Study on Preoperative Treatment with Amivantamab, Carboplatin, and Pemetrexed for Patients with Resectable Non-Small-Cell Lung Cancer with EGFR Mutations

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What is this study about?

This clinical trial is focused on studying treatments for a type of lung cancer known as non-small-cell lung cancer that has specific genetic changes called EGFR mutations. The study will explore the use of a medication called amivantamab, which is given as an infusion into the vein. In some cases, amivantamab will be used alone, and in others, it will be combined with two chemotherapy drugs, carboplatin and pemetrexed disodium. The purpose of the study is to see if these treatments can be given safely before surgery to remove the cancer.

Participants in the study will receive treatment with amivantamab for four weeks. In the first stage, amivantamab will be given by itself. In the second stage, it will be combined with carboplatin and pemetrexed disodium. After the treatment, patients will undergo surgery to remove the cancer. If needed, additional treatments such as chemotherapy, radiation therapy, or medications targeting EGFR mutations may be provided after surgery.

The study aims to determine if this approach is feasible and safe for patients with early-stage or locally advanced non-small-cell lung cancer that can be surgically removed. The study will also look at how the cancer responds to the treatment and how it affects the patient’s health and recovery after surgery.

1 initiation of treatment

Upon joining the study, the patient will begin the treatment phase. This involves receiving amivantamab as a single therapy. The medication is administered through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

This phase lasts for four weeks, during which the patient will receive the infusion at regular intervals as determined by the study protocol.

2 combination therapy

Following the initial phase, the patient will receive a combination of amivantamab, carboplatin, and pemetrexed. These medications are also administered via intravenous infusion.

The combination therapy is designed to enhance the treatment’s effectiveness against non-small-cell lung cancer with specific genetic mutations.

3 surgical intervention

After completing the medication phases, the patient will undergo surgery to remove the lung cancer. This is a standard procedure aimed at achieving a curative outcome.

The surgery is planned to occur within 43 days of starting the study therapy, depending on the patient’s response and overall health condition.

4 post-surgery care

Following surgery, the patient may receive additional treatments if necessary. These could include chemotherapy, radiotherapy, or targeted therapy with EGFR tyrosine kinase inhibitors, depending on the clinical indications.

The goal of these treatments is to eliminate any remaining cancer cells and reduce the risk of recurrence.

5 follow-up and monitoring

The patient will be monitored regularly to assess their recovery and the effectiveness of the treatment. This includes routine check-ups and imaging studies to evaluate the disease status.

The follow-up period is crucial for ensuring the patient’s well-being and addressing any potential complications that may arise after the treatment.

Who Can Join the Study?

Patients must have non-small-cell lung cancer that is confirmed through a biopsy. This type of cancer affects the lungs and is not the small cell type.
The cancer must be at specific stages: Stage I B, II, or selected Stage III A. These stages describe how much the cancer has spread.
Patients must have a specific change in their cancer called an oncogenic EGFR mutation. This is a change in the cancer cells that can be targeted by certain treatments.
Patients must be able to have surgery to remove the cancer.
Patients must be 18 years or older.
Patients must be able to understand and agree to the study by signing a consent form.
Patients must have a good ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
Patients must not have cancer that has spread to many lymph nodes in the chest or to other parts of the body.
Patients must have a tumor that can be measured using imaging techniques.
Patients must have good lung function to safely undergo lung surgery.
Patients must have normal blood, liver, and kidney function. This includes having enough blood cells and normal levels of substances in the blood.
Patients must have a healthy heart with a left ventricular ejection fraction (LVEF) of 50% or higher, which measures how well the heart pumps blood.
Women who can have children must have a negative pregnancy test and agree to use birth control during the study and for 6 months after.
Men must agree to use condoms during the study and for 6 months after, and not donate sperm during this time.

Who Cannot Join the Study?

Patients with other types of cancer besides the specific type of lung cancer being studied.
Patients who do not have the specific genetic change called EGFR mutation in their cancer.
Patients who are not in the early or locally advanced stages of the specific lung cancer being studied.
Patients who are not eligible for surgery to remove the cancer.
Patients who have received certain treatments for cancer that might interfere with the study.
Patients with serious health conditions that could make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend required visits.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Jessa Ziekenhuis	Hasselt	Belgium
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
Urspdtrcgeduvndblzafb Ecvgh Asa	Essen	Germany
Euzzvem Uhtwkyvnoctg Mwoqmgd Cwezfea Rwrqgajrb (ohqyiry Mkw	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	30.06.2024
Germany	Recruiting	30.06.2024
The Netherlands	Recruiting	30.06.2024

Trial locations

Investigated drugs:

Amivantamab

Amivantamab is an antibody therapy used in this trial to treat patients with non-small-cell lung cancer that has specific genetic changes known as EGFR mutations. It is given before surgery to see if it can help shrink the tumor and make it easier to remove.

Carboplatin is a type of chemotherapy used in combination with other medications to treat cancer. In this trial, it is combined with amivantamab and pemetrexed to see if the combination is more effective in treating non-small-cell lung cancer before surgery.

Pemetrexed is another chemotherapy drug used in this trial. It works by stopping the growth of cancer cells. When used with carboplatin and amivantamab, it aims to enhance the treatment’s effectiveness in shrinking the tumor before surgery.

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 lung tissues, which can form tumors. The disease progresses through stages, starting from localized tumors in the lung (stage I) to more advanced stages where cancer spreads to nearby lymph nodes or other parts of the body (stages II and III). In some cases, specific genetic mutations, such as the EGFR mutation, can drive the growth of cancer cells. These mutations can influence the behavior of the cancer and its response to certain therapies. The progression of the disease can vary based on the stage at diagnosis and the presence of specific genetic mutations.

Trial ID:

2023-505662-28-00

Protocol code:

61186372NSC2008

NCT ID:

NCT06784791

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Preoperative Treatment with Amivantamab, Carboplatin, and Pemetrexed for Patients with Resectable Non-Small-Cell Lung Cancer with EGFR Mutations

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?