Efficacy and Safety of Lanreotide Autogel (ATG) in Combination With Temozolomide in Subjects With Thoracic Neuroendocrine Tumors.

What Was Tested

The trial (phase 2) is built around Lanreotide.

It had 1 arm (groups): Lanreotide (Autogel formulation) and Temozolomide (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 40 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Imaging documented progression within 12 months before screening visit (V1), according to RECIST criteria v 1.1;. Measurable disease, as defined by RECIST criteria v 1.1, on a CT scan performed at screening visit (V1);. Octreoscan or Ga68-DOTA-TATE/TOC/NOC-PET-TC within 12 months before screening visit (V1);. Adequate liver, renal and bone marrow function.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: poorly differentiated neuroendocrine carcinoma and mixed neuroendocrine tumours (net), according to who 2004 criteria; neuroendocrine tumours other than lung or thymus; non-neuroendocrine thymic neoplasm.

How the Study Was Run

It was run as a single-group and open-label study.

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

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

It started in 2016-07 with completion listed for 2019-02-08.

It ran at 10 sites in Italy (10).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Disease Control Rate (DCR) Assessed Locally at Month 9 (time frame: Up to Month 9; for sensitivity analysis-2, up to 10.5 months).

It also tracked 15 secondary outcomes, for example DCR Assessed Centrally at Month 9, Median Progression Free Survival (PFS) Assessed Locally and Centrally, Median Time to Response (TTR) Assessed Locally and Centrally, Median Duration of Response (DOR) Assessed Locally and Centrally, Median Time to Progression (TTP) Assessed Locally and Centrally and Best Overall Response (BOR) Assessed Locally and Centrally.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Lanreotide in 40 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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