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

NCT04696042 | Completed

• 1 other identifier: AIM-NETs
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuroendocrine Tumors

Keywords

Neuroendocrine tumor; Somatostatin analogue

Outcome Measures

Primary Outcomes (1)

• Progression-free survival rate at 2 years

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

  2 years

Secondary Outcomes (5)

• Progression-free survival

  2 years

• Response rates

  2 years

• Disease control rates

  2 years

• Overall survival

  2 years

• Chromogranin A response

  2 years

Study Arms (1)

Lanreotide

Patients treated with lanreotide

Drug: Lanreotide autogel

Interventions

Lanreotide autogel DRUG

Lanreotide autogel 90-120 mcg, every 4 weeks

Lanreotide

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

G1-2 GEP-NET patients who would be treated with lanreotide will be included in this study.

You may qualify if:

• 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.

You may not qualify if:

• Parallel participation in an interventional study
• Prior anti-proliferative medication with somatostatin analogue (e.g. Octreotide LAR).
• Concomitant anti-proliferative systemic medication/therapies for GEP-NET are not allowed.

Sponsors & Collaborators

• Asan Medical Center: lead
• Samsung Medical Center: collaborator
• Seoul St. Mary's Hospital: collaborator
• Severance Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator

Study Sites (1)

Changhoon Yoo

Seoul, Seoul, 138-736, South Korea

Location

Related Publications (5)

• Gastrointestinal Pathology Study Group of Korean Society of Pathologists; Cho MY, Kim JM, Sohn JH, Kim MJ, Kim KM, Kim WH, Kim H, Kook MC, Park DY, Lee JH, Chang H, Jung ES, Kim HK, Jin SY, Choi JH, Gu MJ, Kim S, Kang MS, Cho CH, Park MI, Kang YK, Kim YW, Yoon SO, Bae HI, Joo M, Moon WS, Kang DY, Chang SJ. Current Trends of the Incidence and Pathological Diagnosis of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) in Korea 2000-2009: Multicenter Study. Cancer Res Treat. 2012 Sep;44(3):157-65. doi: 10.4143/crt.2012.44.3.157. Epub 2012 Sep 30.

  PMID: 23091441 BACKGROUND

• Kim SJ, Kim JW, Oh DY, Han SW, Lee SH, Kim DW, Im SA, Kim TY, Heo DS, Bang YJ. Clinical course of neuroendocrine tumors with different origins (the pancreas, gastrointestinal tract, and lung). Am J Clin Oncol. 2012 Dec;35(6):549-56. doi: 10.1097/COC.0b013e31821dee0f.

  PMID: 21659833 BACKGROUND

• Pavel M, O'Toole D, Costa F, Capdevila J, Gross D, Kianmanesh R, Krenning E, Knigge U, Salazar R, Pape UF, Oberg K; Vienna Consensus Conference participants. ENETS Consensus Guidelines Update for the Management of Distant Metastatic Disease of Intestinal, Pancreatic, Bronchial Neuroendocrine Neoplasms (NEN) and NEN of Unknown Primary Site. Neuroendocrinology. 2016;103(2):172-85. doi: 10.1159/000443167. Epub 2016 Jan 5. No abstract available.

  PMID: 26731013 BACKGROUND

• Kang J, Yoo C, Hwang HS, Hong SM, Kim KP, Kim SY, Hong YS, Kim TW, Ryoo BY. Efficacy and safety of lanreotide in Korean patients with metastatic, well-differentiated gastroenteropancreatic-neuroendocrine tumors: a retrospective analysis. Invest New Drugs. 2019 Aug;37(4):763-770. doi: 10.1007/s10637-018-0710-x. Epub 2018 Dec 10.

  PMID: 30536151 BACKGROUND

• Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158.

  PMID: 25014687 BACKGROUND

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

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

Study Officials

• Changhoon Yoo

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: January 1, 2021
• Primary Completion: January 30, 2024
• Study Completion: January 27, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)