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Study on the Effectiveness of Lutetium (177Lu) Oxodotreotide and Octreotide in Patients with Advanced GEP-NET Tumors (Grade 2 and 3)

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 cancer known as gastroenteropancreatic neuroendocrine tumors (GEP-NETs), specifically those that are advanced and have a high proliferation rate, classified as Grade 2 and Grade 3. The study aims to evaluate the effectiveness and safety of a treatment called Lutathera, which is a solution for infusion containing the active substance lutetium (177Lu) oxodotreotide. This treatment will be compared to another medication called Sandostatin LAR, which contains octreotide and is given as an injection. The purpose of the study is to determine if Lutathera is better at delaying the progression of the disease or death when used as a first-line treatment.

Participants in the study will receive either Lutathera in combination with supportive care or a higher dose of Sandostatin LAR. Lutathera is administered through an intravenous infusion, which means it is given directly into a vein, while Sandostatin LAR is given as an intramuscular injection, meaning it is injected into a muscle. The study will also involve the use of a solution called LysaKare, which contains L-lysine hydrochloride and L-arginine hydrochloride, to help protect the kidneys during treatment. The trial will follow participants over a period to observe the time it takes for the disease to progress or for any other significant health changes to occur.

The study is designed to be open-label, meaning both the participants and the researchers know which treatment is being administered. It is a randomized trial, which means participants are randomly assigned to receive either Lutathera or the higher dose of Sandostatin LAR. The trial will take place across multiple centers, allowing for a diverse group of participants. The ultimate goal is to gather information that could lead to improved treatment options for patients with advanced GEP-NETs.

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 treatment phase

    The treatment begins with the administration of Lutathera (lutetium (177lu) oxodotreotide) as a solution for infusion. This is given through a vein (intravenous use).

    The infusion of Lutathera is accompanied by LysaKare (l-lysine hydrochloride, l-arginine hydrochloride) to protect the kidneys. This is also administered intravenously.

  2. Step 2

    Supportive care with octreotide

    Following the initial treatment, Sandostatin LAR (octreotide) is administered as a suspension for injection. This is given into a muscle (intramuscular use).

    The dosage of Sandostatin LAR is 30 mg, and it is administered once every four weeks.

  3. Step 3

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and any side effects. This includes imaging tests and health assessments.

    The primary goal is to delay the progression of the disease or death, known as progression-free survival (PFS).

  4. Step 4

    Comparison phase

    The effectiveness of Lutathera combined with supportive care is compared to a higher dose of Sandostatin LAR (60 mg) given alone.

    This phase helps determine which treatment is more effective in managing the condition.

Who can join the trial?

10 criteria

  • The patient must have a type of tumor called a **gastroenteropancreatic neuroendocrine tumor (GEP-NET)** that is either **metastasized** (spread to other parts of the body) or **locally advanced** (grown in the area where it started) and cannot be removed by surgery.
  • The tumor must be **well-differentiated**, which means the cancer cells look somewhat like normal cells, and it should be classified as **Grade 2 or Grade 3**.
  • The tumor must have been diagnosed within the last 6 months.
  • The **Ki67 index**, a measure of how fast the cancer cells are growing, must be between **10% and 55%**.
  • The patient must be at least **15 years old** and weigh more than **40 kg** (about 88 pounds).
  • The tumor must show **somatostatin receptors** on all target lesions, which are specific proteins that can be seen using special imaging tests like **PET/CT** or **MRI** scans.
  • The tumor must take up more of the imaging substance than the normal liver does during these scans.
  • The patient must have a **Karnofsky Performance Score (KPS)** of at least **60**, which is a way to measure the patient's ability to perform daily activities.
  • There must be at least one site of the disease that can be measured.
  • The patient must have signed a form agreeing to participate in the study, which is called an **informed consent form**.

Who cannot join the trial?

7 criteria

  • Patients who do not have a positive result for a test that shows the presence of a specific type of receptor called the somatostatin receptor.
  • Patients whose tumors are not classified as well-differentiated G2 or G3. This means the tumor cells do not look similar to normal cells under a microscope.
  • Patients who do not have advanced GEP NETs, which stands for gastroenteropancreatic neuroendocrine tumors. These are rare tumors that can occur in the stomach, intestines, or pancreas.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial group.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Lutathera is a medication used in this clinical trial to treat patients with advanced neuroendocrine tumors. It works by delivering targeted radiation to the cancer cells, which helps to slow down or stop their growth. The trial aims to show that Lutathera is more effective than the other treatment option in delaying the progression of the disease or death.

What is already known about the treatment

Lutathera – Lutathera is administered intravenously and is used in the treatment of certain types of neuroendocrine tumors, specifically those that are somatostatin receptor positive and well-differentiated. It is currently being evaluated in clinical trials for its effectiveness and safety in treating advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The medication works by delivering targeted radiation to cancer cells, binding to somatostatin receptors on the tumor, and emitting radiation to destroy the cancerous cells. It is classified as a radiopharmaceutical, which is a type of drug that contains radioactive substances used in the treatment of cancer.

Investigated diseases

Gastroenteropancreatic Neuroendocrine Tumors (GEP NETs) – These are a group of rare tumors that originate in the neuroendocrine cells of the gastrointestinal tract and pancreas. They are characterized by their ability to produce hormones, which can lead to various symptoms depending on the hormones released. GEP NETs are classified based on their grade, with G2 and G3 indicating a higher degree of abnormality and potential for growth. These tumors can be well-differentiated, meaning they resemble normal cells and tend to grow more slowly. As they progress, they may spread to other parts of the body, leading to more complex symptoms. The presence of somatostatin receptors on these tumors can influence their behavior and response to certain treatments.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507443-10-00Protocol codeCAAA601A22301Estimated enrolment222 patientsSponsorAdvanced Accelerator Applications

sourced from the EU Clinical Trials Register and site verification

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