AzTrials
AzTrials

Metastatic Digestive System Neuroendocrine Tumor G1Phase 2NCT05773274

Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial

A Phase 2 study testing Biospecimen Collection, Cabozantinib and Computed Tomography in people with Metastatic Digestive System Neuroendocrine Tumor G1 and Metastatic Digestive System Neuroendocrine Tumor G2, run by National Cancer Institute (NCI) at 42 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase II trial compares the effect of retreatment with 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) to the usual approach of treatment with everolimus, sunitinib, or cabozantinib in patients who have previously received 177Lu-DOTATATE for gastroenteropancreatic neuroendocrine tumor (GEPNET) that… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Cabozantinib and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
42 sitesin 2 countries
Study dates
12 Jan 2024to 30 Apr 2029
Phase
Phase 2
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

  • Patients must be at least >= 18 years of age
  • Metastatic, histologically confirmed grade 1 or 2 well-differentiated gastroenteropancreatic neuroendocrine tumours, including NETs of unknown primary thought to be of gastroenterogancreatic origin, with positive Gallium-68 DOTATATE scan, Copper-64 DOTATATE scan or octreotide scan within the last 12 months is recommended but within the last 36 months is allowed. Lesions on Gallium-68 or Copper-64 DOTATATE scan or octreotide scan will be considered positive if the maximum standardized uptake value (SUVmax) of target lesion is > SUV mean of normal liver parenchyma
  • 7th Edition of the TNM Classification of Malignant Tumours
  • Have received 3 or 4 cycles of PRRT using 177Lu-DOTATATE or a cumulative exposure of 22,200 MBq (600mCi) or 29,600 MBq (800 mCi) within +/- 10% variation within a 52-week period. No previous targeted alpha therapy is permitted
  • Have had radiological progression per RECIST 1.1 after prior PRRT treatment and no sooner than 12 months from last scan performed post completion of initial PRRT where either stable disease, partial response, or complete response has been maintained throughout. Patients may have received previous systemic anti-cancer therapy subsequently, as long as they had benefited from initial PRRT for at least 12 months and have had confirmed progression per RECIST 1.1 on the intervening systemic anti-cancer therapy. Somatostatin analogues (SSA) administered for functional control are not considered an intervening systemic anti-cancer therapy. If intervening systemic anti-cancer therapy included a vascular endothelial growth factor (VEGF)-inhibitor, sunitinib can not be selected as standard of care on Arm 2. If intervening systemic anti-cancer therapy included an mammalian target of rapamycin (mTOR)-inhibitor, then everolimus can not be selected as the standard of care on Arm 2. If the intervening therapy is an alkylating agent, exposure of alkylating agent cannot exceed 12 months. The 12-month limit will also be applied to pre PRRT alkylator use as well
  • Patients may have received previous ablative therapy or bland embolization as liver directed therapy however this must not have been received within 12 weeks from randomization date. Previous chemo and radio embolization are not permitted. Any lesion treated with an ablative technique as well as lesions in the lobe(s) of the liver treated with embolization shall not be included in target lesion assessment unless they have since progressed
Show all 24Show fewer
  • No ongoing toxicity from prior PRRT that is grade 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Hemoglobin >= 80 g/L (>= 8.0 g/dL) (measured within 28 days prior to enrollment)
  • Absolute neutrophil count >= 1.0 x 10^9/L (>= 1000/mm^3) (measured within 28 days prior to enrollment)
  • Platelets >= 80 x 10^9/L (>= 80 x 10^3/mm^3) (measured within 28 days prior to enrollment)
  • Total bilirubin < 1.5 x upper limit of normal (ULN) (upper limit of normal) (measured within 28 days prior to enrollment)
  • If confirmed Gilbert's, eligible providing =< 3.0 x ULN
  • Creatinine clearance > 50 mL/min (measured within 28 days prior to enrollment)
  • Creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by Cockcroft and Gault equation
  • Prior or current use of somatostatin analogues is allowed for carcinoid syndrome control or in PRRT re-treatment patient population (Arm 1). Patients randomized to Arm 2 and receiving everolimus or sunitinib (pancreatic NET patients only) or cabozantinib (US patients only) will not be allowed to continue somatostatin analogues unless they have functional syndrome
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
  • Males and females of reproductive potential must have agreed to use a highly effective contraceptive method during protocol treatment and for 7 months after the last dose of protocol treatment for females and 4 months after the last dose of protocol treatment for males. A woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy/vasectomized partner. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Men should avoid fathering a child for 4 months after the last dose of 177Lu-DOTATATE
  • Women of childbearing potential will have a pregnancy test to determine eligibility as part of the Pre-Study Evaluation; this may include an ultrasound to rule-out pregnancy if a false-positive is suspected. For example, when beta-human chorionic gonadotropin is high and partner is vasectomized, it may be associated with tumour production of human chorionic gonadotropin (hCG), as seen with some cancers. Patient will be considered eligible if an ultrasound is negative for pregnancy
  • Patients must be accessible for treatment, response assessment, and follow up. Patients enrolled on this trial must be treated and followed at the participating center. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
  • Patients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial
  • Patient must have access to everolimus or sunitinib (pancreatic NET patients only) or cabozantinib (US patients only). In the event that site/investigator is unable to provide access to the drug, patient will not be eligible for this trial
  • Human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

Who cannot join

  • Major surgical procedures within 6 weeks from randomization date
  • Known brain metastases, unless these metastases have been treated, stabilized and off steroids for at least 4 weeks prior to enrollment in the study. Patients with a history of brain metastases must have a head CT and/or MRI with contrast to document stable disease prior to enrollment in the study
  • Uncontrolled congestive heart failure no worse than New York Heart Association Class (NYHA) IIB
  • Inability to swallow oral medications or gastrointestinal disease limiting absorption of oral agents
  • Patients with any other significant medical or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study
  • Pregnant women are excluded from this study because 177Lu-DOTATATE is a peptide receptor radionuclide therapy with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 177Lu-DOTATATE, breastfeeding should be discontinued if the mother is treated with everolimus or sunitinib or cabozantinib (US patients only) and for 2.5 months following the last treatment with 177Lu-DOTATATE

Trial locations and contacts

42 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

42 sites in 2 countries

United States35 sites, 33 recruiting

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

    Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu

    Bernard Tawfik

    Recruiting

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

    Site Public Contact, 720-848-0650

    Emily Baiyee-Toegel

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

    Site Public Contact, 954-461-2180

    Gretel Terrero

    Recruiting

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

    Site Public Contact, gingerreeves@uabmc.edu

    Garima Gupta

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    Al B. Benson

    Recruiting

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

    Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Chih-Yi Liao

    Recruiting

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Site Public Contact, 800-293-5066, Jamesline@osumc.edu

    Bhavana Konda

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

    Site Public Contact, 305-243-2647

    Gretel Terrero

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

    Site Public Contact, 305-243-2647

    Gretel Terrero

    Recruiting

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Al B. Benson

    Recruiting

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-6727

    Seema Harichand-Herdt

    Recruiting

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Active, not recruiting

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Al B. Benson

    Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

    Site Public Contact, 855-776-0015

    Patrick W. McGarrah

    Recruiting

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

    Active, not recruiting

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

    Site Public Contact, 305-243-2647

    Gretel Terrero

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Kendall

    Miami, Florida, 33176

    Site Public Contact, 305-243-2647

    Gretel Terrero

    Recruiting

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

    Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Chih-Yi Liao

    Recruiting

  • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

    North Miami, Florida, 33181

    Site Public Contact, kginnity@med.miami.edu

    Gretel Terrero

    Recruiting

  • Northwestern Medicine Oak Brook

    Oak Brook, Illinois, 60523

    Site Public Contact, nctnprogram_rhlccc@northwestern.edu

    Al B. Benson

    Recruiting

  • University of Chicago Medicine-Orland Park

    Orland Park, Illinois, 60462

    Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Chih-Yi Liao

    Recruiting

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054

    Site Public Contact, 855-776-0015

    Patrick W. McGarrah

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

    Site Public Contact, 305-243-2647

    Gretel Terrero

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Site Public Contact, 855-776-0015

    Patrick W. McGarrah

    Recruiting

  • University of Rochester

    Rochester, New York, 14642

    Site Public Contact, 585-275-5830

    Haoming Qiu

    Recruiting

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

    Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu

    Heloisa P. Soares

    Recruiting

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158

    Site Public Contact, 877-827-3222, cancertrials@ucsf.edu

    Aman Chauhan

    Recruiting

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

    Site Public Contact, UACC-IIT@uacc.arizona.edu

    Rachna T. Shroff

    Recruiting

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

    Site Public Contact, UACC-IIT@uacc.arizona.edu

    Rachna T. Shroff

    Recruiting

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Al B. Benson

    Recruiting

  • UI Health Care Mission Cancer and Blood - Waukee Clinic

    Waukee, Iowa, 50263

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

Other trials in United States

Canada7 sites, 7 recruiting

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

    Site Public Contact, 519-685-8600

    David Laidley

    Recruiting

  • Ottawa Hospital and Cancer Center-General Campus

    Ottawa, Ontario, K1H 8L6

    Site Public Contact, 613-761-4395

    Timothy R. Asmis

    Recruiting

  • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)

    Québec, Quebec, G1R 2J6

    Site Public Contact, rechclinique@crchuq.ulaval.ca

    Jean-Mathieu Beauregard

    Recruiting

  • Doctor H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

    Site Public Contact, 709-777-7589

    Renee Lester

    Recruiting

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Site Public Contact, 416-480-5000

    Simron Singh

    Recruiting

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

    Site Public Contact, 888-939-3333

    Jonathan M. Loree

    Recruiting

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

    Site Public Contact, 866-561-1026, ctu_web@cancercare.mb.ca

    Hanbo Zhang

    Recruiting

Other trials in Canada

About this study

Official title: NET RETREAT: A Phase II Study of 177 Lutetium-DOTATATE Retreatment vs. Everolimus or Sunitinib or Cabozantinib in Metastatic/Unresectable Gastroenteropancreatic Neuroendocrine Tumours

This phase II trial compares the effect of retreatment with 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) to the usual approach of treatment with everolimus, sunitinib, or cabozantinib in patients who have previously received 177Lu-DOTATATE for gastroenteropancreatic neuroendocrine tumor (GEPNET) that has spread from where it first started (primary site) to other places in the body (metastatic) and that cannot be removed by surgery (unresectable). PRRT is a type of radiation therapy for which a radioactive chemical is linked to a peptide (small protein) that targets tumor cells. When this radioactive peptide is injected into the body, it binds to a specific receptor found on some tumor cells. The radioactive peptide builds up in these cells and helps kill the tumor cells without harming normal cells. In this trial 177Lu-DOTATATE is used for PRRT. 177Lu-DOTATATE PRRT may increase the length of time until worsening of the GEPNET compared to the usual approach. Everolimus is in a class of medications called kinase inhibitors. It is also a type of angiogenesis inhibitor. Everolimus works by stopping tumor cells from reproducing and by decreasing blood supply to the tumor cells. Sunitinib and cabozantinib, block certain proteins, which may help keep tumor cells from growing. They may also prevent the growth of new blood vessels that tumors need to grow. Sunitinib malate is a type of tyrosine kinase inhibitor and a type of antiangiogenesis agent. Retreating with 177Lu-DOTATATE may work better than everolimus, sunitinib or cabozantinib in shrinking or stabilizing tumors in patients with metastatic and unresectable GEPNET who were previously treated with 177Lu-DOTATATE.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the effect of lutetium Lu 177 dotatate (177Lu-DOTATATE) versus (vs.) everolimus or sunitinib (for pancreatic neuroendocrine [NET] patients only) or cabozantinib (United States [US] patients only) on progression-free survival (PFS) in patients with metastatic/unresectable GEPNET who have progressed following previous peptide receptor radionuclide therapy (PRRT).

SECONDARY OBJECTIVES:

  1. To evaluate the toxicity and safety of 177Lu-DOTATATE and everolimus or sunitinib (for pancreatic neuroendocrine NET patients only) or cabozantinib (US patients only).

II. To determine the effect of 177Lu-DOTATATE vs. everolimus or sunitinib (for pancreatic neuroendocrine NET patients only) or cabozantinib (US patients only) on overall response rate (ORR).

III. To evaluate the effect of 177Lu-DOTATATE vs. everolimus or sunitinib (for pancreatic neuroendocrine NET patients only) or cabozantinib (US patients only) on overall survival (OS).

IV. To evaluate post progression survival (PPS) and time to second objective disease progression (PFS2) for patients randomized to Arm 2 of the study and crossed over to Arm 1 at time of objective progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

  1. To evaluate the effect of 177Lu-DOTATATE vs. everolimus or sunitinib (for pancreatic neuroendocrine NET patients only) or cabozantinib (US patients only) on patient quality of life (QoL).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive 177Lu-DOTATATE intravenously (IV) over 30 minutes every 8 weeks (Q8W). Treatment repeats for two cycles in the absence of disease progression or unacceptable toxicities. Patients also undergo computed tomography (CT) scan and/or magnetic resonance imaging (MRI) and collection of blood samples while on study.

ARM II: Patients receive everolimus orally (PO) on a daily basis (QD), sunitinib PO QD or cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicities. Patients whose cancer worsens may cross over to ARM I. Patients also undergo CT scan and/or MRI and collection of blood samples while on study.

After completion of study treatment, patients are followed up every 12 weeks until objective disease progression and then every 6 months until death.

Being tested
Biospecimen Collection, Cabozantinib, Computed Tomography, Everolimus, Lutetium Lu 177 Dotatate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo collection of blood samples

  • CabozantinibDrug

    Given PO

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • EverolimusDrug

    Also called 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor, Certican, RAD 001

    Given PO

  • Lutetium Lu 177 DotatateDrug

    Also called 177 Lu-DOTA-TATE, 177 Lu-DOTA-Tyr3-Octreotate, 177Lu-DOTA0-Tyr3-Octreotate, Lutathera

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • SunitinibDrug

    Given PO

Study groups in NCT05773274
Study groupRoleWhat they receive
Arm I (177Lu-DOTATATE)ExperimentalPatients receive 177Lu-DOTATATE IV over 30 minutes Q8W. Treatment repeats for two cycles in the absence of disease progression or unacceptable toxicities. Patients also undergo CT scan and/or MRI and collection of blood samples while on study.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Lutetium Lu 177 Dotatate; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm II (everolimus)Active comparatorPatients receive everolimus PO QD, sunitinib PO QD or cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicities. Patients whose cancer worsens may cross over to ARM I. Patients also undergo CT scan and/or MRI and collection of blood samples while on study.
Receives: Procedure: Biospecimen Collection; Drug: Cabozantinib; Procedure: Computed Tomography; Drug: Everolimus; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    The PFS of patients of both treatment groups will be described by Kaplan-Meier method and the median PFS will be estimated using the same method. A one-sided stratified log-rank test adjusting for the stratification factor at randomization will be the primary method to compare the difference in PFS between the experimental and control treatments, at the 5% level. A stratified Cox model adjusting for duration of durable response to the initial peptide receptor radionuclide therapy (durable response >= 24 months versus [vs.] < 24 months) at randomization and with one single treatment covariate will be used to estimate the hazard ratio and associated one-sided 95% confidence interval. Sensitivity analysis adjusting for all three stratification factors at randomization will also be performed.

    Measured: From randomization to any documented evidence of tumour progression or death from any cause, assessed up to 3 years

Secondary outcomes (4)

  1. Overall survival (OS)

    The OS of patients of both treatment groups will be described by Kaplan-Meier method and the median OS will be estimated using the same method. A one-sided stratified log-rank test adjusting for the stratification factor at randomization will be the primary method to compare the difference in OS between the experimental and control treatments, at the 5% level. A stratified Cox model adjusting for the stratification factor at randomization and with one single treatment covariate will be used to estimate the hazard ratio and associated one-sided 95% confidence interval.

    Measured: From randomization to death from any cause, assessed up to 3 years

  2. Objective response rate (ORR)

    Defined as the proportion of patients with a documented complete response and partial response based on Response Evaluation Criteria in Solid Tumors 1.1. The primary estimate of ORR will be based on all patients randomized. A Cochran-Mantel-Haenszel test adjusting for the duration of durable response to the initial peptide receptor radionuclide therapy (durable response >= 24 months vs. < 24 months) at the time of randomization will be used to compare the objective response rates between two arms and sensitivity analysis adjusting for all three stratification factors at randomization will also be performed.

    Measured: Up to 3 years

  3. Post progression survival (PPS)

    Median PPS and associated two-sided 90% confidence interval will be estimated using the Kaplan-Meier method.

    Measured: From objective progression on everolimus to objective progression or death from any cause after cross-over to receive 177Lu-DOTATATE, assessed up to 3 years

  4. Time to second objective disease progression (PFS2)

    Median PFS2 and associated two-sided 90% confidence interval will be estimated using the Kaplan-Meier method.

    Measured: From randomization to objective tumor progression or death from any cause after the cross-over, assessed up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2023
  2. Study start12 Jan 2024
  3. Primary completion30 Apr 2029 (estimated)
  4. Study completion30 Apr 2029 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05773274
Sponsor's protocol ID
NCI-2023-00118
Other IDs
NCI-2023-00118, CCTG-NE1, CCTG-NE1, U10CA180863
Status last verified
May 2026
First submitted
16 Mar 2023
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Cabozantinib and Computed Tomography in people with Metastatic Digestive System Neuroendocrine Tumor G1 and Metastatic Digestive System Neuroendocrine Tumor G2, run by National Cancer Institute (NCI) at 42 sites in 2 countries.

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 24 inclusion and 6 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: From randomization to any documented evidence of tumour progression or death from any cause, assessed up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05773274.

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 16 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in