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Retreatment with Lutathera® for patients with progressing intestinal neuroendocrine tumors

A Prospective Randomized Phase II Study Assess the Schema of Retreatment With Lutathera® ([177LU]LU-DOTA-TATE) in Patients With New Progression of Intestinal Well-differenciated Neuroendocrine Tumor

PHASE2 · Institut du Cancer de Montpellier - Val d'Aurelle · NCT04954820

This study is testing if giving more doses of Lutathera® to patients with progressing intestinal neuroendocrine tumors can help them live longer without their cancer getting worse, compared to just keeping an eye on their condition.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment146 (estimated)
Ages18 Years and up
SexAll
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle (other)
Drugs / interventionsradiation
Locations28 sites (Angers and 27 other locations)
Trial IDNCT04954820 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of retreating patients with intestinal well-differentiated neuroendocrine tumors using Lutathera® after they have previously received four cycles of the treatment. Participants who show disease progression after their initial treatment will be randomized to receive either two additional cycles of Lutathera® or undergo active surveillance. The study aims to determine if these additional cycles can improve progression-free survival compared to monitoring without further treatment. The trial is conducted in France and involves multiple cancer treatment centers.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed G1 or G2 intestinal neuroendocrine tumors who have previously benefited from Lutathera® treatment.

Not a fit: Patients who have not previously received Lutathera® or those with non-resectable tumors that do not express somatostatin receptors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide patients with a new option for managing disease progression after initial Lutathera® therapy.

How similar studies have performed: Previous studies have shown promising results for retreatment with Lutathera®, indicating potential efficacy in similar patient populations.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age ≥ 18 years,
* Histologically proven intestinal G1 or G2 neuroendocrine tumors (NET),
* Patient previously treated with 4 cycles of Lutathera® (defined as "First PRRT"),
* Disease control after "First PRRT" ≥ 12 months,
* Patient presenting a progression of disease (clinic, biologic and/or radiologic) after a first PRRT,
* Decision of retreatment with Lutathera® (defined as "Second PRRT") validated by RENATEN and/or multidisciplinary tumor board and in the scope of the French reimbursement process,
* ECOG performance status 0-2,
* Life expectancy ≥ 6 months as prognosticated by the physician,
* Somatostatin receptor imaging positive imaging (SSTRi+) disease within 4 months prior to inclusion : (may be PET imaging (68Ga-based SSTR analogues) or scintigraphy imaging: 111In-pentetreotide or 99mTc-octreotide. At least 90% of lesions must be positive for SSTRi with a significant uptake (\>= liver of surrounding tissue),
* Measurable disease per RECIST 1.1 (Appendix 1), on CT/MRI scans, defined as at least 1 lesion with ≥ 1 cm in longest diameter, and ≥ 2 radiological tumors lesions in total,
* Adequate bone marrow reserve (Hb \> 8 g/dl, neutrophils ≥ 1500/mm³ and platelets ≥ 80 000/mm³),
* Negative pregnancy test in women of childbearing potential (the β-HCG dosage must be ≤ 4 days before inclusion). Women who have no reproductive potential are postmenopausal women or women who have had permanent sterilization, eg. tubal occlusion, hysterectomy, bilateral salpingectomy),
* Effective contraception in men or women of childbearing or pre-menopausal age and up to a minimum of 6 months following the end of treatment,
* Patient´s signed written informed consent,
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,
* Affiliation to the French Social Security System

Exclusion Criteria:

* Patient who did not respond (no CR, PR or SD) to "first PRRT".
* Radiological progression after two cycles of "Second PRRT" according to RECIST version 1.1,
* Grade 4 hematotoxicity and/or nephrotoxicity during the initial PRRT, or unresolved AEs categorized as Grade 2 or higher (as per Common Terminology Criteria for Adverse Events (CTCAE v5.0) from previous PRRT cycles or any other therapy for NET, excluding alopecia and peripheral neuropathy,
* Pancreatic NET,
* NeuroEndocrine Carcinoma,
* Prior external beam radiation therapy to more than 25% of the bone marrow,
* Severe renal (estimated Glomerular Filtration Rate (GFR) according to Modification of Diet in Renal Disease (MDRD) \< 40 mL/min or nephrotic syndrome) or hepatic insufficiency (Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \> 2.5 x ULN or ALT/AST \> 5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin \> 2.5 x ULN),
* Serum albumin \< 3.0 g/dL unless prothrombin time is within the normal range,
* Uncontrolled diabetes mellitus as defined by a fasting blood glucose above 2 ULN,
* Uncontrolled decompensated heart failure, myocardial infarction uncontrolled, stroke, pulmonary embolism or revascularization procedure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months,
* Hypertension that cannot be controlled despite medications (≥ 160/95 mmHg despite optimal medical therapy)
* Brain metastases (unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrolment in the study. Patients with a history of brain metastases must have a head CT scan with contrast or MRI to document stable disease prior to enrolment in the study),
* Pregnancy or breast feeding,
* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results,
* Known hypersensitivity to any of the study drugs, study drug classes, or any constituent of the products,
* Concomitant participation or participation within the last 30 days in another clinical trial,
* History of other solid tumor in 5 years before the inclusion excepted of cancer in situ of the cervix and skin cancer (basal or squamous cell) treated and controlled.
* Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.

Where this trial is running

Angers and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Neuroendocrine Tumors, Intestinal Well Differentiated Endocrine Tumor, Progressive Disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.