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

Inclusion Criteria:

• Male or female patient ≥18 years old

• Histologically confirmed, advanced (unresectable and/or metastatic), andwell-differentiated NET of GEP or presumed GEP origin

• At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1determined 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) forlocally advanced unresectable or metastatic disease

• Known central nervous system metastases

• Consecutive treatment with long-acting SSAs for more than 6 months beforerandomization

• Carcinoid symptoms that are refractory to treatment (according to the Investigator'sjudgement) with conventional doses of octreotide LAR or lanreotide ATG and/or totreatment with daily doses of ≤600 µg of octreotide IR

• Previous treatment with more than 1 cycle of targeted therapies such as mTORinhibitors or vascular endothelial growth factor inhibitors, or more than 1 cycle ofchemotherapy or interferon for GEP-NET

• Treatment of GEP-NET with trans-arterial chemoembolization or trans-arterialembolization within 12 months before screening

• Previously received radioligand therapy (PRRT) at any time