Table 1.
Systemic treatment | Study identifier | Study title | Study design | Population | Intervention | Primary endpoint |
---|---|---|---|---|---|---|
SSAs | NCT02683941 | SPINET |
Phase 3 Randomized double-blind |
TCs and ACs | Lanreotide + BSC vs PCB + BSC | DCR |
NCT02698410 | ATLANT |
Phase 2 Single arm Open-label |
TCs and ACs | Lanreotide + TMZ | PFS | |
NCT02823691 | MetNET-2 | Early Phase 1 | Advanced GI-NENs and lung carcinoids | Lanreotide + metformin | Safety | |
PRRT | NCT03466216 | – | Phase 1 | SSTRs positive advanced NENs | AlphaMedix™ | Safety and DLT |
NCT03273712 | – |
Phase 2 Single arm Open-label |
SSTRs positive advanced NENs | [Yttrium-90-DOTA]TOC | ORR and safety | |
NCT03454763 | LUTHREE |
Phase 2 Randomized Open-label |
SSTRs positive advanced NENs | [Lutetium-177-DOTA]TATE every 5 week (intensive) vs Lutetium-177-DOTA]TATE every 8–10 week (no intensive) | PFS and safety | |
NCT02754297 | P-PRRT |
Phase 2 Single arm Open-label |
SSTRs positive advanced NENs | [Lutetium-177-DOTA]TOC | ORR | |
Everolimus | NCT03629847 | – |
Phase 1–2 Single arm Open-label |
SSTRs positive advanced NENs | Everolimus + [Lutetium-177-DOTA]TATE | Safety |
NCT03670030 | – |
Phase 2 Single arm Open-label |
Advanced well differentiated NENs | ABI-009 | ORR | |
CHT | NCT02698410 | ATLANT |
Phase 2 Single arm Open-label |
TCs and ACs | Lanreotide + temozolomide | DCR |
NCT03217097 | MGMT-NET |
Phase 4 Randomized Open-label |
Advanced well differentiated lung, duodenopancreatic and unknown origin NENs | Oxaliplatin vs temozolomide | ORR |
TCs typical carcinoids, ACs atypical carcinoids, PCB placebo, BSC best supportive care, TMZ temozolomide, DCR disease control rate, PFS progression free survival, GI gastrointestinal, SSTRs somatostatin receptors, ORR objective response rate, CHT chemotherapy