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

ITM Isotope Technologies Munich

Status and phase: Active, not recruiting; Phase 3

Conditions: Neuroendocrine Tumors

Treatments: Drug: 177Lu-edotreotide PRRT; Other: Amino-Acid Solution; Drug: Everolimus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03049189

ITM-LET-01

Details and patient eligibility

About

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).

Enrollment: 309 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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309 participants in 2 patient groups

177Lu-edotreotide PRRT

Experimental group

Description:

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 days/9 months)

Treatment:

Other: Amino-Acid Solution

Drug: 177Lu-edotreotide PRRT

Everolimus

Active Comparator group

Description:

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)

Treatment:

Drug: Everolimus