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Gastro-enteropancreatic Neuroendocrine TumorPhase 3SORENTONCT05050942

A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET

A Phase 3 study testing CAM2029, Octreotide LAR and Lanreotide ATG in people with Gastro-enteropancreatic Neuroendocrine Tumor, run by Camurus AB at 86 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CAM2029, Octreotide LAR and Lanreotide ATG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
332 participants
Where
86 sitesin 12 countries
Study dates
22 Oct 2021to Nov 2028
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patient ≥18 years old
  • Histologically confirmed, advanced (unresectable and/or metastatic), and well-differentiated NET of GEP or presumed GEP origin
  • At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1 determined by multiphasic CT or MRI (performed within 28 days before randomization)
  • ECOG performance status of 0 to 2

Who cannot join

  • Documented evidence of disease progression while on treatment (including SSAs) for locally advanced unresectable or metastatic disease
  • Known central nervous system metastases
  • Consecutive treatment with long-acting SSAs for more than 6 months before randomization
  • Carcinoid symptoms that are refractory to treatment (according to the Investigator's judgement) with conventional doses of octreotide LAR or lanreotide ATG and/or to treatment with daily doses of ≤600 µg of octreotide IR
  • Previous treatment with more than 1 cycle of targeted therapies such as mTOR inhibitors or vascular endothelial growth factor inhibitors, or more than 1 cycle of chemotherapy or interferon for GEP-NET
  • Treatment of GEP-NET with trans-arterial chemoembolization or trans-arterial embolization within 12 months before screening
  • Previously received radioligand therapy (PRRT) at any time

Trial locations and contacts

86 sites in 12 countries.

86 sites in 12 countries

United States15 sites

  • Texas Oncology - Austin

    Austin, Texas, 78705

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Texas Oncology - Dallas

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Centers - Denver - Midtown

    Denver, Colorado, 80218

  • The University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic Hospital - Florida

    Jacksonville, Florida, 32224

  • University of Kentucky (UK) - Markey Cancer Center

    Lexington, Kentucky, 40536

  • Texas Oncology - McAllen

    McAllen, Texas, 78503

  • East Jefferson General Hospital

    Metairie, Louisiana, 70065

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Mayo Clinic Cancer Center (MCCC) - Phoenix

    Phoenix, Arizona, 85054

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Texas Oncology - San Antonio Northeast

    San Antonio, Texas, 78240

  • UCLA Ahmanson Biological Imaging Center

    Santa Monica, California, 90404

Other trials in United States

Spain15 sites

  • Complexo Hospitalario Universitario A Coruña

    A Coruña

  • Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)

    Barcelona

  • Institut Catala d'Oncologia Hospitalet

    Barcelona

  • Hospital General Universitario de Elche

    Elche

  • Hospital Universitari de Girona Doctor Josep Trueta

    Girona

  • Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) (Clinica de la Concepcion)

    Madrid

  • Hospital Universitario Fundación Alcorcón

    Madrid

  • Hospital Universitario La Paz (HULP)

    Madrid

  • Hospital Universitario Ramón y Cajal

    Madrid

  • MD Anderson Cancer Center - Madrid

    Madrid

  • Hospital Universitario Virgen de la Victoria

    Málaga

  • Hospital General Universitario Morales Meseguer

    Murcia

  • Hospital Universitario Central de Asturias

    Oviedo

  • Parc Taulí Sabadell Hospital Universitari

    Sabadell

  • Hospital Universitario Marques de Valdecilla (HUMV)

    Santander

Other trials in Spain

Italy11 sites

  • Universita degli Studi di Bari - Aldo Moro

    Bari

  • Azienda Ospedaliero - Universitaria di Bologna Policlinico S. Orsola - Malpighi

    Bologna

  • ASST degli Spedali Civili di Brescia

    Brescia

  • Universita degli Studi di Firenze - Azienda Ospedaliero - Universitaria Careggi - SC di Oncologia Medical

    Florence

  • Universita Degli Studi di Genova - Center of Excellence for Biomedical Research (CEBR)

    Genova

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS

    Meldola

  • Istituto Clinico Humanitas

    Milan

  • Azienda Ospedaliero - Universitaria di Modena Policlinico

    Modena

  • IRCCS - Istituto Nazionale dei Tumori di Napoli Fondazione G. Pascale - Oncologia Addominale

    Naples

  • Istituto Oncologico Veneto - IRCCS

    Padova

  • Azienda Ospedaliera Sant'Andrea

    Roma

Other trials in Italy

Canada8 sites

  • London Health Sciences Centre

    London

  • Centre Hospitalier de l'Universite de Montreal - Notre-Dame Hospital

    Montreal

  • Jewish General Hospital

    Montreal

  • The Ottawa Hospital - General Campus

    Ottawa

  • Niagara Health System - St. Catharines General Site

    St. Catharines

  • Princess Margaret Cancer Centre

    Toronto

  • Sunnybrook Health Sciences Centre

    Toronto

  • BC Cancer Agency Vancouver Centre

    Vancouver

Other trials in Canada

France8 sites

  • CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque

    Bordeaux

  • CHRU de Tours - Hopital Trousseau

    Chambray-lès-Tours

  • Centre Hospitalier Universitaire Dijon Bourgogne - L'Hopital General

    Dijon

  • Groupe Hospitalier de l'Institut Catholique de Lille - Hopital Saint Vincent de Paul

    Lille

  • CHU de Lyon - Groupement Hospitalier Edouard Herriot

    Lyon

  • CHU de Nantes - Hôtel-Dieu

    Nantes

  • Centre Eugène Marquis

    Rennes

  • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

    Strasbourg

Other trials in France

Germany7 sites

  • Charite - UB - CVK - Medizinische Klinik

    Berlin

  • Universitaetsklinikum Erlangen - Hautklinik

    Erlangen

  • Universitätsklinikum Essen

    Essen

  • Universitätsklinikum Hamburg-Eppendorf (UKE)

    Hamburg

  • Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg

    Heidelberg

  • Medizinischen Fakultät Mannheim der Universität Heidelberg

    Mannheim

  • Universitätsklinikum Ulm

    Ulm

Other trials in Germany

Belgium5 sites

  • Cliniques Universitaires Saint-Luc

    Brussels

  • Hôpital Erasme

    Brussels

  • Antwerp University Hospital

    Edegem

  • Algemeen Ziekenhuis Maria Middelares

    Ghent

  • AZ Nikolaas

    Sint-Niklaas

Other trials in Belgium

Hungary4 sites

  • SE ÁOK I. sz. Belgyógyászati Klinika

    Budapest

  • Petz Aladár Megyei Oktató Kórház

    Győr

  • Bács-Kiskun Megyei Kórház

    Kecskemét

  • Szegedi Tudományegyetem; I.Belgyógyászati Klinika

    Szeged

Other trials in Hungary

Netherlands4 sites

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis

    Amsterdam

  • Rijnstate Ziekenhuis - Arnhem

    Arnhem

  • Maastricht UMC+

    Maastricht

  • Erasmus MC

    Rotterdam

Other trials in Netherlands

Romania4 sites

  • Institutul Clinic Fundeni

    Bucharest

  • Institutul Oncologic "Prof. Dr. Ion Chiricuţă" Cluj Napoca

    Cluj-Napoca

  • Medisprof SRL

    Cluj-Napoca

  • Sigmedical Services S.R.L.

    Suceava

Other trials in Romania

Israel3 sites

  • Rambam Medical Center

    Haifa

  • Hadassah Medical Center (HMC) - Hadassah University Hospital (HUH) - Ein Kerem

    Jerusalem

  • The Chaim Sheba Medical Center

    Ramat Gan

Other trials in Israel

Australia2 sites

  • GenesisCare - North Shore

    Alexandria

  • Fiona Stanley Hospital

    Murdoch

Other trials in Australia

About this study

Official title: A Randomized, Multi-center, Open-label, Active-controlled Phase 3 Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) Versus Octreotide LAR or Lanreotide ATG in Patients With GEP-NET

The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.

Being tested
CAM2029, Octreotide LAR, Lanreotide ATG
Keywords
CAM2029, GEP-NET, Octreotide, SORENTO
Medical subject headings
Gastro-enteropancreatic neuroendocrine tumor

What participants receive

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

  • CAM2029Drug

    CAM2029 (octreotide subcutaneous depot) 20 mg will be administered every 2 weeks as a subcutaneous injection

  • Octreotide LARDrug

    Octreotide LAR 30 mg will be administered every 4 weeks as an intramuscular injection

  • Lanreotide ATGDrug

    Lanreotide ATG 120 mg will be administered every 4 weeks as a deep subcutaneous injection

Study groups in NCT05050942
Study groupRoleWhat they receive
CAM2029ExperimentalNot described
Receives: Drug: CAM2029
Octreotide LAR or lanreotide ATGActive comparatorNot described
Receives: Drug: Octreotide LAR; Drug: Lanreotide ATG

What is being measured

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

  1. Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC)

    PFS is defined as time from the date of randomization to the date of the first documented disease progression as per RECIST 1.1 or death due to any cause (whichever occurs first)

    Measured: From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months

Secondary outcomes (7)

  1. Overall survival

    The time from the date of randomization to the date of death due to any cause

    Measured: Up to 2 years following the primary efficacy analysis

  2. PFS as assessed by local Investigators

    PFS is defined as time from the date of randomization to the date of the first documented disease progression as per RECIST 1.1 or death due to any cause (whichever occurs first)

    Measured: From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months

  3. Overall response rate

    The proportion of patients with best overall response of complete response (CR) or partial response (PR), as per BIRC according to RECIST 1.1

    Measured: From date of randomization until disease progression, assessed up to 48 months

  4. Disease control rate

    The proportion of patients with a best overall response of CR, PR or stable disease (SD), as per BIRC according to RECIST 1.1

    Measured: From date of randomization until disease progression, assessed up to 48 months

  5. Time to tumor response

    The time from the date of randomization to the first documented response of CR or PR, as per BIRC according to RECIST 1.1

    Measured: From date of randomization until disease progression, assessed up to 48 months

  6. Duration of response

    The time from the date of the first documented response of CR or PR to the date of the first documented progression or death due to underlying cancer, as per BIRC according to RECIST 1.1

    Measured: From date of randomization until disease progression or death due to underlying cancer, whichever comes first, assessed up to 48 months

  7. Incidence of treatment-emergent adverse events

    Measured: From screening to the safety follow-up, assessed up to 6 years

Timeline

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

  1. First posted21 Sep 2021
  2. Study start22 Oct 2021
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2028 (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
332 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05050942
Sponsor's protocol ID
HS-19-657
Other IDs
2023-508723-12-00, 2021-000849-40, 2023
Acronym
SORENTO
Status last verified
Jul 2026
First submitted
9 Sep 2021
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Singh S, Ferone D, Capdevila J, Chan JA, de Herder WW, Halperin D, Mailman J, Hellstrom L, Liedman H, Svedberg A, Tiberg F. Methodology of the SORENTO clinical trial: a prospective, randomised, active-controlled phase 3 trial assessing the efficacy and safety of high exposure octreotide subcutaneous depot (CAM2029) in patients with GEP-NET. Trials. 2024 Jan 16;25(1):58. doi: 10.1186/s13063-023-07834-8.

    PubMed 38229199

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CAM2029, Octreotide LAR and Lanreotide ATG in people with Gastro-enteropancreatic Neuroendocrine Tumor, run by Camurus AB at 86 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Spain, Italy, Canada, France 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC) (time frame: From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months). 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 NCT05050942, which also lists 1 linked publication.

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 28 Jul 2026.

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