Study on Atezolizumab, Bevacizumab, and Paclitaxel for Advanced Lung Cancer Patients After Immunotherapy and Chemotherapy

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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-squamous non-small cell lung cancer (NSCLC). The study is evaluating the effectiveness of a combination of medications in patients whose cancer has progressed after previous treatments with immunotherapy and chemotherapy. The medications being tested include Paclitaxel, Bevacizumab, and Atezolizumab. Atezolizumab is also known by its code name, RO5541267. These medications are given as an infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to assess how well these medications work together in treating this type of lung cancer. Participants in the study will receive either a combination of Paclitaxel and Bevacizumab or a combination of Paclitaxel, Bevacizumab, and Atezolizumab. Some participants may receive a placebo instead of Atezolizumab. The study will monitor the participants over a period of time to see how their cancer responds to the treatment and to check for any side effects.

Throughout the study, participants will have regular visits to the clinic for their treatments and to undergo various tests. These tests will help the researchers understand how the cancer is responding to the treatment and to ensure the safety of the participants. The study aims to provide valuable information that could lead to better treatment options for patients with advanced non-squamous NSCLC in the future.

1 initial visit and consent

Upon joining the study, you will attend an initial visit where you will be asked to sign a written informed consent form. This form confirms your understanding of the study and your willingness to participate. It is important to read this document carefully and ask any questions you may have.

During this visit, you will also undergo a series of tests to ensure you meet the study’s eligibility criteria. These tests will include blood tests to check your blood cell counts and organ function, as well as a pregnancy test if applicable.

2 treatment phase

The treatment phase involves receiving medications through an intravenous infusion. This means the medication will be administered directly into your bloodstream through a vein.

You will receive a combination of medications, which may include bevacizumab, paclitaxel, and possibly atezolizumab. The specific combination and dosage will be determined by the study protocol and your medical team.

The frequency and duration of the treatment will be explained to you by your healthcare provider. It is important to attend all scheduled treatment sessions and follow the instructions provided by your medical team.

3 regular monitoring

Throughout the study, you will have regular visits to monitor your health and the effects of the treatment. These visits will include physical examinations, blood tests, and possibly imaging tests to assess the progress of your condition.

You will be asked to report any side effects or changes in your health to your medical team. This information is crucial for ensuring your safety and the success of the study.

4 end of treatment and follow-up

Once the treatment phase is complete, you will have a final visit to assess your overall health and the outcomes of the treatment. This visit will include a comprehensive evaluation by your medical team.

You may be asked to participate in follow-up visits to monitor your long-term health and any lasting effects of the treatment. These visits are important for gathering information about the long-term efficacy and safety of the study medications.

Who Can Join the Study?

Patients must have signed a written consent form agreeing to participate in the study.
Patients must be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary tests.
Patients must be at least 18 years old.
Patients must have a performance status of 0 or 1, which means they are fully active or have some symptoms but do not require bed rest.
Patients must have advanced non-squamous non-small cell lung cancer that cannot be removed by surgery or has spread to other parts of the body.
Patients must have previously received treatment with immunotherapy and a type of chemotherapy called platinum-based chemotherapy.
Patients must not have any medical reasons that prevent them from receiving a drug called bevacizumab.
Patients must have enough tumor tissue available for analysis. This tissue should preferably be collected after the cancer has spread.
Patients must have at least one tumor that can be measured. If the tumor was previously treated with radiation, it must show clear signs of growth since the treatment.
Patients must have a life expectancy of at least 12 weeks.
Patients must have adequate blood and organ function, as shown by specific laboratory test results.
Patients must have a creatinine clearance of at least 50 mL/min, which is a measure of kidney function.
Patients must have recovered from any side effects of previous treatments to an acceptable level, except for certain conditions like hair loss or skin changes.
Women who can become pregnant must have a negative pregnancy test before starting the study.
Women who can become pregnant must agree to use effective birth control methods during the study and for at least 5 months after the last dose of study drugs.
Men with partners who can become pregnant must agree to use a condom during the study and for at least 90 days after the last dose of study drugs.
Participants must have national health insurance coverage.

Who Cannot Join the Study?

Patients with any other type of cancer besides advanced non-squamous non-small cell lung cancer cannot participate.
Patients who have had a previous treatment with the study drugs atezolizumab, bevacizumab, or paclitaxel are not eligible.
Patients with a history of severe allergic reactions to any of the study drugs or similar drugs cannot join the study.
Patients with uncontrolled medical conditions, such as high blood pressure or diabetes, that are not well managed are excluded.
Patients with active infections, including HIV, hepatitis B, or hepatitis C, cannot participate.
Patients who are pregnant or breastfeeding are not eligible for the study.
Patients with a history of bleeding disorders or who are taking blood thinners are excluded.
Patients with significant heart problems, such as heart failure or recent heart attack, cannot join the study.
Patients with brain metastases, which means cancer has spread to the brain, are not eligible unless they have been treated and are stable.
Patients who have participated in another clinical trial within the last 30 days are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Intercommunal Creteil	Creteil	France
Centr Georges Francois Leclerc	Dijon	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier D Avignon	Avignon	France
HIA Sainte Anne	Toulon	France
Centre Hospitalier Le Mans	Le Mans	France
Hopital Ambroise Pare	Boulogne-Billancourt	France
Centre Hospitalier De La Cote Basque	Bayonne	France
Centre Hospitalier De Cholet	Cholet	France
Hopitaux Prives De Metz	Vantoux	France
Hopital Europeen Marseille	Marseille	France
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Hopital Tenon	Paris	France
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Les Hopitaux Universitaires De Strasbourg	STRASBOURG, Alsace	France
Assistance Publique Hopitaux De Paris	Paris	France
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace	Mulhouse	France
Polyclinique Bordeaux Nord Aquitaine	Bordeaux	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
CHU Gabriel-Montpied	Clermont Ferrand	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Centre Hospitalier De Pau	Pau	France
Centre Hospitalier Pasteur	Colmar	France
Cdhjyj Hexzubamzep Udmukgwhwfqjm Dy Dezcm	Dijon	France
Cgotsspf Mpqmzolpoohuzfnqjdk Teqyofem Gwsnyk Ahxtgrzni	Valenciennes	France
Cla Akggum &cxhbfz Gftdjr Hvawgqfupyd Skt	Amiens	France
Cp Vssualmaerro Nhyb Owyst	Villefranche sur Saône	France
Czs dtpgbrtkerscwn	Epagny Metz Tessy	France
Chikzv Haqaejmzdzh Et Uuxslnqsuvima Dg Ljngndz	Limoges	France
Arvhkypast Pqfyyndy Hfnibnxl Da Mkqmnacfe	Marseille	France
Bowufpkb Ukraqplsos Hnfmrjky Clmswx	Besançon	France
Clcsiy Hohguhidqok Raduuybg Uofqwfrheqpte Dx Ttkth	Tours	France
Cieyew Lfny Bjohpg	Lyon	France
Cfneql Hjzwpfixici Rginhxfq Dxmxweslxllmka	Angers	France
Iyqikofc dq Cwvsooipmdyx Hnttecynwho Uxjrdohhlfzsq dw Syjwh Ebythdt (mjjbokk	Saint Priest En Jarez	France
Ictdgbkt Pewttljfrcuhtdv Cgwjih Cedwyr	Marseille	France
Gel Gglbrf hpyoltnbqvm Pwsib Suqadppyyzfr	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.03.2023

Trial locations

Investigated drugs:

Paclitaxel is a type of chemotherapy medication used to treat various kinds of cancer. In this trial, it is being used to help stop the growth of cancer cells in patients with advanced non-squamous non-small cell lung cancer (NSCLC) who have not responded well to previous treatments. Paclitaxel works by interfering with the way cancer cells divide, which can slow down or stop their growth.

Bevacizumab is a medication that helps prevent the growth of new blood vessels that tumors need to grow. By blocking this process, bevacizumab can help slow down the growth of cancer. In this trial, it is used in combination with other medications to treat patients with advanced non-squamous NSCLC.

Atezolizumab is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. It works by blocking a protein that prevents the immune system from attacking cancer cells. In this trial, atezolizumab is being tested in combination with other medications to see if it can improve outcomes for patients with advanced non-squamous NSCLC who have not responded to previous treatments.

Investigated diseases:

Advanced Non-Squamous Non-Small Cell Lung Cancer – This is a type of lung cancer that originates in the epithelial cells of the lung but does not have the squamous cell characteristics. It is categorized as “advanced” when it has spread beyond the lungs to other parts of the body. The disease progresses as cancer cells grow uncontrollably, forming tumors that can interfere with lung function. Over time, these tumors can invade nearby tissues and organs, leading to further complications. The progression can vary, with some cases showing rapid growth and others developing more slowly. As the disease advances, it may cause symptoms such as persistent cough, chest pain, and difficulty breathing.

Trial ID:

2022-502103-30-00

Protocol code:

IFCT-2201

NCT ID:

NCT05781308

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Atezolizumab, Bevacizumab, and Paclitaxel for Advanced Lung Cancer Patients After Immunotherapy and Chemotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?