![NETTER-3 – Clinical Trial: [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET](https://i0.wp.com/ronnyallan.net/wp-content/uploads/2025/08/netter-3-2.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 23rd February 2026 is as follows:
US – 17 locations.
Canada – 3 locations
South Korea – 3 locations
China – 4 locations
Europe – 31 locations, UK, France, Germany, Netherlands, Poland, Italy, Hungary, Spain.
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.
Click here to enter Ronny’s Clinical Trials Archive
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
Click here and answer all questions to join my private Facebook group
Thanks for reading.
Check out my Glossary of Terms – click here
Please Share this post for Neuroendocrine Cancer awareness and to help another patient
- Small tumours – big impact
In oncology, a “small” tumour generally refers to a mass that is 2cm or less in diameter. Tumours under 1 cm are often described as “very small”. These small growths typically fall into the earliest clinical staging categories (such as T1) where they are highly localized and have not spread beyond nearby structures. Tumor Size… Read more: Small tumours – big impact - The Invisibility of Neuroendocrine Tumours (NET) – an awareness post by Ronny Allan
“Invisible cancer” typically refers to malignancies that evade early detection or disguise themselves as other common, non-life-threatening ailments. This term is very frequently associated with Neuroendocrine Tumours which are very often difficult to spot on standard imaging and blood tests. When I was diagnosed, I didn’t even feel ill. It was therefore a bit of… Read more: The Invisibility of Neuroendocrine Tumours (NET) – an awareness post by Ronny Allan - Spotlight on Ovarian Neuroendocrine Neoplasms
Disclaimer: The information in this Spotlight is provided for general information and education only. It is not intended to replace the advice of a qualified healthcare professional, nor to be used for diagnosis or treatment of any medical condition. Always discuss your individual situation, symptoms, test results, and treatment options with your own doctor… Read more: Spotlight on Ovarian Neuroendocrine Neoplasms - Ronny Allan’s Newsletter covering May 2026
Just back from holiday thus why the late publication! Summary of May 2026 on RonnyAllan.NET I think the main story of May is similar to March and April which was a strong blog performance. Other key targets met were the two main primary NET types (small intestine and pancreas) and one not so common(thymus) have finally been… Read more: Ronny Allan’s Newsletter covering May 2026 - Fat‑Soluble Vitamins in Neuroendocrine Tumours (NETs): Why Deficiency Happens and Who Is Most at Risk
This blog provides general educational information only. It does not offer medical advice, diagnosis, or treatment. Patients should always consult their clinical team for personalised guidance. Introduction: What Are Fat‑Soluble Vitamins? Fat‑soluble vitamins — A, D, E and K — are nutrients that can only be absorbed when dietary fat is digested properly. They… Read more: Fat‑Soluble Vitamins in Neuroendocrine Tumours (NETs): Why Deficiency Happens and Who Is Most at Risk - Neuroendocrine Tumours (NETs) – A Spotlight on Vitamin B9 (Folate)
Before you read thisThis information is designed to help you understand how vitamins work in the body and how certain NET-related factors might affect them. It is not a substitute for personalised medical advice. Every NET patient is different — tumour type, treatments, surgery, symptoms, and nutritional needs can vary widely. If you have concerns… Read more: Neuroendocrine Tumours (NETs) – A Spotlight on Vitamin B9 (Folate) - Neuroendocrine Tumours – A Spotlight on Vitamin E (Tocopherols & Tocotrienols)
🟧A general‑population overview with NET‑specific considerations where relevant. Disclaimer: This Spotlight provides general educational information about Vitamin E. It is not a substitute for medical advice. Individual needs vary, particularly for those with conditions affecting digestion or absorption. Always consult your medical team before making changes to supplements or nutrition. What is Vitamin E? Vitamin… Read more: Neuroendocrine Tumours – A Spotlight on Vitamin E (Tocopherols & Tocotrienols) - Neuroendocrine Tumours – A Spotlight on Vitamin A (Retinol)
Disclaimer: This Spotlight provides general educational information about Vitamin A. It is not a substitute for medical advice. Individual needs vary, particularly for those with conditions affecting digestion, absorption, or liver function. Always consult your medical team before making changes to supplements or nutrition. 🟧A general‑population overview with NET‑specific considerations where relevant. What is Vitamin… Read more: Neuroendocrine Tumours – A Spotlight on Vitamin A (Retinol) - 200 Lanreotide Injections: A Milestone in Long‑Term Neuroendocrine Tumour (NET) Management
Disclaimer: Educational and advocacy content only. Not a substitute for medical advice. Two hundred injections. It’s a milestone that carries weight — not because of the number itself, but because of what it represents: continuity, stability, and the lived reality of managing Neuroendocrine Cancer over the long term. Lanreotide has been part of my life… Read more: 200 Lanreotide Injections: A Milestone in Long‑Term Neuroendocrine Tumour (NET) Management - Neuroendocrine Tumours (NETs) – A Spotlight on Vitamin K (Phylloquinone / Menaquinones)
Before you read thisThis information is designed to help you understand how vitamins work in the body and how certain NET-related factors might affect them. It is not a substitute for personalised medical advice. Every NET patient is different — tumour type, treatments, surgery, symptoms, and nutritional needs can vary widely. If you have concerns… Read more: Neuroendocrine Tumours (NETs) – A Spotlight on Vitamin K (Phylloquinone / Menaquinones) - A spotlight on Colon Neuroendocrine Neoplasms
Disclaimer: This Spotlight is for general information only and should not be used as a substitute for personalised medical advice. Neuroendocrine neoplasms (NENs) are diverse, and individual cases vary. Always discuss your specific situation, test results, and treatment options with your own specialist team. Content reflects current evidence and classifications at the time of writing… Read more: A spotlight on Colon Neuroendocrine Neoplasms - Spotlight on Thymic Neuroendocrine Neoplasms (Thymic NENs)
Disclaimer:The information in this Spotlight is for general education and awareness. It does not replace personalised medical advice, diagnosis, or treatment. Thymic Neuroendocrine Neoplasms (NENs) are complex and highly variable, and individual cases may differ significantly from the patterns described here. Always discuss your own situation, test results, and treatment options with your specialist team,… Read more: Spotlight on Thymic Neuroendocrine Neoplasms (Thymic NENs) - An unmissable update from Ronny Allan covering April 2026
A monthly update not to miss……..Summary of April 2026 on RonnyAllan.NET I think the main story of April is similar to March which was a strong blog performance. Some of March was so popular that it has rolled into April and I have tried to beat those figures but failed due to external pressures. Nonetheless, the… Read more: An unmissable update from Ronny Allan covering April 2026 - Spotlight on Small intestine Neuroendocrine Neoplasms (siNENs)
DisclaimerThis Spotlight is for general education and reassurance only. It cannot replace personalised advice from your own medical team, who understand your individual history, imaging, pathology, and treatment needs. Neuroendocrine tumours vary widely in behaviour, presentation, and management, and guidance may evolve as new evidence emerges. If you have questions about your diagnosis, symptoms, or… Read more: Spotlight on Small intestine Neuroendocrine Neoplasms (siNENs) - A Spotlight on Pancreatic Neuroendocrine Neoplasms
DisclaimerThe information in this Spotlight is for general education only. It cannot replace advice from your own medical team, who know your individual situation, test results, and treatment options. Neuroendocrine Neoplasms and related conditions are complex and research is evolving; guidance, classifications, and statistics may change over time. Always discuss any questions or concerns with… Read more: A Spotlight on Pancreatic Neuroendocrine Neoplasms - Neuroendocrine Cancer in UK – a growing crisis?
I was delighted to read about the efforts of Dr Arthur Scott, a Member of the UK Parliament (MP). He is a great advocate for cancer patients and recently introduced a rare cancer bill in the UK Parliament which will hopefully make a difference. The content was very interesting and I was drawn to several… Read more: Neuroendocrine Cancer in UK – a growing crisis? - Bone Metastases in Well‑Differentiated NETs – Part 2 – Treatment
DisclaimerThis information is for education and reassurance only.It is not a substitute for personalised medical advice, diagnosis, or treatment. Bone metastases in neuroendocrine tumours (NETs) vary widely in behaviour, appearance, and clinical significance. Decisions about systemic therapy, radiotherapy, ablation, bone‑targeted agents, surgery, or monitoring must be made by your own specialist NET team, who understand… Read more: Bone Metastases in Well‑Differentiated NETs – Part 2 – Treatment - Neuroendocrine Tumours – Vitamin B3 (Niacin)
Before you read thisThis information is designed to help you understand how vitamins work in the body and how certain NET-related factors might affect them. It is not a substitute for personalised medical advice. Every NET patient is different — tumour type, treatments, surgery, symptoms, and nutritional needs can vary widely. If you have concerns… Read more: Neuroendocrine Tumours – Vitamin B3 (Niacin) - March 2026 Newsletter from Ronny Allan
Here is my monthly summary of March 2026 on RonnyAllan.NET This has been a very good month but to be honest, I had more time at home and on my computer, due to illness. OK I was not that ill that I could not tap away at a keyboard! However, it was pretty erratic access. I… Read more: March 2026 Newsletter from Ronny Allan - Understanding Differentiation, Ki‑67, Mitotic Count, Hotspots, Pathology Workflow, and Primary–Metastasis Heterogeneity in Neuroendocrine Neoplasms (NENs)
Before you read this… This article discusses pathology concepts such as Ki-67, grading, heterogeneity, and biopsy findings in neuroendocrine tumours (NETs). It is provided for educational purposes only and does not interpret any individual pathology report or scan result. Ki-67 values, tumour grade, and sampling limitations can vary between different biopsies and over time. Their… Read more: Understanding Differentiation, Ki‑67, Mitotic Count, Hotspots, Pathology Workflow, and Primary–Metastasis Heterogeneity in Neuroendocrine Neoplasms (NENs)
Please Share this post for Neuroendocrine Cancer awareness and to help another patient
Discover more from Ronny Allan - Living with Neuroendocrine Cancer
Subscribe to get the latest posts sent to your email.
