Lung Cancer, Hepatocellular CarcinomaNCT07284121
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
An observational study of Lung Cancer, Hepatocellular Carcinoma, run by Hoffmann-La Roche at 92 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Hepatocellular Carcinoma
- What is being tested?
- Atezolizumab
- How many people
- 700 participants
- Where
- 92 sitesin 8 countries
- Study dates
- 15 Jul 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
92 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: MO45893 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
92 sites in 8 countries
Spain33 sites, 33 recruiting
- Recruiting
Complejo Hospitalario Universitario de Albacete
Albacete, 02006
- Recruiting
Hospital Universitario Mancha Centro (Alcázar de San Juan);Servicio de digestivo
Alcázar de San Juan, Ciudad REAL, 13600
- Recruiting
Hospital Universitario Mancha Centro (Alcázar de San Juan);Servicio de oncología
Alcázar de San Juan, Ciudad REAL, 13600
- Recruiting
Hospital General de Alicante;servicio de digestivo
Alicante, 03010
- Recruiting
Hospital General Univ. de Alicante
Alicante, 3010
- Recruiting
Complejo Hospitalario Torrecardenas
Almería, Almeria, 04009
- Recruiting
Hospital de Badajoz
Badajoz, 06080
- Recruiting
Hospital de Cruces
Barakaldo, Vizcaya, 48903
- Recruiting
Hospital Clinic I Provincial
Barcelona, 08036
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
- Recruiting
Hospital de Cruces
Bilbao, Vizcaya, 48903
- Recruiting
Hospital General de Ciudad Real
Ciudad Real, 13005
- Recruiting
Hospital Universitario San Cecilio
Granada, 18016
- Recruiting
Hospital General Universitario de Guadalajara
Guadalajara, 19002
- Recruiting
Hospital Sant Joan de Deu de Manresa;Servicio oncologia
Manresa, Barcelona, 08243
- Recruiting
Hospital General Universitario J.M Morales Meseguer
Murcia, 30008
- Recruiting
Hospital Virgen de Arrixaca;servicio de digestivo
Murcia, 30120
- Recruiting
Hospital Univ. Central de Asturias
Oviedo, Principality of Asturias, 33006
- Recruiting
Hospital Univ. Central de Asturias
Oviedo, Principality of Asturias, 33011
- Recruiting
Hospital Son Espases
Palma de Mallorca, Balearic Islands, 7120
- Recruiting
Complejo Hospitalario de Pontevedra
Pontevedra, 36002
- Recruiting
Hospital Universitario Puerto Real
Puerto Real, Cadiz, 11510
- Recruiting
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, 43204
- Recruiting
Complejo Hospitalario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, Tenerife, 38010
- Recruiting
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Tenerife, 38320
- Recruiting
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, LA Coruna, 15706
- Recruiting
Hospital Virgen del Rocio;Servicio de digestivo
Seville, 41013
- Recruiting
Hospital de Toledo;Servicio de digestivo
Toledo, 45007
- Recruiting
Hospital de Toledo;servicio de oncologia
Toledo, 47007
- Recruiting
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
Valencia, 46015
- Recruiting
Hospital Clinico Universitario de Valladolid
Valladolid, 47003
- Recruiting
Hospital Clinico Universitario Valladolid
Valladolid, 47005
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
Italy22 sites, 22 recruiting
- Recruiting
Ente Ecclesiastico Ospedale Generale Regionale F Miulli
Acquaviva Delle Fonti, Piedmont, 70021
- Recruiting
Cliniche Gavazzeni SpA Humanitas Gavazzeni
Bergamo, Lombardy, 24125
- Recruiting
Azienda Sanitaria Territoriale Pesaro Urbino (AST PU) - Ospedale Santa Croce;UOC Oncologia - Stabilimento di Fano
Fano (PU), The Marches, 61032
- Recruiting
IRCCS AOU San Martino - IST
Genoa, Liguria, 16132
- Recruiting
Presidio Ospedaliero Vito Fazzi
Lecce, Apulia, 73044
- Recruiting
Ospedale dell'Angelo
Mestre, Veneto, 30174
- Recruiting
Fondazione IRCCS Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
- Recruiting
Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
- Recruiting
Asst Santi Paolo E Carlo
Milan, Lombardy, 20142
- Recruiting
Humanitas Istituto Clinico Catanese S.p.A
Misterbianco (CT), Sicily, 95045
- Recruiting
A.O. Universitaria Policlinico Di Modena
Modena, Emilia-Romagna, 41100
- Recruiting
AORN Ospedali dei Colli Ospedale Monaldi
Naples, Campania, 80131
- Recruiting
Az. Osp. Cardarelli
Naples, Campania, 80131
- Recruiting
A.O.U. Maggiore della Carità
Novara, Piedmont, 28100
- Recruiting
A.O.U. Policlinico Paolo Giaccone
Palermo, Sicily, 90100
- Recruiting
Casa di Cura La Maddalena
Palermo, Sicily, 90146
- Recruiting
Ospedale Provinciale Santa Maria Delle Croci
Ravenna, Emilia-Romagna, 48100
- Recruiting
Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168
- Recruiting
Università Campus Bio-Medico di Roma
Rome, Lazio, 128
- Recruiting
Azienda Ospedaliero Universitaria Di Sassari
Sassari, Sardinia, 07100
- Recruiting
Ospedale Santa Chiara
Trento, Trentino-Alto Adige, 38100
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Veneto, 37126
Romania9 sites, 9 recruiting
- Recruiting
Spitalul Clinic de Urgenta Prof. Dr. Agrippa Ionescu
Bucharest, 011356
- Recruiting
Institut Oncologic Prof. Dr. Alexandru Trestioreanu
Bucharest, 022328
- Recruiting
Institutul Clinic Fundeni Bucuresti
Bucharest, 022328
- Recruiting
Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. Octavian Fodor
Cluj-Napoca, 400162
- Recruiting
Spitalul Clinic Jude?ean de Urgen?? Sfântul Apostol Andrei Galati;oncology
Galati, 800578
- Recruiting
Institutul Regional de Oncologie Iasi
Iași, 700483
- Recruiting
Spitalul Municipal Ploiesti
Ploieşti, 107071
- Recruiting
Spitalul Judetean de Urgenta Satu Mare
Satu Mare, 440055
- Recruiting
Oncomed SRL
Timișoara, 300239
Bulgaria7 sites, 7 recruiting
- Recruiting
Multiprofile Hospital for Active Treatment Uni Hospital
Panagyurishte, 4500
- Recruiting
Complex Oncological Center-Ruse EOOD
Rousse, 7000
- Recruiting
Tokuda Hospital
Sofia, 1407
- Recruiting
UMHAT "Sv. Ivan Rilski", EAD
Sofia, 1431
- Recruiting
UMHAT Tsaritsa Yoanna - ISUL
Sofia, 1527
- Recruiting
MBAL Serdika EOOD
Sofia, 1632
- Recruiting
MHAT SofiaMed
Sofia, 1797
Belgium6 sites, 6 recruiting
- Recruiting
CHIREC
Auderghem, 1160
- Recruiting
AZ Sint Lucas (Sint Lucas)
Ghent, 9000
- Recruiting
CHU HELORA - Hôpital de la Louvière - Site Jolimont
Haine-Saint-Paul, 7100
- Recruiting
CHC MontLégia
Liège, 4000
- Recruiting
ZNA Jan Palfijn
Merksem, 2170
- Recruiting
CHU UCL Mont-Godinne
Mont-godinne, 5530
Poland6 sites, 6 recruiting
- Recruiting
Narodowy Instytut Onkologii - Panstwowy Instytut Badawczy, Oddzia? w Krakowie
Krakow, 31-115
- Recruiting
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
Lublin, 20-954
- Recruiting
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
Olsztyn, 10-357
- Recruiting
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan, 60-569
- Recruiting
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
Słupsk, 76-200
- Recruiting
NU-MED Centrum Diagnostyki i Terapii Onkologicznej
Tomaszów Mazowiecki, 97-200
United Kingdom5 sites, 5 recruiting
- Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
- Recruiting
Royal Surrey County Hospital
Guildford, GU2 7XX
- Recruiting
Leeds Teaching Hosp NHS Trust
Leeds, LS9 7TF
- Recruiting
James Cook University Hospital
Middlesbrough, TS4 3BW
- Recruiting
James Paget University Hospitals NHS Foundation Trust
Norfolk, NR31 6LA
Austria4 sites, 4 recruiting
- Recruiting
Landesklinikum Krems
Krems, 3500
- Recruiting
Ordensklinikum Linz Elisabethinen
Linz, 4020
- Recruiting
Krankenhaus Nord - Klinik Floridsdorf
Vienna, 1210
- Recruiting
Klinikum Wels-Grieskirchen
Wels, 4600
About this study
Official title: 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.
- Conditions
- Lung Cancer, Hepatocellular Carcinoma
- Being tested
- Atezolizumab
- Medical subject headings
- Lung Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Also called Tecentriq
Atezolizumab will be administered at the discretion of the treating physician and independently of participation in this study.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Atezolizumab | |
| Cohort 3: Extensive stage small cell lung cancer (ES-SCLC) | Participants diagnosed with ES-SCLC who have not previously been treated. Receives: Drug: Atezolizumab | |
| Cohort 4: Hepatocellular Carcinoma (HCC) | Participants diagnosed with advanced or unresectable HCC who have not received prior systemic therapy. Receives: Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) Score
Measured: At Cycle 2 and Cycle 3 (each cycle duration/length is 3 weeks)
Secondary outcomes (4)
Overall Survival (OS)
Measured: Index date up to approximately 3.5 years
OS at 2 Years
Measured: After Index date up to 2 years
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Score
Measured: Baseline or Index date
Percentage of Participants With Adverse Events
Measured: Up to approximately 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start15 Jul 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284121
- Sponsor's protocol ID
- MO45893
- Status last verified
- Oct 2026
- First submitted
- 21 Nov 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional, Multicenter, Multicohort Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Subcutaneous Atezolizumab in Participants Treated in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT07284121
- Acronym / sponsor ID
- MO45893
- Conditions
- Lung Cancer, Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Early Non-small Cell Lung Cancer (NSCLC) | – | Drug: AtezolizumabParticipants 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). |
| Cohort 2: Metastatic NSCLC | – | Drug: AtezolizumabParticipants diagnosed with metastatic NSCLC with PD-L1 expression of >= 50% on TC who have not received prior systemic therapy for metastatic disease. |
| Cohort 3: Extensive stage small cell lung cancer (ES-SCLC) | – | Drug: AtezolizumabParticipants diagnosed with ES-SCLC who have not previously been treated. |
| Cohort 4: Hepatocellular Carcinoma (HCC) | – | Drug: AtezolizumabParticipants diagnosed with advanced or unresectable HCC who have not received prior systemic therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Participants must have one of the following confirmed diagnoses for which atezolizumab is approved in the local SmPC:
- Should not have received > 4 prior cycles of IV Atezolizumab
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAlso: TecentriqAtezolizumab will be administered at the discretion of the treating physician and independently of participation in this study. | Drug | Cohort 1: Early Non-small Cell Lung Cancer (NSCLC), Cohort 2: Metastatic NSCLC, Cohort 3: Extensive stage small cell lung cancer (ES-SCLC), Cohort 4: Hepatocellular Carcinoma (HCC) |
Primary outcome
Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) Score
Time frame: At Cycle 2 and Cycle 3 (each cycle duration/length is 3 weeks)
4 secondary outcomes
Overall Survival (OS)
Time frame: Index date up to approximately 3.5 years
OS at 2 Years
Time frame: 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
Percentage of Participants With Adverse Events
Time frame: Up to approximately 3.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reference Study ID Number: MO45893 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Hoffmann-La Roche
92 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, Hepatocellular Carcinoma, run by Hoffmann-La Roche at 92 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 92 sites in Spain, Italy, Romania, Bulgaria, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: MO45893 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) Score (time frame: At Cycle 2 and Cycle 3 (each cycle duration/length is 3 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.