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

What Was Tested

The trial (phase 3) is built around Octreotide.

It had two arms (groups): [177Lu]Lu-DOTA-TATE + Octreotide LAR (experimental) and Octreotide LAR (active comparator).

Participants in this arm will receive \[177Lu\]Lu-DOTA-TATE plus Octreotide long-acting release (LAR).

Participants in this arm will receive Octreotide LAR only.

The registry classes the interventions as drug and radiation.

More on the Plan

The study consists of a screening phase, a treatment phase and a follow-up phase.

This study compares treatment with \[177Lu\]Lu-DOTA-TATE plus octreotide LAR and octreotide LAR only.

Who Took Part

240 planned participants were the target.

It was open to people of any sex aged from 12 years up to 100 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participants with high disease burden in the Investigator's opinion. Following criteria should be used as the guiding principle for determining high disease burden:. Primary tumor or a metastatic lesion \> 4 cm. More than one tumor or metastatic lesions measuring \> 2 cm. Elevated alkaline phosphatase \> 2.5 X upper limit of normal (ULN). Presence of bone metastasis.

The full record lists 26 inclusion and 10 exclusion criteria; among the exclusions: prior administration of a therapeutic radiopharmaceutical for gep-net at any time prior to randomization in the study; documented recist v1.1 progression during previous ssa treatments for the current gep-net at any time prior to randomization; any previous radioembolization, chemoembolization and radiofrequency ablation for gep-net.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

It started in 2025-05-30 with completion listed for 2028-12-08.

It ran at 67 sites in United States (20), Italy (8), Spain (7), France (6), Poland (6) and Canada (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Progression Free Survival (PFS) centrally assessed by Blinded Independent Review Committee (BIRC).

It also tracked 15 secondary outcomes, for example Time to Deterioration (TDD) (Key Secondary), Progression Free Survival (PFS), Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DOR) and Overall Survival (OS).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 240 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.