A multi-centre, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in patients with inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumours

Trial Profile

A multi-centre, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in patients with inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumours

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Dec 2017

At a glance

  • Drugs Octreotate-Lu-177-DOTA-Tyr-3 (Primary) ; Amino acids; Octreotide
  • Indications Carcinoid tumour; Neuroendocrine tumours
  • Focus Registrational; Therapeutic Use
  • Acronyms NETTER-1
  • Sponsors Advanced Accelerator Applications
  • Most Recent Events

    • 29 Sep 2017 According to an Advanced Accelerator Applications media release, the European Commission (EC) has approved the marketing authorization of lutetium (177Lu) oxodotreotide (Lutathera) for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. The approval is based on results from this and a phase I/II trial (CTP 700269588).
    • 12 Sep 2017 Results assessing impact of 177Lu-DOTATATE treatment on time to health related quality of life deterioration presented at the 42nd European Society for Medical Oncology Congress
    • 28 Aug 2017 The US FDA has acknowledged receipt and considered complete the resubmission of the New Drug Application (NDA) for Lutathera and provided a new Prescription Drug User Fee Act (PDUFA) date of January 26, 2018.
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