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Study of Lutetium-177-DOTA-TATE with octreotide LAR in newly diagnosed patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NET) with high disease burden

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 focuses on patients with Gastroenteropancreatic neuroendocrine tumors (GEP-NET), which are rare tumors that develop in the digestive system or pancreas. The study will test two treatments: Lutathera (a radioactive medicine) combined with Sandostatin LAR (a hormone-based treatment) compared to using Sandostatin LAR alone. The main purpose is to determine if the combination treatment is more effective at delaying the progression of the disease or extending survival compared to the standard treatment.

The treatment involves receiving either Lutathera infusions together with Sandostatin LAR injections, or only Sandostatin LAR injections. Lutathera contains a radioactive substance that specifically targets tumor cells. During Lutathera treatment, patients will also receive an amino acid solution called LysaKare to protect the kidneys. To manage potential side effects, patients may receive anti-nausea medications.

The study will monitor how the disease responds to treatment through regular medical examinations and imaging tests. Doctors will track any changes in tumor size and assess how patients feel during the treatment. The study will continue for several years to determine the long-term effects of both treatments.

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

    Your treatment will involve either Lutathera plus Sandostatin LAR or Sandostatin LAR alone

  2. Step 2

    Pre-medication

    Before receiving Lutathera, you will receive an infusion of LysaKare (amino acid solution) to protect your kidneys

    You may also receive anti-nausea medication (Metoclopramide) if needed

  3. Step 3

    Treatment Administration

    If you are in the Lutathera group, you will receive the medication through an IV infusion

    All patients will receive Sandostatin LAR as an injection into the muscle

    The dose of Sandostatin LAR may be 10 mg, 20 mg, or 30 mg depending on your specific needs

  4. Step 4

    Monitoring and Testing

    Regular blood tests will check your blood cell counts, kidney function, and liver function

    Your vital signs will be monitored throughout treatment

    You will have regular imaging scans to check how your disease is responding to treatment

    You will complete quality of life questionnaires about your symptoms and overall well-being

  5. Step 5

    Follow-up Period

    After completing treatment, you will have regular follow-up visits to monitor your health

    The study will continue until 2035

    Your doctor will continue to check for any side effects and assess how well the treatment is working

Who can join the trial?

17 criteria

  • You must have a confirmed diagnosis of gastroenteropancreatic neuroendocrine tumor (GEP-NET) that is advanced or has spread, and cannot be removed by surgery. This diagnosis must be made within 6 months before screening.
  • You must have a high disease burden, which may include:
    • Primary tumor or spread larger than 4 cm
    • More than one tumor measuring over 2 cm
    • High levels of alkaline phosphatase (a blood test marker)
    • Cancer spread to bones
    • Cancer spread to the abdomen lining
    • Symptoms like pain, tiredness, weight loss, or poor appetite
    • You must be at least 12 years old (18 years or older for some countries)
    • Your tumors must show up on special scans that detect somatostatin receptors (specific proteins on tumor cells)
    • Your blood tests must show:
      • Adequate white blood cell count
      • Adequate platelet count
      • Adequate hemoglobin levels
      • Good kidney function
      • Acceptable liver function
      • Normal potassium levels
      • You must have good physical function, with an ECOG performance status of 0 or 1 (able to perform daily activities with minimal assistance)
      • You must have at least one tumor that can be measured

Who cannot join the trial?

14 criteria

  • History of other cancers within the past 5 years (except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix)
  • Patients who have received previous treatment with peptide receptor radionuclide therapy (PRRT) - a type of targeted radiation therapy
  • Severe heart problems or uncontrolled heart disease
  • Severe kidney problems (creatinine clearance less than 50 mL/min)
  • Severe liver problems or abnormal liver function
  • Pregnant or breastfeeding women
  • Known allergies to study medications or their components
  • Participation in another clinical trial within 30 days before starting this study
  • Mental conditions that could interfere with following study procedures
  • Bone marrow problems or severely low blood cell counts
  • Active or uncontrolled infections
  • Major surgery within 4 weeks before starting the study
  • Life expectancy less than 12 months
  • Unable to follow study procedures or attend scheduled visits
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Investigated drugs

  • Lutetium Lu-177 dotatate

    This is a radioactive medication used to treat certain types of neuroendocrine tumors. It works by delivering targeted radiation to cancer cells that have specific receptors on their surface. The medication attaches to these receptors and delivers radiation directly to the tumor cells, helping to destroy them while minimizing damage to healthy tissue.

  • Octreotide LAR

    This is a long-acting medication that helps control symptoms caused by neuroendocrine tumors. It works by reducing the production of certain hormones that can cause symptoms like diarrhea and flushing. It also helps slow down tumor growth by blocking signals that cancer cells use to multiply.

What is already known about the treatment

  • Lutetium (177Lu) oxodotreotide

    A radioactive medication administered via intravenous infusion, primarily used in the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This radiopharmaceutical works by combining a radioactive isotope (Lutetium-177) with a molecule that specifically targets neuroendocrine tumor cells, delivering targeted radiation therapy to cancer cells while minimizing damage to healthy tissue. Currently used in clinical practice and actively studied in phase III trials as a first-line treatment option, particularly for patients with grade 1 and 2 GEP-NETs, and is classified as a radiopharmaceutical therapeutic agent.

  • Octreotide LAR

    A long-acting synthetic hormone medication administered through intramuscular injection, used in the management of neuroendocrine tumors and related hormonal conditions. The medication works by mimicking natural somatostatin, helping to reduce the production of various hormones and control tumor growth in patients with GEP-NETs. It belongs to the class of somatostatin analogs and is frequently used in combination with other treatments for enhanced therapeutic effect in neuroendocrine tumor management.

Investigated diseases

Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) – A rare type of cancer that develops in the neuroendocrine cells of the digestive system and pancreas. These tumors can form in any part of the gastrointestinal tract or pancreas, where they grow from specialized cells that produce hormones. GEP-NETs typically grow slowly over several years, though their growth pattern can vary. The tumors can produce various hormones and other substances that may cause specific symptoms depending on the tumor's location and type. These tumors can develop in different parts of the digestive system, including the stomach, small intestine, large intestine, rectum, and pancreas.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518325-15-00Protocol codeCAAA601A62301Estimated enrolment241 patientsSponsorNovartis Pharma AG

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