Not recruiting

Study on Amivantamab, Lazertinib, and Bevacizumab for Patients with Advanced EGFR-Mutant Non-Small Cell Lung Cancer After Treatment Progression

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 advanced non-small cell lung cancer (NSCLC) that has a specific change, or mutation, in the EGFR gene. This mutation can cause the cancer to spread to other parts of the body. The study is looking at patients whose cancer has progressed during or after treatment with medications called osimertinib or lazertinib, which are known as third-generation EGFR-TKIs (tyrosine kinase inhibitors). The trial will explore the effects of a combination treatment using three medications: amivantamab, lazertinib, and bevacizumab.

The purpose of the study is to assess how effective this combination treatment is in managing the disease. The study will also evaluate the safety of using these medications together. Participants will receive the treatment over a period of time, and their response to the treatment will be monitored. The medications are administered in different forms: lazertinib is taken as a tablet, while amivantamab and bevacizumab are given as solutions for infusion, which means they are delivered directly into the bloodstream through a vein.

Throughout the study, the health and progress of the participants will be closely observed to gather information on how well the treatment works and to ensure the safety of the participants. This information will help in planning future studies and potentially developing new treatment options for patients with this type of lung cancer.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of advanced non-small cell lung cancer (NSCLC) with certain genetic mutations.
Previous treatment with osimertinib or lazertinib must have been completed at least 8 days before enrollment.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the current state of the disease using imaging techniques.
This assessment helps establish a baseline for measuring the effectiveness of the treatment.
Step 3
Treatment initiation
The treatment involves a combination of three medications: lazertinib, bevacizumab, and amivantamab.
Lazertinib is administered orally in tablet form.
Bevacizumab and amivantamab are given as solutions for infusion, which means they are delivered directly into the bloodstream through a vein.
Step 4
Ongoing treatment
The treatment continues with regular administration of the medications as prescribed.
The frequency and dosage are determined by the study protocol and are monitored by the healthcare team.
Step 5
Regular monitoring
Regular check-ups are scheduled to monitor the response to the treatment and any side effects.
These check-ups include physical examinations, blood tests, and imaging studies.
Step 6
Evaluation of response
After 12 weeks, the response to the treatment is evaluated using specific criteria to measure changes in the disease.
The primary goal is to assess the objective response rate, which indicates how well the cancer is responding to the treatment.
Step 7
Continuation or adjustment
Based on the evaluation, the treatment plan may be continued or adjusted to optimize outcomes.
The safety and tolerability of the treatment are also assessed to ensure the best possible care.
Step 8
End of trial
The trial is expected to conclude by the end of 2025.
Final assessments are conducted to gather comprehensive data on the treatment's effectiveness and safety.

Who can join the trial?

11 criteria

Must have a confirmed diagnosis of non-squamous NSCLC (a type of lung cancer) at stage IIIB/C or stage IV, which means the cancer is advanced and not suitable for surgery.
Must have a specific change in the EGFR gene, known as a mutation, which includes exon 19 deletion or L858R mutation. This must be tested and confirmed by a certified lab.
Must have shown disease progression, meaning the cancer has grown or spread, during previous treatment with the drugs osimertinib or lazertinib.
Must have stopped taking osimertinib at least 8 days before joining the study.
Must have experienced a clinical benefit from osimertinib or lazertinib, such as a partial or complete response, or stable disease for at least 6 months.
Must have measurable disease, which means the cancer can be measured using specific criteria called RECIST v1.1.
Must be 18 years of age or older.
Must have an ECOG performance status of 0 to 2, which is a scale that measures how well a person can perform daily activities.
Must have a life expectancy of at least 12 weeks.
Must have adequate blood, kidney, and liver function.
Must provide written informed consent, which means agreeing to participate in the study after understanding all the details.

Who cannot join the trial?

6 criteria

Patients who have not been diagnosed with **EGFR-mutant advanced non-squamous NSCLC**. This is a type of lung cancer with specific genetic changes.
Patients who have not previously received treatment with a **third-generation EGFR-TKI**. These are specific medications used to treat certain lung cancers.
Patients who have not shown progression, meaning their cancer has not worsened, after treatment with a third-generation EGFR-TKI.
Patients who are not within the specified age range for the study.
Patients who are not able to provide informed consent or understand the study requirements.
Patients who are part of a vulnerable population that the study cannot safely include.

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Verified sites

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

Centre Hospitalier Regional D'Angers
Verified
Angers, France
Centre Leon Berard
Verified
Lyon, France
Hospital Universitario Fundacion Jimenez Diaz
Verified
Madrid, Spain

Trial locations

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Investigated drugs

Amivantamab
is a medication used in this trial to help treat patients with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes. It works by targeting and blocking certain proteins on cancer cells, which may help slow down or stop the growth of the cancer.
Lazertinib
is another medication included in the trial. It is used to treat patients with NSCLC that has specific mutations. Lazertinib works by inhibiting the activity of proteins that are involved in the growth and spread of cancer cells.
Bevacizumab
is a medication that is used to prevent the growth of new blood vessels that tumors need to grow. By blocking these blood vessels, bevacizumab can help slow down the growth of the cancer.
Osimertinib
is a medication that is used as a standard treatment for NSCLC with specific genetic mutations. It works by blocking the activity of proteins that help cancer cells grow and spread. In this trial, it is used in combination with other medications to assess if the treatment is more effective.

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 advanced non-squamous non-small cell lung cancer (NSCLC) with specific EGFR mutations. It is used in combination with other treatments for patients who have progressed on previous therapies. Amivantamab works by targeting and binding to specific proteins on cancer cells, disrupting their growth and survival. It is classified as a monoclonal antibody.
Lazertinib
Lazertinib is taken orally and is under investigation for its role in treating advanced NSCLC with EGFR mutations. It is used alongside other medications for patients who have not responded to earlier treatments. Lazertinib functions by inhibiting the activity of the EGFR protein, which is involved in the growth and spread of cancer cells. It belongs to the class of drugs known as tyrosine kinase inhibitors.
Bevacizumab
Administered intravenously, bevacizumab is being evaluated in clinical trials for its potential to enhance treatment outcomes in advanced NSCLC with EGFR mutations. It is used in combination with other therapies for patients who have experienced disease progression. Bevacizumab works by inhibiting the formation of new blood vessels that tumors need to grow, classified as an angiogenesis inhibitor.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) – 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. NSCLC is the most common type of lung cancer, accounting for about 85% of all cases. The disease progresses as cancer cells grow and potentially spread to other parts of the body. In advanced stages, it may affect the function of the lungs and other organs. The progression can vary depending on genetic mutations, such as EGFR mutations, which can influence the behavior of the cancer cells.