Study on the Effectiveness and Safety of [177Lu]Lu-DOTA-TATE in Patients with Advanced Grade 1 and Grade 2 Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)

Inclusion Criteria

• Have a confirmed diagnosis of advanced gastroenteropancreatic neuroendocrine tumor (GEP-NET) that cannot be surgically removed and was diagnosed within the last 6 months.
• Have a high disease burden, which may include:
  • A primary tumor or metastatic lesion larger than 4 cm
  • More than one tumor or metastatic lesions larger than 2 cm
  • Elevated alkaline phosphatase levels
  • Presence of bone or peritoneal metastasis
  • Symptoms like pain, fatigue, weight loss, or hormone-related issues
• Be 12 years or older.
• Have specific uptake levels on imaging tests for all target lesions.
• Have adequate bone marrow and organ function based on specific lab tests.
• Have an ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Have at least one measurable site of disease.

Exclusion Criteria

• Have received any previous radiopharmaceutical treatment for GEP-NET.
• Have had previous treatments like interferons, mTOR-inhibitors, or chemotherapy for GEP-NET, except for somatostatin analogues.
• Have received more than 4 cycles of prior somatostatin analogues.
• Have shown disease progression during previous somatostatin analogue treatments.
• Have had previous treatments like radioembolization or chemoembolization for GEP-NET.
• Have had major surgery within 12 weeks before the study.
• Have known brain metastases.
• Have an allergy to CT scans with contrast or renal insufficiency, unless MRI can be used.
• Have a known allergy to somatostatin analogues or the study drugs.
• Have severe urinary issues that could interfere with radiation safety instructions.