Continuing Somatostatin Analogues Upon progression in Neuroendocrine tumor pAtients (SAUNA trial) – Study protocol for a bi-national, multi-center, open-label, randomised, pragmatic clinical trial

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Introduction: Advanced gastroenteropancreatic neuroendocrine tumors (GEP NET) are treated with targeted therapy or peptide receptor radionuclide therapy (PRRT) (177Lu-DOTATATE) upon progression under somatostatin analogues (SSA). SSA are continued life-long in functional NET, but the benefit of SSA continuation in non-functional NET is unclear. Due to ongoing activity of the somatostatin receptor pathway in GEP NET progressing on SSA, we hypothesize an added efficacy of SSA during second-line therapy.

Aim(s): To study the efficacy of SSA continuation during second-line therapy in advanced GEP NET.

Materials and methods: The SAUNA trial (clinicaltrials.gov.: NCT05701241) is a bi-national, multi-center (19 sites), open-label, randomized, pragmatic clinical trial. 270 patients with advanced, non-functional grade 1-2 GEP NET progressing on SSA will be divided into study arm 1 (PRRT; n=142) or study arm 2 [targeted therapy (everolimus/sunitinib); n=128] per investigator’s choice of second-line therapy, and randomized (1:1) per study arm between SSA continuation or withdrawal.

Conference:

Presenting Author: Chhajlani S

Authors: Chhajlani S, Kuiper J, Borbath I, Dercksen W, Deroose C,

Keywords: somatostatin analogues, SSA, everolimus, sunitinib, peptide receptor radionuclide therapy, PRRT, quality of life, QoL, gastroenteropancreatic neuroendocrine tumor, GEP NET,