Not yet recruiting

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

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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 trial?

13 criteria

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 1.5x109/L - Platelets above 75x109/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 trial?

13 criteria

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

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Azienda Ospedaliera Di Perugia
Perugia, Italy
Responsive
Azienda Ospedaliero Universitaria Parma
Parma, Italy
Verified
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Novara, Italy

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

Amivantamab – A bispecific antibody medication administered through intravenous infusion, specifically designed for treating non-small cell lung cancer (NSCLC) with EGFR exon20 insertion mutations. This targeted therapy works by simultaneously binding to both EGFR and MET receptors on cancer cells, blocking their signaling pathways that promote tumor growth. It belongs to the class of targeted immunotherapies and represents a significant advancement in precision medicine for patients who are unable to receive platinum-based chemotherapy, offering a more personalized approach to lung cancer treatment.

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.