DRUG
lanreotide
Patients will receive lanreotide 120 mg every 28 days until disease progression
Status
Terminated
Phase
Phase 2 / Phase 3
Enrollment
53
Locations
24
Results
Posted
Publications
3
Study summary
This European, prospective, multicentre, double-blind randomised study will evaluate the effect of lanreotide (120 mg every 28 days until disease progression) versus placebo in patients with metastatic/locally advanced, non-resectable, duodeno-pancreatic neuroendocrine tumours.
This is a European, prospective, multicentre, double-blind randomised study evaluating lanreotide (120 mg every 28 days until disease progression) versus placebo in patients with metastatic/locally advanced, non-resectable, duodeno-pancreatic neuroendocrine tumours. Depending on the phase II results, the study may be continued into phase III. The treatment and follow-up of patients will be the same in phase II and phase III. After the first-line treatment, patients will be randomly assigned with a 1:1 ratio to receive either lanreotide or placebo. The study treatment should be initiated within 6 weeks following the confirmation date of stable disease or objective response. Treatment period: For each patient, the investigational products (lanreotide or placebo) will be provided according to a double-blind procedure until disease progression or toxicity, in accordance with the protocol. The estimated average treatment duration for all patients is 12 months. Follow-up period: To evaluate overall survival, patients in phase II will have a minimum follow-up period of 12 months; if the study continues to phase III, these patients will have a maximum follow-up period of 10 years. Phase III patients will have a minimum follow-up period of 5 years.
Interventions
DRUG
Patients will receive lanreotide 120 mg every 28 days until disease progression
DRUG
Timeline
First posted
Nov 11, 2014
Study start
Jan 2015
Primary completion
Jan 2020
Study completion
Jan 2020
Results posted
Oct 4, 2021
Registry updated
Jan 18, 2023
Outcomes
Proportion of Patients Alive and Progression-free at 6 Months
Time frame · 6 months
The primary endpoint for this phase II study was the proportion of pts alive and progression-free at 6 months after randomisation, evaluated according to the results of the imaging assessment done by the investigator in line with RECIST 1.1 criteria.
Progression-Free Survival
Time frame · up to 2 years
The progression-free survival is the time from inclusion to the first radiological progression or death (all causes). For patients alive without progression date of last news will be considered. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed durin the study (NADIR), or a measurable increase in a nontarget lesion, or the appearance of new lesions
Overall Survival
Time frame · 2 years after the end of the treatment
Overall survival considered all deaths, and time was calculated from randomisation to death.
Eligibility
Inclusion Criteria: * Metastatic (synchronous or metachronous) or locally advanced, non-resectable, well-differentiated duodeno-pancreatic neuroendocrine tumour, of grade 1 or 2 (WHO 2010 classification; Ki-67 ≤ 20%) * Progressive before first-line treatment * Histologically confirmed (either on primary tumour or metastases) * Pathological diagnosis validated by the NET consulting pathologist * Documented stable disease or objective response after first-line treatment, within 4 weeks (28 days) prior to randomisation * The first-line treatment will consist of either a chemotherapy or biotherapy (everolimus or sunitinib) as referred to TNCD or ENETS guidelines. Treatment must have been administered for 3 to 6 months for chemotherapy and for 6 months for biotherapy * Non-functional tumour or gastrinoma controlled by PPIs * Age \> or = 18 years * WHO 0, 1 or 2 * Effective contraception for male or female patients of childbearing age, defined as: oral contraceptives, intra-uterine devices, barrier contraceptive methods along with a spermicide gel, or surgical sterilisation. Female patients should use this contraception throughout the treatment period and for 6 months after the last treatment administration. Male patients should use contraception throughout the treatment period and for 3 months after the last treatment administration. * Signed informed consent prior to initiation of any study-specific procedures or treatment. Exclusion Criteria: * History of haematological malignancy or other cancer, except those treated for more than 5 years and considered as cured, carcinoma in situ of the cervix and treated skin cancer (excluding melanoma) * Poorly differentiated neuroendocrine carcinoma or NET grade 3 ENETS (Ki-67 \> 20%) * If primary resected, bone metastasis exclusively * Pre-treatment by somatostatin long-acting analogue * Total bilirubin ≥ 60 µmol/L * Uncontrolled diabetes * Contraindication to product used in the study or its components * Tumour arising in the context of a genetic disease * Pregnancy or lactation * Patients unable to undergo medical follow-up due to geographical, social, psychological or legal reasons * Concomitant participation in another clinical trial investigating a treatment during the treatment phase and within 30 days prior to the start of the study treatment.
Study locations
Belgium · France · Germany · United Kingdom. Showing up to 24 locations stored in the fast local snapshot.
Clinique Universitaire saint-Luc
Brussels, Belgium
CHU d'Angers - Hôtel Dieu
Angers, France
CHU - Hôpital Avicenne
Bobigny, France
CHU Côte de Nacre
Caen, France
CHU Estaing
Clermont-Ferrand, France
Hôpital Beaujon
Clichy, France
CHU Le Bocage Service d'HGE
Dijon, France
CH Les Oudairies
La Roche-sur-Yon, France
Hôpital Edouard Herriot
Lyon, France
CHU La Timone
Marseille, France
Hôpital de la Source
Orléans, France
CHU Cochin
Paris, France
Hôpital Haut Lévêque Bat Magellan, Service d'hépato-gastroentérologie
Pessac, France
Hôpital de la Milétrie
Poitiers, France
Hôpital Robert Debré
Reims, France
CHU de Rennes - Hôpital Pontchaillou
Rennes, France
CHU Charles Nicolle
Rouen, France
CHU de Saint Etienne
Saint-Priest-en-Jarez, France
Hôpital Rangueil
Toulouse, France
Institut Gustave Roussy
Villejuif, France
Charite Campus Virchow Kilikum
Berlin, Germany
University Hospital Marburg
Marburg, Germany
Royal Free Hospital Neuroendocrine Tumour Unit
London, United Kingdom
Manchester Academic Health Sciences Centre (MAHSC)
Manchester, United Kingdom
Publications
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