Recruiting

Study of Amivantamab, Lazertinib, and Pemetrexed for Patients with Advanced or Metastatic Solid Tumors, Including EGFR-Mutated 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 treatments for advanced or metastatic solid tumors, including a specific type of lung cancer known as EGFR-mutated non-small cell lung cancer. The study involves several medications, including amivantamab, which is given as an injection under the skin, and lazertinib, which is taken as a tablet. Additionally, the study uses pemetrexed and carboplatin, both administered through a vein. The purpose of the study is to evaluate the effectiveness of these treatments in controlling tumor growth.

Participants in the study will receive one or more of these medications, depending on their specific condition and the study group they are assigned to. The study is designed to observe how well the treatments work over a period of time, which can last up to several weeks. Some participants may receive a combination of these medications, while others might receive a single treatment. The study will also include a group that receives a placebo, which is a substance with no active medication, to compare the effects of the actual treatments.

The study aims to provide valuable information on the potential benefits of these treatments for patients with advanced or metastatic solid tumors, particularly those with EGFR-mutated non-small cell lung cancer. By participating in this study, researchers hope to gain insights into how these medications can help manage the disease and improve patient outcomes. The results of this study could lead to new treatment options for patients with these types of 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.

Step 1
Joining the study
Upon joining the study, the participant will be assigned to a specific cohort based on their medical condition and previous treatments. The study involves patients with advanced or metastatic solid tumors, including those with specific mutations in non-small cell lung cancer (NSCLC).
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes verifying the presence of specific genetic mutations and ensuring the participant has not received certain prior treatments. The participant's overall health and organ function will also be evaluated.
Step 3
Treatment administration
Participants will receive treatment based on their assigned cohort. The treatments involve the use of medications such as amivantamab, lazertinib, and carboplatin. These medications may be administered through different routes, including subcutaneous injection, oral tablets, or intravenous infusion.
The specific dosage and frequency of administration will depend on the cohort and the participant's condition. For example, some participants may receive amivantamab subcutaneously, while others may receive it intravenously.
Step 4
Ongoing monitoring
Throughout the study, participants will undergo regular monitoring to assess the effectiveness of the treatment and to check for any side effects. This may include imaging tests, blood tests, and other evaluations as needed.
Step 5
Completion of treatment
The study is expected to continue until July 2026. Participants will complete their treatment regimen as specified for their cohort. After completing the treatment, participants may undergo final assessments to evaluate the overall response to the treatment.

Who can join the trial?

11 criteria

Participants must have a confirmed diagnosis of **non-small cell lung cancer (NSCLC)** that is advanced or has spread to other parts of the body. This type of cancer cannot be treated with surgery or combined treatments like chemotherapy and radiation.
For certain groups, participants must have specific changes in the **epidermal growth factor receptor (EGFR)** gene, which is involved in cell growth. These changes include **Exon 19 deletion** or **Exon 21 L858R mutation** for some groups, and **Exon 20 insertion** for another group.
Some participants should not have received any previous treatments for their advanced or spreading NSCLC, while others must have tried specific treatments and seen their cancer progress.
Participants in one group must currently be receiving a specific treatment called **amivantamab** through an IV, without any dose reductions, for at least 8 weeks.
Participants in certain groups must not have a type of NSCLC called **squamous NSCLC**. The EGFR mutation must be confirmed by a test approved by the **Food and Drug Administration (FDA)** or another validated test.
Participants must have at least one measurable tumor, according to specific criteria. If the tumor was previously treated with radiation, it must show signs of growth since the treatment.
Participants may have another type of cancer, as long as it does not interfere with the study's goals or the effectiveness of the study treatments.
Participants must have normal functioning of their organs, including kidneys, liver, blood, and heart.
Participants must have an **Eastern Cooperative Oncology Group (ECOG)** status of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed.
For one group, participants must be eligible for and agree to take preventive blood-thinning medication during the first 4 months of the study treatment.
Participants must agree not to donate eggs or freeze them for future use during the study and for 6 months after the last dose of the study treatment. They should consider preserving eggs before starting the study treatment, as cancer treatments may affect fertility.

Who cannot join the trial?

10 criteria

Patients with other types of cancer that are not the focus of the study.
Patients who have had a different cancer treatment recently.
Patients with serious health problems that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures.
Patients with allergies to the study medication.
Patients who have participated in another clinical trial recently.
Patients with certain infections that could affect the study.
Patients with a history of drug or alcohol abuse.
Patients who are not able to give informed consent.

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Verified sites

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

ASST Grande Ospedale Metropolitano Niguarda
Verified
Milan, Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli
Verified
Naples, Italy
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain

Trial locations

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Investigated drugs

Amivantamab is a medication being studied for its ability to fight tumors. It is given as an injection under the skin and is being tested in patients with advanced or metastatic solid tumors, including a type of lung cancer known as EGFR-mutated non-small cell lung cancer. The study aims to see how well this medication works when used in combination with other treatments.

What is already known about the treatment

Amivantamab – This medication is administered subcutaneously and is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic solid tumors, including those with EGFR mutations in non-small cell lung cancer. It is an investigational drug, meaning it is still under research and not yet widely available in medical practice. Amivantamab works by targeting specific proteins on cancer cells, helping to block signals that promote tumor growth. It is classified as a monoclonal antibody, which is a type of targeted cancer therapy designed to interfere with cancer cell growth at the molecular level.

Investigated diseases

Advanced or Metastatic Solid Tumors
These are cancers that have spread from their original site to other parts of the body. They can originate in various organs and tissues, forming solid masses. As the disease progresses, the tumors can invade nearby tissues and organs, causing a range of symptoms depending on their location. The spread of these tumors to distant sites is known as metastasis, which can complicate the condition further. The progression of these tumors can vary greatly depending on the type of cancer and its location in the body.
EGFR-mutated Non-Small Cell Lung Cancer
This is a type of lung cancer characterized by mutations in the epidermal growth factor receptor (EGFR) gene. These mutations lead to uncontrolled cell growth and division, contributing to the development of cancer. As the disease progresses, it can spread to other parts of the body, including the bones, brain, and liver. Symptoms may include persistent cough, chest pain, and difficulty breathing. The presence of EGFR mutations can influence the behavior of the cancer and its response to certain treatments.