherapy medication used in this trial. It interferes with the growth of cancer cells by blocking certain enzymes that the cells need to grow and divide. This can help to reduce the size of tumors and slow the progression of the disease.

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 certain types of lung cancer. It is specifically used for patients with EGFR Exon 20 insertion mutations in locally advanced or metastatic non-small cell lung cancer. Amivantamab works by targeting and binding to specific proteins on cancer cells, which helps to inhibit their growth and spread. It is classified as a monoclonal antibody, a type of targeted cancer therapy.

Investigated diseases

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the tissues of the lung. The disease often progresses slowly compared to small cell lung cancer. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease advances, it can spread to other parts of the body. The presence of specific genetic mutations, such as EGFR Exon 20 insertions, can influence the behavior and progression of the cancer.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506033-29-00Protocol code61186372NSC3001Estimated enrolment308 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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