Neuroendocrine NeoplasmPhase 3REMAINNCT07842172
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
A Phase 3 study testing Somatostatin Analogue(s) in people with Neuroendocrine Neoplasm and Gastroenteropancreatic Neuroendocrine Neoplasm, run by Washington University School of Medicine at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Neoplasm
- What is being tested?
- Somatostatin Analogue(s)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Nov 2026to 30 Nov 2034
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University of California - San Francisco
San Francisco, California, 94143
Thomas Hope, MD, 415-476-1000
Thomas Hope, MD
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Nikolaos Trikalinos, MD, MS, 314-273-4959, ntrikalinos@wustl.edu
Nikolaos Trikalinos, MD, MS
About this study
Official title: Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Nonfunctional Neuroendocrine Neoplasms (REMAIN Trial)
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).
- Being tested
- Somatostatin Analogue(s)
- Keywords
- neuroendocrine neoplasm, peptide receptor, radionuclide therapy, carcinoid tumor, octreotide, lanreotide, somatostatin analogues
- Medical subject headings
- Neuroendocrine Tumors, Carcinoid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatostatin Analogue(s)Drug
Also called SSA
SSA will be administered according to standard of care guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Somatostatin Analogue (SSA) | Experimental | 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. Receives: Drug: Somatostatin Analogue(s) |
| Arm 2: Observation | No intervention | Patients will be treated according to current standard of care guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Date of enrollment until disease progression or death from any cause (total estimated time to be 48 months)
Secondary outcomes (3)
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.
Measured: Start of treatment until completion of follow up (total estimated time 48 months)
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.
Measured: Start of treatment until death (total estimated time 48 months)
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.
Measured: Start of treatment until completion of follow up (total estimated time 48 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start2 Nov 2026
- Primary completion30 Nov 2034 (estimated)
- Study completion30 Nov 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine NeoplasmStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Curium US LLC
- Responsible party
- Sponsor
- Investigators
- Nikolaos Trikalinos, MD, MS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842172
- Sponsor's protocol ID
- 202609062
- Acronym
- REMAIN
- Status last verified
- Nov 2026
- First submitted
- 20 Sep 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Nonfunctional Neuroendocrine Neoplasms (REMAIN Trial)
- ClinicalTrials.gov ID
- NCT07842172
- Acronym / sponsor ID
- REMAIN / 202609062
- Keywords
- neuroendocrine neoplasm, peptide receptor, radionuclide therapy, carcinoid tumor, octreotide, lanreotide, somatostatin analogues
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Curium US LLC
- Study start
- 2 Nov 2026 (actual)
- Primary completion
- 30 Nov 2034 (estimated)
- Study completion
- 30 Nov 2034 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Somatostatin Analogue (SSA) | Experimental | Drug: Somatostatin Analogue(s)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. |
| Arm 2: Observation | No intervention | –Patients will be treated according to current standard of care guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatostatin Analogue(s)Also: SSASSA will be administered according to standard of care guidelines. | Drug | Arm 1: Somatostatin Analogue (SSA) |
Primary outcome
Progression-free survival (PFS)
Time frame: Date of enrollment until disease progression or death from any cause (total estimated time to be 48 months)
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.
3 secondary outcomes
Overall Response Rate (ORR)
Time frame: Start of treatment until completion of follow up (total estimated time 48 months)
Overall Survival (OS)
Time frame: Start of treatment until death (total estimated time 48 months)
Incidence of adverse events (AEs) as assessed by CTCAE v6.0
Time frame: Start of treatment until completion of follow up (total estimated time 48 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nikolaos Trikalinos, MD, MS principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Somatostatin Analogue(s) in people with Neuroendocrine Neoplasm and Gastroenteropancreatic Neuroendocrine Neoplasm, run by Washington University School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikolaos Trikalinos, MD, MS (314-273-4959, ntrikalinos@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.