In short
Clinical trials are studying Lutetium (177Lu) Oxodotreotide in several cancer types, especially neuroendocrine tumors and meningioma. These studies look at safety, effectiveness, and the best way to use the treatment in adults, adolescents, and children with specific tumor types.
Key points
- Clinical trials of Lutetium (177Lu) Oxodotreotide are studying several cancers, especially neuroendocrine tumors, meningioma, and neuroblastoma. The biggest groups are adults with gastroenteropancreatic neuroendocrine tumors, but some studies also include adolescents and children. The trials range from Phase 1 to Phase 3, so they include early safety studies and larger comparison studies. Main goals include longer progression-free survival, relapse-free survival, disease control, overall survival, and better safety. Some studies also measure radiation dose in organs or tumors and quality of life. The target populations are usually selected by tumor type, disease stage, and somatostatin receptor status.
Trials Overview
The trial data show that Lutetium (177Lu) Oxodotreotide is being studied in many different cancer settings, especially neuroendocrine tumors and meningioma.23 The studies include both early and later trial phases, and they are testing the treatment alone or with other medicines.45
Some trials compare the treatment with standard care, while others focus on dose, safety, radiation exposure, or how well the cancer responds.67 The enrolled groups range from small pediatric studies to larger adult trials.8
Conditions and Patient Groups
Most trials focus on gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including advanced disease, well-differentiated tumors, and tumors with high proliferation rate.91011 Other trials study midgut neuroendocrine tumors, small intestinal neuroendocrine neoplasms, and neuroendocrine tumors in general.1213
Some studies are designed for patients with meningioma, including recurrent or refractory cases, where local treatment options like surgery or radiotherapy are no longer available.1415 Other trials include children and adolescents with neuroblastoma, recurrent or relapsed solid tumors, or adolescent patients with GEP-NETs and pheochromocytoma/paragangliomas.161718
One study also includes adults with extensive stage small cell lung cancer, showing that the research is not limited to one cancer type.19
Trial Phases and Study Designs
The research includes Phase 1, Phase 2, and Phase 3 trials.20 Phase 1 studies are mainly about safety and dose finding, such as the pediatric neuroblastoma trial and the trial in children and adolescents with relapsed solid tumors.2122
Phase 2 trials look at early signs of benefit and safety, including studies in adolescent patients, recurrent meningioma, and retreatment after progression in intestinal neuroendocrine tumor.232425
Phase 3 trials compare the treatment with active comparator or standard care in larger groups, such as studies in advanced GEP-NET, neuroendocrine tumors, and the SAUNA trial.262728
Some trials are randomized, meaning participants are assigned by chance to different study groups.29 Some are open-label, which means both the study team and the participant know which treatment is being given.30
Main Endpoints and What They Mean
Many trials measure progression-free survival (PFS), which is the time before the cancer gets worse or the patient dies.3132 Other studies use relapse-free survival (RFS), which means the time before the cancer comes back after treatment.33
Several trials measure disease control rate (DCR), overall survival, response rate, or time to deterioration in symptoms or quality of life.343536 In some studies, the main outcome is safety, including adverse events, serious adverse events, laboratory toxicities, and dose-limiting toxicities.3738
Some trials also measure absorbed radiation dose in target organs or tumors, which helps researchers understand how the treatment is distributed in the body.3940 Imaging tools such as PET-CT, MRI, and SPECT/CT are used in several studies to assess tumor changes or radiation uptake.4142
Selected Trials by Research Question
Some trials ask whether adjuvant treatment can lower the risk of relapse after surgery or other initial treatment.43 The phase 3 study in stage III small intestinal neuroendocrine neoplasms compares adjuvant treatment with close surveillance and measures relapse-free survival at 60 months.43
Other trials test whether retreatment or a different schedule can help patients with progressing disease. The phase 2 retreatment study in intestinal well-differentiated neuroendocrine tumor compares two additional cycles with active surveillance and measures disease control rate at 6 months.44 The RIALTO study tests a less intensive schedule every 16 weeks in slowly progressive midgut neuroendocrine tumors and focuses on hematological toxicity, which means blood-related side effects.45
Several studies focus on meningioma. One randomized phase 2 trial in recurrent meningioma looks at progression-free survival, and another phase 2b study in grades 2 and 3 refractory meningioma tests whether adding everolimus improves PFS-6.4647
Pediatric research includes a phase 2 study in children with relapsed or refractory high-risk neuroblastoma and a phase 1 study in children with recurrent or refractory neuroblastoma, both focused on response and dose or safety.4849 Another pediatric and adolescent study evaluates the treatment with olaparib in recurrent or relapsed solid tumors and looks at objective tumor response, safety, tolerability, and quality of life.50
One phase 1b/2 study in extensive stage small cell lung cancer combines the treatment with carboplatin, etoposide, and atezolizumab and measures dose-limiting toxicities and overall survival.51
Who Might Qualify
Eligibility depends on the trial, but most studies require a specific diagnosis and disease stage.52 Many trials also require somatostatin receptor positive disease, which means the tumor has a feature that can be seen on certain scans and helps identify patients for these studies.53
Some studies are for adults only, while others are for adolescents or children.54 A few studies also require that patients have no local treatment options left, or that their disease has already come back or progressed after earlier treatment.55
Patient-Friendly Terms
Randomization means a computer or chance decides which study group a person joins.56 Active comparator means the new treatment is compared with another treatment already being used.57
Objective tumor response means the study team checks whether the tumor shrinks, stays stable, or grows on scans.58 Quality of life means how the treatment affects daily life, symptoms, and overall well-being.59
Laboratory toxicities are changes in blood tests or other lab tests that may show the body is reacting to treatment.60 Dose-limiting toxicities are side effects that are serious enough to limit how much treatment can be given.61