Comparing [177Lu]Lu-DOTA-TATE with Octreotide LAR for somatostatin receptor positive (SSTR+)
Official title: Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
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)
- Phase 3
- 2 groups
- Sites in Edmonton, London and 2 more cities
- Recruiting
Interventions
- Radiation therapy
[177Lu]Lu-DOTA-TATE
\[177Lu\]Lu-DOTA-TATE will be administered 4 times during treatment period with frequency of every 8 weeks (Q8W)
- Medication
Octreotide LAR
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.
Canadian Sites (4)
4 of 4 recruiting
- Recruiting
Novartis Investigative Site
Edmonton, Alberta
- Recruiting
Novartis Investigative Site
London, Ontario
- Recruiting
Novartis Investigative Site
Toronto, Ontario
- Recruiting
Novartis Investigative Site
Montreal, Quebec
Eligibility Criteria
See who this study is looking for37 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +Participants with high disease burden in the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →. 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.
- +Presence of at least 1 measurable siteTrial siteA hospital or clinic where a study is actually run.Read more → of disease.
- +ECOG performance status 0-1.
Exclusion
- −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.
- −Known brain metastases.
- −Prior administration of a therapeutic radiopharmaceutical for GEP-NET at any time prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → in the study.
- −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.
- −Other protocolProtocolThe detailed plan a study must follow.Read more →-defined InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → may apply.
- −Any previous therapy with interferons, mTOR-inhibitors, chemotherapy or other systemic therapies except somatostatin analogues (SSAs) of GEP-NET. If as per InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion a participant is candidate for such therapies, such participant must not be enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more →.
- −Any major surgery within 12 weeks prior to randomization in the study.
- −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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives [177Lu]Lu-DOTA-TATE and Octreotide LAR.
Registry label: A: [177Lu]Lu-DOTA-TATE + Octreotide LAR
Group B, the comparison group, receives Octreotide LAR.
Registry label: B: Octreotide LAR
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 12 years to 100 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 240 people.
The study is currently expected to finish around January 2034.
The main measurement is taken over: After observing approximately 88 PFS events as per BIRC assessments, expected after approximately 33 months from study start.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
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.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06784752 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About [177Lu]Lu-DOTA-TATERadiation
\[177Lu\]Lu-DOTA-TATE will be administered 4 times during treatment period with frequency of every 8 weeks (Q8W)
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
About Octreotide LARDrug
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.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 12 years to 100 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 12 years to 100 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: After observing approximately 88 PFS events as per BIRC assessments, expected after approximately 33 months from study start.
The study as a whole is currently expected to finish around 2034-01-23.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 240 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 7 locations, including: Edmonton, Alberta, Canada; London, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Detroit, Michigan, United States; New York, New York, United States, and 1 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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
Other Sites (3)
Henry Ford Hospital
Detroit, Michigan, United States
Mount Sinai Medical Center
New York, New York, United States
Northwest Medical Specialties
Tacoma, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.