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Study of amivantamab and pemetrexed for patients with non-small cell lung cancer who have EGFR exon20 insertion mutations and cannot receive platinum therapy

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What is this study about?

This study focuses on patients with Non-small cell lung cancer (NSCLC) who have a specific genetic change called EGFR exon20 insertion mutation. The cancer in these patients has spread to other parts of the body (stage IV) or has come back after previous treatment. The study will test a combination of two medications: amivantamab (also known as JNJ-61186372) and pemetrexed.

The purpose of this study is to determine how well this combination treatment works and how safe it is for patients who cannot receive standard platinum-based chemotherapy. During the study, patients will receive amivantamab through an injection under the skin and pemetrexed through an intravenous infusion (a slow injection into a vein). The treatment may continue for up to 24 months.

The study will track how the cancer responds to treatment by taking regular scans to measure tumors. The researchers will also monitor how long patients live without their cancer getting worse and check for any side effects from the treatment. This study is particularly meant for patients who have not received any previous systemic treatment for their cancer and who cannot receive standard platinum-based chemotherapy due to certain health conditions.

1 Initial assessment

You will undergo tests to confirm non-small cell lung cancer (NSCLC) with specific genetic changes in the EGFR exon20 gene

Your doctor will perform tests to verify your eligibility, including blood tests to check bone marrow, liver, and kidney function

A pregnancy test will be required for female patients of childbearing potential

2 Treatment preparation

Your doctor will confirm that you have not received any previous systemic treatment

Your physical condition will be assessed using the ECOG Performance Status scale (ranging from 0-2)

If you have brain metastases, imaging will confirm they are stable for at least two weeks

3 Treatment administration

You will receive two medications: amivantamab and pemetrexed

Amivantamab will be given as an injection under the skin

Pemetrexed will be administered through an intravenous infusion

Regular imaging scans will monitor your response to treatment

4 Monitoring period

Your response to treatment will be measured using specialized imaging criteria (RECIST 1.1)

Regular assessments will track how long the treatment remains effective

Blood tests and physical examinations will continue throughout the treatment period

The study will continue until September 2028

Who Can Join the Study?

  • Must be at least 18 years old, male or female
  • Must provide written informed consent to participate in the study
  • Must have confirmed stage IV or recurrent non-squamous non-small cell lung cancer with specific genetic mutation (EGFR exon20 insertion)
  • Must not have received any previous systemic treatment for cancer
  • Must be considered unsuitable for platinum-based chemotherapy due to either:
    – Reduced kidney function (filtration rate less than 50 ml/min)
    – Age 80 years or older
    – Neurological disorders
    – Known allergic reaction to platinum
  • Must have at least one tumor that can be measured by imaging tests
  • Must have adequate blood cell counts:
    – White blood cells above 1.5×109/L
    – Platelets above 75×109/L
    – Hemoglobin above 9 g/dl
  • Must have normal liver function tests
  • Must have adequate kidney function
  • If female and able to have children, must:
    – Use effective birth control
    – Not be breastfeeding
    – Have negative pregnancy test before starting treatment
    – Continue pregnancy testing during the study
  • If brain metastases are present, they must be:
    – Not causing symptoms
    – Stable for at least 2 weeks
    – Not causing worsening neurological symptoms
  • Must have good physical ability status (ECOG score 0-2)
  • Must be able to follow all study procedures

Who Cannot Join the Study?

  • History of any other type of cancer in the past 3 years, except for successfully treated skin cancer or early-stage cancer
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Previous treatment with EGFR-targeting therapy (specific medications targeting a protein called EGFR)
  • Significant heart problems, including:
    • Heart attack within the last 6 months
    • Unstable heart rhythm problems
    • Heart failure with symptoms
  • Severe lung disease or breathing problems not related to cancer
  • Active or chronic infections, including hepatitis B, hepatitis C, or HIV
  • Any medical condition that could interfere with the study treatment or make participation unsafe
  • Pregnancy or breastfeeding
  • Unable to swallow medications
  • Known allergies to the study medications or their components
  • Participation in another clinical trial within the last 30 days

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Ospedaliera Di Perugia Perugia Italy
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
IRCCS Ospedale Policlinico San Martino Genoa Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
IRCCS CROB Rionero In Vulture Italy
Atztzif Obzcwzoqwys Uaskhhzlgeymy Pknrf Parma Italy
Ithdhq Iljhlgbw Ffpmnchbmbhlu Onndqbkvntm Rome Italy
Apzjmna Oqfdedayyzt S Ghpvjvcq Awdxndkhtb Rome Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
01.09.2025

Trial locations

Investigated drugs:

Amivantamab is a targeted therapy medication that works specifically against lung cancer cells with certain genetic changes (EGFR exon20 insertion mutations). It is an antibody that attaches to specific proteins on cancer cells to help stop them from growing and spreading. This medication is given through an intravenous infusion (through a vein).

Monochemotherapy refers to the use of a single chemotherapy medication to treat cancer. In this case, it is combined with amivantamab to treat non-small cell lung cancer in patients who cannot receive platinum-based chemotherapy. The chemotherapy works by killing fast-growing cancer cells or stopping them from dividing.

Investigated diseases:

Non-small cell lung cancer (NSCLC) – A type of lung cancer that begins in the epithelial cells of the lung tissue. It develops when cells in the lungs begin to grow uncontrollably, forming tumors that can spread to other parts of the body. NSCLC typically grows and spreads more slowly than small cell lung cancer. The disease usually starts in the cells that line the airways of the lungs, gradually affecting normal lung function. NSCLC accounts for the majority of all lung cancer cases and can occur in different parts of the lung tissue.

Trial ID:
2025-520676-26-00
Trial Phase:
Therapeutic exploratory (Phase II)

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