Prescribing information (external link)

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Hero banner. LUTATHERA® (lutetium [177Lu] oxodotreotide) logo.

NETTER-1 trial

LUTATHERA® (lutetium [177Lu] oxodotreotide) is indicated for the treatment of unresectable or metastatic, progressive, well-differentiated (G1 and G2), somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.1

LUTATHERA® Summary of Product Characteristics (SmPC) can be found here

LUTATHERA® is the first licensed radioligand therapy (RLT) for treatment of GEP-NETs, with approval in the EU and UK1,2

The approval of LUTATHERA® was supported by NETTER-1, a pivotal randomised, open-label, Phase III clinical trial.3

NETTER-1: LUTATHERA®’s pivotal Phase III trial with a median follow-up of over 6 years3,4

NETTER-1 is a Phase III, randomised, open-label, active-controlled trial with 229 midgut patients.3,4

  • Mean baseline KPS score of patients was ~88, reflecting a generally well-functioning population3

  • All patients had failed previous treatment with 20–30 mg octreotide LAR* before randomisation3

NETTER-1 study design3–5

NETTER-1 study design graphic.

Adapted from Strosberg J, et al. 2017,3 Strosberg J, et al 2021,4 Strosberg J, et al. 2020.5

Please note that octreotide 60 mg is NOT the licensed dose. Scientific opinion from published literature and clinical opinion supported the use of up to 60 mg octreotide as standard of care when lower doses are inadequate.6

†Long-acting octreotide 30 mg was replaced by short-acting octreotide in the four-week interval before LUTATHERA® administration, as long-acting somatostatin analogues (SSAs) should be avoided within 30 days prior to receiving LUTATHERA®. Please see the SmPC for further information on SSAs.1

Sandostatin® LAR® (octreotide acetate) is indicated for the treatment of patients with symptoms associated with functional GEP endocrine tumours e.g., carcinoid tumours with features of the carcinoid syndrome, and also for the treatment of patients with advanced NET of the midgut or of unknown primary origin where non-midgut sites of origin have been excluded.

Sandostatin Prescribing information

This link will take you to the electronic medicines compendium (emc) website, which is a non-Novartis website.

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Primary endpoint3

 

  • Progression-free survival (PFS), defined as the time from randomisation to documented disease progression or death from any cause

Icon to represent secondary endpoints.

Secondary endpoints3

 

  • Overall survival (OS), defined as time from randomisation to death from any cause

  • Objective response rate

  • Safety and tolerability

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Key inclusion criteria

 

  • Inoperable midgut NET that had metastasised or were locally advanced

  • Disease progression despite previous treatment with 20–30 mg octreotide LAR every 3–4 weeks for a minimum of 12 weeks before randomisation, up to a maximum of 3 years

  • KPS score ≥60

  • SSTRs present on all target lesions

  • Ki67 ≤20%

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Key exclusion criteria

 

  • Serum creatinine level of >150 μmol/L or creatinine clearance of <50 mL/min

  • Haemoglobin level of <8.0 g/dL

  • White cell count of <2,000/mm3

  • Platelet count of <75,000/mm3

  • Total bilirubin level of >3 times the upper limit of normal range

  • Serum albumin level of ≥3.0 g/dL

  • Treatment with >30 mg octreotide LAR within 12 weeks of randomisation

  • RLT at any time before randomisation

  • Any surgery, liver-directed transarterial therapy or chemotherapy within 12 weeks of randomisation

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Safety profile

Safety profile
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Dosing and administration

Dosing and administration
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Mechanism of action

Mechanism of action
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*May also be referred to as ‘long-acting release’.

GEP-NET, gastroenteropancreatic neuroendocrine tumour; IM, intramuscular; IV, intravenous; KPS, Karnofsky performance status; LAR, long-acting repeatable; OS, overall survival; PFS, progression-free survival; RLT, radioligand therapy; SmPC, summary of product characteristics; SSA, somatostatin analogue; SSTR, somatostatin receptor.

References

  1. LUTATHERA® Summary of Product Characteristics.

  2. Novartis. Novartis announces presentation of new Lutathera® NETTER-1 data at ESMO demonstrating significant improvement in PFS regardless of baseline liver tumor burden. Available at: https://www.novartis.com/news/media-releases/novartis-announces-presentation-new-lutathera-netter-1-data-esmo-demonstrating-significant-improvement-pfs-regardless-baseline-liver-tumor-burden [Accessed December 2025].

  3. Strosberg J, al. N Engl J Med 2017; 376(2):125–135 and supplementary material.

  4. Strosberg J, et al. Lancet Oncol 2021; 22(12):1752–1763.

  5. Strosberg J, et al. Eur J Nucl Med Mol Imaging 2020;47(10):2372–2382.

  6. Broder MS, et al. World J Gastroenterol 2015;21(6):1945–1955.

 

UK | December 2025 | FA-11462533-1

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.