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Recruiting NCT07284121

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
Fano (PU) , The Marches
IRCCS AOU San Martino - IST
Genoa , Liguria
Presidio Ospedaliero Vito Fazzi
Lecce , Apulia
Ospedale dell'Angelo
Mestre , Veneto
Fondazione IRCCS Ospedale Maggiore Policlinico
Milan , Lombardy
Ospedale Maggiore Policlinico
Milan , Lombardy
Asst Santi Paolo E Carlo
Milan , Lombardy
Humanitas Istituto Clinico Catanese S.p.A
Misterbianco (CT) , Sicily
A.O. Universitaria Policlinico Di Modena
Modena , Emilia-Romagna
AORN Ospedali dei Colli Ospedale Monaldi
Naples , Campania
Az. Osp. Cardarelli
Naples , Campania
A.O.U. Maggiore della Carità
Novara , Piedmont
A.O.U. Policlinico Paolo Giaccone
Palermo , Sicily
Casa di Cura La Maddalena
Palermo , Sicily
Ospedale Provinciale Santa Maria Delle Croci
Ravenna , Emilia-Romagna
Policlinico Universitario Agostino Gemelli
Rome , Lazio
Università Campus Bio-Medico di Roma
Rome , Lazio
Azienda Ospedaliero Universitaria Di Sassari
Sassari , Sardinia
Ospedale Santa Chiara
Trento , Trentino-Alto Adige
Azienda Ospedaliera Universitaria Integrata Verona
Verona , Veneto
Poland (6)
Narodowy Instytut Onkologii - Panstwowy Instytut Badawczy, Oddzia? w Krakowie
Krakow
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
Lublin
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
Olsztyn
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
Słupsk
NU-MED Centrum Diagnostyki i Terapii Onkologicznej
Tomaszów Mazowiecki
Romania (8)
Institut Oncologic Prof. Dr. Alexandru Trestioreanu
Bucharest
Institutul Clinic Fundeni Bucuresti
Bucharest
Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. Octavian Fodor
Cluj-Napoca
Spitalul Clinic Jude?ean de Urgen?? Sfântul Apostol Andrei Galati;oncology
Galati
Institutul Regional de Oncologie Iasi
Iași
Spitalul Municipal Ploiesti
Ploieşti
Spitalul Judetean de Urgenta Satu Mare
Satu Mare
Oncomed SRL
Timișoara
Spain (33)
Complejo Hospitalario Universitario de Albacete
Albacete
Hospital Universitario Mancha Centro (Alcázar de San Juan);Servicio de digestivo
Alcázar de San Juan , Ciudad REAL
Hospital Universitario Mancha Centro (Alcázar de San Juan);Servicio de oncología
Alcázar de San Juan , Ciudad REAL
Hospital General de Alicante;servicio de digestivo
Alicante
Hospital General Univ. de Alicante
Alicante
Complejo Hospitalario Torrecardenas
Almería , Almeria
Hospital de Badajoz
Badajoz
Hospital de Cruces
Barakaldo , Vizcaya
Hospital Clinic I Provincial
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital de Cruces
Bilbao , Vizcaya
Hospital General de Ciudad Real
Ciudad Real
Hospital Universitario San Cecilio
Granada
Hospital General Universitario de Guadalajara
Guadalajara
Hospital Sant Joan de Deu de Manresa;Servicio oncologia
Manresa , Barcelona
Hospital General Universitario J.M Morales Meseguer
Murcia
Hospital Virgen de Arrixaca;servicio de digestivo
Murcia
Hospital Univ. Central de Asturias
Oviedo , Principality of Asturias
Hospital Univ. Central de Asturias
Oviedo , Principality of Asturias
Hospital Son Espases
Palma de Mallorca , Balearic Islands
Complejo Hospitalario de Pontevedra
Pontevedra
Hospital Universitario Puerto Real
Puerto Real , Cadiz
Hospital Universitari Sant Joan de Reus
Reus , Tarragona
Complejo Hospitalario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife , Tenerife
Hospital Universitario de Canarias
Santa Cruz de Tenerife , Tenerife
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela , LA Coruna
Hospital Virgen del Rocio;Servicio de digestivo
Seville
Hospital de Toledo;Servicio de digestivo
Toledo
Hospital de Toledo;servicio de oncologia
Toledo
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
Valencia
Hospital Clinico Universitario de Valladolid
Valladolid
Hospital Clinico Universitario Valladolid
Valladolid
Hospital Universitario Miguel Servet
Zaragoza
United Kingdom (5)
University Hospitals Birmingham NHS Foundation Trust
Birmingham
Royal Surrey County Hospital
Guildford
Leeds Teaching Hosp NHS Trust
Leeds
James Cook University Hospital
Middlesbrough
James Paget University Hospitals NHS Foundation Trust
Norfolk
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
15.07.2025
Completion date
31.12.2028
Registry ID
NCT07284121
Source
clinicaltrials.gov
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