RecruitingNCT07284121

A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice

A Non-Interventional, Multicenter, Multicohort Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Subcutaneous Atezolizumab in Participants Treated in Routine Clinical Practice


Sponsor

Hoffmann-La Roche

Enrollment

700 participants

Start Date

Jul 17, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria4

  • 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

DRUGAtezolizumab

Atezolizumab will be administered at the discretion of the treating physician and independently of participation in this study.


Locations(85)

Landesklinikum Krems

Krems, Austria

Ordensklinikum Linz Elisabethinen

Linz, Austria

Krankenhaus Nord - Klinik Floridsdorf

Vienna, Austria

Klinikum Wels-Grieskirchen

Wels, Austria

AZ Sint Lucas (Sint Lucas)

Ghent, Belgium

CHU HELORA - Hôpital de la Louvière - Site Jolimont

Haine-Saint-Paul, Belgium

CHU UCL Mont-Godinne

Mont-godinne, Belgium

Multiprofile Hospital for Active Treatment Uni Hospital

Panagyurishte, Bulgaria

Complex Oncological Center-Ruse EOOD

Rousse, Bulgaria

Tokuda Hospital

Sofia, Bulgaria

UMHAT "Sv. Ivan Rilski", EAD

Sofia, Bulgaria

MBAL Serdika EOOD

Sofia, Bulgaria

MHAT SofiaMed

Sofia, Bulgaria

Presidio Ospedaliero Vito Fazzi

Lecce, Apulia, Italy

AORN Ospedali dei Colli Ospedale Monaldi

Napoli, Campania, Italy

Az. Osp. Cardarelli

Napoli, Campania, Italy

A.O. Universitaria Policlinico Di Modena

Modena, Emilia-Romagna, Italy

Ospedale Provinciale Santa Maria Delle Croci

Ravenna, Emilia-Romagna, Italy

Policlinico Universitario Agostino Gemelli

Rome, Lazio, Italy

Università Campus Bio-Medico di Roma

Rome, Lazio, Italy

IRCCS AOU San Martino - IST

Genoa, Liguria, Italy

Humanitas Gavazzeni

Bergamo, Lombardy, Italy

Fondazione IRCCS Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

Asst Santi Paolo E Carlo

Milan, Lombardy, Italy

Ente Ecclesiastico Ospedale Generale Regionale F Miulli

Acquaviva Delle Fonti, Piedmont, Italy

A.O.U. Maggiore della Carità

Novara, Piedmont, Italy

Azienda Ospedaliero Universitaria Di Sassari

Sassari, Sardinia, Italy

Humanitas Istituto Clinico Catanese S.p.A

Misterbianco (CT), Sicily, Italy

A.O.U. Policlinico Paolo Giaccone

Palermo, Sicily, Italy

Casa di Cura La Maddalena

Palermo, Sicily, Italy

Azienda Sanitaria Territoriale Pesaro Urbino (AST PU) - Ospedale Santa Croce;UOC Oncologia - Stabilimento di Fano

Fano (PU), The Marches, Italy

Ospedale Santa Chiara

Trento, Trentino-Alto Adige, Italy

Ospedale dell'Angelo

Mestre, Veneto, Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Veneto, Italy

Narodowy Instytut Onkologii - Panstwowy Instytut Badawczy, Oddzia? w Krakowie

Krakow, Poland

Uniwersytecki Szpital Kliniczny nr 4 w Lublinie

Lublin, Poland

Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

Olsztyn, Poland

Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

Poznan, Poland

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

Słupsk, Poland

NU-MED Centrum Diagnostyki i Terapii Onkologicznej

Tomaszów Mazowiecki, Poland

Institut Oncologic Prof. Dr. Alexandru Trestioreanu

Bucharest, Romania

Institutul Clinic Fundeni Bucuresti

Bucharest, Romania

Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. Octavian Fodor

Cluj-Napoca, Romania

Spitalul Clinic Jude?ean de Urgen?? Sfântul Apostol Andrei Galati;oncology

Galati, Romania

Institutul Regional de Oncologie Iasi

Iași, Romania

Spitalul Municipal Ploiesti

Ploieşti, Romania

Spitalul Judetean de Urgenta Satu Mare

Satu Mare, Romania

Oncomed SRL

Timișoara, Romania

Complejo Hospitalario Torrecardenas

Almería, Almeria, Spain

Hospital Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital Sant Joan de Deu de Manresa;Servicio oncologia

Manresa, Barcelona, Spain

Hospital Universitario Puerto Real

Puerto Real, Cadiz, Spain

Hospital Universitario Mancha Centro (Alcázar de San Juan);Servicio de digestivo

Alcázar de San Juan, Ciudad REAL, Spain

Hospital Universitario Mancha Centro (Alcázar de San Juan);Servicio de oncología

Alcázar de San Juan, Ciudad REAL, Spain

Complejo Hospitalario Universitario de Santiago (CHUS)

Santiago de Compostela, LA Coruna, Spain

Hospital Clínico Universitario Valladolid;servicio de digestivo

Valladolid, Madrid, Spain

Hospital Univ. Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Univ. Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, Spain

Complejo Hospitalario Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, Tenerife, Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Tenerife, Spain

Hospital de Cruces

Barakaldo, Vizcaya, Spain

Hospital de Cruces

Bilbao, Vizcaya, Spain

Complejo Hospitalario Universitario de Albacete

Albacete, Spain

Hospital General de Alicante;servicio de digestivo

Alicante, Spain

Hospital General Univ. de Alicante

Alicante, Spain

Hospital de Badajoz

Badajoz, Spain

Hospital Clinic I Provincial

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital General de Ciudad Real

Ciudad Real, Spain

Hospital Universitario San Cecilio

Granada, Spain

Hospital General Universitario de Guadalajara

Guadalajara, Spain

Hospital General Universitario J.M Morales Meseguer

Murcia, Spain

Hospital Virgen de Arrixaca;servicio de digestivo

Murcia, Spain

Complejo Hospitalario de Pontevedra

Pontevedra, Spain

Hospital Virgen del Rocio;Servicio de digestivo

Seville, Spain

Hospital de Toledo;Servicio de digestivo

Toledo, Spain

Hospital de Toledo;servicio de oncologia

Toledo, Spain

Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

Valencia, Spain

Hospital Clinico Universitario de Valladolid

Valladolid, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

James Cook University Hospital

Middlesbrough, United Kingdom

James Paget University Hospitals NHS Foundation Trust

Norfolk, United Kingdom

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NCT07284121