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

Recruiting

• Conditions: Neuroendocrine Tumors
• Interventions: Drug: Lanreotide autogel

• Registration Number: NCT04696042
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-06
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19
• Primary Completion: 2024-01-30
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 95

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.

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lanreotide	Lanreotide autogel	Patients treated with lanreotide

Primary Outcome Measures

Name	Time	Method
Progression-free survival rate at 2 years	2 years	Proportion of patients without tumor progression defined by RECIST version 1.1 at 2 years

Secondary Outcome Measures

Name	Time	Method
Disease control rates	2 years	Proportion of patients with tumor response and stable disease by RECIST version 1.1
Progression-free survival	2 years	Time between lanreotide treatment initiation and disease progression or death
Response rates	2 years	Proportion of patients with tumor response by RECIST version 1.1
Overall survival	2 years	Time between lanreotide treatment initiation and death due to any cause
Chromogranin A response	2 years	Change of serum chromogranin A levels during lanreotide treatment

Trial Locations

Locations (1)

Changhoon Yoo; 🇰🇷 Seoul, Korea, Republic of