Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET

Cannot have received: therapeutic radiopharmaceutical

Prior administration of a therapeutic radiopharmaceutical for GEP-NET at any time prior to randomization in the study

Cannot have received: interferon

Any previous therapy with interferons, mTOR-inhibitors, chemotherapy or other systemic therapies except somatostatin analogues (SSAs) of GEP-NET

Cannot have received: mTOR inhibitor

Any previous therapy with interferons, mTOR-inhibitors, chemotherapy or other systemic therapies except somatostatin analogues (SSAs) of GEP-NET

Cannot have received: chemotherapy

Any previous therapy with interferons, mTOR-inhibitors, chemotherapy or other systemic therapies except somatostatin analogues (SSAs) of GEP-NET

Cannot have received: systemic therapy

Exception: except somatostatin analogues (SSAs) of GEP-NET

Any previous therapy with interferons, mTOR-inhibitors, chemotherapy or other systemic therapies except somatostatin analogues (SSAs) of GEP-NET

Cannot have received: somatostatin analogue

Exception: more than 4 cycles of prior SSAs (e.g., octreotide long-acting release) are not eligible

Participant who received more than 4 cycles of prior SSAs (e.g., octreotide long-acting release) are not eligible

Cannot have received: somatostatin analogue (short-acting octreotide)

Exception: cannot be interrupted for 24 h before the administration of [177Lu]Lu-DOTA-TATE

any participant receiving treatment with short-acting octreotide, which cannot be interrupted for 24 h before the administration of [177Lu]Lu-DOTA-TATE

Cannot have received: somatostatin analogue

Exception: cannot be interrupted for at least 4 weeks before the administration of [177Lu]Lu-DOTA-TATE

any participant receiving treatment with SSAs, which cannot be interrupted for at least 4 weeks before the administration of [177Lu]Lu-DOTA-TATE

Cannot have received: radioembolization

Any previous radioembolization, chemoembolization and radiofrequency ablation for GEP-NET

Cannot have received: chemoembolization

Any previous radioembolization, chemoembolization and radiofrequency ablation for GEP-NET

Cannot have received: radiofrequency ablation

Any previous radioembolization, chemoembolization and radiofrequency ablation for GEP-NET