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

Verified siteRegistered drugNo placebo
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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 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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

17 criteria

  • 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 trial?

10 criteria

  • 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.
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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.

What is already known about the treatment

  • Atezolizumab

    Atezolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating advanced non-squamous non-small cell lung cancer, especially in patients who have not responded to previous treatments. The medication works by blocking a protein called PD-L1, which helps cancer cells hide from the immune system, thereby allowing the immune system to better detect and attack cancer cells. Atezolizumab is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.

  • Bevacizumab

    Bevacizumab is also administered as an intravenous infusion. It is being evaluated in clinical trials for its role in treating advanced non-squamous non-small cell lung cancer. Bevacizumab works by inhibiting a protein called VEGF, which is responsible for the growth of new blood vessels that tumors need to grow and spread. By blocking this protein, bevacizumab helps to starve the tumor of nutrients and slow its growth. It is classified as an angiogenesis inhibitor, a type of drug that prevents the formation of new blood vessels.

  • Paclitaxel

    Paclitaxel is given as an intravenous infusion and is being tested in combination with other drugs for treating advanced non-squamous non-small cell lung cancer. It works by interfering with the normal function of microtubules, which are structures that help cells divide. By disrupting these structures, paclitaxel prevents cancer cells from dividing and growing. It is classified as a mitotic inhibitor, a type of chemotherapy drug that targets cell division.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502103-30-00Protocol codeIFCT-2201Estimated enrolment156 patientsSponsorIntergroupe Francophone De Cancerologie Thoracique

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