Recruiting

Study Comparing Atezolizumab Alone and Atezolizumab with Bevacizumab for First-Line Treatment in Patients with Advanced 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 non-small-cell lung cancer, a type of lung cancer that has spread beyond the lungs. The study is comparing two treatments: one using a medication called atezolizumab and another using a combination of atezolizumab and bevacizumab. Both medications are given as a solution for infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to determine if the combination of atezolizumab and bevacizumab can improve the overall survival of patients compared to using atezolizumab alone. Patients participating in the study will receive one of these treatments and will be monitored over a period of time to assess their health and response to the treatment. The study aims to provide valuable information on the effectiveness of these treatments for patients with this specific type of lung cancer.

Participants in the study will be randomly assigned to receive either the single medication or the combination treatment. The study will continue for a set period, during which patients will receive regular infusions and follow-up assessments to track their progress. This research is important for understanding how these treatments can help improve the lives of people with advanced non-small-cell lung 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, you will be randomly assigned to one of two groups. One group will receive atezolizumab alone, and the other group will receive a combination of atezolizumab and bevacizumab.
This assignment is random, meaning it is like flipping a coin to decide which treatment you will receive.
Step 2
Treatment administration
If you are in the group receiving atezolizumab alone, you will receive a dose of 1,200 mg. This medication is given as a solution for infusion, which means it is administered directly into your vein through an intravenous (IV) line.
If you are in the group receiving both atezolizumab and bevacizumab, you will receive the same 1,200 mg dose of atezolizumab along with bevacizumab at a concentration of 25 mg/ml. Both medications are given as solutions for infusion through an IV line.
Step 3
Treatment schedule
The treatment is administered on a regular schedule. You will receive the infusion every three weeks.
This schedule will continue as long as the treatment is effective and you do not experience any severe side effects.
Step 4
Monitoring and follow-up
Throughout the trial, your health will be closely monitored. This includes regular check-ups, blood tests, and imaging tests to assess how the treatment is working and to check for any side effects.
You will be required to visit the clinic regularly for these assessments, and it is important to attend all scheduled appointments.
Step 5
End of treatment
The treatment will continue until the study ends, or until it is determined that the treatment is no longer beneficial for you.
At the end of the study, you will have a final assessment to evaluate your overall health and the effects of the treatment.

Who can join the trial?

18 criteria

Diagnosis of stage IV non-squamous non-small-cell lung cancer (NSCLC) confirmed by a tissue sample. This means the cancer is advanced and has spread to other parts of the body.
No specific genetic changes in the cancer, known as EGFR sensitizing mutations or ALK or ROS1 rearrangements.
Availability of a sample of the tumor tissue for testing.
High levels of a protein called PD-L1 in the tumor, which is checked using a special test called immunohistochemistry.
No previous chemotherapy for metastatic disease. If you had chemotherapy, radiotherapy, or both for non-metastatic disease, it must have been at least 6 months ago.
Good physical condition, as measured by an ECOG performance status of 0 or 1. This is a scale that assesses how well you can perform daily activities.
Life expectancy of more than 3 months.
Age 18 years or older.
Presence of measurable disease, which means the cancer can be measured using specific criteria called RECIST v1.1.
Good blood and organ function, based on specific laboratory tests:
ANC (a type of white blood cell) of at least 1500 cells/µL without support from medications.
Platelet count of at least 100,000/µL without transfusion.
Hemoglobin level of at least 9.0 g/dL, with the possibility of receiving a transfusion to meet this level.
AST, ALT, and alkaline phosphatase levels within 2.5 times the upper limit of normal, with exceptions for patients with liver or bone metastases.
Serum bilirubin level within 1.25 times the upper limit of normal, with exceptions for patients with a condition called Gilbert disease.
Creatinine clearance (a measure of kidney function) of at least 45 mL/min, or 60 mL/min if calculated differently.
Willingness and ability to follow the trial procedures.
Signed written consent to participate in the study.

Who cannot join the trial?

10 criteria

Patients with other types of cancer cannot participate.
Patients who have received treatment for their lung cancer before cannot participate.
Patients with serious heart problems cannot participate.
Patients with uncontrolled high blood pressure cannot participate.
Patients with active infections cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of severe allergic reactions to similar medications cannot participate.
Patients with autoimmune diseases, which are conditions where the immune system attacks the body, cannot participate.
Patients with brain metastases, which means cancer has spread to the brain, cannot participate unless treated and stable.
Patients who are participating in another clinical trial cannot participate.

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Verified sites

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Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy
Verified
Azienda Ospedaliero Universitaria Di Modena
Modena, Italy
Responsive
Universita' Degli Studi Di Verona
Verona, Italy

Trial locations

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Investigated drugs

Atezolizumab
is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, atezolizumab is being used to treat patients with a specific type of lung cancer called non-small-cell lung cancer (NSCLC) that has high levels of a protein called PD-L1. The goal is to see if this medication can help improve the survival of patients with this type of cancer.
Bevacizumab
is a medication that works by blocking the growth of new blood vessels that tumors need to grow. This process is called anti-angiogenesis. In this trial, bevacizumab is being combined with atezolizumab to see if the combination can improve the overall survival of patients with advanced non-small-cell lung cancer compared to using atezolizumab alone. The hope is that by using both medications together, they can more effectively slow down or stop the growth of the cancer.

What is already known about the treatment

Atezolizumab
Atezolizumab is administered as an intravenous infusion, meaning it is given directly into a vein through a drip. It is currently used in medicine to treat certain types of cancer, including advanced non-small-cell lung cancer (NSCLC). The main therapeutic indication for atezolizumab is to help the immune system fight cancer by targeting a protein called PD-L1, which can prevent the immune system from attacking cancer cells. It belongs to a class of drugs known as immune checkpoint inhibitors, which work by blocking the PD-L1 protein and allowing the immune system to better recognize and destroy cancer cells.
Bevacizumab
Bevacizumab is also administered as an intravenous infusion. It is used in medicine to treat various types of cancer by inhibiting the growth of blood vessels that supply nutrients to tumors. The main therapeutic indication for bevacizumab is to slow the growth of cancer by blocking a protein called VEGF, which is responsible for the formation of new blood vessels. It is classified as an angiogenesis inhibitor, meaning it prevents the formation of new blood vessels, thereby starving the tumor of the nutrients it needs to grow.

Investigated diseases

Advanced non-small-cell lung cancer – This is a type of lung cancer that is characterized by the uncontrolled growth of cells in the lung tissues. It is called "non-small-cell" because the cancer cells are larger than those found in small-cell lung cancer. The disease progresses as the cancer cells grow and spread to other parts of the body, often through the lymphatic system or bloodstream. As it advances, it can cause symptoms such as persistent cough, chest pain, and difficulty breathing. The progression can lead to the involvement of other organs, which may result in additional symptoms depending on the areas affected. The disease is often diagnosed at an advanced stage due to its subtle early symptoms.