Clinical Trials

Inclusion Criteria:

• Presence of metastasized or locally advanced, inoperable (curative intent) histologically proven, well differentiated Grade 2 or Grade 3 gastroenteropancreatic neuroendocrine (GEP-NET) tumor diagnosed within 6 months prior to screening.
• Ki67 index ≥10 and ≤ 55%
• Patients ≥ 15 years of age and a body weight of > 40 kg at screening
• Expression of somatostatin receptors on all target lesions documented by CT/MRI scans, assessed by the following somatostatin receptor imaging (SRI) modalities within 3 months prior to randomization: [68Ga]-DOTA-TOC (e.g. Somakit-TOC) PET/CT imaging or [68Ga]-DOTA-TATE PET/CT imaging (e.g. NETSPOT) or Somatostatin Receptor scintigraphy (SRS) with 111In-pentetreotide (Octreoscan SPECT/CT).
• The tumor uptake observed in the target lesions must be > normal liver uptake observed on planar imaging.
• Karnofsky Performance Score (KPS) ≥ 60.
• Presence of at least 1 measurable site of disease.
• Patients who have provided a signed informed consent form to participate in the study, obtained prior to the start of any protocol related activities.

Exclusion Criteria:

• Creatinine clearance < 40 mL/min calculated by the Cockroft Gault method.
• Hb concentration < 5.0 mmol/L (<8.0 g/dL); WBC < 2x10E9/L (2000/mm^3); platelets < 75x10E9/L (75x10E3/mm^3).
• Total bilirubin > 3 x ULN.
• Serum albumin < 3.0 g/dL unless prothrombin time is within the normal range.
• Pregnancy or lactation.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, are not allowed to participate in this study UNLESS they are using highly effective methods of contraception throughout the study and for 6 months after study drug discontinuation.
• Peptide receptor radionuclide therapy (PRRT) at any time prior to randomization in the study.
• Documented RECIST progression to previous treatments for the current GEP-NET at any time prior to randomization.
• Patients for whom in the opinion of the investigator other therapeutic options (eg chemo-, targeted therapy) are considered more appropriate than therapy offered in the study, based on patient and disease characteristics.
• Any previous therapy with Interferons, Everolimus (mTOR-inhibitors), chemotherapy or other systemic therapies administered for more than 1 month and within 12 weeks prior to randomization in the study.
• Any previous radioembolization, chemoembolization and radiofrequency ablation.
• Any surgery within 12 weeks prior to randomization in the study.
• Additional Criteria apply.