Actively Recruiting
Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
Led by Novartis Pharmaceuticals · Updated on 2026-04-30
240
Participants Needed
65
Research Sites
451 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Metastasized or locally advanced, unresectable, well differentiated Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumor diagnosed within 6 months before screening
- High disease burden based on investigator's opinion, including criteria such as tumor or metastatic lesion >4 cm, more than one lesion >2 cm, elevated alkaline phosphatase >2.5 times upper limit of normal, bone or peritoneal metastasis, symptoms from tumor volume or hormone excess
- Age 12 years or older
- Somatostatin receptor uptake on all target lesions at least as high as normal liver uptake assessed within 3 months before randomization
- Adequate bone marrow and organ function with specified blood counts and kidney and liver tests
- ECOG performance status of 0 or 1
- At least one measurable site of disease
You will not qualify if you...
- Prior therapeutic radiopharmaceutical treatment for GEP-NET before randomization
- Previous therapy with interferons, mTOR-inhibitors, chemotherapy, or other systemic therapies except somatostatin analogues
- More than 4 cycles of prior somatostatin analogue treatment or inability to interrupt short-acting or long-acting octreotide before study treatment
- Documented disease progression during previous somatostatin analogue treatments
- Previous radioembolization, chemoembolization, or radiofrequency ablation for GEP-NET
- Major surgery within 12 weeks before randomization
- Known brain metastases
- Known intolerance to CT scans with intravenous contrast unless MRI can be used
- Hypersensitivity to somatostatin analogues, investigational drug components, or excipients
- Severe urinary conditions preventing adherence to radiation safety instructions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 65 locations
1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
Actively Recruiting
3
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
Actively Recruiting
4
Hartford Hospital
Hartford, Connecticut, United States, 06102
Actively Recruiting
5
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
Actively Recruiting
6
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
7
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
St Elizabeth Healthcare
Edgewood, Kentucky, United States, 41017
Actively Recruiting
9
LSU Medical Center
New Orleans, Louisiana, United States, 70112
Actively Recruiting
10
Henry Ford Hospital
Detroit, Michigan, United States, 48202-2689
Actively Recruiting
11
Mount Sinai Medical Center
New York, New York, United States, 10029-6574
Actively Recruiting
12
Piedmont Healthcare
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
13
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
14
TxO Austin Midtown
Austin, Texas, United States, 78705
Active, Not Recruiting
15
Texas Oncology
Dallas, Texas, United States, 75251
Actively Recruiting
16
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
17
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
18
Blue Ridge Cancer Center
Wytheville, Virginia, United States, 24382
Actively Recruiting
19
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Actively Recruiting
20
Novartis Investigative Site
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
21
Novartis Investigative Site
London, Ontario, Canada, N6A 5W9
Actively Recruiting
22
Novartis Investigative Site
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
23
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
24
Novartis Investigative Site
Beijing, China, 100036
Actively Recruiting
25
Novartis Investigative Site
Beijing, China, 100730
Actively Recruiting
26
Novartis Investigative Site
Beijing, China, 102200
Actively Recruiting
27
Novartis Investigative Site
Shanghai, China, 200032
Actively Recruiting
28
Novartis Investigative Site
Bron, France, 69677
Actively Recruiting
29
Novartis Investigative Site
Clichy, France, 92110
Actively Recruiting
30
Novartis Investigative Site
Montpellier, France, 34298
Actively Recruiting
31
Novartis Investigative Site
Nantes, France, 44093
Actively Recruiting
32
Novartis Investigative Site
Pessac, France, 33604
Actively Recruiting
33
Novartis Investigative Site
Toulouse, France, 31059
Actively Recruiting
34
Novartis Investigative Site
Erlangen, Germany, 91054
Actively Recruiting
35
Novartis Investigative Site
Essen, Germany, 45147
Actively Recruiting
36
Novartis Investigative Site
München, Germany, 80377
Actively Recruiting
37
Novartis Investigative Site
Budapest, Hungary, H-1083
Actively Recruiting
38
Novartis Investigative Site
Szeged, Hungary, 6725
Actively Recruiting
39
Novartis Investigative Site
Cona, FE, Italy, 44124
Actively Recruiting
40
Novartis Investigative Site
Genova, GE, Italy, 16132
Actively Recruiting
41
Novartis Investigative Site
Milan, MI, Italy, 20133
Actively Recruiting
42
Novartis Investigative Site
Rozzano, MI, Italy, 20089
Actively Recruiting
43
Novartis Investigative Site
Pisa, PI, Italy, 56126
Actively Recruiting
44
Novartis Investigative Site
Roma, RM, Italy, 00168
Actively Recruiting
45
Novartis Investigative Site
Roma, RM, Italy, 00189
Actively Recruiting
46
Novartis Investigative Site
Milan, Italy, 20141
Actively Recruiting
47
Novartis Investigative Site
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
48
Novartis Investigative Site
Utrecht, Netherlands, 3584 CX
Actively Recruiting
49
Novartis Investigative Site
Gdansk, Poland, 80-214
Actively Recruiting
50
Novartis Investigative Site
Gliwice, Poland, 44 101
Actively Recruiting
51
Novartis Investigative Site
Krakow, Poland, 30-688
Actively Recruiting
52
Novartis Investigative Site
Poznan, Poland, 60-355
Actively Recruiting
53
Novartis Investigative Site
Warsaw, Poland, 02-351
Actively Recruiting
54
Novartis Investigative Site
Warsaw, Poland, 04-141
Actively Recruiting
55
Novartis Investigative Site
Seoul, South Korea, 03080
Actively Recruiting
56
Novartis Investigative Site
Seoul, South Korea, 03722
Actively Recruiting
57
Novartis Investigative Site
Seoul, South Korea, 05505
Actively Recruiting
58
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Actively Recruiting
59
Novartis Investigative Site
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
60
Novartis Investigative Site
Barcelona, Spain, 08035
Actively Recruiting
61
Novartis Investigative Site
Madrid, Spain, 28034
Actively Recruiting
62
Novartis Investigative Site
Madrid, Spain, 28040
Actively Recruiting
63
Novartis Investigative Site
Madrid, Spain, 28041
Actively Recruiting
64
Novartis Investigative Site
Salamanca, Spain, 37007
Actively Recruiting
65
Novartis Investigative Site
London, United Kingdom, SE5 9RS
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here