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NCT03972488 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
A Phase 3 study of Gastro-enteropancreatic Neuroendocrine Tumor, sponsored by Advanced Accelerator Applications.
- Active
- Registry status
- Phase 3
- Development phase
- 226
- Enrollment target
- 20
- Study locations
NCT03972488 is a Phase 3 study of Gastro-enteropancreatic Neuroendocrine Tumor that is active but no longer recruiting, run by Advanced Accelerator Applications. The registered enrollment target is 226 participants. The trial reports 20 study locations across 7 states.
The verdict
NCT03972488, a Phase 3 study of Gastro-enteropancreatic Neuroendocrine Tumor, is active but no longer recruiting, sponsored by Advanced Accelerator Applications.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 226 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. 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 8 total studies on file at ClinicalTrials.gov.
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.
NCT03972488 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, Connecticut, Florida.
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.
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).
Who is sponsoring clinical trial NCT03972488?
This trial is sponsored by Advanced Accelerator Applications, which has 8 total clinical trials registered on ClinicalTrials.gov.
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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