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

NCT ID: NCT07284121

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-17

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer, Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1: Early Non-small Cell Lung Cancer (NSCLC)

Participants diagnosed with early-stage NSCLC following complete resection and platinum-based chemotherapy with Programmed Cell-Death Ligand 1 (PD-L1) expression of \>= 50% on Tumor Cell (TC).

Atezolizumab

Intervention Type DRUG

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

Cohort 2: Metastatic NSCLC

Participants diagnosed with metastatic NSCLC with PD-L1 expression of \>= 50% on TC who have not received prior systemic therapy for metastatic disease.

Atezolizumab

Intervention Type DRUG

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

Cohort 3: Extensive stage small cell lung cancer (ES-SCLC)

Participants diagnosed with ES-SCLC who have not previously been treated.

Atezolizumab

Intervention Type DRUG

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

Cohort 4: Hepatocellular Carcinoma (HCC)

Participants diagnosed with advanced or unresectable HCC who have not received prior systemic therapy.

Atezolizumab

Intervention Type DRUG

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

Interventions

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Atezolizumab

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

Intervention Type DRUG

Other Intervention Names

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Tecentriq

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Landesklinikum Krems

Krems, , Austria

Site Status RECRUITING

Ordensklinikum Linz Elisabethinen

Linz, , Austria

Site Status RECRUITING

Krankenhaus Nord - Klinik Floridsdorf

Vienna, , Austria

Site Status RECRUITING

Klinikum Wels-Grieskirchen

Wels, , Austria

Site Status RECRUITING

CHU UCL Mont-Godinne

Mont-godinne, , Belgium

Site Status RECRUITING

Multiprofile Hospital for Active Treatment Uni Hospital

Panagyurishte, , Bulgaria

Site Status RECRUITING

Complex Oncological Center-Ruse EOOD

Rousse, , Bulgaria

Site Status RECRUITING

UMHAT "Sv. Ivan Rilski", EAD

Sofia, , Bulgaria

Site Status RECRUITING

MBAL Serdika EOOD

Sofia, , Bulgaria

Site Status RECRUITING

MHAT SofiaMed

Sofia, , Bulgaria

Site Status RECRUITING

Presidio Ospedaliero Vito Fazzi

Lecce, Apulia, Italy

Site Status RECRUITING

AORN Ospedali dei Colli Ospedale Monaldi

Napoli, Campania, Italy

Site Status RECRUITING

Az. Osp. Cardarelli

Napoli, Campania, Italy

Site Status RECRUITING

A.O. Universitaria Policlinico Di Modena

Modena, Emilia-Romagna, Italy

Site Status RECRUITING

Ospedale Provinciale Santa Maria Delle Croci

Ravenna, Emilia-Romagna, Italy

Site Status RECRUITING

Policlinico Universitario Agostino Gemelli

Rome, Lazio, Italy

Site Status RECRUITING

Università Campus Bio-Medico di Roma

Rome, Lazio, Italy

Site Status RECRUITING

IRCCS AOU San Martino - IST

Genoa, Liguria, Italy

Site Status RECRUITING

Humanitas Gavazzeni

Bergamo, Lombardy, Italy

Site Status RECRUITING

Fondazione IRCCS Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

Site Status RECRUITING

Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

Site Status RECRUITING

Asst Santi Paolo E Carlo

Milan, Lombardy, Italy

Site Status RECRUITING

Ente Ecclesiastico Ospedale Generale Regionale F Miulli

Acquaviva Delle Fonti, Piedmont, Italy

Site Status RECRUITING

A.O.U. Maggiore della Carità

Novara, Piedmont, Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Di Sassari

Sassari, Sardinia, Italy

Site Status RECRUITING

Humanitas Istituto Clinico Catanese S.p.A

Misterbianco (CT), Sicily, Italy

Site Status RECRUITING

A.O.U. Policlinico Paolo Giaccone

Palermo, Sicily, Italy

Site Status RECRUITING

Casa di Cura La Maddalena

Palermo, Sicily, Italy

Site Status RECRUITING

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

Fano (PU), The Marches, Italy

Site Status RECRUITING

Ospedale Santa Chiara

Trento, Trentino-Alto Adige, Italy

Site Status RECRUITING

Ospedale dell'Angelo

Mestre, Veneto, Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Veneto, Italy

Site Status RECRUITING

Uniwersytecki Szpital Kliniczny nr 4 w Lublinie

Lublin, , Poland

Site Status RECRUITING

Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

Olsztyn, , Poland

Site Status RECRUITING

Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

Poznan, , Poland

Site Status RECRUITING

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

Słupsk, , Poland

Site Status RECRUITING

NU-MED Centrum Diagnostyki i Terapii Onkologicznej

Tomaszów Mazowiecki, , Poland

Site Status RECRUITING

Institutul Clinic Fundeni Bucuresti

Bucharest, , Romania

Site Status RECRUITING

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

Cluj-Napoca, , Romania

Site Status RECRUITING

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

Galati, , Romania

Site Status RECRUITING

Institutul Regional de Oncologie Iasi

Iași, , Romania

Site Status RECRUITING

Spitalul Municipal Ploiesti

Ploieşti, , Romania

Site Status RECRUITING

Spitalul Judetean de Urgenta Satu Mare

Satu Mare, , Romania

Site Status RECRUITING

Oncomed SRL

Timișoara, , Romania

Site Status RECRUITING

Complejo Hospitalario Torrecardenas

Almería, Almeria, Spain

Site Status RECRUITING

Hospital Son Espases

Palma de Mallorca, Balearic Islands, Spain

Site Status RECRUITING

Hospital Sant Joan de Deu de Manresa;Servicio oncologia

Manresa, Barcelona, Spain

Site Status RECRUITING

Hospital Universitario Puerto Real

Puerto Real, Cadiz, Spain

Site Status RECRUITING

Complejo Hospitalario Universitario de Santiago (CHUS)

Santiago de Compostela, LA Coruna, Spain

Site Status RECRUITING

Hospital Clínico Universitario Valladolid;servicio de digestivo

Valladolid, Madrid, Spain

Site Status RECRUITING

Hospital Univ. Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status RECRUITING

Hospital Univ. Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status RECRUITING

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, Spain

Site Status RECRUITING

Complejo Hospitalario Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, Tenerife, Spain

Site Status RECRUITING

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Tenerife, Spain

Site Status RECRUITING

Hospital de Cruces

Bilbao, Vizcaya, Spain

Site Status RECRUITING

Hospital Universitario de Cruces;servicio de digestivo

Vizcaya, Vizcaya, Spain

Site Status RECRUITING

Hospital General de Alicante;servicio de digestivo

Alicante, , Spain

Site Status RECRUITING

Hospital General Univ. de Alicante

Alicante, , Spain

Site Status RECRUITING

Hospital de Badajoz

Badajoz, , Spain

Site Status RECRUITING

Hospital Clinic I Provincial

Barcelona, , Spain

Site Status RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Hospital General de Ciudad Real

Ciudad Real, , Spain

Site Status RECRUITING

Hospital Universitario San Cecilio

Granada, , Spain

Site Status RECRUITING

Hospital General Universitario de Guadalajara

Guadalajara, , Spain

Site Status RECRUITING

Hospital General Universitario J.M Morales Meseguer

Murcia, , Spain

Site Status RECRUITING

Hospital Virgen de Arrixaca;servicio de digestivo

Murcia, , Spain

Site Status RECRUITING

Complejo Hospitalario de Pontevedra

Pontevedra, , Spain

Site Status RECRUITING

Hospital Virgen del Rocio;Servicio de digestivo

Seville, , Spain

Site Status RECRUITING

Hospital de Toledo;Servicio de digestivo

Toledo, , Spain

Site Status RECRUITING

Hospital de Toledo;servicio de oncologia

Toledo, , Spain

Site Status RECRUITING

Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

Valencia, , Spain

Site Status RECRUITING

Hospital Clinico Universitario de Valladolid

Valladolid, , Spain

Site Status RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Site Status RECRUITING

James Paget University Hospitals NHS Foundation Trust

Norfolk, , United Kingdom

Site Status RECRUITING

Countries

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Austria Belgium Bulgaria Italy Poland Romania Spain United Kingdom

Central Contacts

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Reference Study ID Number: MO45893 https://forpatients.roche.com/

Role: CONTACT

888-662-6728 (U.S. and Canada)

Other Identifiers

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MO45893

Identifier Type: -

Identifier Source: org_study_id

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