CClinicalTrials.gg
RecruitingNCT07284121Updated Sep 11, 2026

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

An observational study in Lung Cancer, Hepatocellular Carcinoma, sponsored by Hoffmann-La Roche. Recruiting at 92 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Hoffmann-La Roche · Observational

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
700
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Cancer, Hepatocellular Carcinoma
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 700 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
700 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

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

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

    Drug: Atezolizumab

  • Cohort 4: Hepatocellular Carcinoma (HCC)

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

    Drug: Atezolizumab

Interventions

  • DrugAtezolizumab

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

    Also known as: Tecentriq

06

What researchers measure

Primary outcomes

  1. Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) Score

    Time frame: At Cycle 2 and Cycle 3 (each cycle duration/length is 3 weeks)

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Index date up to approximately 3.5 years

  2. OS at 2 Years

    Time frame: After Index date up to 2 years

  3. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Score

    Time frame: Baseline or Index date

  4. Percentage of Participants With Adverse Events

    Time frame: Up to approximately 3.5 years

07

Study locations

92 of 92 sites recruiting
  • Landesklinikum Krems
    Krems, 3500, Austria
    Recruiting
  • Ordensklinikum Linz Elisabethinen
    Linz, 4020, Austria
    Recruiting
  • Krankenhaus Nord - Klinik Floridsdorf
    Vienna, 1210, Austria
    Recruiting
  • Klinikum Wels-Grieskirchen
    Wels, 4600, Austria
    Recruiting
  • CHIREC
    Auderghem, 1160, Belgium
    Recruiting
  • AZ Sint Lucas (Sint Lucas)
    Ghent, 9000, Belgium
    Recruiting
  • CHU HELORA - Hôpital de la Louvière - Site Jolimont
    Haine-Saint-Paul, 7100, Belgium
    Recruiting
  • CHC MontLégia
    Liège, 4000, Belgium
    Recruiting
  • ZNA Jan Palfijn
    Merksem, 2170, Belgium
    Recruiting
  • CHU UCL Mont-Godinne
    Mont-godinne, 5530, Belgium
    Recruiting
  • Multiprofile Hospital for Active Treatment Uni Hospital
    Panagyurishte, 4500, Bulgaria
    Recruiting
  • Complex Oncological Center-Ruse EOOD
    Rousse, 7000, Bulgaria
    Recruiting
  • Tokuda Hospital
    Sofia, 1407, Bulgaria
    Recruiting
  • UMHAT "Sv. Ivan Rilski", EAD
    Sofia, 1431, Bulgaria
    Recruiting
  • UMHAT Tsaritsa Yoanna - ISUL
    Sofia, 1527, Bulgaria
    Recruiting
  • MBAL Serdika EOOD
    Sofia, 1632, Bulgaria
    Recruiting
  • MHAT SofiaMed
    Sofia, 1797, Bulgaria
    Recruiting
  • Presidio Ospedaliero Vito Fazzi
    Lecce, Apulia 73044, Italy
    Recruiting
  • AORN Ospedali dei Colli Ospedale Monaldi
    Naples, Campania 80131, Italy
    Recruiting
  • Az. Osp. Cardarelli
    Naples, Campania 80131, Italy
    Recruiting
  • A.O. Universitaria Policlinico Di Modena
    Modena, Emilia-Romagna 41100, Italy
    Recruiting
  • Ospedale Provinciale Santa Maria Delle Croci
    Ravenna, Emilia-Romagna 48100, Italy
    Recruiting
  • Policlinico Universitario Agostino Gemelli
    Rome, Lazio 00168, Italy
    Recruiting
  • Università Campus Bio-Medico di Roma
    Rome, Lazio 128, Italy
    Recruiting
  • IRCCS AOU San Martino - IST
    Genoa, Liguria 16132, Italy
    Recruiting
  • Cliniche Gavazzeni SpA Humanitas Gavazzeni
    Bergamo, Lombardy 24125, Italy
    Recruiting
  • Fondazione IRCCS Ospedale Maggiore Policlinico
    Milan, Lombardy 20122, Italy
    Recruiting
  • Ospedale Maggiore Policlinico
    Milan, Lombardy 20122, Italy
    Recruiting
  • Asst Santi Paolo E Carlo
    Milan, Lombardy 20142, Italy
    Recruiting
  • Ente Ecclesiastico Ospedale Generale Regionale F Miulli
    Acquaviva Delle Fonti, Piedmont 70021, Italy
    Recruiting
  • A.O.U. Maggiore della Carità
    Novara, Piedmont 28100, Italy
    Recruiting
  • Azienda Ospedaliero Universitaria Di Sassari
    Sassari, Sardinia 07100, Italy
    Recruiting
  • Humanitas Istituto Clinico Catanese S.p.A
    Misterbianco (CT), Sicily 95045, Italy
    Recruiting
  • A.O.U. Policlinico Paolo Giaccone
    Palermo, Sicily 90100, Italy
    Recruiting
  • Casa di Cura La Maddalena
    Palermo, Sicily 90146, Italy
    Recruiting
  • Azienda Sanitaria Territoriale Pesaro Urbino (AST PU) - Ospedale Santa Croce;UOC Oncologia - Stabilimento di Fano
    Fano (PU), The Marches 61032, Italy
    Recruiting
  • Ospedale Santa Chiara
    Trento, Trentino-Alto Adige 38100, Italy
    Recruiting
  • Ospedale dell'Angelo
    Mestre, Veneto 30174, Italy
    Recruiting
  • Azienda Ospedaliera Universitaria Integrata Verona
    Verona, Veneto 37126, Italy
    Recruiting
  • Narodowy Instytut Onkologii - Panstwowy Instytut Badawczy, Oddzia? w Krakowie
    Krakow, 31-115, Poland
    Recruiting
  • Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
    Lublin, 20-954, Poland
    Recruiting
  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
    Olsztyn, 10-357, Poland
    Recruiting
  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
    Poznan, 60-569, Poland
    Recruiting
  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
    Słupsk, 76-200, Poland
    Recruiting
  • NU-MED Centrum Diagnostyki i Terapii Onkologicznej
    Tomaszów Mazowiecki, 97-200, Poland
    Recruiting
  • Spitalul Clinic de Urgenta Prof. Dr. Agrippa Ionescu
    Bucharest, 011356, Romania
    Recruiting
  • Institut Oncologic Prof. Dr. Alexandru Trestioreanu
    Bucharest, 022328, Romania
    Recruiting
  • Institutul Clinic Fundeni Bucuresti
    Bucharest, 022328, Romania
    Recruiting
  • Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. Octavian Fodor
    Cluj-Napoca, 400162, Romania
    Recruiting
  • Spitalul Clinic Jude?ean de Urgen?? Sfântul Apostol Andrei Galati;oncology
    Galati, 800578, Romania
    Recruiting
  • Institutul Regional de Oncologie Iasi
    Iași, 700483, Romania
    Recruiting
  • Spitalul Municipal Ploiesti
    Ploieşti, 107071, Romania
    Recruiting
  • Spitalul Judetean de Urgenta Satu Mare
    Satu Mare, 440055, Romania
    Recruiting
  • Oncomed SRL
    Timișoara, 300239, Romania
    Recruiting
  • Complejo Hospitalario Torrecardenas
    Almería, Almeria 04009, Spain
    Recruiting
  • Hospital Son Espases
    Palma de Mallorca, Balearic Islands 7120, Spain
    Recruiting
  • Hospital Sant Joan de Deu de Manresa;Servicio oncologia
    Manresa, Barcelona 08243, Spain
    Recruiting
  • Hospital Universitario Puerto Real
    Puerto Real, Cadiz 11510, Spain
    Recruiting
  • Hospital Universitario Mancha Centro (Alcázar de San Juan);Servicio de digestivo
    Alcázar de San Juan, Ciudad REAL 13600, Spain
    Recruiting
  • Hospital Universitario Mancha Centro (Alcázar de San Juan);Servicio de oncología
    Alcázar de San Juan, Ciudad REAL 13600, Spain
    Recruiting
  • Complejo Hospitalario Universitario de Santiago (CHUS)
    Santiago de Compostela, LA Coruna 15706, Spain
    Recruiting
  • Hospital Univ. Central de Asturias
    Oviedo, Principality of Asturias 33006, Spain
    Recruiting
  • Hospital Univ. Central de Asturias
    Oviedo, Principality of Asturias 33011, Spain
    Recruiting
  • Hospital Universitari Sant Joan de Reus
    Reus, Tarragona 43204, Spain
    Recruiting
  • Complejo Hospitalario Nuestra Señora de la Candelaria
    Santa Cruz de Tenerife, Tenerife 38010, Spain
    Recruiting
  • Hospital Universitario de Canarias
    Santa Cruz de Tenerife, Tenerife 38320, Spain
    Recruiting
  • Hospital de Cruces
    Barakaldo, Vizcaya 48903, Spain
    Recruiting
  • Hospital de Cruces
    Bilbao, Vizcaya 48903, Spain
    Recruiting
  • Complejo Hospitalario Universitario de Albacete
    Albacete, 02006, Spain
    Recruiting
  • Hospital General de Alicante;servicio de digestivo
    Alicante, 03010, Spain
    Recruiting
  • Hospital General Univ. de Alicante
    Alicante, 3010, Spain
    Recruiting
  • Hospital de Badajoz
    Badajoz, 06080, Spain
    Recruiting
  • Hospital Clinic I Provincial
    Barcelona, 08036, Spain
    Recruiting
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, 08041, Spain
    Recruiting
  • Hospital General de Ciudad Real
    Ciudad Real, 13005, Spain
    Recruiting
  • Hospital Universitario San Cecilio
    Granada, 18016, Spain
    Recruiting
  • Hospital General Universitario de Guadalajara
    Guadalajara, 19002, Spain
    Recruiting
  • Hospital General Universitario J.M Morales Meseguer
    Murcia, 30008, Spain
    Recruiting
  • Hospital Virgen de Arrixaca;servicio de digestivo
    Murcia, 30120, Spain
    Recruiting
  • Complejo Hospitalario de Pontevedra
    Pontevedra, 36002, Spain
    Recruiting
  • Hospital Virgen del Rocio;Servicio de digestivo
    Seville, 41013, Spain
    Recruiting
  • Hospital de Toledo;Servicio de digestivo
    Toledo, 45007, Spain
    Recruiting
  • Hospital de Toledo;servicio de oncologia
    Toledo, 47007, Spain
    Recruiting
  • Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
    Valencia, 46015, Spain
    Recruiting
  • Hospital Clinico Universitario de Valladolid
    Valladolid, 47003, Spain
    Recruiting
  • Hospital Clinico Universitario Valladolid
    Valladolid, 47005, Spain
    Recruiting
  • Hospital Universitario Miguel Servet
    Zaragoza, 50009, Spain
    Recruiting
  • University Hospitals Birmingham NHS Foundation Trust
    Birmingham, B15 2TH, United Kingdom
    Recruiting
  • Royal Surrey County Hospital
    Guildford, GU2 7XX, United Kingdom
    Recruiting
  • Leeds Teaching Hosp NHS Trust
    Leeds, LS9 7TF, United Kingdom
    Recruiting
  • James Cook University Hospital
    Middlesbrough, TS4 3BW, United Kingdom
    Recruiting
  • James Paget University Hospitals NHS Foundation Trust
    Norfolk, NR31 6LA, United Kingdom
    Recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07284121
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Dec 16, 2025
Start date
Jul 15, 2025
Primary completion
Mar 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 11, 2026

Study contacts

Reference Study ID Number: MO45893 https://forpatients.roche.com/ No attachments to email below.
Contact
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact
Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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