Etude : IMREAL / Cohort 2



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

Nom : Cohort 2

Traitement : Métastasique ou localement avancé

Type d'étude : Qualité de vie / Observationnelle

Dernière MÀJ : 28/06/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Non-Interventional, Multicenter, Multiple Cohort Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice

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 : III à IV

2
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 :
global-roche-genentech-trials@gene.com
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Clinique Tessier – Groupe AHNAC - 118 Avenue Désandrouin - 59300 VALENCIENNES

Investigateur :
Docteur Thomas GEY

TEC / ARC / IDE :
Madame Marielle FERY
fery-m@
ch-valenciennes.fr
03 27 14 07 15

Ouverture de l'essai : OUVERT

MAJ : 28/06/2019