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Somatostatin Receptor Positive (SSTR+)Phase 3NETTER-3NCT06784752

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

A Phase 3 study testing [177Lu]Lu-DOTA-TATE and Octreotide LAR in people with Somatostatin Receptor Positive (SSTR+) and Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET), run by Novartis Pharmaceuticals at 67 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 12 to 100 years
What is being tested?
[177Lu]Lu-DOTA-TATE and Octreotide LAR
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
67 sitesin 12 countries
Study dates
30 May 2025to 23 Jan 2034
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 26Show fewer
  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

67 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals contact

+41613241111

67 sites in 12 countries

United States20 sites, 19 recruiting

  • Piedmont Healthcare

    Atlanta, Georgia, 30318

    Jeff Whorton, Jeff.Whorton@piedmont.org

    Eyal Meiri

    Recruiting

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

    Bridget Fielder, 404-686-8210, bfielde@emory.edu

    Amol Takalkar

    Recruiting

  • TxO Austin Midtown

    Austin, Texas, 78705

    Active, not recruiting

  • Texas Oncology

    Dallas, Texas, 75251

    Danielle Koetter, danielle.koetter@usoncology.com

    Scott Scott Paulson

    Recruiting

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

    Ciara Bair, 303-388-4676, ciara.bair@usoncology.com

    Allen Cohn

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202-2689

    Christina Vu, 313-876-1850, cvu1@hfhs.org

    Philip A Philip

    Recruiting

  • St Elizabeth Healthcare

    Edgewood, Kentucky, 41017

    Lauren Willett, lauren.willett@stelizabeth.com

    Minsig Choi

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Spencer Lockhart, spencer.lockhart@usoncology.com

    Gregory Scott Sibley

    Recruiting

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

    Tina Patrick, +1 479 878 7098, tpatrick@hogonc.com

    Joseph Thaddeus Beck

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, 06102

    Jennifer Selmer-Larsen, Jennifer.Selmer-Larsen@hhchealth.org

    Andrew Salner

    Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

    Minoshka Chaparro Gardner, 904-953-2451, chaparrogardner.minoshka@mayo.edu

    Jason Starr

    Recruiting

  • Tennessee Oncology

    Nashville, Tennessee, 37203

    Don Merriman, dmerriman@tnonc.com

    Joseph Merriman

    Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520

    Melissa George, melissa.george@yale.edu

    Pamela Kunz

    Recruiting

  • LSU Medical Center

    New Orleans, Louisiana, 70112

    Dominique Breaux, dkell3@lsuhsc.edu

    Mary Maluccio

    Recruiting

  • Mount Sinai Medical Center

    New York, New York, 10029-6574

    Nicole Laratta, 212-824-7876, nicole.laratta@mssm.edu

    Edward Wolin

    Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

    Amber Ingram, amber.ingram@usoncology.com

    Jedrzej Wykretowicz

    Recruiting

  • AdventHealth

    Orlando, Florida, 32804

    Joseph Guzzo, 407-303-3235, joseph.guzzo@adventhealth.com

    Jawad Francis

    Recruiting

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

    Rochelle Quinonez, 480-301-6795, quinonez.rochelle@mayo.edu

    Mohamad Sonbol

    Recruiting

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

    Patricia Walsh, 253-841-4296, pwalsh@nwmsonline.com

    Mohammed N Kanaan

    Recruiting

  • Blue Ridge Cancer Center

    Wytheville, Virginia, 24382

    Andrea L Pollard, andi.pollard@usoncology.com

    David Buck

    Recruiting

Other trials in United States

Italy8 sites, 8 recruiting

  • Novartis Investigative Site

    Cona, FE, 44124

    Recruiting

  • Novartis Investigative Site

    Genova, GE, 16132

    Recruiting

  • Novartis Investigative Site

    Milan, MI, 20133

    Recruiting

  • Novartis Investigative Site

    Milan, MI, 20141

    Recruiting

  • Novartis Investigative Site

    Pisa, PI, 56126

    Recruiting

  • Novartis Investigative Site

    Roma, RM, 00168

    Recruiting

  • Novartis Investigative Site

    Roma, RM, 00189

    Recruiting

  • Novartis Investigative Site

    Rozzano, MI, 20089

    Recruiting

Other trials in Italy

Spain7 sites, 7 recruiting

  • Novartis Investigative Site

    Barcelona, 08035

    Recruiting

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907

    Recruiting

  • Novartis Investigative Site

    Madrid, 28034

    Recruiting

  • Novartis Investigative Site

    Madrid, 28040

    Recruiting

  • Novartis Investigative Site

    Madrid, 28041

    Recruiting

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33011

    Recruiting

  • Novartis Investigative Site

    Salamanca, 37007

    Recruiting

Other trials in Spain

France6 sites, 6 recruiting

  • Novartis Investigative Site

    Bron, 69677

    Recruiting

  • Novartis Investigative Site

    Clichy, 92110

    Recruiting

  • Novartis Investigative Site

    Montpellier, 34298

    Recruiting

  • Novartis Investigative Site

    Nantes, 44093

    Recruiting

  • Novartis Investigative Site

    Pessac, 33604

    Recruiting

  • Novartis Investigative Site

    Toulouse, 31059

    Recruiting

Other trials in France

Poland6 sites, 6 recruiting

  • Novartis Investigative Site

    Gdansk, 80-214

    Recruiting

  • Novartis Investigative Site

    Gliwice, 44-101

    Recruiting

  • Novartis Investigative Site

    Krakow, 30-688

    Recruiting

  • Novartis Investigative Site

    Poznan, 60-355

    Recruiting

  • Novartis Investigative Site

    Warsaw, 02-351

    Recruiting

  • Novartis Investigative Site

    Warsaw, 04-141

    Recruiting

Other trials in Poland

Canada4 sites, 4 recruiting

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 1Z2

    Recruiting

  • Novartis Investigative Site

    London, Ontario, N6A 5W9

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1E2

    Recruiting

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5

    Recruiting

Other trials in Canada

China4 sites, 4 recruiting

  • Novartis Investigative Site

    Beijing, 100036

    Recruiting

  • Novartis Investigative Site

    Beijing, 100730

    Recruiting

  • Novartis Investigative Site

    Beijing, 102200

    Recruiting

  • Novartis Investigative Site

    Shanghai, 200032

    Recruiting

Other trials in China

Germany3 sites, 3 recruiting

  • Novartis Investigative Site

    Erlangen, 91054

    Recruiting

  • Novartis Investigative Site

    Essen, 45147

    Recruiting

  • Novartis Investigative Site

    München, 80377

    Recruiting

Other trials in Germany

South Korea3 sites, 3 recruiting

  • Novartis Investigative Site

    Seoul, 03080

    Recruiting

  • Novartis Investigative Site

    Seoul, 03722

    Recruiting

  • Novartis Investigative Site

    Seoul, 05505

    Recruiting

Other trials in South Korea

Hungary2 sites, 2 recruiting

  • Novartis Investigative Site

    Budapest, 1083

    Recruiting

  • Novartis Investigative Site

    Szeged, 6725

    Recruiting

Other trials in Hungary

Netherlands2 sites, 2 recruiting

  • Novartis Investigative Site

    Rotterdam, South Holland, 3015 GD

    Recruiting

  • Novartis Investigative Site

    Utrecht, 3584 CX

    Recruiting

Other trials in Netherlands

United Kingdom2 sites, 2 recruiting

  • Novartis Investigative Site

    Glasgow, G12 0YN

    Recruiting

  • Novartis Investigative Site

    London, SE5 9RS

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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)

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

Read the detailed description

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.

Being tested
[177Lu]Lu-DOTA-TATE, Octreotide LAR
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)
Medical subject headings
Gastro-enteropancreatic neuroendocrine tumor, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [177Lu]Lu-DOTA-TATERadiation

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

  • Octreotide LARDrug

    Also called SOM230

    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.

Study groups in NCT06784752
Study groupRoleWhat they receive
[177Lu]Lu-DOTA-TATE + Octreotide LARExperimentalParticipants in this arm will receive [177Lu]Lu-DOTA-TATE plus Octreotide long-acting release (LAR).
Receives: Radiation: [177Lu]Lu-DOTA-TATE; Drug: Octreotide LAR
Octreotide LARActive comparatorParticipants in this arm will receive Octreotide LAR only.
Receives: Drug: Octreotide LAR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) centrally assessed by Blinded Independent Review Committee (BIRC)

    PFS is defined as the time from randomization to the first occurrence of progression (centrally assessed by Blinded Independent Review Committee (BIRC) according to RECIST v1.1) or death due to any cause.

    Measured: After observing approximately 88 PFS events as per BIRC assessments, expected after approximately 33 months from study start

Secondary outcomes (15)

  1. Time to Deterioration (TDD) (Key Secondary)

    Time to deterioration is defined as the time from randomization to the first occurrence of a deterioration compared to the baseline scores or death from any cause for each of the following domains (tested separately) of EORTC QLQ-GI.NET21 [gastrointestinal scale (GI scale)] and EORTC QLQ-C30 questionnaires (fatigue, diarrhea, and global health scale).

    Measured: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start

  2. Progression Free Survival (PFS)

    PFS is defined as the time from randomization to the first occurrence of progression (Investigator assessed according to RECIST v1.1) or death due to any cause.

    Measured: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start

  3. Objective Response Rate (ORR)

    ORR: Rate of participants with best overall response (BOR) of partial response (PR) or complete response (CR) as per RECIST v1.1 (both Investigator and centrally assessed by BIRC).

    Measured: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start

  4. Disease Control Rate (DCR)

    DCR: Rate of participants with BOR of PR, CR or stable disease (SD) as per RECIST v1.1 (both Investigator and centrally assessed by BIRC).

    Measured: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start

  5. Duration of Response (DOR)

    DOR: The time from initially meeting the criteria for response (CR or PR) until the time of progression according to RECIST v1.1 or death due to underlying disease only.

    Measured: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start

  6. Overall Survival (OS)

    OS: Time from the randomization date until the date of death due to any cause.

    Measured: Until 60 month from randomization

  7. Time to Deterioration (TDD)

    TTD is the time from randomization to the first occurrence of a deterioration compared to the baseline scores or death from any cause for EORTC QLQ-G.I.NET21 and EORTC QLQ-C30 domains not included among key secondary endpoints.

    Measured: At the time of primary PFS analysis after observing approximately 88 PFS events per BIRC assessment

  8. Absolute change from baseline in EORTC QLQ-G.I.NET21 domain

    Quality of Life assessed by EORTC QLQ-G.I.NET21 (excluding GI scale) (domains not included as key secondary objectives)

    Measured: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start

  9. Absolute change from baseline in the EQ-5D-5L index at each time point

    Quality of Life assessed by EQ-5D-5L

    Measured: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start

  10. Absolute change from baseline in EORTC QLQ-C30 domain

    Quality of Life assessed by EORTC QLQ-C30 (domains not included as key secondary objectives)

    Measured: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start.

  11. Dosimetry

    Absorbed radiation dose in selected organs, tumor lesions and total body

    Measured: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start

  12. Pharmacokinetic (PK) parameter: Area Under Curve (AUC) from [177Lu]Lu-DOTA-TATE blood radioactivity data

    The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1).

    The AUC from time zero to infinity (mass x time x volume-1)

    Measured: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start

  13. PK parameter: Clearance from [177Lu]Lu-DOTA-TATE blood radioactivity data

    Clearance is the total body clearance of drug from the plasma or blood (volume x time-1).

    Measured: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start

  14. PK parameter: Distribution volume (Vz) from [177Lu]Lu-DOTA-TATE blood radioactivity data

    The apparent volume of distribution during terminal phase (associated with λz) (volume)

    Measured: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start

  15. PK parameter: half-life (T1/2) from [177Lu]Lu-DOTA-TATE blood radioactivity data

    The elimination half-life associated with the terminal slope (λz) of a semi logarithmic concentration-time curve (time). Use qualifier for other half-lives

    Measured: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2025
  2. Study start30 May 2025
  3. Primary completion8 Dec 2028 (estimated)
  4. Study completion23 Jan 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06784752
Sponsor's protocol ID
CAAA601A62301
Other IDs
2024-518325-15-00
Acronym
NETTER-3
Status last verified
Sep 2026
First submitted
19 Dec 2024
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing [177Lu]Lu-DOTA-TATE and Octreotide LAR in people with Somatostatin Receptor Positive (SSTR+) and Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET), run by Novartis Pharmaceuticals at 67 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Italy, Spain, France, Poland and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06784752.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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