This is a multicenter, randomized, open-label, phase III study comparing standard of care use of somatostatin analogues (SSAs) to standard of care observation in patients with neuroendocrine neoplasms following treatment with Peptide Receptor Radionuclide Therapy (PRRT) (ethanol-stabilized Lu-177 dotatate).
Histologically or cytologically confirmed metastatic, unresectable, well- or moderately-differentiated, nonfunctional gastrointestinal neuroendocrine tumor (GI-NETs). This includes pancreatic neuroendocrine neoplasms. Any grade (grade 1, grade 2, or grade 3) is permitted.
Measurable disease per RECIST 1.1.
Appropriate for ethanol-stabilized Lu-177 dotatate treatment, as determined by positive screening with SSTR PET/CT and/or currently having received up to 3 fractions of PRRT. (Patients will be randomized prior to the start of PRRT or during PRRT, depending on the timing of enrollment.)
Eligible for somatostatin analogue treatment per the treating physician.
Completed prior treatment with PRRT for non-GI-NET diagnosis (i.e. in need of salvage PRRT treatment).
Major surgery within 4 weeks from randomization to the trial.
Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
Currently receiving any investigational agents.
Parallel
Somatostatin Analogue(s)
DrugSSA will be administered according to standard of care guidelines.
Progression-free survival (PFS)
PFS is defined as the time from date of study enrollment to disease progression or death from any cause, whichever occurs first. The alive patients without progression or the dropouts, are censored at the last follow-up.
Overall Response Rate (ORR)
ORR is defined as the proportion of patients with Complete Response (CR) or Partial Response (PR). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Overall Survival (OS)
OS is defined as the time from the date of treatment to the date of death. The alive patients or the dropouts will be censored at the last follow-up otherwise.
Incidence of adverse events (AEs) as assessed by CTCAE v6.0
This subset of events consists of all grade 3 or greater events as well as any events (even if \< grade 3) that result in discontinuation of SSAs.
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Washington University School of Medicine
Lead sponsor
Curium US LLC
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
