The OCLURANDOM trial

In this video, Prof Dr Ivan Borbath, digestive oncologist at the Cliniques Universitaires Saint-Luc in Brussels discusses the updated results of the OCLURANDOM trial as presented during the 2025 annual ENETS meeting in Krakow.

OCLURANDOM is a French, academic, randomized phase II trial comparing ¹⁷⁷Lu-Dota-Octreotate to sunitinib in previously treated patients with an unresectable, well-differentiated, pancreatic neuroendocrine tumor (PanNET). Patients who previously received a tyrosine kinase inhibitor (TKI), or peptide receptor radionuclide therapy (PRRT) were excluded from the study. One prior line of chemotherapy was allowed. In total, 84 patients were randomly assigned to receive ¹⁷⁷Lu-Dota-Octreotate (7.4 GBq per injection with a maximum of 4 injections), or sunitinib (37.5 mg QD). About 80% of these patients had grade 2 or 3 disease, 37% had a Ki-67 index >10% and about 40% received 2 or more prior lines of therapy. Just short of 60% of patients previously received chemotherapy. 

Earlier reports of this study showed a significantly higher 12-month PFS rate among patients treated with ¹⁷⁷Lu-Dota-Octreotate compared to sunitinib (80.5% vs. 41.9%). An update of the PFS data at ENETS 2025 indicated a median PFS of 20.7 months in the ¹⁷⁷Lu-Dota-Octreotate arm as compared to 11 months in sunitinib-treated patients. This PFS benefit does not (yet) translate into a benefit in OS, with a median of 55.8 months for ¹⁷⁷Lu-Dota-Octreotate as compared to 64.4 months with sunitinib. The updated results of OCLURANDOM also show an impressive benefit in ORR for ¹⁷⁷Lu-Dota-Octreotate compared to sunitinib with an ORR of 63% and 30%, respectively. 

¹⁷⁷Lu-Dota-Octreotate also outperformed sunitinib in terms of safety, with 56% of patients in the ¹⁷⁷Lu-Dota-Octreotate arm reporting to be free from all side effects at week 36 as compared to 13% in the sunitinib arm. Overall, the incidence of grade ≥3 adverse events was reported at 56% with ¹⁷⁷Lu-Dota-Octreotate as compared to 72% with sunitinib. This lower rate of adverse events also translated into a better quality of life for patients treated with ¹⁷⁷Lu-Dota-Octreotate, reflected by a 10-point average difference in global health status score for patients treated with ¹⁷⁷Lu-Dota-Octreotate compared to sunitinib.

In conclusion, these updated results of OCLURANDOM further support the use of PRRT in the treatment of patients with previously treated Grade 2/3 GEP-NETs.