A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.

Official Title
-----------------
A Randomized, Multi-center, Open-label, Active-controlled Phase 3 Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) Versus Octreotide LAR or Lanreotide ATG in Patients With GEP-NET

Conditions
-----------------
Gastro-enteropancreatic Neuroendocrine Tumor

Intervention / Treatment
-----------------
* Drug: CAM2029
* Drug: Octreotide LAR
* Drug: Lanreotide ATG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patient ≥18 years old Histologically confirmed, advanced (unresectable and/or metastatic), and well-differentiated NET of GEP or presumed GEP origin At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1 determined by multiphasic CT or MRI (performed within 28 days before randomization) ECOG performance status of 0 to 2 Exclusion Criteria: Documented evidence of disease progression while on treatment (including SSAs) for locally advanced unresectable or metastatic disease Known central nervous system metastases Consecutive treatment with long-acting SSAs for more than 6 months before randomization Carcinoid symptoms that are refractory to treatment (according to the Investigator's judgement) with conventional doses of octreotide LAR or lanreotide ATG and/or to treatment with daily doses of ≤600 µg of octreotide IR Previous treatment with more than 1 cycle of targeted therapies such as mTOR inhibitors or vascular endothelial growth factor inhibitors, or more than 1 cycle of chemotherapy or interferon for GEP-NET Treatment of GEP-NET with trans-arterial chemoembolization or trans-arterial embolization within 12 months before screening Previously received radioligand therapy (PRRT) at any time

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAM2029<br> | Drug: CAM2029<br>* CAM2029 (octreotide subcutaneous depot) 20 mg will be administered every 2 weeks as a subcutaneous injection<br>|
| Active Comparator: Octreotide LAR or lanreotide ATG<br> | Drug: Octreotide LAR<br>* Octreotide LAR 30 mg will be administered every 4 weeks as an intramuscular injection<br>Drug: Lanreotide ATG<br>* Lanreotide ATG 120 mg will be administered every 4 weeks as a deep subcutaneous injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC) | PFS is defined as time from the date of randomization to the date of the first documented disease progression as per RECIST 1.1 or death due to any cause (whichever occurs first) | From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The time from the date of randomization to the date of death due to any cause | Up to 2 years following the primary efficacy analysis | 
| PFS as assessed by local Investigators | PFS is defined as time from the date of randomization to the date of the first documented disease progression as per RECIST 1.1 or death due to any cause (whichever occurs first) | From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months | 
| Overall response rate | The proportion of patients with best overall response of complete response (CR) or partial response (PR), as per BIRC according to RECIST 1.1 | From date of randomization until disease progression, assessed up to 48 months | 
| Disease control rate | The proportion of patients with a best overall response of CR, PR or stable disease (SD), as per BIRC according to RECIST 1.1 | From date of randomization until disease progression, assessed up to 48 months | 
| Time to tumor response | The time from the date of randomization to the first documented response of CR or PR, as per BIRC according to RECIST 1.1 | From date of randomization until disease progression, assessed up to 48 months | 
| Duration of response | The time from the date of the first documented response of CR or PR to the date of the first documented progression or death due to underlying cancer, as per BIRC according to RECIST 1.1 | From date of randomization until disease progression or death due to underlying cancer, whichever comes first, assessed up to 48 months | 
| Incidence of treatment-emergent adverse events |  | From screening to the safety follow-up, assessed up to 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAM2029, GEP-NET, Octreotide, SORENTO