Etude : MO40653 / IMREAL



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : MO40653

Nom : IMREAL

Traitement : Métastasique ou localement avancé

Type d'étude : Qualité de vie / Observationnelle

Dernière MÀJ : 29/07/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude de cohortes non-interventionnelle, multicentrique, évaluant l'efficacité et la tolérance d'Atezolizumab en conditions réelles chez des patients traités en pratique clinique de routine

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C34 - Tumeur maligne des bronches et du poumon
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : This is a non-interventional, multi-country, multi-centre, multiple cohort prospective study, with retrospective collection of prior medical/treatment history data from medical records, designed to assess the real-world outcomes and safety of atezolizumab for indications in the existing label in the real world setting of routine clinical practice.


Phase : NA

Stade : Localement avancé à Métastatique

2, 3, 4, X
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Patient must have one of the following confirmed diagnoses for which atezolizumab is locally approved in the SmPC: (1) As monotherapy for the treatment of adult patients with la/mUC after prior platinum-containing chemotherapy or (2) As monotherapy for the treatment of adult patients with la/mNSCLC after prior chemotherapy. Patients with EGFR activating mutations or ALK-positive tumour mutations should also have received targeted therapy before receiving atezolizumab.
- Patient is prescribed atezolizumab therapy for the first time.
- Decision to prescribe atezolizumab must be made and documented prior to inclusion into the study and must follow local clinical practice.
- Initiation of atezolizumab is not more than 28 days before signing informed consent. In countries where enrollment is only allowed after starting treatment, enrollment must be preceded by the administration of the first cycle of atezolizumab.

Critères de non-inclusion : - Treatment with atezolizumab for an indication that is not included in the study cohorts. Cisplatin ineligible participants receiving atezolizumab as first line of therapy for la/mUC will be excluded.
- Concomitant anti-cancer therapy at the time of starting atezolizumab on the index date, as per locally approved Summary of Product Characteristics (SmPC).
- Treatment with atezolizumab as part of a clinical trial or for compassionate use as part of an access or compassionate use program.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03782207
Promoteur :
HOFFMANN-LA ROCHE
Type de sponsor : Industriel
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
CHU de Caen - Avenue de la Côte de Nacre - 14033 Caen Cedex - 14000 CAEN

Investigateur :
Youssef OULKHOUIR

TEC / ARC / IDE :
Vincent LEON
leon-v@chu-caen.fr

Ouverture de l'essai : OUVERT

MAJ : 29/07/2019