Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 Gastroenteropancreatic Neuroendocrine Tumor, sponsored by Advanced Accelerator Applications.
- Active
- Registry status
- Phase 3
- Development phase
- 226
- Enrollment target
- 20
- Study locations
NCT03972488: Active Phase 3 study of Gastroenteropancreatic Neuroendocrine Tumor, sponsored by Advanced Accelerator Applications.
NCT03972488 is a Phase 3 study of Gastroenteropancreatic Neuroendocrine Tumor that is active but no longer recruiting, run by Advanced Accelerator Applications. The registered enrollment target is 226 participants, below the 499-participant average among 7 other Gastroenteropancreatic Neuroendocrine Tumor trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03972488, a Phase 3 study of Gastroenteropancreatic 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.
Primary Outcome
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.
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 |
What the registry record for NCT03972488 still lists
NCT03972488 is an interventional study that assigns participants to a tested intervention. The registered 226 participants enrollment target is mid-sized for trials with a published cap, below the 499-participant average among 7 other Gastroenteropancreatic Neuroendocrine Tumor trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Gastroenteropancreatic Neuroendocrine Tumor appearing as the primary indexed condition, and to 4 interventions - of which Lutathera is the first listed.
NCT03972488 names 20 study sites across 7 states, led by 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: Gastroenteropancreatic 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.
Learn More About Clinical Trials
Similar trials for Gastroenteropancreatic Neuroendocrine Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
RECRUITING · Phase 3
-
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
ACTIVE NOT RECRUITING · Phase 3
-
Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery
RECRUITING · Phase 1
-
Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Neuroendocrine Tumors
RECRUITING · Phase 1
-
Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors
RECRUITING
-
NP-101 (TQ Formula) With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04419272 · 226 participants · Phase 4
Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits
- NCT05449002 · 226 participants · NA
Digital Single Session Intervention for Youth Mental Health
- NCT05488054 · 226 participants · NA
Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery
- NCT05924477 · 226 participants · NA
Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI