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Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
NCT03972488 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG Lutathera
- DRUG 30 mg Octreotide long acting repeatable (LAR) (Sandostatin LAR Depot)
- DRUG 2.5% Lys-Arg sterile amino acid solution
- DRUG High dose 60 mg octreotide long-acting repeatable
Study Locations (20)
Other
- London Health Sciences Centre, University of Western Ontario - Oncology — London
- Centre Hospitalier Universitaire de Quebec — Québec
- Sunnybrook Health Sciences Centre — Toronto
- BC Cancer Agency — Vancouver
- CHU Paris Nord-Val de Seine — Clichy
- Hospices Civils de Lyon (HCL) - Hopital Edouard Herriot — Lyon
- Institut du Cancer de Montpellier - Oncology — Montpellier
- CHU-Hôtel Dieu Service de Médecine Nucléaire — Nantes
- Institut Gustave Roussy — Villejuif
- Universitätsklinikum Erlangen — Erlangen
- Universitätsklinikum Essen - Klinik für Nuklearmedizin — Essen
- A.O.di Bologna Policl.S.Orsola — Bologna
- University of Genova - Oncology — Genova
- Istituto Oncologico Romagnolo — Meldola
Connecticut
- Yale Cancer Center — New Haven
Florida
- USF - H. Lee Moffitt Cancer Center and Research Institute — Tampa
Iowa
- University of Iowa Hospitals and Clinics - Oncology — Iowa City
Kentucky
- University of Kentucky UK Markey Cancer Center — Lexington
Minnesota
- Mayo Clinic - Oncology — Rochester
Texas
- MD Anderson Cancer Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2020-01-08 |
| Est. Completion | 2027-10-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03972488
The ClinicalTrials.gov registry entry for NCT03972488 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 226 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advanced Accelerator Applications, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Gastro-enteropancreatic Neuroendocrine Tumor appearing as the primary indexed condition, and to 4 interventions — of which Lutathera is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03972488 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, Connecticut, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03972488 about?
NCT03972488 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET". 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 tr...
What is the current status of trial NCT03972488?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 226 participants. The study started on 2020-01-08. Estimated completion is 2027-10-29.
What conditions does trial NCT03972488 study?
This clinical trial studies the following conditions: Gastro-enteropancreatic Neuroendocrine Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03972488?
The interventions under investigation include: Lutathera (DRUG), 30 mg Octreotide long acting repeatable (LAR) (Sandostatin LAR Depot) (DRUG), 2.5% Lys-Arg sterile amino acid solution (DRUG), High dose 60 mg octreotide long-acting repeatable (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03972488?
This trial is sponsored by Advanced Accelerator Applications, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03972488 being conducted?
This trial has 20 study locations across Connecticut, Florida, Iowa, Kentucky, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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