NETTER-1 — 177Lu-DOTATATE Plus Octreotide LAR Versus High-Dose Octreotide LAR in Advanced Midgut Neuroendocrine Tumors

Phase 3 · 2017 · Neuroendocrine Tumors

Design

Randomized open-label to 177Lu-DOTATATE 7.4 GBq every 8 weeks (four cycles) plus octreotide LAR 30 mg vs high-dose octreotide LAR 60 mg every 4 weeks.

Population

Progressive, somatostatin-receptor-positive, well-differentiated advanced midgut neuroendocrine tumors.

Primary Endpoint

progression-free survival (PFS)

Key Result

Median PFS not reached vs 8.5 mo (HR 0.18, P<0.0001); ORR 18% vs 3%. Final OS 48.0 vs 36.3 mo (HR 0.84, P=0.30) — not significant after heavy control-arm crossover.

Guideline Impact

NCCN-endorsed 177Lu-DOTATATE for progressive somatostatin-receptor-positive midgut neuroendocrine tumors