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)

Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arkansas
Highlands Oncology Group
RECRUITING
Fayetteville
Colorado
Rocky Mountain Cancer Centers
RECRUITING
Denver
Connecticut
Yale New Haven Hospital
RECRUITING
New Haven
Louisiana
LSU Medical Center
RECRUITING
New Orleans
North Carolina
Piedmont Healthcare
RECRUITING
Winston-salem
New York
Mount Sinai Medical Center
RECRUITING
New York
Texas
TxO Austin Midtown
WITHDRAWN
Austin
Texas Oncology
RECRUITING
Dallas
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Virginia Oncology Associates
RECRUITING
Norfolk
Blue Ridge Cancer Center
RECRUITING
Wytheville
Other Locations
Canada
Novartis Investigative Site
RECRUITING
London
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
Toronto
China
Novartis Investigative Site
RECRUITING
Shanghai
France
Novartis Investigative Site
RECRUITING
Clichy
Novartis Investigative Site
RECRUITING
Montpellier
Novartis Investigative Site
RECRUITING
Nantes
Novartis Investigative Site
RECRUITING
Pessac
Novartis Investigative Site
RECRUITING
Toulouse
Germany
Novartis Investigative Site
RECRUITING
Erlangen
Novartis Investigative Site
RECRUITING
Essen
Hungary
Novartis Investigative Site
RECRUITING
Budapest
Novartis Investigative Site
RECRUITING
Szeged
Italy
Novartis Investigative Site
RECRUITING
Cona
Novartis Investigative Site
RECRUITING
Genova
Novartis Investigative Site
RECRUITING
Milan
Novartis Investigative Site
RECRUITING
Pisa
Netherlands
Novartis Investigative Site
RECRUITING
Utrecht
Poland
Novartis Investigative Site
RECRUITING
Gdansk
Novartis Investigative Site
RECRUITING
Krakow
Novartis Investigative Site
RECRUITING
Poznan
Novartis Investigative Site
RECRUITING
Warsaw
Republic of Korea
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Spain
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Salamanca
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2025-05-30
Estimated Completion Date: 2034-01-05
Participants
Target number of participants: 240
Treatments
Experimental: [177Lu]Lu-DOTA-TATE + Octreotide LAR
Participants in this arm will receive \[177Lu\]Lu-DOTA-TATE plus Octreotide long-acting release (LAR).
Active_comparator: Octreotide LAR
Participants in this arm will receive Octreotide LAR only.
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov