Study of [177Lu]Lu-DOTA-TATE for Advanced GEP-NET
This study is testing a treatment called [177Lu]Lu-DOTA-TATE, given with octreotide LAR, against octreotide LAR alone. It's for people newly diagnosed with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs), which are a type of cancer that starts in the digestive system. To join, you need to have Grade 1 or Grade 2 GEP-NETs that have spread or cannot be removed by surgery, and your tumor cells must have a specific protein called a somatostatin receptor (SSTR+). The main goal is to see if the combination treatment helps people live longer without their cancer getting worse. The study is currently recruiting patients.
- Study design
- This interventional study plans to enroll 240 participants and compares two treatment approaches.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed after treatment to assess progression-free survival, expected for approximately 33 months from the study start.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06784752
Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
Recruiting
PHASE3Ages 12+InterventionalTreatmentNovartis Pharmaceuticals
~240 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:[177Lu]Lu-DOTA-TATEOctreotide LAR
At a glance
Recruiting sites
64 of 65 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS) centrally assessed by Blinded Independent Review Committee (BIRC)
Measured over After observing approximately 88 PFS events as per BIRC assessments, expected after approximately 33 months from study start
Conditions
Where it's being run
65 sites across 36 statesFrance6
Poland6
Spain5
China4
Virginia3
Germany3
South Korea3
Connecticut2
Study leadership
- Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Somatostatin receptor scintigraphy (SRS) (planar and/or SPECT/CT) with \[111In\]In-pentetreotide
SRS (planar and/or SPECT/CT) with \[99mTc\]Tc-octreotide.
Adequate bone marrow and organ function as defined by the following laboratory values prior to receiving the first study treatment:
White blood cell (WBC) count ≥ 2 x 109/L
Platelet count ≥ 75 x 109/L
Hemoglobin (Hb) ≥ 8 g/dL
Creatinine clearance \> 40 mL/min calculated by the Cockcroft Gault method
Total bilirubin ≤ 3 x ULN
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.
ECOG performance status 0-1.
Presence of at least 1 measurable site of disease.
Exclusion
Prior administration of a therapeutic radiopharmaceutical for GEP-NET at any time prior to randomization in the study.
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.
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.
Documented RECIST v1.1 progression during previous SSA treatments for the current GEP-NET at any time prior to randomization.
Any previous radioembolization, chemoembolization and radiofrequency ablation for GEP-NET.
Any major surgery within 12 weeks prior to randomization in the study.
Known brain metastases.
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.
Hypersensitivity to any somatostatin analogues, to the Investigational Medicinal Products (IMPs) active substance or to any of the excipients.
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.
What this trial measures
- Progression Free Survival (PFS) centrally assessed by Blinded Independent Review Committee (BIRC)After observing approximately 88 PFS events as per BIRC assessments, expected after approximately 33 months from study start
PFS is defined as the time from randomization to the first occurrence of progression (centrally assessed by Blinded Independent Review Committee (BIRC) according to RECIST v1.1) or death due to any cause.