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Study on the Safety and Effectiveness of Cabozantinib and Lanreotide for Patients with Gastroenteropancreatic and Thoracic Neuroendocrine Tumors

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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 cancer known as neuroendocrine tumors (NETs), which can occur in the gastroenteropancreatic (GEP) system and the thoracic region, including the lungs. The study is investigating the effects of two medications: cabozantinib and lanreotide. Cabozantinib is taken orally in the form of a film-coated tablet, while lanreotide is administered as an injection. The purpose of the study is to evaluate the safety and effectiveness of using these two medications together in treating patients with these types of tumors.

Participants in the study will receive a combination of cabozantinib and lanreotide over a period of up to 24 months. The study will monitor how well patients tolerate the treatment and how the tumors respond to the medication. The trial aims to gather information on the safety of the treatment and its ability to control the growth of the tumors. Additionally, researchers will explore certain biological markers that might help predict how well the treatment works or how safe it is for patients.

The study is divided into different stages, with the initial stage focusing on assessing the safety and tolerability of the treatment. Subsequent stages will continue to evaluate safety while also looking at how effective the treatment is in terms of reducing tumor size or slowing its growth. The trial will also consider the overall survival and progression-free survival of participants, which refers to the length of time patients live without the disease getting worse. This research is important for understanding how these medications can be used to treat neuroendocrine tumors more effectively.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure the patient meets the criteria for participation.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of cabozantinib and lanreotide. Cabozantinib is taken orally, while lanreotide is given through an intramuscular injection.

    The dosage and frequency of these medications are determined by the study protocol and are monitored closely by the medical team.

  3. Step 3

    Monitoring and evaluation

    Regular monitoring is conducted to evaluate the safety and effectiveness of the treatment. This includes routine blood tests, imaging studies, and assessments of any side effects experienced.

    The objective is to ensure the treatment is well-tolerated and to measure its impact on the neuroendocrine tumors.

  4. Step 4

    Follow-up assessments

    Follow-up assessments are scheduled at specific intervals to track the progression of the disease and the patient's overall health.

    These assessments help in determining the long-term effects of the treatment and in making any necessary adjustments.

  5. Step 5

    Completion of trial

    The trial is expected to conclude by August 31, 2026. At the end of the trial, a final evaluation is conducted to summarize the findings and assess the overall outcomes of the treatment.

Who can join the trial?

15 criteria

  • Must provide voluntary written consent to participate, understanding that they can withdraw at any time without affecting future medical care.
  • Must have a type of cancer called **neuroendocrine tumor (NET)** that is advanced or cannot be removed by surgery. This includes tumors in the pancreas, small intestine, stomach, rectum, lungs, thymus, or unknown primary location.
  • The cancer must be **progressive**, meaning it is getting worse, as shown by specific imaging tests like CT scans or MRIs.
  • Must have at least one measurable tumor that can be evaluated during the study.
  • Must be 18 years of age or older.
  • Must have a good general health status, as determined by a specific scale called the **ECOG performance status**.
  • Must have positive results from specific imaging tests or tissue tests that show the presence of certain receptors related to the tumor.
  • Can have had previous treatments for advanced disease, but with certain limitations on the type and duration of those treatments.
  • Any previous **PRRT therapy** must have been completed at least 6 months before joining the study.
  • Any previous treatments like chemotherapy, biologic therapy, or radiation must have been completed at least 28 days before joining the study.
  • Any previous liver-related treatments must have been completed at least 28 days before joining the study.
  • Must have recovered from any side effects of previous treatments, except for hair loss and fatigue, to a mild level.
  • Must have completed any major surgery at least two months before joining the study and any minor surgery at least 28 days before joining the study, with complete healing.
  • Can have either functioning or non-functioning tumors.
  • Must meet specific laboratory test requirements, including adequate levels of hemoglobin, white blood cells, neutrophils, and platelets, as well as liver and kidney function tests.

Who cannot join the trial?

9 criteria

  • Patients who have a different type of cancer than the specific ones being studied, which are gastroenteropancreatic (GEP) and thoracic neuroendocrine tumors (NET).
  • Patients who are not within the age range specified for the study.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care.
  • Patients who are not able to safely take the study medications, cabozantinib and lanreotide.
  • Patients who have other medical conditions that could interfere with the study or make it unsafe for them to participate.
  • Patients who are currently participating in another clinical trial or have recently participated in one.
  • Patients who are pregnant or breastfeeding, as the study medications might affect the baby.
  • Patients who have allergies or reactions to the study medications or similar drugs.
  • Patients who are unable to follow the study procedures or attend the required visits.
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Investigated drugs

  • Cabozantinib

    is a medication used in this trial to treat neuroendocrine tumors. It works by blocking certain proteins that promote tumor growth and spread. This medication is being studied to see how well it can help control the disease and improve patient outcomes when used in combination with another treatment.

  • Lanreotide

    is another medication involved in the trial. It is used to manage symptoms and slow the growth of certain types of tumors. Lanreotide works by mimicking a natural hormone in the body that helps regulate various functions, including the growth of some tumors. In this trial, it is being combined with cabozantinib to evaluate the effectiveness and safety of the combination in treating neuroendocrine tumors.

What is already known about the treatment

  • Cabozantinib

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating gastroenteropancreatic and thoracic neuroendocrine tumors. It is classified as a tyrosine kinase inhibitor and works by blocking certain proteins that promote tumor growth and blood vessel formation. Cabozantinib is being evaluated for its safety and ability to improve response rates in patients with these types of tumors.

  • Lanreotide

    This medication is administered via injection and is also under investigation in clinical trials for its use in treating gastroenteropancreatic and thoracic neuroendocrine tumors. Lanreotide is a somatostatin analog, which means it mimics a natural hormone that inhibits the release of several other hormones. It is being studied for its potential to enhance the therapeutic effects of cabozantinib in combination therapy, focusing on safety and treatment response.

Investigated diseases

  • Gastroenteropancreatic Neuroendocrine Tumor (GEP NET)

    This is a type of tumor that arises from neuroendocrine cells located in the gastrointestinal tract and pancreas. These tumors can produce hormones that cause various symptoms, depending on their location and the hormones they secrete. GEP NETs are often slow-growing, but their progression can vary significantly among individuals. They may remain localized for a long time or spread to other parts of the body. The symptoms can include abdominal pain, diarrhea, and changes in blood sugar levels, among others.

  • Thoracic Neuroendocrine Tumor (Thoracic NET)

    This type of tumor originates from neuroendocrine cells in the lungs and other parts of the chest. Thoracic NETs can be either slow-growing or more aggressive, affecting how they progress over time. They may produce hormones that lead to symptoms such as coughing, wheezing, or chest pain. The progression of these tumors can vary, with some remaining stable for years while others may grow or spread more rapidly. Symptoms can also include difficulty breathing and changes in weight or appetite.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516612-16-00Protocol codeLOLA trialEstimated enrolment69 patientsSponsorFondazione IRCCS Istituto Nazionale Dei Tumori

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