Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

Korábbi kezelés

• Indication for chemotherapy treatment of GEP NET in second-line
• Prior treatment with everolimus, sunitinib or PRRT
• Concurrent anti-cancer treatment in another investigational trial

Más betegség

• Contra-indication, proven allergy or other indication than functional NET for the use of a SSA
• Patient showing progressive disease while being on a lower than the registered dose
• Functional NET, defined as the presence of clinical and biochemical evidence of a hormonal NET-related syndrome
• Patient undergoing palliative, systemic oncological treatment for other malignancy than GEP NET

Laborértékek

• Any abnormal findings at screening, clinical finding, including psychiatric and behavioural problems, or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study

Egyéb

• Presence of poorly differentiated grade 3 neuroendocrine carcinoma (NEC), well-differentiated grade 3 NET or rapidly progressive NET
• Pregnant or lactating patient at screening or if the patient wishes to get pregnant during treatment phase of the trial

• Age ≥18 years
• Written informed consent prior to any study-related procedures
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2,
• Histologically-proven diagnosis of locally advanced or metastatic, non-functional, well-differentiated World Health Organisation 2019 grade 1-2 GEP NET
• Documented radiological disease progression on first-line SSA treatment at label dose or higher
• For targeted therapy substudy: indication to start with either sunitinib or everolimus as second-line therapy, according to local investigator
• For PRRT substudy: indication to start with PRRT with Lutetium (177Lu) oxodotreotide as second-line therapy, according to local investigator