Assessing the safety and activity of cabozantinib combined with lanreotide in gastroenteropancreatic and thoracic neuroendocrine tumors: rationale and protocol of the phase II LOLA trial

What Was Tested

This clinical study looks at Somatostatin and Lanreotide.

LOLA is the first prospective phase II trial aiming to assess the safety and activity of cabozantinib combined with lanreotide in WD NETs of gastroenteropancreatic (GEP), thoracic and of unknown origin.

Why It Was Studied

Well-differentiated (WD) neuroendocrine tumors (NETs) are a group of rare neoplasms with limited therapeutic options.

Cabozantinib is an inhibitor of multiple tyrosine kinases with a pivotal role in NET pathogenesis, including c-MET and Vascular Endothelial Growth Factor Receptor 2 (VEGFR2).

Who Took Part

Exploratory objectives include the assessment of c-MET, AXL and VEGFR2 IHC expression, to identify predictive or prognostic tissue biomarkers.

Enrolment started in July 2020, with an expected trial duration of 42 months comprehensive of accrual, treatment and follow-up.

How the Study Was Run

The design is described as open-label and multicenter.

Nothing was hidden in this open-label Somatostatin study: the participants and staff both knew the treatment.

Running at several centres spread the Somatostatin study over different clinics and patient groups.

This is a multicenter, open-label, double-cohort, non comparative, non-randomized, three-stage phase II trial.

Two cohorts will be considered: pNETs and carcinoids (typical or atypical lung and thymus NETs, gastro-intestinal NETs or NETs of unknown origin).

In stage II and III, co-primary endpoints are safety and overall response rate (ORR) according to RECIST version 1.1.

Secondary endpoints are progression-free survival and overall survival.

What Was Measured

PubMed files the paper under topics including Neuroendocrine Tumors, Vascular Endothelial Growth Factor A, Thoracic Neoplasms, Clinical Trials, Phase II as Topic, Peptides, Cyclic, Somatostatin and Anilides.

Author keywords: Cabozantinib, Lanreotide, Somatostatin analogs and Tyrosine kinase inhibitors.

What This Means in Plain Language

The paper is an open-label and multicenter study of Somatostatin and Lanreotide.

Its findings take up roughly 1 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2023 (BMC cancer), a journal based in England.

More context: the Somatostatin compound page and the Lanreotide compound page, all human trials.