Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs

What Was Tested

In this phase 3 trial, researchers set out to test Lanreotide.

The study will include a screening period of up to 4 weeks followed by a 48-week intervention period.

It had 1 arm (groups): one (other).

The registry classes the interventions as drug.

Who Took Part

43 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: Capable of giving signed informed consent. Male or female of 18 years of age or older when informed consent is obtained. Has a histologically proven Grade 1 or 2 GEP-NET according to WHO (World Health Organisation) classification. Has an unresectable metastatic or locally advanced NET. Has an Eastern Cooperative Oncology Group (ECOG) performance status lower or equal to 2.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: participants with poorly differentiated gastroenteropancreatic neuroendocrine carcinoma (gep-nec), high-grade gep-nec and goblet cell carcinoid; has been treated with subcutaneous or intravenous octreotide acetate within 1 week prior to screening tests; has been treated with mammalian target of rapamycin (mtor) inhibitors or multi-target tyrosine kinase (mtk) inhibitors within 4 weeks prior to screening tests.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Lanreotide study did not mask who received what.

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

It started in 2021-05-24 with completion listed for 2022-06-10.

It ran at 14 sites in China (14).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 11 secondary outcomes, for example Progression Free Survival (PFS) by BICR Within Weeks 24 and 48, Overall Survival (OS) at the End of the Main Intervention Period, Time to Progression (TTP) During Main Intervention Period, Percentage of Participants Alive and Without Tumour Progressive at Weeks 24 and 48, Overall Response Rate (ORR) at Weeks 24 and 48 and Disease Control Rate (DCR) at Weeks 24 and 48.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Lanreotide in 43 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.