RECRUITING

Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET

Talk to us

Conditions

Somatostatin Receptor Positive (SSTR+)Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET)SSTR+GEP-NETKi-67 <10%AAA601[177Lu]Lu-DOTA-TATEnewly diagnosedwell differentiatedadvanced GEP-NETshigh disease burdenNETTER-3Grade 1Grade 2Tumor-targeted radioligand therapyRLToctreotide LARGastroenteropancreatice Neuroendocrine TumorPFSQuality of life (QOL)/PROQoLneuroendocrine tumor(s)LutatheraLutetium dotatateLutetium oxodotreotide

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the current study is to evaluate the efficacy and safety of \[177Lu\]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with high disease burden

Official Title

A Phase III Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients Newly Diagnosed With Grade 1 and Grade 2 (Ki-67 <10%) Advanced GEP-NET With High Disease Burden (NETTER-3)

Quick Facts

Study Start:2025-05-29
Study Completion:2034-01-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06784752

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Presence of metastasized or locally advanced, unresectable (curative intent), histologically proven, well differentiated Grade 1 or Grade 2 (Ki-67 \<10%) gastroenteropancreatic neuroendocrine tumor (GEP-NET) diagnosed within 6 months prior to screening.
  2. * Participants with high disease burden in the Investigator's opinion. Following criteria should be used as the guiding principle for determining high disease burden:
  3. * Primary tumor or a metastatic lesion \> 4 cm
  4. * More than one tumor or metastatic lesions measuring \> 2 cm
  5. * Elevated alkaline phosphatase \> 2.5 X upper limit of normal (ULN)
  6. * Presence of bone metastasis
  7. * Presence of peritoneal metastasis
  8. * Symptoms due to tumor volume such as pain, fatigue, weight loss, anorexia etc.
  9. * Symptoms due to hormone excess requiring active management
  10. * Additionally, participants who, in the Investigator's opinion, have high disease burden due to their disease characteristics not specified above could also be considered eligible.
  11. * Participants ≥ 12 years of age.
  12. * RLI somatostatin receptor (SSTR) uptake on all target lesions (defined by RECIST v1.1 criteria) at least as high as normal liver uptake assessed within 3 months prior to randomization. Any of the RLI modalities as available (some examples are listed below) can be used as per local practice:
  13. * \[68Ga\]Ga-DOTA-TOC PET/CT or PET/MRI
  14. * \[68Ga\]Ga-DOTA-TATE PET/CT or PET/MRI
  15. * \[64Cu\]Cu-DOTA-TATE PET/CT or PET/MRI
  16. * Somatostatin receptor scintigraphy (SRS) (planar and/or SPECT/CT) with \[111In\]In-pentetreotide
  17. * SRS (planar and/or SPECT/CT) with \[99mTc\]Tc-octreotide.
  18. * Adequate bone marrow and organ function as defined by the following laboratory values prior to receiving the first study treatment:
  19. * White blood cell (WBC) count ≥ 2 x 109/L
  20. * Platelet count ≥ 75 x 109/L
  21. * Hemoglobin (Hb) ≥ 8 g/dL
  22. * Creatinine clearance \> 40 mL/min calculated by the Cockcroft Gault method
  23. * Total bilirubin ≤ 3 x ULN
  24. * Potassium within normal limits. Potassium level of up to 6.0 millimoles per liter (mmol/L) is acceptable at study entry if associated with creatinine clearance within normal limits calculated using Cockcroft-Gault formula. Mild decrease (grade 1) below lower limit of normal (LLN) is acceptable at study entry if considered not clinically significant by Investigator.
  25. * ECOG performance status 0-1.
  26. * Presence of at least 1 measurable site of disease.
  1. * Prior administration of a therapeutic radiopharmaceutical for GEP-NET at any time prior to randomization in the study.
  2. * Any previous therapy with interferons, mTOR-inhibitors, chemotherapy or other systemic therapies except somatostatin analogues (SSAs) of GEP-NET. If as per Investigator's opinion a participant is candidate for such therapies, such participant must not be enrolled.
  3. * Participant who received more than 4 cycles of prior SSAs (e.g., octreotide long-acting release) are not eligible. In addition, any participant receiving treatment with short-acting octreotide, which cannot be interrupted for 24 h before the administration of \[177Lu\]Lu-DOTA-TATE, or any participant receiving treatment with SSAs, which cannot be interrupted for at least 4 weeks before the administration of \[177Lu\]Lu-DOTA-TATE.
  4. * Documented RECIST v1.1 progression during previous SSA treatments for the current GEP-NET at any time prior to randomization.
  5. * Any previous radioembolization, chemoembolization and radiofrequency ablation for GEP-NET.
  6. * Any major surgery within 12 weeks prior to randomization in the study.
  7. * Known brain metastases.
  8. * Participant with known intolerance to CT scans with intravenous (i.v.) contrast due to allergic reaction or renal insufficiency. If such a participant can be imaged with MRI, then the participant would not be excluded.
  9. * Hypersensitivity to any somatostatin analogues, to the Investigational Medicinal Products (IMPs) active substance or to any of the excipients.
  10. * Active severe urinary incontinence, severe voiding dysfunction, or urinary obstruction requiring an indwelling/condom catheter that, in the judgment of the Investigator, could prevent adhering to radiation safety instructions.

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
+41613241111

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

Highlands Oncology Group
Fayetteville, Arkansas, 72703
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-29
Study Completion Date2034-01-05

Study Record Updates

Study Start Date2025-05-29
Study Completion Date2034-01-05

Terms related to this study

Keywords Provided by Researchers

  • SSTR+
  • GEP-NET
  • Ki-67 <10%
  • AAA601
  • [177Lu]Lu-DOTA-TATE
  • newly diagnosed
  • well differentiated
  • advanced GEP-NETs
  • high disease burden
  • NETTER-3
  • Grade 1
  • Grade 2
  • Tumor-targeted radioligand therapy
  • RLT
  • octreotide LAR
  • Gastroenteropancreatice Neuroendocrine Tumor
  • PFS
  • Quality of life (QOL)/PRO
  • QoL
  • neuroendocrine tumor(s)
  • Lutathera
  • Lutetium dotatate
  • Lutetium oxodotreotide

Additional Relevant MeSH Terms

  • Somatostatin Receptor Positive (SSTR+)
  • Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET)