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

Official Title

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

Summary:

The aim of NETTER-2 is to determine if Lutathera in combination with long-acting octreotide prolongs PFS in GEP-NET patients with high proliferation rate tumours (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 are eligible, as well as patients previously treated with SSAs in the absence of progression.

Trial Description

Primary Outcome:

• Progression Free Survival (PFS)

• Objective Response Rate
• Time to Decline (TTD) global health status, diarrhea, fatigue, pain (EORTC QLQ-C30)
• Time to Decline (TTD) Total Health Status (EORTC QLQ-G.I.NET21)
• Disease Control Rate (DCR)
• Duration of Response (DOR)
• Rate of Adverse Events
• Rate of laboratory toxicities
• Time to death

View this trial on ClinicalTrials.gov