Skip to main content
OpenTrials
Completed

NCT Number: NCT04696042

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neuroendocrine Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhoon Yoo

Seoul, 138-736, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lanreotide autogel

Drug

Lanreotide autogel 90-120 mcg, every 4 weeks

Primary outcomes

  1. Progression-free survival rate at 2 years

    Time frame: 2 years

    Proportion of patients without tumor progression defined by RECIST version 1.1 at 2 years

Secondary outcomes

  1. Progression-free survival

    Time frame: 2 years

    Time between lanreotide treatment initiation and disease progression or death

  2. Response rates

    Time frame: 2 years

    Proportion of patients with tumor response by RECIST version 1.1

  3. Disease control rates

    Time frame: 2 years

    Proportion of patients with tumor response and stable disease by RECIST version 1.1

  4. Overall survival

    Time frame: 2 years

    Time between lanreotide treatment initiation and death due to any cause

  5. Chromogranin A response

    Time frame: 2 years

    Change of serum chromogranin A levels during lanreotide treatment

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Samsung Medical Center
  • Seoul National University Bundang Hospital
  • Seoul St. Mary's Hospital
  • Severance Hospital

Registry information

Official study title

Prospective Observational Study to Assess the Effectiveness and Safety of Lanreotide Autogel® in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) in Asia Region

Acronym: AIM-NETs

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jan 6, 2021
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.