Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
Condition(s) studied
Investigational drug(s) / intervention(s)
Lutathera: Lutathera is a sterile radiopharmaceutical supplied as a ready-to-use solution for infusion containing 177Lu-DOTA0-Tyr3-octreotate as a drug substance with a volumetric activity of 370 MBq/mL at reference date and time (calibration time). Each Lutathera infusion continued for 30 min.
30 mg Octreotide long acting repeatable (LAR) (Sandostatin LAR Depot): Sandostatin® LAR Depot (octreotide LAR) is a pharmaceutical that was available in single-use kits containing a 6-mL vial of 10 mg, 20 mg, or 30 mg strength for intramuscular injection, a syringe containing 2.5 mL of diluent, two sterile 1½" 19-gauge needles, and two alcohol wipes.
2.5% Lys-Arg sterile amino acid solution: Participants who received Lutathera were administered a concomitant 2.5% Lys-Arg solution for kidney protection, with each Lutathera dose. The 2.5% Lys-Arg solution was administered intravenously for 4 hours (infusion rate: 250 ml/h); the infusion was to start 30 minutes prior to the start of the Lutathera infusion and continue during (30 min) and up to at least 3 hours after the Lutathera infusion.
High dose 60 mg octreotide long-acting repeatable: Sandostatin® LAR Depot (octreotide LAR) is a pharmaceutical that was available in single-use kits containing a 6-mL vial of 10 mg, 20 mg, or 30 mg strength for intramuscular injection, a syringe containing 2.5 mL of diluent, two sterile 1½" 19-gauge needles, and two alcohol wipes.
Study summary
The aim of NETTER-2 was to determine if Lutathera in combination with long-acting octreotide prolongs progression free survival (PFS) in gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to treatment with high dose (60 mg) long-acting octreotide. Somatostatin analog (SSA) naive patients were eligible, as well as patients previously treated with SSAs in the absence of progression.
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) Per Central Assessment — from randomization to the first line progression or death due to any cause, up to approx. 42 months
PFS is the time from randomization to the first line progression (centrally assessed according to RECIST 1.1) or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumor Criteria (RECIST 1.1) as a 20% increase in the sum of diameters of all measured target lesions or unequivocal progression of non-target lesions or appearance of a new lesion.
Trial sites (40)
| Facility | City | Region | Status |
|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | |
| USF - H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | |
| University of Iowa Hospitals and Clinics - Oncology | Iowa City | Iowa | |
| University of Kentucky UK Markey Cancer Center | Lexington | Kentucky | |
| Mayo Clinic - Oncology | Rochester | Minnesota | |
| MD Anderson Cancer Center | Houston | Texas | |
| London Health Sciences Centre, University of Western Ontario - Oncology | London | Canada | |
| Centre Hospitalier Universitaire de Quebec | Québec | Canada | |
| Sunnybrook Health Sciences Centre | Toronto | Canada | |
| BC Cancer Agency | Vancouver | Canada | |
| CHU Paris Nord-Val de Seine | Clichy | France | |
| Hospices Civils de Lyon (HCL) - Hopital Edouard Herriot | Lyon | France | |
| Institut du Cancer de Montpellier - Oncology | Montpellier | France | |
| CHU-Hôtel Dieu Service de Médecine Nucléaire | Nantes | France | |
| Institut Gustave Roussy | Villejuif | France | |
| Universitätsklinikum Erlangen | Erlangen | Germany | |
| Universitätsklinikum Essen - Klinik für Nuklearmedizin | Essen | Germany | |
| A.O.di Bologna Policl.S.Orsola | Bologna | Italy | |
| University of Genova - Oncology | Genova | Italy | |
| Istituto Oncologico Romagnolo | Meldola | Italy | |
| Fondazione Irccs Istituto Nazionale Tumori | Milan | Italy | |
| Ieo, Irccs | Milan | Italy | |
| IRCCS fondazione Pascale - Oncology | Naples | Italy | |
| Arcispedale Santa Maria Nuova, Reggio Emilia - Oncology | Reggio Emilia | Italy | |
| Azienda Ospedaliera Sant'Andrea - Università La Sapienza U.O.C. Mal App. Digerente e - Oncology | Roma | Italy | |
| Erasmus Medisch Centrum | Rotterdam | Netherlands | |
| UMC Utrecht - Oncology | Utrecht | Netherlands | |
| Seoul National University Bundang Hospital | Seongnam-si | South Korea | |
| Asan Medical Center - Oncology | Seoul | South Korea | |
| Seoul National University Hospital - Department of Internal Medicine | Seoul | South Korea | |
| Severance Hospital, Yonsei University Health System - Medical Oncology | Seoul | South Korea | |
| Hospital Universitario Vall d'Hebrón | Barcelona | Spain | |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | |
| Hospital Universitario Ramón y Cajal | Madrid | Spain | |
| Hospital Universitari i Politecnic La Fe | Valencia | Spain | |
| Bristol Haematology and Oncology Centre | Bristol | United Kingdom | |
| Guys And St Thomas Hospital | London | United Kingdom | |
| Kings College Hospital - Oncology | London | United Kingdom | |
| Royal Free Hospital, London | London | United Kingdom | |
| Weston Park Hospital | Sheffield | United Kingdom |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03972488 on ClinicalTrials.gov ↗ ← All trials in Italy