Asian Investigation of Lanreotide Autogel® in the Management of GEP-NETs (AIM-NETs)

Asan Medical Center

Status: Completed

Conditions: Neuroendocrine Tumors

Treatments: Drug: Lanreotide autogel

Study type: Observational

Funder types: Other

Identifiers

NCT04696042

AIM-NETs

Details and patient eligibility

About

Lanreotide Autogel® has been established as a standard of care for patients with locally advanced or metastatic GEP-NETs based on the success of CLARINET trial. However, only few patients with Asian ethnicity were included in the trial.

According to the nationwide comprehensive study of patients with GEP-NET in Korea, hindgut primary NETs(Rectal) occured more frequently than western countries. However, small intestine or lung primary NET is relatively rare compared with western countries.1) Considering the clinical characteristics of GEP-NETs are distinct between the patients in Asian and Western countries, further evaluation on the efficacy and safety of Lanreotide Autogel® in Asian patients with GEP-NETs is needed.

Enrollment: 71 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• Male or female subject aged ≥18 years and legally capable to provide informed consent
• Functioning or non-functioning gastroenteropancreatic (GEP)-neuroendocrine tumor (NET) or unknown primary-NET
• Well differentiated tumor
• Grade (G) 1, G2 according to the 2017 World Health Organization (WHO) criteria
• Subject already treated with Lanreotide Autogel® for the period up to 5 months, according to local standard of care, prior to documentation into this study
• Use of Lanreotide autogel® monotherapy by local label (SmPC).
• Concomitant locoregional therapy such as surgery, RFA or TAE is allowed.

Exclusion criteria

• Parallel participation in an interventional study
• Lanreotide treatment for more than 5 months prior inclusion into the study
• Prior anti-proliferative medication with somatostatin analogue (e.g. Octreotide LAR).
• Concomitant anti-proliferative systemic medication/therapies for GEP-NET are not allowed.

Trial design

71 participants in 1 patient group

Lanreotide

Description:

Patients treated with lanreotide

Treatment:

Drug: Lanreotide autogel