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Study of Lutetium (177Lu) Edotreotide compared to standard treatment in patients with aggressive Grade 2 and Grade 3 gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs), which are rare tumors that develop in the digestive system or pancreas. The main treatment being tested is Lutetium-177 Edotreotide, a radioactive medication that specifically targets tumor cells. This treatment, also known as Peptide Receptor Radionuclide Therapy (PRRT), will be compared to standard cancer treatments to determine if it works better.

The study includes several standard cancer treatments that may be used as comparison: Everolimus, Temozolomide, Capecitabine, Oxaliplatin, and Fluorouracil. Some patients will also receive supportive medications like Calcium Folinate and an amino acid solution to protect their kidneys during treatment. The purpose is to determine if the radioactive treatment is more effective than current standard treatments for these types of tumors.

During the study, patients will be randomly assigned to receive either the radioactive treatment or one of the standard treatments. The doctors will monitor how well the treatments work by taking regular scans and checking patients' overall health. They will also track how the treatments affect patients' quality of life using questionnaires.

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 treatment assignment

    You will be randomly assigned to one of two treatment groups: either lutetium (177Lu) edotreotide therapy or best standard of care treatment.

    The assignment is done through a computerized system to ensure fairness in group distribution.

  2. Step 2

    Medical imaging

    You will undergo CT scan or MRI imaging to measure your tumor(s).

    These scans will be used to track changes in your condition throughout the study.

  3. Step 3

    Treatment administration

    If assigned to the lutetium group: You will receive lutetium (177Lu) edotreotide through intravenous infusion.

    If assigned to standard care group: You may receive one or more of the following medications:

    - Oxaliplatin (intravenous)

    - Everolimus (oral tablets)

    - Folinic acid or calcium folinate (intravenous)

    - Fluorouracil (intravenous)

    - Temozolomide (oral tablets)

    - Capecitabine (oral tablets)

  4. Step 4

    Regular assessments

    Your condition will be monitored through regular medical examinations.

    You will complete two quality of life questionnaires: EORTC QLQ-C30 and GI.NET21.

    Laboratory tests and vital signs will be checked regularly.

    Imaging scans will be performed to assess tumor response.

  5. Step 5

    Study duration

    The study runs from December 2021 to June 2030.

    Your participation duration will depend on your response to treatment and overall health status.

Who can join the trial?

7 criteria

  • Must be 18 years of age or older
  • Must have confirmed GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) that cannot be surgically removed. These are tumors that occur in the digestive system or pancreas
  • Must have tumors that can be measured using special imaging tests (CT scan or MRI)
  • Must have tumors that are somatostatin receptor-positive (SSTR+), which means the tumors have specific proteins on their surface that can be targeted by treatment
  • Both men and women can participate in the study
  • Must have tumors that are classified as either:
    • Grade 2 with Ki67 between 15 and 20%, or
    • Grade 3 with Ki67 above 20% up to 55%

Who cannot join the trial?

13 criteria

  • Prior treatment with Peptide Receptor Radionuclide Therapy (PRRT) - a type of targeted radiation therapy
  • Presence of tumors that do not show positive results for somatostatin receptors (special proteins on tumor cells)
  • Ki-67 index (a measure of tumor growth) less than 15% or greater than 55%
  • Tumors originating from areas other than the digestive system or pancreas
  • Severe kidney or liver problems that could interfere with treatment
  • Pregnancy or breastfeeding
  • Serious heart conditions or uncontrolled high blood pressure
  • Active infections requiring treatment
  • Other types of cancer that require immediate treatment
  • Unable to undergo required imaging procedures
  • Participation in other clinical trials within the past 30 days
  • Mental conditions that prevent understanding of trial requirements
  • Life expectancy less than 6 months
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Investigated drugs

  • Lutetium (177Lu) edotreotide

    This is a peptide receptor radionuclide therapy (PRRT) medication used to treat certain types of neuroendocrine tumors. It works by delivering targeted radiation therapy to cancer cells that have specific receptors called somatostatin receptors. The medication consists of a radioactive substance (lutetium) attached to a molecule that binds to these specific receptors on tumor cells.

  • Best Standard of Care

    This refers to the currently accepted and widely used treatments that doctors would typically prescribe for patients with neuroendocrine tumors. The specific treatment is chosen by the doctor from an approved list of treatment options based on what they believe would work best for each individual patient.

What is already known about the treatment

Lutetium (177Lu) edotreotide - A radiopharmaceutical medication administered intravenously as peptide receptor radionuclide therapy (PRRT) for treating aggressive neuroendocrine tumors of gastroenteropancreatic origin. This targeted therapy works by binding to somatostatin receptors on tumor cells, delivering radiation directly to cancer cells while minimizing damage to surrounding healthy tissue. The medication belongs to the class of radiotherapeutic agents and is currently being evaluated in clinical trials for patients with well-differentiated Grade 2 and Grade 3 somatostatin receptor-positive tumors, showing promise as a potential treatment option compared to standard care approaches.

Investigated diseases

Neuroendocrine Tumors of GastroEnteric or Pancreatic Origin (GEP-NET) - A rare type of cancer that develops in specialized cells called neuroendocrine cells, which are found throughout the digestive system and pancreas. These tumors can form in the stomach, intestines, pancreas, or other parts of the digestive system. GEP-NETs can be categorized into different grades based on how quickly the cells divide, with Grade 2 and Grade 3 representing more aggressive forms of the disease. These tumors often produce excess hormones that can affect various body functions. The disease typically progresses gradually, though the rate varies depending on the tumor grade.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510812-64-00Protocol codeDP-1111-02CTEstimated enrolment250 patientsSponsorITM Solucin GmbH

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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).