Efficacy And Safety Of 177Lu-edotreotide PRRT In GEP-NET Patients

Study Overview

Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients

The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).

N/A

Neuroendocrine Tumors

DRUG: 177Lu-edotreotide PRRT
DRUG: Everolimus
OTHER: Amino-Acid Solution

ITM-LET-01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-01-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-26
First Submitted that Met QC Criteria 2017-02-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-30
First Posted (ACTUAL) 2017-02-09	Results First Posted N/A	Last Verified 2025-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 177Lu-edotreotide PRRT 177Lu-edotreotide (177Lu-DOTATOC) A maximum of four cycles of 7.5 ± 0.7 GBq (gigabequerel) 177Lu-edotreotide, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, 90 days apart (total duration: 270 d	DRUG: 177Lu-edotreotide PRRT PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered. OTHER: Amino-Acid Solution The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of 25 g lysine and 25 g arginine diluted in 2000 mL of electrolyte solution, infused over 4 - 6 h, starting 30 - 60 min before PRRT
ACTIVE_COMPARATOR: Everolimus Everolimus (Afinitor ®) Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS)	DRUG: Everolimus Everolimus will be administered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 177Lu-edotreotide PRRT

177Lu-edotreotide (177Lu-DOTATOC) A maximum of four cycles of 7.5 ± 0.7 GBq (gigabequerel) 177Lu-edotreotide, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, 90 days apart (total duration: 270 d

DRUG: 177Lu-edotreotide PRRT

PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.

OTHER: Amino-Acid Solution

The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of 25 g lysine and 25 g arginine diluted in 2000 mL of electrolyte solution, infused over 4 - 6 h, starting 30 - 60 min before PRRT

ACTIVE_COMPARATOR: Everolimus

Everolimus (Afinitor ®) Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS)

DRUG: Everolimus

Everolimus will be administered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.

Primary Outcome Measures	Measure Description	Time Frame
progression-free survival (PFS)	PFS will be assessed individually per patient from date of randomization until the date of first documented progression or death, assessed up to 30 months, primary outcome will be measured by CT/MRI every 12 weeks +/- 14 days	12 weeks +/- 14 days, up to 30 months

Secondary Outcome Measures	Measure Description	Time Frame
objective response rates (ORR)	ORR will be assessed, defined as the proportion of patients achieving partial response (PR) or complete response (CR) as best outcome, after treatment with 177Lu-edotreotide compared to everolimus	12 weeks +/- 14 days, up to 30 months
overall survival (OS)	OS as secondary outcome measure will be assessed per patient from date of randomization until the date of death	12 weeks +/- 14 days, up to 90 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically confirmed diagnosis of well-differentiated neuro-endocrine tumour of non-functional gastroenteric origin (GE-NET) or both functional or non-functional pancreatic origin (P-NET)
Measurable disease per RECIST 1.1
Somatostatin receptor positive (SSTR+) disease
Progressive disease based on RECIST 1.1. criteria as evidenced by two morphological imaging examinations made with the same imaging method (either CT or MRI)

Known hypersensitivity to edotreotide or everolimus
Known hypersensitivity to DOTA, lutetium-177, or any excipient of edotreotide or everolimus or any other Rapamycin derivative
Prior exposure to any peptide receptor radionuclide therapy (PRRT)
Prior therapy with mTor inhibitors
Prior EFR (external field radiation) to GEP-NET lesions within 90 days before randomisation or radioembolisation therapy
Therapy with an investigational compound and/or medical device within 30 days prior to randomisation
Indication for surgical lesion removal with curative potential
Planned alternative therapy (for the period of study participation)
Serious non-malignant disease
Clinically relevant renal, hepatic, cardiovascular, or haematological organ dysfunction, potentially interfering with the safety of the study treatments
Pregnant or breast-feeding women
Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders) or any other vulnerable population to that sense (e.g. persons institutionalised, incarcerated etc.).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

ABX CRO
PSI CRO

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record