![Clinical Trial: [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET (NETTER-3)](https://i0.wp.com/ronnyallan.net/wp-content/uploads/2025/08/netter-3-1.jpg?fit=960%2C720&ssl=1)
Why is this trial important?
The output of NETTER-2, suggested Lutathera for GEP-Grade 2 and 3 NETs could be used as a first line treatment. In some areas this appeared to be controversial. The data from NETTER-1, which was focused on Grade 1 and 2 (less than ki67 of 10%), did not conclude the same, different aim. However, this appears to be the main aim of NETTER-3, to look at the data in the same way as NETTER-2 but for Grade 1 and 2 with similar criteria used on NETTER-1. You might say NETTER-3 is a follow on from NETTER-1 but with the specific aim of providing data to evaluate the efficacy and safety of [177Lu]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 <10%) advanced gastroenteropancreatic neuroendocrine tumours (GEP-NETs) with high disease burden. And that is the brief summary of the clinical trial document below.
It follows that the aim is to provide data to support the use of Lutathera for this group of patients in a first line setting.
What is NETTER-3?
Brief Summary
The purpose of the current study is to evaluate the efficacy and safety of [177Lu]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 <10%) advanced gastroenteropancreatic neuroendocrine tumours (GEP-NETs) with high disease burden.
Detailed Description
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.
Official Title
A Phase III Multi-centre, Randomized, Open-label Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients Newly Diagnosed With Grade 1 and Grade 2 (Ki-67 <10%) Advanced GEP-NET With High Disease Burden (NETTER-3)
Conditions
Trial Summary
Dates
The clinical trial is recruiting now. Primary Completion (Estimated) 2030-09-27, Full Study Completion (Estimated) 2034-01-05. This is a long term trial!
Locations
The current breakdown at 15th January 2026 is as follows:
US – 13 locations.
Canada – 3 locations
Korea – 3 locations
China – 3 locations
Europe – 31 locations, France, Germany, Netherlands, Poland, Spain, Hungary.
Note: For UK patients – UK participation is expected, because the trial is registered in the EU CTIS system, which includes UK submissions post‑Brexit for multinational studies. NETTER‑1 and NETTER‑2 both included UK sites, and Novartis typically maintains UK participation for GEP‑NET PRRT trials. I have agents looking out for news.
The entire list of site locations can be found in Reference 1 along with the full list of Inclusion and Exclusion criteria. Most are showing as “Recruiting”
Participants
They are looking for approximately 240 patients across 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 tumour (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.
Read more here
1. ClinicalTrials.gov Identifier NCT06784752 – click here.
2. Novartis casts a broader ‘Netter’ for Lutathera – click here
3. NETTER-1 – click here
4. NETTER-2 – click here
General Clinical Trials Disclaimer
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact. If you need questions, the articles here is very useful Questions to Ask About Clinical Trials | Cancer.Net
The inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan.
Disclaimer
I am not a doctor or any form of medical professional, practitioner or counsellor. None of the information on my website, or linked to my website(s), or conveyed by me on any social media or presentation, should be interpreted as medical advice given or advised by me.
Neither should any post or comment made by a follower or member of my private group be assumed to be medical advice, even if that person is a healthcare professional.
Please also note that mention of a clinical service, trial/study or therapy does not constitute an endorsement of that service, trial/study or therapy by Ronny Allan, the information is provided for education and awareness purposes and/or related to Ronny Allan’s own patient experience. This element of the disclaimer includes any complementary medicine, non-prescription over the counter drugs and supplements such as vitamins and minerals.
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Whenever I post about a trial or study, some people get excited without understanding that these new treatments and capabilities can very often take years to come to fruition and it’s also possible that clinical trials can be halted, or that national approval agencies will not approve the final product. Plus, not everyone will be eligible, so always check the exclusion and inclusion criteria in the relevant clinical trials document. Please bear that in mind when reading studies/clinical trials posted on RonnyAllan.NET
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