Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Gra… (NCT06784752) | Clinical Trial Compass
RecruitingPhase 3
Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
United States240 participantsStarted 2025-05-30
Plain-language summary
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
Who can participate
Age range12 Years – 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Participants with high disease burden in the Investigator's opinion. Following criteria should be used as the guiding principle for determining high disease burden:
* Primary tumor or a metastatic lesion \> 4 cm
* More than one tumor or metastatic lesions measuring \> 2 cm
* Elevated alkaline phosphatase \> 2.5 X upper limit of normal (ULN)
* Presence of bone metastasis
* Presence of peritoneal metastasis
* Symptoms due to tumor volume such as pain, fatigue, weight loss, anorexia etc.
* Symptoms due to hormone excess requiring active management
* 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.
* Participants ≥ 12 years of age.
* 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:
* \[68Ga\]Ga-DOTA-TOC PET/CT or PET/MRI
* \[68Ga\]Ga-DOTA-TATE PET/CT or PET/MRI
* \[64Cu\]Cu-DOTA-TATE PET/CT or PET/MRI
* Somatostat…