A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Conditions:
Lung Cancer, Hepatocellular Carcinoma
Sponsor: Hoffmann-La Roche
trial.available_in:
БГ
Overview
This is a non-interventional, multi-country, multi-centre, multicohort, primary data collection study, designed to assess patients' reported satisfaction with Atezolizumab Subcutenous (SC) treatment and Health-related Quality of Life (HRQoL), as well as the effectiveness and safety of Atezolizumab SC in participants treated for selected approved indications in routine clinical practice.
Who can participate
Inclusion Criteria:
* Participants must have one of the following confirmed diagnoses for which atezolizumab is approved in the local SmPC:
* Early stage NSCLC following complete resection and platinum-based chemotherapy with a high risk of recurrence and PD-L1 expression on ≥ 50% of TC and with no EGFR-mutant or ALK-positive NSCLC
* Metastatic stage NSCLC with PD-L1 expression on ≥ 50% TC or ≥ 10% tumor infiltrating immune cells (IC) and with no EGFR-mutant or ALK-positive NSCLC not previously treated
* Extensive-stage small cell lung cancer (ES-SCLC) not previously treated
* Advanced or unresectable HCC not previously treated with systemic therapy
* Should not have received \> 4 prior cycles of IV Atezolizumab
Exclusion Criteria:
* Not receiving treatment with Atezolizumab according to standard of care and in line with the current SmPC or local labelling
* Receiving concomitant systemic anticancer therapy at the time of initiation of Atezolizumab or an Atezolizumab-containing regimen for treatment of the same disease, as per label
* Receiving treatment with Atezolizumab as part of a clinical trial, pre-approval access program, compassionate use program, expanded use program, post-trial access program, or continued access program
* Unwilling to complete questionnaires related to treatment satisfaction and treatment-related quality of life
Interventions
Atezolizumab
DRUG
Locations
88
Austria (4)
Landesklinikum Krems
Krems
Ordensklinikum Linz Elisabethinen
Linz
Krankenhaus Nord - Klinik Floridsdorf
Vienna
Klinikum Wels-Grieskirchen
Wels
Belgium (3)
AZ Sint Lucas (Sint Lucas)
Ghent
CHU HELORA - Hôpital de la Louvière - Site Jolimont
Haine-Saint-Paul
CHU UCL Mont-Godinne
Mont-godinne
Bulgaria (7)
Multiprofile Hospital for Active Treatment Uni Hospital
Panagyurishte
Complex Oncological Center-Ruse EOOD
Rousse
Tokuda Hospital
Sofia
UMHAT "Sv. Ivan Rilski", EAD
Sofia
UMHAT Tsaritsa Yoanna - ISUL
Sofia
MBAL Serdika EOOD
Sofia
MHAT SofiaMed
Sofia
Italy (22)
Ente Ecclesiastico Ospedale Generale Regionale F Miulli
Acquaviva Delle Fonti , Piedmont
Humanitas Gavazzeni
Bergamo , Lombardy
Azienda Sanitaria Territoriale Pesaro Urbino (AST PU) - Ospedale Santa Croce;UOC Oncologia - Stabilimento di Fano