Loading
A phase 3 trial of Lutetium-177 dotatate in pancreatic ductal adenocarcinoma, run by Advanced Accelerator Applications, active and no longer recruiting.
Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET is a phase 3 interventional study registered as NCT03972488 by Advanced Accelerator Applications, with 226 participants enrolled, started 2020-01-08 and due to reach its primary completion in 2023-07-20. Interventions recorded: Lutathera, 30 mg Octreotide long acting repeatable (LAR) (Sandostatin LAR Depot), 2.5% Lys-Arg sterile amino acid solution and High dose 60 mg octreotide long-acting repeatable. Results have been posted on the registry.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
226 enrolled.
95% CI 19.4 to NA; Figures from the ClinicalTrials.gov results section (first posted 2024-10-10), not from a publication · 95% CI 7.7 to 13.8
Source95% CI 35.0 to 51.3; Figures from the ClinicalTrials.gov results section (first posted 2024-10-10), not from a publication · 95% CI 3.8 to 18.3
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression Free Survival (PFS) Per Central Assessmentprimary | Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) | 151 | 22.8 months | 0.276 (0.182 to 0.418) | <0.0001 | link |
| Octreotide LAR 60 mg (Control Arm) | 75 | 8.5 months | ||||
| Overall Response Rate (ORR) Per Central Assessment (Key Secondary) | Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) | 151 | 43% | - | <0.0001 | link |
| Octreotide LAR 60 mg (Control Arm) | 75 | 9.3% |
Shares Dosimetry-personalised PRRT instead of four fixed cycles, Grade 3 well-differentiated neuroendocrine tumour, Small intestinal neuroendocrine tumours, Pancreatic neuroendocrine tumours and the tag pipeline.
Shares Small intestinal neuroendocrine tumours, Pancreatic neuroendocrine tumours, Neuroendocrine tumours and the tag pipeline.
Shares Advanced Accelerator Applications (Novartis), Pancreatic ductal adenocarcinoma and the tag pipeline.
Shares Small intestinal neuroendocrine tumours, Neuroendocrine tumours, Pancreatic ductal adenocarcinoma and the tag pipeline.
Shares Advanced Accelerator Applications (Novartis), Radioligand therapy (beta emitters) and the tag pipeline.
Shares Pancreatic neuroendocrine tumours, Pancreatic ductal adenocarcinoma and the tag pipeline.
Shares Neuroendocrine tumours, Pancreatic ductal adenocarcinoma and the tag pipeline.
Shares Small intestinal neuroendocrine tumours, Neuroendocrine tumours and the tag pipeline.