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A study comparing XL092 versus everolimus in patients with previously treated advanced or metastatic neuroendocrine tumors

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 study involves people with neuroendocrine tumors, which are growths that can develop in different parts of the body including the pancreas, digestive system, lungs, or other organs. These tumors arise from cells that produce hormones. The study is for people whose cancer has spread to other parts of the body or cannot be removed by surgery, and whose cancer has continued to grow despite previous treatment. The study will compare two different medicines taken by mouth in tablet form: zanzalintinib, which is also known as XL092, and everolimus. Zanzalintinib is an experimental medicine being tested in this study, while everolimus is an already approved treatment for this type of cancer.

The purpose of this study is to find out how long people live without their cancer getting worse when treated with zanzalintinib compared to everolimus. The study will also look at how many people respond to the treatment, meaning their tumors shrink or disappear, and how long people live overall. Participants will be randomly assigned to receive either zanzalintinib or everolimus, and both the participants and their doctors will know which treatment they are receiving. During the study, participants will have regular check-ups and imaging scans to monitor their cancer and overall health.

Participants will continue taking their assigned medicine as long as it is helping them and not causing unacceptable side effects. The study will collect information about how well each medicine works and what side effects occur. Blood tests and other medical assessments will be done regularly to monitor safety. Some participants may continue taking other hormone-related medicines they were already using if their tumor produces hormones that cause symptoms. The study aims to help doctors understand which treatment option may work better for people with this type of cancer who have already received some previous treatment.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Random assignment to treatment group

    After joining the study, you will be randomly assigned to receive one of two treatment options. This process is similar to flipping a coin and determines which medication you will receive.

    You will receive either zanzalintinib or everolimus. Both medications are taken by mouth in tablet form.

  2. Step 2

    Treatment administration

    You will take your assigned medication orally as tablets on a continuous basis throughout the study.

    The specific dosage, frequency, and timing of your medication will be determined by the study doctor and provided to you with detailed instructions.

    If you have a functional tumor (a tumor that causes symptoms by producing hormones) and have been taking somatostatin analog therapy at a stable dose for at least 8 weeks before starting the study, you may continue this medication during the trial.

  3. Step 3

    Regular monitoring and imaging assessments

    Throughout the study, you will undergo regular imaging scans using computed tomography or magnetic resonance imaging. These scans create detailed pictures of the inside of your body to monitor your tumor.

    The scans will be reviewed by independent medical experts who do not know which treatment you are receiving. This helps ensure an objective assessment of how the treatment is working.

    The imaging assessments will follow standardized criteria called RECIST 1.1, which is a set of rules used to measure tumor size and determine if the disease is responding to treatment, staying stable, or progressing.

  4. Step 4

    Laboratory tests and safety monitoring

    You will have regular blood and urine tests to monitor your overall health and the function of your organs.

    These tests will check various markers including blood cell counts, liver function, kidney function, cholesterol and triglyceride levels, blood sugar control, and other safety parameters.

    Heart function monitoring will be performed using echocardiogram (an ultrasound of the heart) and electrocardiogram (a test that measures the electrical activity of the heart).

  5. Step 5

    Management of side effects

    Any side effects or unwanted symptoms you experience will be assessed and managed by the study doctor.

    The severity of side effects will be graded using a standardized system to ensure appropriate care.

    Treatment adjustments may be made as needed to manage any side effects while continuing your participation in the study.

  6. Step 6

    Ongoing treatment until disease progression or other reasons

    You will continue taking your assigned study medication until your disease progresses, you experience unacceptable side effects, or another reason for stopping treatment occurs.

    The study doctor will regularly evaluate whether continuing treatment remains appropriate for you.

  7. Step 7

    Follow-up period

    After you stop taking the study medication, you will enter a follow-up period where your health status will continue to be monitored.

    This follow-up is important to assess long-term outcomes and overall survival.

    The estimated duration of the entire study, including follow-up, extends until June 2029.

Who can join the trial?

24 criteria

  • You must have a confirmed diagnosis of neuroendocrine tumors, which are tumors that develop from cells that release hormones into the blood. These tumors must be well-differentiated Grade 1, 2, or 3, and can originate from the pancreas or other areas such as the digestive system, lung, thymus, or other sites. The tumor must be locally advanced, cannot be removed by surgery, or has spread to other parts of the body.
  • You may have tumors that cause symptoms related to hormone release or tumors that do not cause such symptoms.
  • Your tumor can be positive or negative for SSTR, which are special receptors on the surface of some tumor cells. If your SSTR status is unknown, you will need to have a special scan during the screening period to determine this.
  • You must have received a specific number of prior treatments depending on your tumor type. If you have a pancreatic tumor or a non-functional tumor from outside the pancreas, you can have received up to one prior treatment. If you have a functional tumor from outside the pancreas, you must have received exactly one prior treatment with either PRRT, which is a type of radiation therapy, or chemotherapy.
  • Your tumor must have grown or progressed within the past 12 months, as shown by imaging scans such as CT or MRI, which are types of scans that create detailed pictures of the inside of your body.
  • You must have measurable tumor that can be seen on scans and measured according to specific criteria.
  • If available, you must provide a sample of your tumor tissue from a previous biopsy or surgery. If not available, a new biopsy may be needed if it can be done safely.
  • You must have recovered from side effects of any previous treatments to either your normal state or to mild symptoms.
  • You must be 18 years of age or older.
  • Your overall health status must be good, rated as 0 or 1 on the ECOG performance status scale, which means you are able to carry out normal activities or have only minor symptoms.
  • You must be able to understand the study requirements and sign an informed consent document.
  • Your blood tests must show adequate function of your organs and bone marrow, including sufficient levels of white blood cells, which fight infection, platelets, which help blood clot, and hemoglobin, which carries oxygen in your blood.
  • Your blood clotting tests must be within acceptable ranges.
  • Your liver function tests, including ALT, AST, alkaline phosphatase, and bilirubin, which are enzymes and substances that show how well your liver is working, must be within acceptable limits.
  • Your kidney function must be adequate, as measured by creatinine clearance, which shows how well your kidneys filter waste from your blood.
  • Your urine protein levels must be within acceptable limits.
  • You must test negative for hepatitis B and hepatitis C, which are viral infections of the liver, unless you have cleared the hepatitis C virus and are not receiving treatment for it.
  • Your cholesterol and triglycerides, which are types of fat in your blood, must be within acceptable limits or controlled with medication.
  • Your blood sugar control must be adequate, as shown by HbA1c, which measures average blood sugar levels over the past few months, or by fasting blood sugar levels.
  • Your heart function must be adequate, with a left ventricular ejection fraction of at least 50 percent, which measures how well your heart pumps blood.
  • Your heart rhythm must be normal, as measured by an electrocardiogram, which is a test that records the electrical activity of your heart.
  • If you are a woman who can become pregnant, you must not be pregnant or breastfeeding at the time of screening.
  • If you are a woman who can become pregnant or a man with a female partner who can become pregnant, you must agree to use highly effective birth control methods during the study and for several months after your last dose of study treatment.
  • You must agree not to donate sperm or eggs during the study and for several months after your last dose of study treatment.

Who cannot join the trial?

3 criteria

  • The study does not list specific reasons why patients cannot participate in this trial based on the available information
  • General exclusion criteria (reasons you cannot join) are not provided in the current study details
  • You should discuss with your doctor whether this study is suitable for your specific medical situation
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Investigated drugs

  • Zanzalintinib

    is an investigational medication being tested in this clinical trial. It is being studied as a potential treatment for neuroendocrine tumors that cannot be removed by surgery, have spread to other parts of the body, or have come back after previous treatment. This medication is being compared to another treatment to see how well it works at slowing down the growth or spread of the disease.

  • Everolimus

    is a medication that is already approved and used to treat certain types of cancer, including neuroendocrine tumors. It works by blocking signals that help cancer cells grow and survive. In this study, it is being used as a comparison treatment to see if the investigational medication works better, worse, or about the same at controlling the disease.

What is already known about the treatment

  • Zanzalintinib

    Zanzalintinib is an investigational medication currently being studied in clinical trials and is not yet approved for standard medical use. It is being tested as a treatment for neuroendocrine tumors that have spread to other parts of the body or cannot be removed by surgery. The medication works by blocking specific proteins that help cancer cells grow and form new blood vessels, which may help slow down or stop tumor growth. In this trial, it is being compared to another cancer medication called everolimus to see which treatment works better at preventing the disease from getting worse.

  • Everolimus

    Everolimus is an approved oral medication taken by mouth in tablet form that is used to treat various types of cancer, including neuroendocrine tumors. It works by blocking a protein called mTOR inside cells, which helps control cell growth and division, thereby slowing down the growth of cancer cells and reducing the blood supply to tumors. This medication belongs to a class of drugs known as mTOR inhibitors and is an established treatment option in cancer care. In this clinical trial, it serves as the comparison treatment to evaluate how well the investigational drug zanzalintinib performs.

Investigated diseases

Neuroendocrine Tumors – Neuroendocrine tumors are abnormal growths that develop from cells that release hormones into the bloodstream in response to signals from the nervous system. These tumors can occur in various parts of the body, most commonly in the digestive system, pancreas, and lungs. The cells in these tumors retain some ability to produce and release hormones, which can cause specific symptoms depending on the type of hormone involved. Neuroendocrine tumors grow at different rates, with some developing very slowly over many years while others grow more quickly. As the tumor grows, it may spread to nearby tissues or other organs in the body. The progression of the disease varies widely depending on the tumor's location, size, and how quickly the abnormal cells are multiplying.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-521043-20-00Protocol codeXL092-311Estimated enrolment440 patientsSponsorExelixis Inc.

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