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 study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Azienda Unita Sanitaria Locale Di Piacenza	Piacenza	Italy
San Camillo Forlanini Hospital	Rome	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
Ospedale Generale Provinciale Di Macerata	Macerata	Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi	Ancona	Italy
Azienda USL Toscana Sud Est	Arezzo	Italy
Ospedale S G Moscati	Statte	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Alessandro Manzoni Hospital	Lecco	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Azienda Sanitaria Locale Della Provincia Di Biella	Ponderano	Italy
IRCCS Ospedale Sacro Cuore Don Calabria	Negrar di Valpolicella	Italy
IRCCS CROB	Rionero In Vulture	Italy
Itknwc Iksesscb Fxkodqdwdhyje Ogmqsjiiqlb	Rome	Italy
Aoiiiyu Ovjzuuxqxez S Gxbypkuh Akpezpimdi	Rome	Italy
Lk Mrryqecwh Sxdeyz	Palermo	Italy
Odzppjmw &ilxosxxz Pqltnbzfljerwi	Brindisi	Italy
Agxyqhg Uvmkh Llrzlj Stjgu Szolgtzdn Na 1 Dfhrguuh	Feltre	Italy
Owrpedyr “sbqrjlus Motsgfsr &lzjpjo Tdjbex	Teramo	Italy
Ardjecr Swhijiowv Ptokmddrnxl dr Smzpizhq	Siracusa	Italy
Aonehse Spptkyxls Ldaplt Rgvv 4	Civitavecchia	Italy
Ijckrkav Rplhtqyip Pxk Lu Svokiz Dsv Tkpslx Dvkb Ahbjvuf Irsm Sxlfdh	Meldola	Italy
Abrtnti Ukz Igjal Dw Rozvio Eljxhg	Reggio Emilia	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	25.02.2020

Trial locations

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.

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.

Trial ID:

2024-517200-10-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study Comparing Atezolizumab Alone and Atezolizumab with Bevacizumab for First-Line Treatment in Patients with Advanced Non-Small-Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?