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Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET | Clinical Trials | Clareo Health

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Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET

A Phase III Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET

NCT03972488•Advanced Accelerator Applications

View on ClinicalTrials.gov

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.

Detailed Description

The study consisted of a screening phase, a treatment phase, an optional cross-over phase for subjects assigned to the control arm, optional re-treatment phase for subjects assigned to the Lutathera arm, and a follow-up phase. This study compared treatment with Lutathera (7.4 GBq/200 mCi 4 × administrations every 8 weeks ± 1 week; cumulative dose: 29.6 GBq/800mCi) plus octreotide long-acting release (LAR) (30 mg every 8 weeks during Lutathera treatment and every 4 weeks after last Lutathera treatment) and high dose octreotide LAR (60 mg every 4 weeks).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Presence of metastasized or locally advanced, inoperable (curative intent) histologically proven, well differentiated Grade 2 or Grade 3 gastroenteropancreatic neuroendocrine (GEP-NET) tumor diagnosed within 6 months prior to screening.
•Ki67 index ≥10 and ≤ 55%
•Patients ≥ 15 years of age and a body weight of \> 40 kg at screening
•Expression of somatostatin receptors on all target lesions documented by CT/MRI scans, assessed by any of the following somatostatin receptor imaging (SRI) modalities within 3 months prior to randomization: \[68Ga\]-DOTA-TOC (e.g. Somakit-TOC®) PET/CT (or MRI when applicable based on target lesions) imaging, \[68Ga\]-DOTA-TATE PET/CT (or MRI when applicable based on target lesions) imaging (e.g. NETSPOT®), Somatostatin Receptor scintigraphy (SRS) with \[111In\]-pentetreotide (Octreoscan® SPECT/CT), SRS with \[99mTc\]-Tektrotyd, \[64Cu\]-DOTA-TATE PET/CT (or MRI when applicable based on target lesions) imaging.
•The tumor uptake observed in the target lesions must be \> normal liver uptake.
•Karnofsky Performance Score (KPS) ≥ 60
•Presence of at least 1 measurable site of disease
•Patients who have provided a signed informed consent form to participate in the study, obtained prior to the start of any protocol related activities

Exclusion Criteria

•Creatinine clearance \< 40 mL/min calculated by the Cockroft Gault method
•Hb concentration \< 5.0 mmol/L (\<8.0 g/dL); WBC \< 2x10E9/L (2000/mm3); platelets \< 75x10E9/L (75x10E3/mm3)
•Total bilirubin \> 3 x ULN
•Serum albumin \< 3.0 g/dL unless prothrombin time is within the normal range
•Pregnancy or lactation
•Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, are not allowed to participate in this study UNLESS they are using highly effective methods of contraception throughout the study treatment period (including cross-over and re-treatment, if applicable) and for 7 months after study drug discontinuation
•Peptide receptor radionuclide therapy (PRRT) at any time prior to randomization in the study.
•Documented RECIST progression to previous treatments for the current GEP-NET at any time prior to randomization
•Patients for whom in the opinion of the investigator other therapeutic options (eg chemo-, targeted therapy) are considered more appropriate than therapy offered in the study, based on patient and disease characteristics
•Any previous therapy with Interferons, Everolimus (mTOR-inhibitors), chemotherapy or other systemic therapies for GEP-NET administered for more than 1 month or within 12 weeks prior to randomization in the study.
+15 more criteria

Locations (40)

Yale Cancer Center

New Haven, Connecticut, United States

USF - H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

University of Iowa Hospitals and Clinics - Oncology

Iowa City, Iowa, United States

University of Kentucky UK Markey Cancer Center

Lexington, Kentucky, United States

Mayo Clinic - Oncology

Rochester, Minnesota, United States

MD Anderson Cancer Center

Houston, Texas, United States

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

Key Dates

Start Date

January 8, 2020

Primary Completion Date

July 20, 2023

Completion Date

October 29, 2027

Last Updated

January 21, 2026

Enrollment

226

ACTUAL participants

Conditions

Gastro-enteropancreatic Neuroendocrine Tumor

Interventions

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

Study of CVM-1118 for Patients With Advanced Neuroendocrine Tumors

NCT03600233

Neuroendocrine TumorsPancreatic Neuroendocrine Tumor+3 more

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COMPLETED

A Study to Understand Participant's Experiences in Gastro-enteropancreatic Neuroendocrine Tumors (GEP-NETs) and Acromegaly

NCT06253897

Gastro-enteropancreatic Neuroendocrine TumorAcromegaly

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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