Clinical Trials

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 3/22/23. Questions regarding updates should be directed to the study team contact.