[177Lu]Lu-edotreotide versus everolimus for gastroenteropancreatic neuroendocrine tumours (COMPETE): a phase 3, multicentre, randomised, open-label, superiority trial

Walter, T; Jann, H; Ansquer, C; Deshayes, E; Garcia-Carbonero, R; Teulé, A; Baum, RP; Verberne, HJ; Ćwikła, JB; Srirajaskanthan, R; de Mestier, L; Grana, CM; Buck, A; Hörsch, D; Pavel, M; Dierickx, LO; Michael, M; Strosberg, J; Kollár, A; Jimenez-Fonseca, P; Rinke, A; Del Olmo-García, M; Flaus, A; Hernando, J; Kluge, A; Breuninger, M; Melnyk, S; Zhernosekov, K; Capdevila, J; COMPETE Investigator Team

doi:10.1016/s0140-6736(26)00604-5

Endocrine oncology

[177Lu]Lu-edotreotide versus everolimus for gastroenteropancreatic neuroendocrine tumours (COMPETE): a phase 3, multicentre, randomised, open-label, superiority trial

LancetPublished 2 Jul 2026Randomised controlled trial

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Authors' conclusion

[177Lu]Lu-edotreotide led to statistically significant and clinically meaningful improvements in progression-free survival.

Study context

Population: Adults ≥18 years with treatment-naive or previously treated unresectable or metastatic grade 1–2 GEP-NETs, advanced, progressive, somatostatin receptor-positive; 49 centres in 14 countries324 enrolled
Participants: 309 adults

Comparison: [177Lu]Lu-edotreotide vs everolimus
[177Lu]Lu-edotreotiden = 207
Everolimusn = 102reference
Primary endpoint: Progression-free survival by blinded independent central review, in all randomly assigned patients
Follow-up: Up to 30 months

Methodological detailsphase 3, multicentre, open-label, superiority, stratified by primary tumour origin and previous therapy, Enrolment April 13, 2017 to June 20, 2022

Phase 3
Multicentre
Open-label
Superiority
Stratified by primary tumour origin and previous therapy
Enrolment April 13, 2017 to June 20, 2022

Primary result

Median progression-free survival

Stratified HR

0.67

95% CI 0.48–0.95

P = 0.022

By group

[177Lu]Lu-edotreotide23.9median · 95% CI 18.7–30.0 · months

Everolimus14.1median · CI 9.2–20.9 · months

[177Lu]Lu-edotreotidevs Everolimus

stratified HR 0.67 (95% CI 0.48–0.95); P = 0.022

As reported in the abstract

Further findings

No treatment-related deaths occurred in either study group

Safety

Treatment-related adverse events · patients who received at least one dose of a study drug

[177Lu]Lu-edotreotide82%

Everolimus97%

n assessed [177Lu]Lu-edotreotide 217 · Everolimus 99

Treatment-related grade 3-4 adverse event (≥1)

[177Lu]Lu-edotreotide18%

Everolimus40%

Outcome	[177Lu]Lu-edotreotide	Everolimus
Most common treatment-related adverse events
Diarrhoea	79 [36%]	45 [45%]
Nausea	79 [36%]	— not stated in the abstract
Asthenia	66 [33%]	36 [36%]
Anaemia	— not stated in the abstract	27 [27%]

— not stated in the abstract

Reference

Authors: Walter T, Jann H, Ansquer C, Deshayes E, Garcia-Carbonero R, Teulé A, et al.
All 30 authors
Walter T, Jann H, Ansquer C, Deshayes E, Garcia-Carbonero R, Teulé A, Baum RP, Verberne HJ, Ćwikła JB, Srirajaskanthan R, de Mestier L, Grana CM, Buck A, Hörsch D, Pavel M, Dierickx LO, Michael M, Strosberg J, Kollár A, Jimenez-Fonseca P, Rinke A, Del Olmo-García M, Flaus A, Hernando J, Kluge A, Breuninger M, Melnyk S, Zhernosekov K, Capdevila J, COMPETE Investigator Team
Journal: The Lancet
Published: 2 Jul 2026
DOI: 10.1016/s0140-6736(26)00604-5
PubMed: 42392118
Registration: NCT03049189

Topic: Endocrine oncology

Intervention details

[177Lu]Lu-edotreotide: intravenous 7.5 ± 0.7 GBq every 3 months, maximum four cycles
Everolimus: oral 10 mg/day for up to 30 months

Key notes

Median follow-up 27.5 months (IQR 19.6-30.4) vs 21.2 months (8.9-29.4)

Original publication

[177Lu]Lu-edotreotide versus everolimus for gastroenteropancreatic neuroendocrine tumours (COMPETE): a phase 3, multicentre, randomised, open-label, superiority trial. Lancet. Published 2 July 2026. doi:10.1016/s0140-6736(26)00604-5

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