The LOLA trial: Phase II trial with combination of cabozantinib plus lanreotide in gastroenteropancreatic (GEP) and thoracic neuroendocrine tumours (NETs) – Interim results of step 1

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Introduction: LOLA is an Italian, multicentre, open-label, double cohort, non-randomised, 3-stage, phase 2 trial aiming to assess the safety and activity of the combination of cabozantinib (CABO) + lanreotide (LAN) in patients (pts) with advanced or metastatic GEP and unknown primary NETs with Ki-67 > 10% or thoracic NET. In NETs sunitinib is the only TKI approved in advanced pancreatic NETs. While CABO has been reported superior to sunitinib in renal cancer its role in NETs is still investigational.

Aim(s): In step 1, safety and tolerability are the primary endpoints. In step 2 and 3, safety, tolerability and overall response rate are the primary endpoints. Secondary endpoints are progression free-survival and overall survival.

Materials and methods: For each type of NET, the optimal Simon two-stage design will be used. Two cohorts were identified: pancreatic and other NETs. In step 1, if G3-G5 adverse events (AEs) or clinically manageable and reversible G3 AEs within 7 days from their onset were observed in more than 1 patient, then CABO starting dose of 60mg was reduced to 40mg. Treatment was halted if also 40mg was too toxic.

Conference:

Presenting Author: Oldani S

Authors: Oldani S, Morano F, Brizzi M, Giuffrida D, Panzuto F,

Keywords: gastroenteropancreatic neuroendocrine tumour, cabozantinib, lanreotide, clinical trial,