A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Best Standard of Care in Patients With Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor-Positive (SSTR+), Neuroendocrine Tumours of GastroEnteric or Pancreatic Origin
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- ITM Solucin GmbH
- Enrollment
- 259
- Locations
- 42
- Primary Endpoint
- Progression-Free Survival
Study Overview
Brief Summary
The purpose of the study is to evaluate the efficacy, safety & patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged ≥ 18 years.
- •Histologically confirmed diagnosis of unresectable, well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). measurable site of disease per RECIST v1.1 (Response evaluation criteria in solid tumors) using contrast computed tomography (CT) / magnetic resonance imaging (MRI).
- •Somatostatin receptor-positive (SSTR+) disease.
Exclusion Criteria
- •Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g. rapamycin).
- •Prior (Peptide Receptor Radionuclide Therapy) PRRT.
- •Any major surgery within 4 weeks prior to randomization in the trial.
- •Therapy with an investigational compound and/or medical device within 30 days or 7 half-life periods (whichever is longer) prior to randomization.
- •Other known malignancies.
- •Serious non-malignant disease.
- •Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially interfering with the safety of the trial treatments.
- •Pregnant or breastfeeding women.
- •Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that.
Arms & Interventions
Peptide Receptor Radionuclide Therapy (PRRT) Arm
Intervention: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT (Drug)
Peptide Receptor Radionuclide Therapy (PRRT) Arm
Intervention: Amino-Acid Solution (Other)
CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin)
Intervention: CAPTEM (Capecitabine and Temozolomide) (Drug)
CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin)
Intervention: Everolimus (Drug)
CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin)
Intervention: FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin) (Drug)
Outcomes
Primary Outcomes
Progression-Free Survival
Time Frame: Every 12 weeks from randomization until disease progression or death whichever occurs earlier, during the time necessary to observe 148 Progression Free Survival (PFS) events.
PFS (Progression-Free Survival), defined as the time from randomization until documented RECIST v1.1 (Response evaluation criteria in solid tumors) progression or death, whichever occurs first.
Secondary Outcomes
- Overall Survival(Up to 3 years after disease progression, or to a maximum of 5 years after randomization)