A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
September 10, 2026 updated by: Hoffmann-La Roche
A Non-Interventional, Multicenter, Multicohort Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Subcutaneous Atezolizumab in Participants Treated in Routine Clinical Practice
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
700
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Study Contact Backup
- Name: Reference Study ID Number: MO45893 https://forpatients.roche.com/ No attachments to email below.
- Phone Number: 888-662-6728 (U.S. and Canada)
- Email: global-roche-genentech-trials@gene.com
Study Locations
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Krems, Austria, 3500
- Recruiting
- Landesklinikum Krems
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Linz, Austria, 4020
- Recruiting
- Ordensklinikum Linz Elisabethinen
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Vienna, Austria, 1210
- Recruiting
- Krankenhaus Nord - Klinik Floridsdorf
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Wels, Austria, 4600
- Recruiting
- Klinikum Wels-Grieskirchen
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Auderghem, Belgium, 1160
- Recruiting
- CHIREC
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Ghent, Belgium, 9000
- Recruiting
- AZ Sint Lucas (Sint Lucas)
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Haine-Saint-Paul, Belgium, 7100
- Recruiting
- CHU HELORA - Hôpital de la Louvière - Site Jolimont
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Liège, Belgium, 4000
- Recruiting
- Chc Montlegia
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Merksem, Belgium, 2170
- Recruiting
- ZNA Jan Palfijn
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Mont-godinne, Belgium, 5530
- Recruiting
- CHU UCL Mont-Godinne
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Panagyurishte, Bulgaria, 4500
- Recruiting
- Multiprofile Hospital for Active Treatment Uni Hospital
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Rousse, Bulgaria, 7000
- Recruiting
- Complex Oncological Center-Ruse EOOD
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Sofia, Bulgaria, 1431
- Recruiting
- UMHAT "Sv. Ivan Rilski", EAD
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Sofia, Bulgaria, 1632
- Recruiting
- MBAL Serdika EOOD
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Sofia, Bulgaria, 1407
- Recruiting
- Tokuda Hospital
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Sofia, Bulgaria, 1527
- Recruiting
- UMHAT Tsaritsa Yoanna - ISUL
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Sofia, Bulgaria, 1797
- Recruiting
- MHAT SofiaMed
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Apulia
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Lecce, Apulia, Italy, 73044
- Recruiting
- Presidio Ospedaliero Vito Fazzi
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Campania
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Naples, Campania, Italy, 80131
- Recruiting
- AORN Ospedali dei Colli Ospedale Monaldi
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Naples, Campania, Italy, 80131
- Recruiting
- Az. Osp. Cardarelli
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Emilia-Romagna
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Modena, Emilia-Romagna, Italy, 41100
- Recruiting
- A.O. Universitaria Policlinico Di Modena
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Ravenna, Emilia-Romagna, Italy, 48100
- Recruiting
- Ospedale Provinciale Santa Maria Delle Croci
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Lazio
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Rome, Lazio, Italy, 00168
- Recruiting
- Policlinico Universitario Agostino Gemelli
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Rome, Lazio, Italy, 128
- Recruiting
- Università Campus Bio-Medico di Roma
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Liguria
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Genoa, Liguria, Italy, 16132
- Recruiting
- IRCCS AOU San Martino - IST
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Lombardy
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Bergamo, Lombardy, Italy, 24125
- Recruiting
- Cliniche Gavazzeni SpA Humanitas Gavazzeni
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Milan, Lombardy, Italy, 20142
- Recruiting
- Asst Santi Paolo E Carlo
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Milan, Lombardy, Italy, 20122
- Recruiting
- Fondazione IRCCS Ospedale Maggiore Policlinico
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Milan, Lombardy, Italy, 20122
- Recruiting
- Ospedale Maggiore Policlinico
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Piedmont
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Acquaviva Delle Fonti, Piedmont, Italy, 70021
- Recruiting
- Ente Ecclesiastico Ospedale Generale Regionale F Miulli
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Novara, Piedmont, Italy, 28100
- Recruiting
- A.O.U. Maggiore della Carità
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Sardinia
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Sassari, Sardinia, Italy, 07100
- Recruiting
- Azienda Ospedaliero Universitaria Di Sassari
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Sicily
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Misterbianco (CT), Sicily, Italy, 95045
- Recruiting
- Humanitas Istituto Clinico Catanese S.p.A
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Palermo, Sicily, Italy, 90146
- Recruiting
- Casa di Cura La Maddalena
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Palermo, Sicily, Italy, 90100
- Recruiting
- A.O.U. Policlinico Paolo Giaccone
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The Marches
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Fano (PU), The Marches, Italy, 61032
- Recruiting
- Azienda Sanitaria Territoriale Pesaro Urbino (AST PU) - Ospedale Santa Croce;UOC Oncologia - Stabilimento di Fano
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Trentino-Alto Adige
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Trento, Trentino-Alto Adige, Italy, 38100
- Recruiting
- Ospedale Santa Chiara
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Veneto
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Mestre, Veneto, Italy, 30174
- Recruiting
- Ospedale dell'Angelo
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Verona, Veneto, Italy, 37126
- Recruiting
- Azienda Ospedaliera Universitaria Integrata Verona
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Krakow, Poland, 31-115
- Recruiting
- Narodowy Instytut Onkologii - Panstwowy Instytut Badawczy, Oddzia? w Krakowie
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Lublin, Poland, 20-954
- Recruiting
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
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Olsztyn, Poland, 10-357
- Recruiting
- Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
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Poznan, Poland, 60-569
- Recruiting
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
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Słupsk, Poland, 76-200
- Recruiting
- Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
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Tomaszów Mazowiecki, Poland, 97-200
- Recruiting
- NU-MED Centrum Diagnostyki i Terapii Onkologicznej
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Bucharest, Romania, 022328
- Recruiting
- Institutul Clinic Fundeni Bucuresti
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Bucharest, Romania, 022328
- Recruiting
- Institut Oncologic Prof. Dr. Alexandru Trestioreanu
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Bucharest, Romania, 011356
- Recruiting
- Spitalul Clinic de Urgenta Prof. Dr. Agrippa Ionescu
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Cluj-Napoca, Romania, 400162
- Recruiting
- Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. Octavian Fodor
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Galati, Romania, 800578
- Recruiting
- Spitalul Clinic Jude?ean de Urgen?? Sfântul Apostol Andrei Galati;oncology
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Iași, Romania, 700483
- Recruiting
- Institutul Regional de Oncologie Iasi
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Ploieşti, Romania, 107071
- Recruiting
- Spitalul Municipal Ploiesti
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Satu Mare, Romania, 440055
- Recruiting
- Spitalul Judetean de Urgenta Satu Mare
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Timișoara, Romania, 300239
- Recruiting
- Oncomed SRL
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Albacete, Spain, 02006
- Recruiting
- Complejo Hospitalario Universitario de Albacete
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Alicante, Spain, 3010
- Recruiting
- Hospital General Univ. de Alicante
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Alicante, Spain, 03010
- Recruiting
- Hospital General de Alicante;servicio de digestivo
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Badajoz, Spain, 06080
- Recruiting
- Hospital de Badajoz
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Barcelona, Spain, 08041
- Recruiting
- Hospital de la Santa Creu i Sant Pau
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Barcelona, Spain, 08036
- Recruiting
- Hospital Clinic I Provincial
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Ciudad Real, Spain, 13005
- Recruiting
- Hospital General de Ciudad Real
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Granada, Spain, 18016
- Recruiting
- Hospital Universitario San Cecilio
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Guadalajara, Spain, 19002
- Recruiting
- Hospital General Universitario de Guadalajara
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Murcia, Spain, 30008
- Recruiting
- Hospital General Universitario J.M Morales Meseguer
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Murcia, Spain, 30120
- Recruiting
- Hospital Virgen de Arrixaca;servicio de digestivo
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Pontevedra, Spain, 36002
- Recruiting
- Complejo Hospitalario de Pontevedra
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Seville, Spain, 41013
- Recruiting
- Hospital Virgen del Rocio;Servicio de digestivo
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Toledo, Spain, 45007
- Recruiting
- Hospital de Toledo;Servicio de digestivo
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Toledo, Spain, 47007
- Recruiting
- Hospital de Toledo;servicio de oncologia
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Valencia, Spain, 46015
- Recruiting
- Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
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Valladolid, Spain, 47003
- Recruiting
- Hospital Clinico Universitario de Valladolid
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Valladolid, Spain, 47005
- Recruiting
- Hospital Clinico Universitario Valladolid
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Zaragoza, Spain, 50009
- Recruiting
- Hospital Universitario Miguel Servet
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Almeria
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Almería, Almeria, Spain, 04009
- Recruiting
- Complejo Hospitalario Torrecardenas
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Balearic Islands
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Palma de Mallorca, Balearic Islands, Spain, 7120
- Recruiting
- Hospital Son Espases
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Barcelona
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Manresa, Barcelona, Spain, 08243
- Recruiting
- Hospital Sant Joan de Deu de Manresa;Servicio oncologia
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Cadiz
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Puerto Real, Cadiz, Spain, 11510
- Recruiting
- Hospital Universitario Puerto Real
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Ciudad REAL
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Alcázar de San Juan, Ciudad REAL, Spain, 13600
- Recruiting
- Hospital Universitario Mancha Centro (Alcázar de San Juan);Servicio de digestivo
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Alcázar de San Juan, Ciudad REAL, Spain, 13600
- Recruiting
- Hospital Universitario Mancha Centro (Alcázar de San Juan);Servicio de oncología
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LA Coruna
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Santiago de Compostela, LA Coruna, Spain, 15706
- Recruiting
- Complejo Hospitalario Universitario de Santiago (CHUS)
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Principality of Asturias
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Oviedo, Principality of Asturias, Spain, 33006
- Recruiting
- Hospital Univ. Central de Asturias
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Oviedo, Principality of Asturias, Spain, 33011
- Recruiting
- Hospital Univ. Central de Asturias
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Tarragona
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Reus, Tarragona, Spain, 43204
- Recruiting
- Hospital Universitari Sant Joan de Reus
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Tenerife
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Santa Cruz de Tenerife, Tenerife, Spain, 38320
- Recruiting
- Hospital Universitario de Canarias
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Santa Cruz de Tenerife, Tenerife, Spain, 38010
- Recruiting
- Complejo Hospitalario Nuestra Señora de la Candelaria
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Vizcaya
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Barakaldo, Vizcaya, Spain, 48903
- Recruiting
- Hospital de Cruces
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Bilbao, Vizcaya, Spain, 48903
- Recruiting
- Hospital de Cruces
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Birmingham, United Kingdom, B15 2TH
- Recruiting
- University Hospitals Birmingham NHS Foundation Trust
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Guildford, United Kingdom, GU2 7XX
- Recruiting
- Royal Surrey County Hospital
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Leeds, United Kingdom, LS9 7TF
- Recruiting
- Leeds Teaching Hosp NHS Trust
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Middlesbrough, United Kingdom, TS4 3BW
- Recruiting
- James Cook University Hospital
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Norfolk, United Kingdom, NR31 6LA
- Recruiting
- James Paget University Hospitals NHS Foundation Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Participants diagnosed with early-stage NSCLC following complete resection and platinum-based chemotherapy with PD-L1 expression of >= 50% on TC, participants diagnosed with metastatic NSCLC with PD-L1 expression of ≥ 50% on TC who have not received prior systemic therapy for metastatic disease, participants diagnosed with ES-SCLC who have not previously been treated, and participants diagnosed with advanced or unresectable HCC who have not received prior systemic therapy.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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).
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Atezolizumab will be administered at the discretion of the treating physician and independently of participation in this study.
Other Names:
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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.
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Atezolizumab will be administered at the discretion of the treating physician and independently of participation in this study.
Other Names:
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Cohort 3: Extensive stage small cell lung cancer (ES-SCLC)
Participants diagnosed with ES-SCLC who have not previously been treated.
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Atezolizumab will be administered at the discretion of the treating physician and independently of participation in this study.
Other Names:
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Cohort 4: Hepatocellular Carcinoma (HCC)
Participants diagnosed with advanced or unresectable HCC who have not received prior systemic therapy.
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Atezolizumab will be administered at the discretion of the treating physician and independently of participation in this study.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) Score
Time Frame: At Cycle 2 and Cycle 3 (each cycle duration/length is 3 weeks)
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At Cycle 2 and Cycle 3 (each cycle duration/length is 3 weeks)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Overall Survival (OS)
Time Frame: Index date up to approximately 3.5 years
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Index date up to approximately 3.5 years
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OS at 2 Years
Time Frame: After Index date up to 2 years
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After Index date up to 2 years
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European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Score
Time Frame: Baseline or Index date
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Baseline or Index date
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Percentage of Participants With Adverse Events
Time Frame: Up to approximately 3.5 years
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Up to approximately 3.5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2025
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
December 31, 2028
Study Registration Dates
First Submitted
November 21, 2025
First Submitted That Met QC Criteria
December 2, 2025
First Posted (Actual)
December 16, 2025
Study Record Updates
Last Update Posted (Actual)
September 11, 2026
Last Update Submitted That Met QC Criteria
September 10, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Digestive System Neoplasms
- Digestive System Diseases
- Lung Diseases
- Liver Diseases
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Liver Neoplasms
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Lung Neoplasms
- atezolizumab
Other Study ID Numbers
- MO45893
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.