A Phase 3 interventional study of [177Lu]Lu-DOTA-TATE and Octreotide LAR in Somatostatin Receptor Positive (SSTR+) and Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET), sponsored by Novartis Pharmaceuticals. Recruiting at 67 sites in 12 countries. Open to participants aged 12 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
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Among 30 studies in Gastro-enteropancreatic neuroendocrine tumor with a site in United States — 7 open to participants now, 16 under way, 5 of them phase 3. Gastro-enteropancreatic neuroendocrine tumor · United States.
Among the 30 studies in Gastro-enteropancreatic neuroendocrine tumor with a site in United States, this one is the 6th largest by planned enrollment of the 22 interventional ones that give a count, is one of 4 that started in 2025, is one of 5 in phase 3, reaches primary completion later than 14 of the 15 other live ones, and was the 27th registered.
73 studies on the registry are indexed under Gastro-enteropancreatic neuroendocrine tumor; 25 are open to participants now.
Browse Gastro-enteropancreatic neuroendocrine tumor studies →7 of the 30 studies in Gastro-enteropancreatic neuroendocrine tumor with a site in United States are open now. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in United States
Ages 18–110
RayzeBio, Inc. · Sites in United States, Canada
Ages 18+
Emory University · Sites in United States
Ages 18+
ITM Solucin GmbH · Sites in United States, France, Spain
Ages 24 mo–18 yrs
Methodist Health System · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 21 Gastro-enteropancreatic neuroendocrine tumor studies recruiting now, 13 (62%) set no upper age limit and 4 (19%) stop at 75 or younger; 2 take children under 18; none take healthy volunteers.
This study: 12 Years to 100 Years · all sexes · no healthy volunteers.
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30 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 11 · Phase 3 5
First in 2011; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 240 is above the median of 53 across 49 interventional studies indexed under Gastro-enteropancreatic neuroendocrine tumor.
Median enrollment 21 across the 22 interventional studies, 75 across the 8 observational. Of the 13 that completed or were terminated, 5 (38%) have results posted.
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16 of 30 have an industry lead sponsor. The 10 most frequent:
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Novartis has 7 studies filed under Gastro-enteropancreatic neuroendocrine tumor — fewer than ten, so there is no comparison to draw.
6 of the studies in Gastro-enteropancreatic neuroendocrine tumor with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05050942Phase 3Camurus ABA Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET | 2026-11 |
| NCT05477576Phase 3RayzeBio, Inc.Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy | 2026-12 |
| NCT04919226Phase 3ITM Solucin GmbHLutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE | 2027-06 |
| NCT04609592Stanford UniversityStudy of PRRT in Metastatic, WHO Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery | 2026-11 |
| NCT07165132RayzeBio, Inc.Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs. | 2027-02 |
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Among the 30 studies in Gastro-enteropancreatic neuroendocrine tumor with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
The study consists of a screening phase, a treatment phase and a follow-up phase. This study compares treatment with [177Lu]Lu-DOTA-TATE plus octreotide LAR and octreotide LAR only.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with high disease burden in the Investigator's opinion. Following criteria should be used as the guiding principle for determining high disease burden:
RLI somatostatin receptor (SSTR) uptake on all target lesions (defined by 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:
Adequate bone marrow and organ function as defined by the following laboratory values prior to receiving the first study treatment:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive \[177Lu\]Lu-DOTA-TATE plus Octreotide long-acting release (LAR).
Radiation: [177Lu]Lu-DOTA-TATE · Drug: Octreotide LAR
Participants in this arm will receive Octreotide LAR only.
Drug: Octreotide LAR
\[177Lu\]Lu-DOTA-TATE will be administered 4 times during treatment period with frequency of every 8 weeks (Q8W)
Octreotide LAR will be administered Q8W when co-administered with \[177Lu\]Lu-DOTA-TATE in the investigational arm followed by Q4W. In the control arm Octreotide LAR will be administered Q4W.
Also known as: SOM230
Progression Free Survival (PFS) centrally assessed by Blinded Independent Review Committee (BIRC)
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.
Time frame: After observing approximately 88 PFS events as per BIRC assessments, expected after approximately 33 months from study start
Time to Deterioration (TDD) (Key Secondary)
Time to deterioration is defined as the time from randomization to the first occurrence of a deterioration compared to the baseline scores or death from any cause for each of the following domains (tested separately) of EORTC QLQ-GI.NET21 \[gastrointestinal scale (GI scale)\] and EORTC QLQ-C30 questionnaires (fatigue, diarrhea, and global health scale).
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
Progression Free Survival (PFS)
PFS is defined as the time from randomization to the first occurrence of progression (Investigator assessed according to RECIST v1.1) or death due to any cause.
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
Objective Response Rate (ORR)
ORR: Rate of participants with best overall response (BOR) of partial response (PR) or complete response (CR) as per RECIST v1.1 (both Investigator and centrally assessed by BIRC).
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
Disease Control Rate (DCR)
DCR: Rate of participants with BOR of PR, CR or stable disease (SD) as per RECIST v1.1 (both Investigator and centrally assessed by BIRC).
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
Duration of Response (DOR)
DOR: The time from initially meeting the criteria for response (CR or PR) until the time of progression according to RECIST v1.1 or death due to underlying disease only.
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
Overall Survival (OS)
OS: Time from the randomization date until the date of death due to any cause.
Time frame: Until 60 month from randomization
Time to Deterioration (TDD)
TTD is the time from randomization to the first occurrence of a deterioration compared to the baseline scores or death from any cause for EORTC QLQ-G.I.NET21 and EORTC QLQ-C30 domains not included among key secondary endpoints.
Time frame: At the time of primary PFS analysis after observing approximately 88 PFS events per BIRC assessment
Absolute change from baseline in EORTC QLQ-G.I.NET21 domain
Quality of Life assessed by EORTC QLQ-G.I.NET21 (excluding GI scale) (domains not included as key secondary objectives)
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
Absolute change from baseline in the EQ-5D-5L index at each time point
Quality of Life assessed by EQ-5D-5L
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
Absolute change from baseline in EORTC QLQ-C30 domain
Quality of Life assessed by EORTC QLQ-C30 (domains not included as key secondary objectives)
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start.
Dosimetry
Absorbed radiation dose in selected organs, tumor lesions and total body
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
Pharmacokinetic (PK) parameter: Area Under Curve (AUC) from [177Lu]Lu-DOTA-TATE blood radioactivity data
The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1). The AUC from time zero to infinity (mass x time x volume-1)
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
PK parameter: Clearance from [177Lu]Lu-DOTA-TATE blood radioactivity data
Clearance is the total body clearance of drug from the plasma or blood (volume x time-1).
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
PK parameter: Distribution volume (Vz) from [177Lu]Lu-DOTA-TATE blood radioactivity data
The apparent volume of distribution during terminal phase (associated with λz) (volume)
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
PK parameter: half-life (T1/2) from [177Lu]Lu-DOTA-TATE blood radioactivity data
The elimination half-life associated with the terminal slope (λz) of a semi logarithmic concentration-time curve (time). Use qualifier for other half-lives
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
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Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Data sharing details ↗ · www.clinicalstudydatarequest.com
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Dec 2028, 42 months after the start.
How these figures are worked out, and which studies are left out of them.
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Gastro-enteropancreatic neuroendocrine tumor →