A Trial Aiming to Assess the Safety and Activity of the Combination of Cabozantinib Plus Lanreotide in GEP and NET

What Was Tested

The trial (phase 2) is built around Lanreotide.

A Phase II trial aiming to assess the safety and activity of the combination of cabozantinib plus lanreotide in gastroenteropancreatic (GEP) and thoracic neuroendocrine tumor (NET): The LOLA trial.

It had 1 arm (groups): Cabozantinib+lanreotide (experimental).

The registry classes the interventions as drug.

More on the Plan

Phase II, multicenter, open-label, non-comparative, non-randomized study with three-stage design.

Who Took Part

The registry lists 69 planned participants were the target.

It was open to people of any sex aged from 18 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients with unresectable, advanced or metastatic neuroendocrine well differentiated thoracic NET (typical and atypical lung NET, thymus NET). Locally advanced or metastatic disease documented as progressive by RECIST v1.1. on CT-scan or MRI at baseline and within 12 months prior to baseline. Disease that is not amenable to surgery with curative intent;. Presence of at least one measurable target lesion for further evaluation according to RECIST v1.1;. Age ≥18 years;.

The full record lists 36 inclusion and 31 exclusion criteria; among the exclusions: patients with undifferentiated, poorly differentiated gep-net, thoracic or unknown primary net;; previous therapy for advanced disease \> 1 line; any medical adjuvant treatment must have been stopped at least six months before entry into the study;; prior treatment with cabozantinib;.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Lanreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2020-06-20 with completion listed for 2023-11.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Objective Response Rate (ORR) (time frame: 42 months). Primary Safety Endpoint (time frame: 42 months).

It also tracked 4 secondary outcomes, for example Progression-free survival (PFS), Safety Endpoint and Exploratory objectives analysis.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Lanreotide in 69 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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