Trial Summary

Dates

The clinical trial is recruting now. Primary Completion (Estimated) 2030-09-27, Full Study Completion (Estimated) 2034-01-05.  This is a long term trial!

Locations

The trial document as at the day of publishing this blog indicates the trial is taking place in two regions, North America and The Republic of Korea. There is no mention of Europe of other locations not lists above (sometimes their entry on the locations list is delayed). However, it is not clear what the final list of locations will be but I will update you if and when it is updated.    The current breakdown at 11th August 2025 is as follows:

US – 5 locations. 

Canada – 1 location

Korea – 2 locations

The entire list of site locations can be found in Reference 1 along with the full list of Inclusion and Exclusion criteria.

Participants

They are looking for approximately 240 patients accross all locations.

The key headlines from Inclusion Criteria are:

• Presence of metastasized or locally advanced, unresectable (curative intent), histologically proven, well differentiated Grade 1 or Grade 2 (Ki-67 <10%) gastroenteropancreatic neuroendocrine tumor (GEP-NET) diagnosed within 6 months prior to screening.
• Participants with high disease burden in the Investigator’s opinion.
• Somatostatin receptor (SSTR) uptake on all target lesions 

Key headlines from Exclusion Criteria:

• Prior administration of a therapeutic radiopharmaceutical for GEP-NET at any time prior to randomization in the study.
• Any previous therapy with interferons, mTOR-inhibitors, chemotherapy or other systemic therapies except somatostatin analogues (SSAs) of GEP-NET.
• Participant who received more than 4 cycles of prior SSAs (e.g., octreotide long-acting release) are not eligible. In addition, any participant receiving treatment with short-acting octreotide, which cannot be interrupted for 24 h before the administration of [177Lu]Lu-DOTA-TATE, or any participant receiving treatment with SSAs, which cannot be interrupted for at least 4 weeks before the administration of [177Lu]Lu-DOTA-TATE.
• 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.
• Any major surgery within 12 weeks prior to randomization in the study.
• Known brain metastases.

  *there are others, see Reference 1.