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Study comparing 177Lu-edotreotide versus everolimus in patients with inoperable progressive neuroendocrine tumors of gastroenteric or pancreatic origin

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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 neuroendocrine tumors that originate in the digestive system or pancreas (GEP-NET). These are rare tumors that develop from hormone-producing cells in these organs. The study compares two different treatments: a radioactive medication called 177Lu-Edotreotide given through intravenous infusion, and everolimus (also known as Afinitor) taken as tablets by mouth.

The purpose of the study is to determine if treatment with 177Lu-Edotreotide is more effective at slowing down tumor growth compared to everolimus in patients whose tumors cannot be removed by surgery and continue to grow. During the study, patients will receive either 177Lu-Edotreotide through an intravenous infusion along with a protective amino acid solution, or they will take everolimus tablets daily.

The treatment with 177Lu-Edotreotide, known as Peptide Receptor Radionuclide Therapy (PRRT), involves giving a radioactive substance that specifically targets tumor cells. Patients receiving this treatment will also get an Arginine-Lysine solution through an intravenous line to protect their kidneys. Those in the everolimus group will take tablets that work by blocking signals that cancer cells use to grow.

The research process

The trial runs in 6 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

    The assignment determines whether you will receive 177Lu-Edotreotide through intravenous infusion or Everolimus tablets

  2. Step 2

    Treatment pathway A - 177Lu-Edotreotide

    If assigned to this group, you will receive 177Lu-Edotreotide through an intravenous infusion

    Before each 177Lu-Edotreotide treatment, you will receive an Arginine-Lysine solution through intravenous infusion for kidney protection

  3. Step 3

    Treatment pathway B - Everolimus

    If assigned to this group, you will take Everolimus tablets orally

    The tablets come in two possible strengths: 5 mg or 10 mg

    You will need to take the tablets as prescribed by your doctor

  4. Step 4

    Regular monitoring

    Your condition will be regularly assessed through medical imaging to track disease progression

    Regular health checks will include vital signs, heart monitoring (ECG), and laboratory tests

    You will complete quality of life questionnaires about your health status

  5. Step 5

    Safety monitoring

    Your kidney function will be regularly monitored

    Any side effects or unusual symptoms will be recorded

    Regular assessments of your overall health status will be conducted

  6. Step 6

    Study duration

    The study continues until March 2029

    Your participation duration will depend on how your condition responds to treatment

    Treatment will continue until disease progression or if you need to stop for other medical reasons

Who can join the trial?

6 criteria

  • You must provide written informed consent to participate in the study
  • You must be 18 years or older, both men and women can participate
  • You must have a confirmed diagnosis of well-differentiated neuroendocrine tumor (a type of slow-growing tumor) that originates from either: - the digestive tract (gastroenteric) or - the pancreas
  • Your disease must be measurable through imaging scans according to specific measurement criteria (RECIST 1.1)
  • Your tumor must be somatostatin receptor positive (meaning it has specific proteins on its surface that can be targeted by treatment)
  • You must have progressive disease, which means your condition has worsened over time, as shown by two imaging scans (either CT or MRI) using the same method

Who cannot join the trial?

14 criteria

  • History of any other cancer within the last 3 years (except adequately treated non-melanoma skin cancer or carcinoma in situ)
  • Previous treatment with PRRT (Peptide Receptor Radionuclide Therapy) or everolimus
  • Severe heart problems, including heart failure or uncontrolled heart rhythm disorders
  • Severe kidney problems (creatinine clearance less than 50 mL/min)
  • Severe liver problems, including cirrhosis or liver failure
  • Pregnant or breastfeeding women
  • Uncontrolled diabetes (blood sugar levels that are not well managed)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Major surgery within 4 weeks before starting the study
  • Any serious medical condition that could interfere with study participation
  • Known allergies to study medications or their components
  • Participation in another clinical trial within 30 days before this study
  • Unable to follow study procedures or attend scheduled visits
  • Life expectancy less than 6 months
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Investigated drugs

  • 177Lu-Edotreotide

    This is a radioactive medication used in Peptide Receptor Radionuclide Therapy (PRRT). It targets specific receptors found on neuroendocrine tumors to deliver radiation directly to cancer cells. This treatment is designed for patients with gastrointestinal or pancreatic neuroendocrine tumors that cannot be surgically removed.

  • Everolimus

    This is a targeted therapy medication that works by blocking certain proteins that help cancer cells grow and divide. It is taken as a tablet and is used to treat various types of cancer, including neuroendocrine tumors of the digestive system and pancreas. It belongs to a class of drugs known as mTOR inhibitors.

What is already known about the treatment

  • 177Lu-edotreotide

    A radiopharmaceutical medication administered intravenously as part of Peptide Receptor Radionuclide Therapy (PRRT) for treating neuroendocrine tumors of gastroenteric or pancreatic origin. This targeted therapy works by binding to somatostatin receptors on tumor cells while delivering radioactive lutetium-177, which helps destroy cancer cells through radiation. The medication is currently being evaluated in phase III clinical trials as a potential alternative to existing molecular therapies for patients with inoperable, progressive neuroendocrine tumors.

  • Everolimus

    An oral medication belonging to the class of drugs called mTOR inhibitors, used in the treatment of various cancers including neuroendocrine tumors of gastroenteric or pancreatic origin. It works by blocking a specific protein (mTOR) that promotes cancer cell growth and division, thereby helping to slow or stop tumor growth. The medication is an established targeted molecular therapy and serves as the control treatment in clinical trials comparing new therapeutic approaches.

Investigated diseases

Neuroendocrine tumors (GEP-NETs) - A group of rare tumors that develop in the cells of the digestive system (gastrointestinal tract) or pancreas. These tumors begin in specialized cells called neuroendocrine cells, which have traits similar to nerve cells and hormone-producing cells. GEP-NETs typically grow slowly over several years and can produce various hormones. The tumors can develop in different parts of the digestive system or pancreas, affecting the normal function of these organs. These tumors can vary in their behavior and characteristics depending on their location and the type of cells involved.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510444-21-00Protocol codeITM-LET-01Estimated enrolment324 patientsSponsorITM Solucin GmbH

sourced from the EU Clinical Trials Register and site verification

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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).