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Study on Bevacizumab and Erlotinib for Patients with Advanced Non-Small Cell Lung Cancer with EGFR Mutation

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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 Non-Small Cell Lung Cancer (NSCLC), specifically the non-squamous subtype. The study is investigating the effectiveness of two treatments: erlotinib and a combination of bevacizumab with erlotinib. Erlotinib is a medication that targets specific proteins in cancer cells, while bevacizumab is a protein-based treatment that helps prevent the growth of blood vessels that supply nutrients to tumors.

The purpose of this study is to determine if the combination of bevacizumab and erlotinib can extend the time patients live without their cancer getting worse, compared to using erlotinib alone. The study involves patients with NSCLC who have a specific change in their cancer cells called an EGFR mutation. This mutation affects how cells grow and divide, and the study aims to see if the combination treatment is more effective for these patients.

Participants in the study will receive either the combination of bevacizumab and erlotinib or erlotinib alone. The treatments will be administered over a period of time, with bevacizumab given through a vein (intravenous use) and erlotinib taken by mouth (oral use). The study will monitor the patients' health and the progression of their cancer to assess the effectiveness of the treatments. The goal is to provide valuable information that could improve treatment options for patients with this type of lung cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of a specific type of lung cancer known as non-squamous non-small cell lung cancer with an EGFR mutation.
The assessment involves a review of medical history, physical examination, and necessary imaging tests to identify the stage of the disease.
Step 2
Randomization
Participants are randomly assigned to one of two treatment groups. One group receives a combination of bevacizumab and erlotinib, while the other group receives erlotinib alone.
This process ensures that each participant has an equal chance of being assigned to either treatment group.
Step 3
Treatment administration
For those receiving the combination treatment, erlotinib is taken orally once daily. Bevacizumab is administered through an intravenous infusion every two weeks.
Participants in the erlotinib-only group take the medication orally once daily.
Step 4
Regular monitoring
Participants undergo regular monitoring to assess the effectiveness of the treatment and to check for any side effects.
This includes routine blood tests, imaging studies, and clinical evaluations at scheduled intervals.
Step 5
Progress evaluation
The primary goal is to determine if the combination of bevacizumab and erlotinib can extend the time the disease does not worsen compared to erlotinib alone.
Progress is evaluated through imaging tests and clinical assessments, reviewed by an independent panel of radiologists.
Step 6
Completion of trial
The trial is expected to conclude by September 2025. Participants will continue to receive treatment and monitoring until the study ends or until it is determined that the treatment is no longer beneficial.
Upon completion, participants may discuss further treatment options with their healthcare provider.

Who can join the trial?

9 criteria

Must be at least 18 years old.
Must have a confirmed diagnosis of a type of lung cancer called non-squamous non-small cell lung carcinoma.
Must have advanced cancer, specifically Stage IV or Stage IIIB with cancer spread to certain lymph nodes.
Must have a specific change in a gene called EGFR (epidermal growth factor receptor), which helps the cancer grow. This change must be confirmed by a test done at a certified lab.
Must have visible signs of cancer, either through a physical exam or imaging tests like X-rays or CT scans.
Must have an ECOG performance status of 0 to 2, which is a scale that measures how well a person can perform daily activities. A score of 0 means fully active, while 2 means able to do some activities but not work.
Must have a life expectancy of more than 3 months.
If able to have children, must use an acceptable method of birth control.
Must agree to participate by signing a written consent form.

Who cannot join the trial?

3 criteria

Patients with a type of lung cancer called Non-squamous Non-small Cell Lung Cancer cannot participate.
Patients who do not have an activating mutation of EGFR in their cancer cells are excluded. This is a specific change in the cancer's genetic material that affects how the cancer grows.
Patients who are part of a vulnerable population are not allowed to join. This means people who might need special protection or care.

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Verified sites

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

Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Verified
Naples, Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Verified
Novara, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy

Trial locations

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Investigated drugs

Bevacizumab
is a medication used in this trial to see if it can help patients with a specific type of lung cancer live longer without the disease getting worse. It works by blocking a protein that helps cancer cells grow new blood vessels, which they need to grow and spread.
Erlotinib
is another medication used in this trial. It is designed to target and block a specific protein that is often overactive in certain cancer cells, including those in some lung cancers. This can help slow down or stop the growth of cancer cells.

What is already known about the treatment

Bevacizumab
This medication is administered intravenously and is currently used in clinical trials for treating non-squamous non-small cell lung cancer. It is an established treatment in medical literature, often used in combination with other drugs. Bevacizumab works by inhibiting the growth of blood vessels that supply tumors, effectively starving the cancer cells. It is classified as an angiogenesis inhibitor.
Erlotinib
This medication is taken orally in tablet form and is being studied in clinical trials for its effectiveness in treating non-squamous non-small cell lung cancer. It is well-documented in medical literature and is used primarily for cancers with specific genetic mutations. Erlotinib functions by blocking the activity of a protein called EGFR, which is involved in the growth and spread of cancer cells. It is classified as a tyrosine kinase inhibitor.

Investigated diseases

Non-squamous Non-small Cell Lung Cancer – This is a type of lung cancer that does not originate from the squamous cells, which are flat cells lining the airways. It is one of the most common types of lung cancer and includes subtypes such as adenocarcinoma and large cell carcinoma. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. It often progresses slowly, but the rate can vary depending on the specific characteristics of the cancer cells. Symptoms may include persistent cough, chest pain, and shortness of breath. As the disease advances, it may lead to more severe respiratory issues and other systemic symptoms.