drugset / Trial / NCT05459844

A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With GEP-NETs

NCT05459844 ↗

Phase 3 Active not recruiting 196 enrolled Sinotau Pharmaceutical Group
RandomizedParallel-groupOpen-labelTreatment

Summary

This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutetium\[177Lu\] Oxodotreotide Injection to high dose (60 mg) Octreotide LAR in patients with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours.

Timeline

Start
2022-08-31
Primary completion
2024-06-26
Completion
2028-12

Outcome

Met primary endpoint

release “研究表明,在胃肠胰神经内分泌肿瘤患者中,镥[ 177 Lu]氧奥曲肽安全性整体可控,并且与高剂量长效奥曲肽相比,能显著改善PFS。” hengrui.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject 177Lu-DOTATATE Peptide 7400 mbq —
Comparator Octreotide Peptide 60 mg Intramuscular