NCT07842172 Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
| NCT ID | NCT07842172 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Washington University School of Medicine |
| Condition | Neuroendocrine Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2026-11-02 |
| Primary Completion | 2034-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 240 participants in total. It began in 2026-11-02 with a primary completion date of 2034-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * 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. * At least 18 years of age. * ECOG performance status ≤ 2 or Karnofsky ≥ 60% * Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression, as determined by a repeat imaging study at least 4 weeks following the completion of treatment. Patients with treated brain metastases must also be off steroids for at least 1 month and stable. * The effects of ethanol-stabilized Lu-177 dotatate and SSAs on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because radionucleotides and anti-angiogenic agents are known to be teratogenic, people of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months following last administration of PRRT for males and 7 months after last administration of PRRT for females, or 4 months after last day of SSA, whichever is later. * Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants. Exclusion Criteria: * 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. * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to SSAs. * Evidence of hypersensitivity to ethanol containing compounds. * Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 15 days of study entry.
Contact & Investigator
Nikolaos Trikalinos, MD, MS
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT07842172 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neuroendocrine Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07842172 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 240 participants.
Is NCT07842172 currently recruiting?
Yes, NCT07842172 is actively recruiting participants. Contact the research team at ntrikalinos@wustl.edu for enrollment information.
Where is the NCT07842172 trial being conducted?
This trial is being conducted at San Francisco, United States, St Louis, United States.
Who is sponsoring the NCT07842172 clinical trial?
NCT07842172 is sponsored by Washington University School of Medicine. The principal investigator is Nikolaos Trikalinos, MD, MS at Washington University School of Medicine. The trial plans to enroll 240 participants.