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

May 21, 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

Study Locations

  • Austria
      • Krems, Austria, 3500
        • Recruiting
        • Landesklinikum Krems
      • Linz, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz Elisabethinen
      • Vienna, Austria, 1210
        • Recruiting
        • Krankenhaus Nord - Klinik Floridsdorf
      • Wels, Austria, 4600
        • Recruiting
        • Klinikum Wels-Grieskirchen
  • Belgium
      • Auderghem, Belgium, 1160
        • Recruiting
        • CHIREC
      • Ghent, Belgium, 9000
        • Recruiting
        • AZ Sint Lucas (Sint Lucas)
      • Haine-Saint-Paul, Belgium, 7100
        • Recruiting
        • CHU HELORA - Hôpital de la Louvière - Site Jolimont
      • Liège, Belgium, 4000
        • Recruiting
        • CHC MontLegia
      • Merksem, Belgium, 2170
        • Recruiting
        • ZNA Jan Palfijn
      • Mont-godinne, Belgium, 5530
        • Recruiting
        • CHU UCL Mont-Godinne
  • Bulgaria
      • Panagyurishte, Bulgaria, 4500
        • Recruiting
        • Multiprofile Hospital for Active Treatment Uni Hospital
      • Rousse, Bulgaria, 7000
        • Recruiting
        • Complex Oncological Center-Ruse EOOD
      • Sofia, Bulgaria, 1431
        • Recruiting
        • UMHAT "Sv. Ivan Rilski", EAD
      • Sofia, Bulgaria, 1632
        • Recruiting
        • MBAL Serdika EOOD
      • Sofia, Bulgaria, 1407
        • Recruiting
        • Tokuda Hospital
      • Sofia, Bulgaria, 1527
        • Recruiting
        • UMHAT Tsaritsa Yoanna - ISUL
      • Sofia, Bulgaria, 1797
        • Recruiting
        • MHAT SofiaMed
  • Italy
    • Apulia
      • Lecce, Apulia, Italy, 73044
        • Recruiting
        • Presidio Ospedaliero Vito Fazzi
    • Campania
      • Naples, Campania, Italy, 80131
        • Recruiting
        • AORN Ospedali dei Colli Ospedale Monaldi
      • Naples, Campania, Italy, 80131
        • Recruiting
        • Az. Osp. Cardarelli
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41100
        • Recruiting
        • A.O. Universitaria Policlinico Di Modena
      • Ravenna, Emilia-Romagna, Italy, 48100
        • Recruiting
        • Ospedale Provinciale Santa Maria Delle Croci
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Recruiting
        • Policlinico Universitario Agostino Gemelli
      • Rome, Lazio, Italy, 128
        • Recruiting
        • Università Campus Bio-Medico di Roma
    • Liguria
      • Genoa, Liguria, Italy, 16132
        • Recruiting
        • IRCCS AOU San Martino - IST
    • Lombardy
      • Bergamo, Lombardy, Italy, 24125
        • Recruiting
        • Cliniche Gavazzeni SpA Humanitas Gavazzeni
      • Milan, Lombardy, Italy, 20142
        • Recruiting
        • Asst Santi Paolo E Carlo
      • Milan, Lombardy, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ospedale Maggiore Policlinico
      • Milan, Lombardy, Italy, 20122
        • Recruiting
        • Ospedale Maggiore Policlinico
    • Piedmont
      • Acquaviva Delle Fonti, Piedmont, Italy, 70021
        • Recruiting
        • Ente Ecclesiastico Ospedale Generale Regionale F Miulli
      • Novara, Piedmont, Italy, 28100
        • Recruiting
        • A.O.U. Maggiore della Carità
    • Sardinia
      • Sassari, Sardinia, Italy, 07100
        • Recruiting
        • Azienda Ospedaliero Universitaria Di Sassari
    • Sicily
      • Misterbianco (CT), Sicily, Italy, 95045
        • Recruiting
        • Humanitas Istituto Clinico Catanese S.p.A
      • Palermo, Sicily, Italy, 90146
        • Recruiting
        • Casa di Cura La Maddalena
      • Palermo, Sicily, Italy, 90100
        • Recruiting
        • A.O.U. Policlinico Paolo Giaccone
    • The Marches
      • Fano (PU), The Marches, Italy, 61032
        • Recruiting
        • Azienda Sanitaria Territoriale Pesaro Urbino (AST PU) - Ospedale Santa Croce;UOC Oncologia - Stabilimento di Fano
    • Trentino-Alto Adige
      • Trento, Trentino-Alto Adige, Italy, 38100
        • Recruiting
        • Ospedale Santa Chiara
    • Veneto
      • Mestre, Veneto, Italy, 30174
        • Recruiting
        • Ospedale dell'Angelo
      • Verona, Veneto, Italy, 37126
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona
  • Poland
      • Krakow, Poland, 31-115
        • Recruiting
        • Narodowy Instytut Onkologii - Panstwowy Instytut Badawczy, Oddzia? w Krakowie
      • Lublin, Poland, 20-954
        • Recruiting
        • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
      • Olsztyn, Poland, 10-357
        • Recruiting
        • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
      • Poznan, Poland, 60-569
        • Recruiting
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
      • Słupsk, Poland, 76-200
        • Recruiting
        • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
      • Tomaszów Mazowiecki, Poland, 97-200
        • Recruiting
        • NU-MED Centrum Diagnostyki i Terapii Onkologicznej
  • Romania
      • Bucharest, Romania, 022328
        • Recruiting
        • Institutul Clinic Fundeni Bucuresti
      • Bucharest, Romania, 022328
        • Recruiting
        • Institut Oncologic Prof. Dr. Alexandru Trestioreanu
      • Cluj-Napoca, Romania, 400162
        • Recruiting
        • Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor
      • Galati, Romania, 800578
        • Recruiting
        • Spitalul Clinic Jude?ean de Urgen?? Sfântul Apostol Andrei Galati;oncology
      • Iași, Romania, 700483
        • Recruiting
        • Institutul Regional de Oncologie Iasi
      • Ploieşti, Romania, 107071
        • Recruiting
        • Spitalul Municipal Ploiesti
      • Satu Mare, Romania, 440055
        • Recruiting
        • Spitalul Județean de Urgență Satu Mare
      • Timișoara, Romania, 300239
        • Recruiting
        • Oncomed SRL
  • Spain
      • Albacete, Spain, 02006
        • Recruiting
        • Complejo Hospitalario Universitario de Albacete
      • Alicante, Spain, 3010
        • Recruiting
        • Hospital General Univ. de Alicante
      • Alicante, Spain, 03010
        • Recruiting
        • Hospital General de Alicante;servicio de digestivo
      • Badajoz, Spain, 06080
        • Recruiting
        • Hospital de Badajoz
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic i Provincial
      • Ciudad Real, Spain, 13005
        • Recruiting
        • Hospital General de Ciudad Real
      • Granada, Spain, 18016
        • Recruiting
        • Hospital Universitario San Cecilio
      • Guadalajara, Spain, 19002
        • Recruiting
        • Hospital General Universitario de Guadalajara
      • Murcia, Spain, 30008
        • Recruiting
        • Hospital General Universitario J.M Morales Meseguer
      • Murcia, Spain, 30120
        • Recruiting
        • Hospital Virgen de Arrixaca;servicio de digestivo
      • Pontevedra, Spain, 36002
        • Recruiting
        • Complejo Hospitalario de Pontevedra
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Virgen del Rocio;Servicio de digestivo
      • Toledo, Spain, 45007
        • Recruiting
        • Hospital de Toledo;Servicio de digestivo
      • Toledo, Spain, 47007
        • Recruiting
        • Hospital de Toledo;servicio de oncologia
      • Valencia, Spain, 46015
        • Recruiting
        • Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
      • Valladolid, Spain, 47003
        • Recruiting
        • Hospital Clínico Universitario de Valladolid
      • Valladolid, Spain, 47005
        • Recruiting
        • Hospital Clinico Universitario Valladolid
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Universitario Miguel Servet
    • Almeria
      • Almería, Almeria, Spain, 04009
        • Recruiting
        • Complejo Hospitalario Torrecárdenas
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 7120
        • Recruiting
        • Hospital Son Espases
    • Barcelona
      • Manresa, Barcelona, Spain, 08243
        • Recruiting
        • Hospital Sant Joan de Deu de Manresa;Servicio oncologia
    • Cadiz
      • Puerto Real, Cadiz, Spain, 11510
        • Recruiting
        • Hospital Universitario Puerto Real
    • Ciudad REAL
      • Alcázar de San Juan, Ciudad REAL, Spain, 13600
        • Recruiting
        • Hospital Universitario Mancha Centro (Alcázar de San Juan);Servicio de digestivo
      • Alcázar de San Juan, Ciudad REAL, Spain, 13600
        • Recruiting
        • Hospital Universitario Mancha Centro (Alcázar de San Juan);Servicio de oncología
    • LA Coruna
      • Santiago de Compostela, LA Coruna, Spain, 15706
        • Recruiting
        • Complejo Hospitalario Universitario de Santiago (CHUS)
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33006
        • Recruiting
        • Hospital Univ. Central de Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Recruiting
        • Hospital Univ. Central de Asturias
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • Recruiting
        • Hospital Universitari Sant Joan de Reus
    • Tenerife
      • Santa Cruz de Tenerife, Tenerife, Spain, 38320
        • Recruiting
        • Hospital Universitario de Canarias
      • Santa Cruz de Tenerife, Tenerife, Spain, 38010
        • Recruiting
        • Complejo Hospitalario Nuestra Señora de la Candelaria
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Recruiting
        • Hospital De Cruces
      • Bilbao, Vizcaya, Spain, 48903
        • Recruiting
        • Hospital De Cruces
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust
      • Guildford, United Kingdom, GU2 7XX
        • Recruiting
        • Royal Surrey County Hospital
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • Leeds Teaching Hosp NHS Trust
      • Middlesbrough, United Kingdom, TS4 3BW
        • Recruiting
        • James Cook University Hospital
      • Norfolk, United Kingdom, NR31 6LA
        • Recruiting
        • James Paget University Hospitals NHS Foundation Trust

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
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).
Drug: Atezolizumab
Atezolizumab will be administered at the discretion of the treating physician and independently of participation in this study.
Other Names:
  • Tecentriq
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.
Drug: Atezolizumab
Atezolizumab will be administered at the discretion of the treating physician and independently of participation in this study.
Other Names:
  • Tecentriq
Cohort 3: Extensive stage small cell lung cancer (ES-SCLC)
Participants diagnosed with ES-SCLC who have not previously been treated.
Drug: Atezolizumab
Atezolizumab will be administered at the discretion of the treating physician and independently of participation in this study.
Other Names:
  • Tecentriq
Cohort 4: Hepatocellular Carcinoma (HCC)
Participants diagnosed with advanced or unresectable HCC who have not received prior systemic therapy.
Drug: Atezolizumab
Atezolizumab will be administered at the discretion of the treating physician and independently of participation in this study.
Other Names:
  • Tecentriq

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) Score
Time Frame: At Cycle 2 and Cycle 3 (each cycle duration/length is 3 weeks)
At Cycle 2 and Cycle 3 (each cycle duration/length is 3 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Index date up to approximately 3.5 years
Index date up to approximately 3.5 years
OS at 2 Years
Time Frame: After Index date up to 2 years
After Index date up to 2 years
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Score
Time Frame: Baseline or Index date
Baseline or Index date
Percentage of Participants With Adverse Events
Time Frame: Up to approximately 3.5 years
Up to approximately 3.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

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)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.

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