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

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What is this study about?

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.

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.

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Santa Maria Della Misericordia	Perugia	Italy
Hospital Universitario Basurto	Bilbao	Spain
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Centre Hospitalier D Avignon	Avignon	France
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Netherlands Cancer Institute	Amsterdam	The Netherlands
Cxxrnc Lfta Bzgqdb	Lyon	France
Iuhuamno Czoulz Doeulaktvhuoptaeb	L'hospitalet De Llobregat	Spain
Cfoalw Hbrjrvmuisn Rtabwfju Dubhvfvuqebfng	Angers	France
Hgdcckhw Vxxs dlaeoeyc	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	02.06.2023
Italy	Not recruiting	02.06.2023
Spain	Not recruiting	02.06.2023
The Netherlands	Not recruiting	02.06.2023

Trial locations

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.

Investigated diseases:

Non-small cell lung cancer

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.

Trial ID:

2024-512288-29-00

NCT ID:

NCT05601973

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?