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Somatostatin Analog
Lutathera for Neuroendocrine Tumors (NETTER-2 Trial)
Phase 3
Waitlist Available
Research Sponsored by Advanced Accelerator Applications
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky Performance Score (KPS) ≥ 60
Expression of somatostatin receptors on all target lesions documented by CT/MRI scans, assessed by any of the following somatostatin receptor imaging (SRI) modalities within 3 months prior to randomization: [68Ga]-DOTA-TOC (e.g. Somakit-TOC®) PET/CT (or MRI when applicable based on target lesions) imaging, [68Ga]-DOTA-TATE PET/CT (or MRI when applicable based on target lesions) imaging (e.g. NETSPOT®), Somatostatin Receptor scintigraphy (SRS) with [111In]-pentetreotide (Octreoscan® SPECT/CT), SRS with [99mTc]-Tektrotyd, [64Cu]-DOTA-TATE PET/CT (or MRI when applicable based on target lesions) imaging.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years from randomization of last patient
Awards & highlights
NETTER-2 Trial Summary
This trial is testing a new cancer drug to see if it can help treat a certain type of tumor.
Who is the study for?
This trial is for adults and adolescents (15 years or older, over 40 kg) with advanced Grade 2 or Grade 3 gastroenteropancreatic neuroendocrine tumors (GEP-NET), diagnosed within the last 6 months. Participants must have a certain level of tumor cell proliferation (Ki67 index ≥10 and ≤55%), express somatostatin receptors on all target lesions, and have a Karnofsky Performance Score of at least 60. Pregnant women, those unable to use effective contraception, or patients who've had certain prior treatments are excluded.Check my eligibility
What is being tested?
The NETTER-2 study tests whether Lutathera combined with long-acting octreotide can extend the time without disease progression in GEP-NET patients compared to high-dose long-acting octreotide alone. It's designed for first-line treatment; some participants may cross over to Lutathera after progression or receive re-treatment.See study design
What are the potential side effects?
Lutathera could cause nausea, vomiting, fatigue, low blood counts leading to increased infection risk or bleeding problems. Kidney damage and liver toxicity are also possible side effects. Long-term risks include secondary cancers due to radiation exposure.
NETTER-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may need occasional help.
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My scans show my cancer has somatostatin receptors.
Select...
My scans show my cancer has somatostatin receptors.
Select...
I have at least one tumor that can be measured.
Select...
I am 15 years or older and weigh more than 40 kg.
NETTER-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years from randomization of last patient
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years from randomization of last patient
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
Objective Response Rate
+4 moreNETTER-2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Lutathera plus long-acting octreotideExperimental Treatment3 Interventions
Group II: high dose long-acting octreotideActive Control3 Interventions
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Who is running the clinical trial?
Advanced Accelerator ApplicationsLead Sponsor
35 Previous Clinical Trials
2,721 Total Patients Enrolled
9 Trials studying Neuroendocrine Tumors
1,500 Patients Enrolled for Neuroendocrine Tumors
Novartis PharmaceuticalsStudy DirectorNovartis Pharmaceuticals
2,153 Previous Clinical Trials
4,011,093 Total Patients Enrolled
26 Trials studying Neuroendocrine Tumors
2,903 Patients Enrolled for Neuroendocrine Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My GEP-NET tumor is advanced, cannot be removed by surgery, and was diagnosed within the last 6 months.My potassium levels are high and not corrected before joining the study.My GEP-NET tumor is advanced, cannot be removed by surgery, and was diagnosed within the last 6 months.My heart functions well enough for the trial, with an ejection fraction of 40% or higher.My brain metastases have been stable for at least 24 weeks.I can care for myself but may need occasional help.I haven't taken Interferons, Everolimus, chemotherapy, or other systemic therapies for my GEP-NET in the last 3 months.My scans show my cancer has somatostatin receptors.I am using effective birth control if I can become pregnant and will continue for 6 months after the study ends.My scans show my cancer has somatostatin receptors.My current tumor has grown despite previous treatments.I have undergone PRRT treatment before joining this study.My kidney function is reduced, with a creatinine clearance below 40 mL/min.I have not had any surgery in the last 12 weeks.I experience involuntary urine leakage.I have at least one tumor that can be measured.I've had radiation therapy to over a quarter of my bone marrow.I am not on octreotide or similar drugs that can't be paused for Lutathera treatment.I am 15 years or older and weigh more than 40 kg.I do not have any uncontrolled health issues that could affect my participation.I have no other cancers except for certain skin cancers or treated cervical cancer with no signs of return in 5 years.I have had treatments like radioembolization for my neuroendocrine tumor.
Research Study Groups:
This trial has the following groups:- Group 1: high dose long-acting octreotide
- Group 2: Lutathera plus long-acting octreotide
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any severe dangers associated with Lutathera?
"Lutathera is a phase 3 trial medication, meaning that it has undergone some efficacy testing and multiple rounds of safety testing. Therefore, our team rates its safety at a 3."
Answered by AI
Why is Lutathera prescribed to patients?
"octreotide is often administered Lutathera. However, Lutathera has also been found to be effect against other conditions like acromegaly, metastatic carcinoid tumors, and diarrhea."
Answered by AI
Are patients still being enrolled in this clinical trial?
"Yes, this is accurate. The information available on clinicaltrials.gov suggests that this particular trial is not recruiting patients at the moment. However, there are 208 other trials that are still looking for participants."
Answered by AI
What other research has there been on Lutathera?
"5 out of the 38 clinical trials currently underway for Lutathera are in Phase 3. Many research facilities for this drug are based in Columbus, Ohio but there are a total 894 locations running these types of tests."
Answered by AI
How many people are being asked to participate in this clinical trial?
"As of October 4th, 2022, this study is no longer recruiting patients. It was initially posted on 1/22/2020. If you are looking for other active trials, there are 170 and 38 respectively for gastro entero pancreatic neuroendocrine tumors and Lutathera."
Answered by AI
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