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Study of Sacituzumab Govitecan and Bevacizumab for Treating Brain Metastases in Patients with Non-Small Cell Lung Cancer

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 the effects of a treatment combination for patients with a type of lung cancer known as non-small cell lung cancer (NSCLC) that has spread to the brain, referred to as brain metastases. The treatment being tested includes two medications: Sacituzumab govitecan and Bevacizumab. Sacituzumab govitecan is a medication that targets cancer cells, while Bevacizumab is used to prevent the growth of blood vessels that supply tumors.

The purpose of the study is to evaluate how effective this combination is in treating brain metastases in patients who have already received certain other treatments. Participants in the study will receive the medications through an infusion, which means the drugs are delivered directly into the bloodstream. The study will monitor the effects of the treatment over a period of time, with regular assessments using MRI scans to check the response of the brain metastases to the treatment.

Throughout the study, the safety of the treatment will be closely monitored, and participants will have regular check-ups to ensure they are responding well to the treatment. The study aims to provide valuable information on whether this combination of medications can be an effective treatment option for patients with NSCLC that has spread to the brain.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The treatment involves the administration of two medications: sacituzumab govitecan and bevacizumab. Both medications are given as a solution for infusion, which means they are delivered directly into the bloodstream through a vein.

    The first dose of these medications is administered after ensuring that the patient is asymptomatic from brain metastases and is on a stable dose of corticosteroids, with a maximum of 4 mg dexamethasone per day. The patient should also have a stable dose of any anti-epileptic medication for at least 7 days prior to the first dose.

  2. Step 2

    Treatment monitoring

    After six weeks of treatment, an MRI of the brain is performed to evaluate the response of brain metastases. This imaging is repeated every six weeks to monitor the condition.

    The primary goal is to assess the response of brain metastases using specific criteria known as RANO-BM. A confirmed response is measured at 12 weeks.

  3. Step 3

    Ongoing assessments

    In addition to brain imaging, CT scans of the chest and upper abdomen are conducted every six weeks to evaluate any changes in areas outside the brain.

    The study also monitors overall progression-free survival and overall survival, as well as the safety of the treatment using established criteria during each visit.

Who can join the trial?

20 criteria

  • You must sign a form to show you understand and agree to join the study.
  • You need to be at least 18 years old.
  • Your overall health should be good enough to perform daily activities, as measured by a test called the ECOG performance status, which should be 0 or 1. This means you are fully active or have some symptoms but can still do light work.
  • You should have a life expectancy of at least 12 weeks.
  • You must have a type of lung cancer called metastatic non-squamous NSCLC, which means the cancer has spread from the lungs to other parts of the body.
  • If you do not have a specific type of cancer mutation, your cancer should have worsened after treatment with immunotherapy (a treatment that helps your immune system fight cancer) and/or platinum-doublet chemotherapy (a combination of two chemotherapy drugs). If you cannot have immunotherapy, your cancer should have worsened after platinum-doublet chemotherapy.
  • If you have a specific type of cancer mutation, your cancer should have worsened after treatment with targeted therapy (drugs that target specific parts of cancer cells) and platinum-doublet chemotherapy. You may have had immunotherapy, but it is not required.
  • You should have brain metastases (cancer that has spread to the brain) that are not in critical areas of the brain. Your case should be discussed with a neurologist, and preferably in a group of brain specialists.
  • The largest brain metastasis should be no more than 2 cm in size.
  • You should have at least one untreated brain metastasis that is 5 mm or larger. If the largest brain metastasis is between 5 mm and 10 mm, you may still join the study if the main doctor agrees. You should have a special type of brain scan called an MRI with thin slices. If you had local treatment for brain metastases, they should have clearly worsened or new ones should have appeared. You should not have symptoms from brain metastases and should be on a stable dose of a steroid called dexamethasone (up to 4 mg per day) and a stable dose of any anti-seizure medication for at least 7 days before starting the study treatment.
  • You should have recovered from any side effects of previous treatments to a mild level, except for hair loss and nerve damage, which can be of any severity.
  • Your organs should be working well, as shown by certain blood tests. These include:
    • Absolute neutrophil count (ANC) of at least 1.5 x 109/L without help from growth factors.
    • Platelets of at least 100 x 109/L without help from growth factors.
    • Hemoglobin (Hb) of at least 9 g/dL without blood transfusions or growth factors for 7 days.
    • Aspartate transaminase (AST) and Alanine transaminase (ALT)
    • Serum albumin should be more than 3 g/dL.
    • Total bilirubin should be no more than 1.5 times the upper limit of normal.
    • Creatinine clearance should be at least 30 mL/min, which measures how well your kidneys are working.
    • You should be able to follow instructions for the study treatment and communicate with the study doctor.
    • If you are a woman who can have children, you must have a negative pregnancy test within 7 days before starting the study treatment. You must agree to use effective birth control methods, such as a physical barrier like a condom, along with an intrauterine device or hormonal contraception, until at least 4 months after stopping the study drug. If you are postmenopausal or have had surgery to prevent pregnancy, this does not apply.

Who cannot join the trial?

6 criteria

  • Patients who have not been treated with platinum-doublet chemotherapy and immune checkpoint inhibitors (ICI) cannot participate. These are specific types of cancer treatments.
  • Patients with targetable oncogenic drivers who have not been treated with at least one tyrosine kinase inhibitor and platinum-doublet chemotherapy are excluded. Oncogenic drivers are specific changes in cancer cells, and tyrosine kinase inhibitors are drugs that block these changes.
  • Patients with active brain metastases (BM) that are not asymptomatic or have not been treated locally, or are clearly getting worse after local treatment, cannot join. Brain metastases are cancer cells that have spread to the brain.
  • Individuals who are not within the specified age range for the study are excluded.
  • Both male and female patients are eligible, so gender is not an exclusion factor.
  • Vulnerable populations, such as those unable to give consent, are not included in this study.
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Investigated drugs

  • Sacituzumab govitecan

    is a medication used in this trial to treat patients with brain metastases from non-small cell lung cancer. It is an antibody-drug conjugate, which means it combines an antibody with a chemotherapy drug. The antibody part helps the medication find and attach to cancer cells, while the chemotherapy part works to kill these cells.

  • Bevacizumab

    is another medication used in this trial. It is a type of drug known as a monoclonal antibody. Bevacizumab works by blocking a protein called VEGF, which helps tumors form new blood vessels. By blocking this protein, bevacizumab can help slow the growth of tumors by cutting off their blood supply.

What is already known about the treatment

  • Sacituzumab govitecan

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating brain metastases in patients with non-small cell lung cancer (NSCLC). It is primarily indicated for patients who have previously undergone chemotherapy and immunotherapy. Sacituzumab govitecan works by delivering a chemotherapy agent directly to cancer cells, targeting a specific protein on their surface, which helps to destroy the cancer cells. It is classified as an antibody-drug conjugate.

  • Bevacizumab

    This medication is also administered intravenously and is used in combination with Sacituzumab govitecan in clinical trials for treating brain metastases in NSCLC patients. Bevacizumab is known for its ability to inhibit the growth of blood vessels that supply nutrients to tumors, effectively starving the cancer cells. It is classified as a monoclonal antibody and is widely recognized in medical literature for its role in cancer treatment.

Investigated diseases

Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that begins in the non-squamous cells of the lung and has spread to other parts of the body. It often progresses by forming tumors in distant organs, including the brain, bones, and liver. Patients with this condition may have previously undergone treatments such as chemotherapy and immunotherapy. The disease can continue to progress despite these treatments, leading to further complications. It is characterized by the presence of oncogenic drivers, which are specific genetic mutations that promote cancer growth. The progression of the disease is monitored through imaging techniques to assess the response to ongoing treatments.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514066-40-00Protocol codeCO-NL-979-6888Estimated enrolment25 patientsSponsorAcademisch Ziekenhuis Maastricht

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).