NANETS2025 18th Annual Multidisciplinary NET Medical Symposium NANETS 2025 Trials In Progress Section (15 abstracts)
NETTER-3: [177Lu]Lu-DOTA-TATE in patients with newly diagnosed, Grade 1/2 (Ki-67 <10%) advanced gastroenteropancreatic neuroendocrine tumors and high disease burden
Pamela L Kunz 1 , Jaume Capdevila 2 , Thorvardur R Halfdanarson 3 , Daniel Halperin 4 , Ken Herrmann 5 , Marianne E Pavel 6 , Jiapan Xu 7 , Dhrubajyoti Pathak 8 & Simron Singh 9
1Yale School of Medicine, Yale University, New Haven, CT, USA; 2Medical Oncology Department, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain; 3Division of Medical Oncology, Mayo Clinic, Rochester, MN, USA; 4Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, GA, USA; 5Department of Nuclear Medicine, University of Duisburg-Essen, and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany; 6Department of Medicine, Friedrich-Alexander University Erlangen-Nuernberg, Erlangen, Germany; 7Advanced Quantitative Sciences, China Novartis Institutes for Biomedical Research, Shanghai, China; 8Clinical Development, Novartis Pharma AG, Basel, Switzerland; 9Division of Medical Oncology, University of Toronto, Sunnybrook Odette Cancer Center, Toronto, ON, Canada
Background: Patients with newly diagnosed, Grade 1 (G1) and 2 (G2), somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are typically treated with somatostatin analogs (SSAs); however, the optimal treatment for patients with high disease burden who are at elevated risk of rapid deterioration and disease progression is unknown, and prospective clinical data are lacking. NETTER-3 will evaluate the efficacy and safety of the radioligand therapy [177Lu]Lu-DOTA-TATE (177Lu-DOTATATE) in patients with high disease burden who were newly diagnosed with G1 and G2 (Ki-67 < 10%) advanced GEP-NETs.
Methods: NETTER-3 (NCT06784752) is a Phase III, open-label, randomized study of 177Lu-DOTATATE + octreotide long-acting release (LAR) vs octreotide LAR in patients aged ≥12 years with newly diagnosed (≤6 months), well-differentiated, G1 and G2 (Ki-67 <10%) advanced GEP-NETs and high disease burden (investigator’s opinion; guided by tumor bulk, liver involvement, disease spread, and symptoms due to tumor burden or hormone excess). Prior systemic therapy is not permitted (except ≤4 prior cycles of SSAs without disease progression). Radioligand imaging using locally approved SSTR imaging agents ensures SSTR uptake on all target lesions. An estimated 240 patients will be randomized 1:1 to receive either 177Lu-DOTATATE (7.4 GBq × 4 Q8W) + octreotide LAR (30 mg Q8W during treatment with 177Lu-DOTATATE then Q4W thereafter) or octreotide LAR (30 mg Q4W) until disease progression. Randomization will be stratified by NET grade (G1 vs G2) and origin (pancreas vs other). The primary endpoint is progression-free survival based on blinded central review according to RECIST v1.1. A key secondary endpoint is time to deterioration in selected quality-of-life domains; other secondary endpoints include objective response rate, disease control rate, duration of response, overall survival, and safety. Dosimetry and pharmacokinetics of 177Lu-DOTATATE will be assessed in a subset of patients.
Results: NETTER-3 is being conducted in North America, Europe, and Asia.
Conclusions: Not applicable; trial in progress.
Abstract ID #33272
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Endocrine Abstracts
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