Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs

Study Overview
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Brief Summary
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This study will be conducted to support the registration of the lanreotide Autogel 120 mg formulation in China for the treatment of GEP-NETs and treatment of clinical symptoms of NETs. The study will include a screening period of up to 4 weeks followed by a 48-week intervention period. After completion of the main study period, approximately five participants will continue in a self/partner injection cohort with lanreotide Autogel 120 mg every 28 days for 24 weeks.

Official Title
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A Phase 3, Single-arm, Open-label, Multicentre Study to Assess the Efficacy and Safety of Deep Subcutaneous Injections of Lanreotide Autogel® 120 mg Administered Every 28 Days in Chinese Participants With Unresectable, Locally Advanced or Metastatic Grade 1 or 2 Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs)

Conditions
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Gastroenteropancreatic Neuroendocrine Tumor

Intervention / Treatment
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* Drug: Lanreotide autogel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capable of giving signed informed consent Male or female of 18 years of age or older when informed consent is obtained Has a histologically proven Grade 1 or 2 GEP-NET according to WHO (World Health Organisation) classification Has an unresectable metastatic or locally advanced NET. Has an Eastern Cooperative Oncology Group (ECOG) performance status lower or equal to 2. Exclusion Criteria: Participants with poorly differentiated Gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC), high-grade GEP-NEC and goblet cell carcinoid. Has been treated with octreotide acetate long-acting release or lanreotide acetate Autogel formulation within 8 weeks prior to screening tests or lanreotide PR 40 mg within 4 weeks prior to screening tests. Has been treated with subcutaneous or intravenous octreotide acetate within 1 week prior to screening tests. Has been treated with mammalian target of rapamycin (mTOR) inhibitors or multi-target tyrosine kinase (MTK) inhibitors within 4 weeks prior to screening tests.

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: lanreotide Autogel 120 mg<br>Subjects will be treated with lanreotide Autogel® 120mg, every 28 days (+/- 3 days). | Drug: Lanreotide autogel<br>* Administered as deep subcutaneous (SC) injections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Benefit Rate (CBR) of tumour response assessed using RECIST (Version 1.1) and confirmed by Blinded independent central review (BICR) | CBR is defined as the proportion of participants with a best overall response of confirmed Complete Response (CR), confirmed Partial Response (PR), or continued Stable Disease (SD) until the time of assessment. | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) within 24 and 48 weeks after first administration of study intervention | PFS is defined as the time from the first administration of study intervention to the date of the first documented Progressive Disease (PD) measured using RECIST (Version 1.1) and confirmed by BICR, or death from any cause, whichever comes first. | Week 24 and 48 | 
| Overall Survival (OS) at the end of the main study | OS is defined as the time from the first administration of study intervention to the date of death from any cause. | Up to 48 weeks (end of main study) | 
| Time to Progression (TTP) within 48 weeks after first administration of study intervention | TTP is defined as the time from the first administration of study intervention to the date of the first documented PD, or clinical progression confirmed by the investigator. | Up to 48 weeks (end of study) | 
| Proportion of participants alive and without tumour progressive at W24 and W48 |  | Week 24 and 48 | 
| CBR | CBR is defined as the proportion of participants with a best overall response of confirmed CR, confirmed PR, or continued SD until the time of assessment. | Week 48 | 
| Overall Response Rate (ORR) | ORR is the proportion of participants with a best overall response of confirmed CR or confirmed PR. | Week 24 and 48 | 
| Disease Control Rate (DCR) | DCR is the proportion of participants with a best overall response of confirmed CR, confirmed PR or SD. | Week 24 and 48 | 
| Change from baseline in NET-related clinical symptoms |  | Week 24 and 48 | 
| Change from baseline in plasma Chromogranin A (CgA) |  | Week 12, 24, 36 and 48 | 
| Change from baseline in 5-hydroxyindoleacetic acid (5-HIAA) |  | Week 12, 24, 36 and 48 | 
| Change from baseline in Quality of Life (QoL) assessment |  | Day 1, week 12, 24, 36 and 48. | 
| Incidence of Adverse Events (AEs) | AEs assessed through laboratory tests, physical examination, vital signs, and medical tests. | Up to 48 weeks. |