Recruiting

Phase 3

\[177Lu\]Lu-DOTA-TATE vs. Octreotide LARStudy to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET

Sponsor:

Novartis Pharmaceuticals

Code:

NCT06784752

Conditions

Somatostatin Receptor Positive (SSTR+)

Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET)

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Interventions

[177Lu]Lu-DOTA-TATE

Octreotide LAR

Study Details

Brief 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

Conditions

Somatostatin Receptor Positive (SSTR+)

Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET)

Study ID

NCT06784752

Start date

May 30, 2025

Status verified date

Apr, 2026

Completion date

Jan 23, 2034

Anticipated

Primary completion date

Dec 8, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.

Exclusion Criteria:

Prior administration of a therapeutic radiopharmaceutical for GEP-NET at any time prior to randomization in the study.
Any previous therapy with interferons, mTOR-inhibitors, chemotherapy or other systemic therapies except somatostatin analogues (SSAs) of GEP-NET. If as per Investigator's opinion a participant is candidate for such therapies, such participant must not be enrolled.
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.
Any major surgery within 12 weeks prior to randomization in the study.
Known brain metastases.
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.
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.

Other protocol-defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

[177Lu]Lu-DOTA-TATE

\[177Lu\]Lu-DOTA-TATE will be administered 4 times during treatment period with frequency of every 8 weeks (Q8W)

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.

Primary outcome measure

Progression Free Survival (PFS) centrally assessed by Blinded Independent Review Committee (BIRC) [ Time Frame: After observing approximately 88 PFS events as per BIRC assessments, expected after approximately 33 months from study start ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Mayo Clinic Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Rochelle Quinonez

480-301-6795 quinonez.rochelle@mayo.edu

Principal Investigator:

Mohamad Sonbol

Highlands Oncology Group

Recruiting

Fayetteville, Arkansas, United States, 72703

Contacts

Tina Patrick

+1 479 878 7098 tpatrick@hogonc.com

Principal Investigator:

Joseph Thaddeus Beck

Rocky Mountain Cancer Centers

Recruiting

Denver, Colorado, United States, 80218

Contacts

Madison Schultz

303-388-4676 madison.schultz@usoncology.com

Principal Investigator:

Allen Cohn

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Hayley Dunnack

Hayley.Dunnack@hhchealth.org

Principal Investigator:

Andrew Salner

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Melissa George

melissa.george@yale.edu

Principal Investigator:

Pamela Kunz

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Alberta Lalljie

904-953-2451 Lalljie.Albertha@mayo.edu

Principal Investigator:

Jason Starr

Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Bridget Fielder

404-686-8210 bfielde@emory.edu

Principal Investigator:

Amol Takalkar

St Elizabeth Healthcare

Recruiting

Edgewood, Kentucky, United States, 41017

Contacts

Lauren Willett

lauren.willett@stelizabeth.com

Principal Investigator:

Minsig Choi

LSU Medical Center

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Taylor Green

tgre19@lsuhsc.edu

Principal Investigator:

Mary Maluccio

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202-2689

Contacts

Farjana Jahan

313-876-1850 fjahan1@hfhs.org

Principal Investigator:

Philip A Philip

Mount Sinai Medical Center

Recruiting

New York, New York, United States, 10029-6574

Contacts

Nicole Laratta

212-824-7876 nicole.laratta@mssm.edu

Principal Investigator:

Edward Wolin

Piedmont Healthcare

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Jeff Whorton

Jeff.Whorton@piedmont.org

Principal Investigator:

Eyal Meiri

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Chasity McHone

cmchone@tnonc.com

Principal Investigator:

Joseph Merriman

Texas Oncology

Recruiting

Dallas, Texas, United States, 75251

Contacts

Danielle Koetter

danielle.koetter@usoncology.com

Principal Investigator:

Scott Scott Paulson

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Kristi Ben-Barka

kristi.ben-barka@usoncology.com

Principal Investigator:

Gregory Scott Sibley

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

Amber Ingram

amber.ingram@usoncology.com

Principal Investigator:

Jedrzej Wykretowicz

Blue Ridge Cancer Center

Recruiting

Wytheville, Virginia, United States, 24382

Contacts

Natasha Holt

natasha.holt@usoncology.com

Principal Investigator:

David Buck

Northwest Medical Specialties

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Patricia Walsh

253-841-4296 pwalsh@nwmsonline.com

Principal Investigator:

Mohammed N Kanaan

Novartis Investigative Site

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Novartis Investigative Site

Recruiting

London, Ontario, Canada, N6A 5W9

Novartis Investigative Site

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

SSTR+
GEP-NET
Ki-67 <10%
AAA601
[177Lu]Lu-DOTA-TATE
newly diagnosed
well differentiated
advanced GEP-NETs
high disease burden
NETTER-3
Grade 1
Grade 2
Tumor-targeted radioligand therapy
RLT
octreotide LAR
Gastroenteropancreatice Neuroendocrine Tumor
PFS
Quality of life (QOL)/PRO
QoL
neuroendocrine tumor(s)
Lutathera
Lutetium dotatate
Lutetium oxodotreotide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-04-30.