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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Neuroendocrine Tumors

Intervention / Treatment
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* Drug: Lanreotide autogel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lanreotide<br>Patients treated with lanreotide | Drug: Lanreotide autogel<br>* Lanreotide autogel 90-120 mcg, every 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuroendocrine tumor, Somatostatin analogue