Safety of Lanreotide 120 mg ATG (LAN) in Combination with Metformin (MET) in Patients (pts) with Progressive Advanced Well-Differentiated (WD) Gastro-Intestinal (GI) or Lung Carcinoids. A Pilot, One-Arm, Open-Label, Prospective Study: The MetNET-2 Trial

#1725

Introduction: Anti proliferative effect of LAN ATG 120 mg has been investigated in 204 GI-NET pts in Clarinet study with a 53% reduction in risk of death/progression vs placebo. An increasing number of trials have associated MET with better outcome in cancer pts due to a reduction of insulin/IGF1 levels and modulation of AMPK and TSC1-2/mTOR. The retrospective PRIME-net study conducted on 445 Italian pts, suggest that addition of MET to everolimus and/or SSA provides clinical benefit in diabetic pancreatic NETs.

Aim(s): MetNET-2 prospective study evaluates the safety of the combination LAN ATG 120 mg and MET in advanced, progressive GI/ lung NET

Materials and methods: 20 G1-G2, WDNET pts, will receive LAN ATG 120mg/28 days and MET 2550mg/day, until progression or inacceptable toxicity. Primary objective is incidence of adverse events (AEs) and severe AEs (SAEs). 1-stage Hern design will be used. The H0 hypothesis (treatment related SAE = 25%) will be tested against a one-sided alternative. H0 hypothesis will be rejected if ≤ 2 pts will experience SAE with a type I error rate of 10% and power of 85%. Expression of 111 genes potentially involved in MET pathway will be assessed by Target NGS approach.

Conference: 14th Annual ENETSConcerence (2017)

Presenting Author: pusceddu s

Authors: Prinzi N, Femia D, Concas L, Lo Russo G, Vernieri C,

Keywords: lanreotide, metformin,