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Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET

NCT ID: NCT06784752

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-30

Study Completion Date

2034-01-05

Brief Summary

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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

Detailed Description

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The study consists of a screening phase, a treatment phase and a follow-up phase. This study compares treatment with \[177Lu\]Lu-DOTA-TATE plus octreotide LAR and octreotide LAR only.

Conditions

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Somatostatin Receptor Positive (SSTR+) Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET)

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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[177Lu]Lu-DOTA-TATE + Octreotide LAR

Participants in this arm will receive \[177Lu\]Lu-DOTA-TATE plus Octreotide long-acting release (LAR).

Group Type EXPERIMENTAL

[177Lu]Lu-DOTA-TATE

Intervention Type RADIATION

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

Octreotide LAR

Intervention Type DRUG

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.

Octreotide LAR

Participants in this arm will receive Octreotide LAR only.

Group Type ACTIVE_COMPARATOR

Octreotide LAR

Intervention Type DRUG

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.

Interventions

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[177Lu]Lu-DOTA-TATE

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

Intervention Type RADIATION

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.

Intervention Type DRUG

Other Intervention Names

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SOM230

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Highlands Oncology Group

Fayetteville, Arkansas, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Site Status RECRUITING

Hartford Hospital

Hartford, Connecticut, United States

Site Status RECRUITING

Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status RECRUITING

LSU Medical Center

New Orleans, Louisiana, United States

Site Status RECRUITING

Mount Sinai Medical Center

New York, New York, United States

Site Status RECRUITING

Piedmont Healthcare

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Tennessee Oncology

Nashville, Tennessee, United States

Site Status RECRUITING

TxO Austin Midtown

Austin, Texas, United States

Site Status WITHDRAWN

Texas Oncology

Dallas, Texas, United States

Site Status RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, United States

Site Status RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, United States

Site Status RECRUITING

Blue Ridge Cancer Center

Wytheville, Virginia, United States

Site Status RECRUITING

Novartis Investigative Site

London, Ontario, Canada

Site Status RECRUITING

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status RECRUITING

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status RECRUITING

Novartis Investigative Site

Beijing, , China

Site Status RECRUITING

Novartis Investigative Site

Beijing, , China

Site Status RECRUITING

Novartis Investigative Site

Shanghai, , China

Site Status RECRUITING

Novartis Investigative Site

Bron, , France

Site Status RECRUITING

Novartis Investigative Site

Clichy, , France

Site Status RECRUITING

Novartis Investigative Site

Montpellier, , France

Site Status RECRUITING

Novartis Investigative Site

Nantes, , France

Site Status RECRUITING

Novartis Investigative Site

Pessac, , France

Site Status RECRUITING

Novartis Investigative Site

Toulouse, , France

Site Status RECRUITING

Novartis Investigative Site

Erlangen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Essen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Budapest, , Hungary

Site Status RECRUITING

Novartis Investigative Site

Szeged, , Hungary

Site Status RECRUITING

Novartis Investigative Site

Cona, FE, Italy

Site Status RECRUITING

Novartis Investigative Site

Genova, GE, Italy

Site Status RECRUITING

Novartis Investigative Site

Milan, MI, Italy

Site Status RECRUITING

Novartis Investigative Site

Milan, MI, Italy

Site Status RECRUITING

Novartis Investigative Site

Rozzano, MI, Italy

Site Status RECRUITING

Novartis Investigative Site

Pisa, PI, Italy

Site Status RECRUITING

Novartis Investigative Site

Utrecht, , Netherlands

Site Status RECRUITING

Novartis Investigative Site

Gdansk, , Poland

Site Status RECRUITING

Novartis Investigative Site

Gliwice, , Poland

Site Status RECRUITING

Novartis Investigative Site

Krakow, , Poland

Site Status RECRUITING

Novartis Investigative Site

Poznan, , Poland

Site Status RECRUITING

Novartis Investigative Site

Warsaw, , Poland

Site Status RECRUITING

Novartis Investigative Site

Warsaw, , Poland

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

Novartis Investigative Site

Salamanca, Castille and León, Spain

Site Status RECRUITING

Novartis Investigative Site

Madrid, , Spain

Site Status RECRUITING

Novartis Investigative Site

Madrid, , Spain

Site Status RECRUITING

Novartis Investigative Site

Madrid, , Spain

Site Status RECRUITING

Countries

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United States Canada China France Germany Hungary Italy Netherlands Poland South Korea Spain

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: 1-888-669-6682

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Facility Contacts

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Shelly Farrow

Role: primary

Nate Guillen

Role: primary

Sierra Cugno

Role: primary

Olenka Omeliach

Role: primary

Michele Seeman

Role: primary

Fatima Nabizada-Pace

Role: primary

Jeff Whorton

Role: primary

Austin Windsor

Role: primary

Sheena Davis

Role: primary

Hoang Anh Dinh

Role: primary

Ruth Turman

Role: primary

Alexis Gliniecki

Role: primary

Other Identifiers

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2024-518325-15-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CAAA601A62301

Identifier Type: -

Identifier Source: org_study_id