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

  • STATUS
    Recruiting
  • End date
    Jan 30, 2025
  • participants needed
    95
  • sponsor
    Asan Medical Center
Updated on 4 October 2022

Summary

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.

Details
Condition Neuroendocrine Tumors
Treatment Lanreotide Autogel
Clinical Study IdentifierNCT04696042
SponsorAsan Medical Center
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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