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Le groupe d'étude des tumeurs endocrines est une société savante créée en 2002 réunissant les différentes spécialités impliquées dans la prise en charge des tumeurs neuro-endocrines (TNE) : anatomopathologistes, biologistes, chirurgiens, endocrinologues, gastroentérologues, généticiens, médecins nucléaires, oncologues et radiologues.

SPINET

Evaluation du Lanréotide Autogel 120 mg vs placebo en première ligne de traitement des TNE du Poumon avancées - Ouverture au premier semestre 2017

Type d'étude Promoteur Etat actuel de l'étude
Phase III IPSEN En cours de recrutement

 

A Phase 3, Prospective, Randomized, Double-Blind, Multi-Center, Study of the Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg plus BSC vs. Placebo plus BSC for Tumor Control in Subjects with Well Differentiated, Metastatic and/or Unresectable Typical or Atypical Lung Neuroendocrine Tumors

Code de l’étude

SPINET

Promoteur/ sponsor

IPSEN

Tumeur éligible

Lung Neuroendocrine Tumors

Type d’étude

Interventionnel

Phase

 Phase 3  Study

Nombre de patients à inclure

216

Investigateur(s) principal

E.Baudin (Villejuif) + Dr. Lombard-Bohas (Coordonnateur Administratif Lyon)

Centres Français

Lyon, Lille, Villejuif, Marseille, Rennes, Nantes, Montpellier

Objectifs

Primary Outcome Measures:
• Progression-Free Survival (PFS), assessed by central review using RECIST v1.1 criteria [ Time Frame: From randomisation up to 18 months (approximately) after the last patient is randomised (175 progression/death events)] ] [ Designated as safety issue: No ]
PFS measured by central review using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria, every 12 weeks, defined as the time from randomization to disease progression or death from any causes

Secondary Outcome Measures:
• PFS, assessed by local review using RECIST v1.1 criteria [ Time Frame: From randomisation up to 18 months (approximately) after the last patient is randomised (175 progression/death events)] ] [ Designated as safety issue: No ]
The analysis will occur when the target number of events (175 progression/death events) among the two treatment groups has been observed.
• Time to treatment failure, defined as the time from randomization to disease progression, withdrawal for any reason, or death using RECIST v1.1. assessment [ Time Frame: From randomisation up to 18 months (approximately) after the last patient is randomised (175 progression/death events)] ] [ Designated as safety issue: No ]
The analysis will occur when the target number of events (175 progression/death events) among the two treatment groups has been observed.

Critères d’inclusion

• Have metastatic and/or unresectable pathologically confirmed well-differentiated, typical or atypical neuroendocrine tumor of the lung
• Histologic evidence of Well differentiated Neuroendocrine tumors (NETs) of the lung (typical and atypical according to the World Health Organisation (WHO criteria), evaluated locally)
• Has a mitotic index <2 mitoses/2 mm2 for typical carcinoid (TC) and <10 mitoses/2 mm2 and/or foci of necrosis for atypical carcinoid (AC)
• At least one measurable lesion of the disease on imaging (CT or MRI; RECIST 1.1)
• Positive Somatostatin receptors (SSTR) imaging

Critères d’exclusion  

• Poorly differentiated or high grade carcinoma, or patients with neuroendocrine tumors not of lung origin are excluded
• Has been treated with an Somatostatin analogs (SSA) at any time prior to randomization, except if that treatment was for less than 15 days (e.g. peri-operatively) of short acting SSA or one dose of long acting SSA and the treatment was received more than 6 weeks prior to randomization
• Has been treated with Peptide receptor radionuclide therapy (PRRT) at any time prior to randomization
• Has been treated with more than one line of cytotoxic chemotherapy or molecular targeted therapy or interferon for Lung NET