Recruiting
Phase 3

SSAs vs. Observation

Sponsor:

Washington University School of Medicine

Code:

NCT07842172

Conditions

Neuroendocrine Neoplasm

Gastroenteropancreatic Neuroendocrine Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Somatostatin Analogue(s)

Study Details

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).

Conditions

Neuroendocrine Neoplasm

Gastroenteropancreatic Neuroendocrine Neoplasm

Study ID

NCT07842172

Start date

Nov 2, 2026

Status verified date

Nov, 2026

Completion date

Nov 30, 2034

Anticipated

Primary completion date

Nov 30, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1: Somatostatin Analogue (SSA)

Patients will receive SSA as per standard of care, starting within 3 months after PRRT. SSA administration (route of administration, dosing, and adjustments) is not dictated by this protocol, and SSAs may be given indefinitely.

no intervention: Arm 2: Observation

Patients will be treated according to current standard of care guidelines.

Interventions

Somatostatin Analogue(s)

SSA will be administered according to standard of care guidelines.

Primary outcome measure

  • Progression-free survival (PFS) [ Time Frame: Date of enrollment until disease progression or death from any cause (total estimated time to be 48 months) ]

Central Contacts and Locations

Central contacts

Nikolaos Trikalinos, MD, MS

314-273-4959ntrikalinos@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Nikolaos Trikalinos, MD, MS

314-273-4959ntrikalinos@wustl.edu

Principal Investigator:

Nikolaos Trikalinos, MD, MS

More Information

Sponsor

Washington University School of Medicine

Last update posted

Nov 6, 2026

Last verified

Nov, 2026

Keywords

  • neuroendocrine neoplasm
  • peptide receptor
  • radionuclide therapy
  • carcinoid tumor
  • octreotide
  • lanreotide
  • somatostatin analogues

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-08. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-11-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.