Tests radioactive lutetium with octreotide in neuroendocrine tumors
Tests lutetium-177 DOTA-TATE plus octreotide in newly diagnosed advanced GEP-NET patients.
Plain-language title generated from the registry record
Registry title: Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
Key facts
- Where
- Edmonton, London, Montreal, and Toronto, CanadaSee the 4 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 12 or older who were newly diagnosed with an advanced Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumor (GEP-NET) with a high disease burden.
- Age
- 12 years or older (up to 100 years)
- Sex
- All sexes can join.
- Disease stage
- Spread or locally advanced tumor that cannot be removed by surgery, well differentiated Grade 1 or Grade 2 (Ki-67 <10%), diagnosed within 6 months before screening. The doctor must judge the disease burden to be high.
- Earlier treatment
- No earlier radiopharmaceutical treatment for GEP-NET. No earlier interferons, mTOR-inhibitors, chemotherapy or other systemic therapy except somatostatin analogues. No more than 4 earlier cycles of somatostatin analogues. No earlier radioembolization, chemoembolization or radiofrequency ablation. No major surgery within 12 weeks before randomization.
- Biomarker or test result
- Somatostatin receptor uptake on all target lesions at least as high as normal liver uptake on a scan done within 3 months before randomization.
Main reasons for not taking part
- Disease progression during earlier somatostatin analogue treatment
- Known brain metastases
- Known hypersensitivity to somatostatin analogues or to the study drug ingredients
- Severe urinary incontinence, voiding problems or urinary obstruction needing a catheter
- Known intolerance to CT contrast that cannot be replaced by MRI
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 100 years old?
- What type of cancer has the patient been diagnosed with?
Source: NCT06784752, who can take part
Where in Canada
- Edmonton, AlbertaHospital not named in the registryTaking people
- London, OntarioHospital not named in the registryTaking people
- Montreal, QuebecHospital not named in the registryTaking people
- Toronto, OntarioHospital not named in the registryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT06784752EU 2024-518325-15-00
- Record updated
- 11 September 2026
- Original description
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 tumors (GEP-NETs) with high disease burdenRead full original descriptionShow less
A Phase III Multi-center, 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)
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 tumors (GEP-NETs) with high disease burden
Inclusion: 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. 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; Presence of peritoneal metastasis; Symptoms due to tumor volume such as pain, fatigue, weight loss, anorexia etc; Symptoms due to hormone excess requiring active management; Additionally, participants who, in the Investigator's opinion, have high disease burden due to their disease characteristics not specified above could also be considered eligible; Participants ≥ 12 years of age; RLI somatostatin receptor (SSTR) uptake on all target lesions (defined by RECIST v1.1 criteria) at least as high as normal liver uptake assessed within 3 months prior to randomization. Any of the RLI modalities as available (some examples are listed below) can be used as per local practice:; [68Ga]Ga-DOTA-TOC PET/CT or PET/MRI; [68Ga]Ga-DOTA-TATE PET/CT or PET/MRI; [64Cu]Cu-DOTA-TATE PET/CT or PET/MRI; Somatostatin receptor scintigraphy (SRS) (planar and/or SPECT/CT) with [111In]In-pentetreotide; SRS (planar and/or SPECT/CT) with [99mTc]Tc-octreotide; Adequate bone marrow and organ function as defined by the following laboratory values prior to receiving the first study treatment:; White blood cell (WBC) count ≥ 2 x 109/L; Platelet count ≥ 75 x 109/L; Hemoglobin (Hb) ≥ 8 g/dL; Creatinine clearance > 40 mL/min calculated by the Cockcroft Gault method; Total bilirubin ≤ 3 x ULN; Potassium within normal limits. Potassium level of up to 6.0 millimoles per liter (mmol/L) is acceptable at study entry if associated with creatinine clearance within normal limits calculated using Cockcroft-Gault formula. Mild decrease (grade 1) below lower limit of normal (LLN) is acceptable at study entry if considered not clinically significant by Investigator; ECOG performance status 0-1; Presence of at least 1 measurable site of disease.
Exclusion: 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. If as per Investigator's opinion a participant is candidate for such therapies, such participant must not be enrolled; 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; Active severe urinary incontinence, severe voiding dysfunction, or urinary obstruction requiring an indwelling/condom catheter that, in the judgment of the Investigator, could prevent adhering to radiation safety instructions; Other protocol-defined Inclusion/Exclusion criteria may apply; Participant with known intolerance to CT scans with intravenous (i.v.) contrast due to allergic reaction or renal insufficiency. If such a participant can be imaged with MRI, then the participant would not be excluded; Hypersensitivity to any somatostatin analogues, to the Investigational Medicinal Products (IMPs) active substance or to any of the excipients; Known brain metastases.