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

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What is this study about?

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.

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 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 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 Study?

  • 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)</b) levels should be no more than 2.5 times the upper limit of normal, or no more than 5 times if you have liver metastases.
    • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Maastricht Maastricht The Netherlands

Other Sites

Site Name City Country Status
Netherlands Cancer Institute Amsterdam The Netherlands
Uulcxcfsbrxh Mqquucy Cmazhyh Gzciobocr Groningen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
02.09.2024

Trial locations

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.

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 ID:
2024-514066-40-00
Protocol code:
CO-NL-979-6888
NCT ID:
NCT06401824
Trial Phase:
Therapeutic exploratory (Phase II)

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