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Promising new combo therapy targets Hard-to-Treat gut tumors

NCT ID NCT06784752

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This study tests whether adding a radioactive drug (177Lu-DOTA-TATE) to standard therapy (octreotide) helps control advanced neuroendocrine tumors of the gut or pancreas better than standard therapy alone. About 240 newly diagnosed patients with slow-growing but high-burden tumors will participate. The goal is to see if the combination delays tumor growth and maintains quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jan 2034

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

digestive system neuroendocrine neoplasm digestive system neuroendocrine tumor, grade 1/2 follicular lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastroenteropancreatic neuroendocrine tumor (gep-net) Somatostatin receptor positive (SSTR+)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    66 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AdventHealth

    RECRUITING

    Orlando, Florida, 32804, United States

  • Blue Ridge Cancer Center

    RECRUITING

    Wytheville, Virginia, 24382, United States

  • Hartford Hospital

    RECRUITING

    Hartford, Connecticut, 06102, United States

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202-2689, United States

  • Highlands Oncology Group

    RECRUITING

    Fayetteville, Arkansas, 72703, United States

  • LSU Medical Center

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Mayo Clinic Arizona

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mount Sinai Medical Center

    RECRUITING

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

  • Northwest Medical Specialties

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Novartis Investigative Site

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Novartis Investigative Site

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • Novartis Investigative Site

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100036, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100730, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 102200, China

  • Novartis Investigative Site

    RECRUITING

    Shanghai, 200032, China

  • Novartis Investigative Site

    RECRUITING

    Bron, 69677, France

  • Novartis Investigative Site

    RECRUITING

    Clichy, 92110, France

  • Novartis Investigative Site

    RECRUITING

    Montpellier, 34298, France

  • Novartis Investigative Site

    RECRUITING

    Nantes, 44093, France

  • Novartis Investigative Site

    RECRUITING

    Pessac, 33604, France

  • Novartis Investigative Site

    RECRUITING

    Toulouse, 31059, France

  • Novartis Investigative Site

    RECRUITING

    Erlangen, 91054, Germany

  • Novartis Investigative Site

    RECRUITING

    Essen, 45147, Germany

  • Novartis Investigative Site

    RECRUITING

    München, 80377, Germany

  • Novartis Investigative Site

    RECRUITING

    Budapest, 1083, Hungary

  • Novartis Investigative Site

    RECRUITING

    Szeged, 6725, Hungary

  • Novartis Investigative Site

    RECRUITING

    Cona, FE, 44124, Italy

  • Novartis Investigative Site

    RECRUITING

    Genova, GE, 16132, Italy

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20133, Italy

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20141, Italy

  • Novartis Investigative Site

    RECRUITING

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    RECRUITING

    Pisa, PI, 56126, Italy

  • Novartis Investigative Site

    RECRUITING

    Roma, RM, 00168, Italy

  • Novartis Investigative Site

    RECRUITING

    Roma, RM, 00189, Italy

  • Novartis Investigative Site

    RECRUITING

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Utrecht, 3584 CX, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Gdansk, 80-214, Poland

  • Novartis Investigative Site

    RECRUITING

    Gliwice, 44-101, Poland

  • Novartis Investigative Site

    RECRUITING

    Krakow, 30-688, Poland

  • Novartis Investigative Site

    RECRUITING

    Poznan, 60-355, Poland

  • Novartis Investigative Site

    RECRUITING

    Warsaw, 02-351, Poland

  • Novartis Investigative Site

    RECRUITING

    Warsaw, 04-141, Poland

  • Novartis Investigative Site

    RECRUITING

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28034, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28040, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28041, Spain

  • Novartis Investigative Site

    RECRUITING

    Salamanca, 37007, Spain

  • Novartis Investigative Site

    RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Piedmont Healthcare

    RECRUITING

    Atlanta, Georgia, 30318, United States

  • Rocky Mountain Cancer Centers

    RECRUITING

    Denver, Colorado, 80218, United States

  • St Elizabeth Healthcare

    RECRUITING

    Edgewood, Kentucky, 41017, United States

  • Tennessee Oncology

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Texas Oncology

    RECRUITING

    Dallas, Texas, 75251, United States

  • TxO Austin Midtown

    ACTIVE_NOT_RECRUITING

    Austin, Texas, 78705, United States

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Virginia Oncology Associates

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Yale New Haven Hospital

    RECRUITING

    New Haven, Connecticut, 06520, United States