NETTER-2

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Official title

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

Phase

Phase 3

Status

Active not recruiting

Conditions

Gastro-enteropancreatic Neuroendocrine Tumor

Interventions

Lutathera; 30 mg Octreotide long acting repeatable (LAR) (Sandostatin LAR Depot); 2.5% Lys-Arg sterile amino acid solution; High dose 60 mg octreotide long-acting repeatable

Arms

• Lutathera® plus Octreotide LAR 30 mg (Investigational arm) · Experimental
• Octreotide LAR 60 mg (Control arm) · Active comparator
• Optional post-progression re-treatment with Lutathera · Experimental
• Optional post-progression cross-over to Lutathera · Active comparator
• Optional post-progression re-treatment with Lutathera after cross-over · Active comparator

Enrollment

226

Primary outcomes

• Progression Free Survival (PFS) Per Central Assessment

Sponsor

Advanced Accelerator Applications

Start

Jan 8, 2020

Primary completion

Jul 20, 2023

Results posted

Yes

Registry record

NCT03972488 · updated Jan 21, 2026

• Singh S, Halperin D, Myrehaug S, Herrmann K, Pavel M, Kunz PL, Chasen B, Tafuto S, Lastoria S, Capdevila J, Garcia-Burillo A, Oh DY, Yoo C, Halfdanarson TR, Falk S, Folitar I, Zhang Y, Aimone P, de Herder WW, Ferone D; all the NETTER-2 Trial Investigators. [177Lu]Lu-DOTA-TATE plus long-acting octreotide versus high-dose long-acting octreotide for the treatment of newly diagnosed, advanced grade 2-3, well-differentiated, gastroenteropancreatic neuroendocrine tumours (NETTER-2): an open-label, randomised, phase 3 study. Lancet. 2024 Jun 29;403(10446):2807-2817. doi: 10.1016/S0140-6736(24)00701-3. Epub 2024 Jun 5. PubMed 38851203
• Ferone D, Pavel M, Herrmann K, Kunz PL, Myrehaug S, Halperin D, Chasen B, Capdevila J, Garcia-Burillo A, Tafuto S, Lastoria S, Oh DY, Yoo C, Falk S, Halfdanarson TR, Sansovini M, Gerard L, Deshayes E, Filice A, Folitar I, Zhang Y, de Herder WW, Singh S. [177Lu]Lu-DOTA-TATE plus long-acting octreotide in patients with newly diagnosed, advanced, grade 2-3, gastroenteropancreatic neuroendocrine tumours: preplanned and post-hoc efficacy analyses from the randomised, phase 3 NETTER-2 trial. EClinicalMedicine. 2026 Aug 7;98:104109. doi: 10.1016/j.eclinm.2026.104109. eCollection 2026 Aug. PubMed 42604001
• Holzgreve A, Unterrainer LM, Tiling M, Mansour N, Spitzweg C, Brendel M, Ricke J, Unterrainer M, Kunz WG, Mehrens D. Cost-Effectiveness of [177Lu]Lu-DOTATATE for the Treatment of Newly Diagnosed Advanced Gastroenteropancreatic Neuroendocrine Tumors: An Analysis Based on Results of the NETTER-2 Trial. J Nucl Med. 2025 Jul 1;66(7):1075-1081. doi: 10.2967/jnumed.124.269416. PubMed 40473457
• Bahri N, Crook C, Daneng Li. Casting a Wide NET: When Is the Optimal Time for 177Lu-Dotatate Treatment? Oncology (Williston Park). 2024 Nov 5;38(11):442-443. doi: 10.46883/2024.25921029. PubMed 39570708
• Jungels C, Deleporte A. State of the art and future directions in the systemic treatment of neuroendocrine neoplasms. Curr Opin Oncol. 2021 Jul 1;33(4):378-385. doi: 10.1097/CCO.0000000000000740. PubMed 33973550