Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

The SAUNA trial is a multi-national, multi-centre, open-label, randomised, controlled, pragmatic clinical trial in patients with advanced, non-functional gastroenteropancreatic (GEP) neuroendocrine tumours (NET) with progressive disease on first-line therapy with somatostatine analogues (SSA). Eligible patients will be divided into two substudies according to the second-line therapy of choice (peptide receptor radionuclide therapy (PRRT) or targeted therapy, at the discretion of the local investigator). Patients within each substudy will be randomised 1:1 between continuation or withdrawal from SSA at the start of second-line systemic therapy. Stratification will occur according to study site and according to the Ki67 value (below 10% (grade 1 and low grade 2) and equal to or above 10% (high grade 2)).

Inclusion Criteria:Age ≥18 yearsWritten informed consent prior to any study-related proceduresEastern 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 NETDocumented radiological disease progression on first-line SSA treatmentFor targeted therapy substudy: indication to start with either sunitinib or everolimus as second-line therapy, according to local investigatorFor PRRT substudy: indication to start with PRRT with Lutetium (177Lu) oxodotreotide as second-line therapy, according to local investigatorExclusion Criteria:Indication for chemotherapy treatment of GEP NET in second-linePresence of poorly differentiated grade 3 neuroendocrine carcinoma (NEC), well-differentiated grade 3 NET or rapidly progressive NETPrior treatment with everolimus, sunitinib or PRRTContra-indication, proven allergy or other indication than functional NET for the use of a SSAPatient showing progressive disease while being on a lower than the registered doseFunctional NET, defined as the presence of clinical and biochemical evidence of a hormonal NET-related syndromePatient undergoing palliative, systemic oncological treatment for other malignancy than GEP NETConcurrent anti-cancer treatment in another investigational trialAny abnormal findings at baseline, 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 studyPregnant or lactating patient at screening or if the patient wishes to get pregnant during treatment phase of the trial