Atezolizumab subcutaneous: patient satisfaction, effectiveness, and safety in routine care
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
Run by Hoffmann-La Roche · NCT07284121 · Data updated 2026-11-12
This will see if subcutaneous Atezolizumab given in routine care is satisfying, helpful, and safe for people with certain types of lung cancer or advanced liver cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 700 (estimated) |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | atezolizumab, chemotherapy |
| Locations | 92 sites (Krems and 91 other locations) |
| Status | Recruiting |
| Started | July 15, 2025 |
| Main results expected | March 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT07284121 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with an approved indication for Atezolizumab (specific NSCLC subtypes, ES-SCLC, or advanced/unresectable HCC) who are starting subcutaneous Atezolizumab per local labeling and have not received more than four prior IV Atezolizumab cycles.
✕Probably not a fit
Patients whose tumors or molecular profiles are not covered by local labeling (for example EGFR-mutant or ALK-positive NSCLC where Atezolizumab is not indicated), those receiving concurrent systemic anticancer therapy at Atezolizumab initiation, or those with more than four prior IV Atezolizumab cycles are unlikely to gain benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a non-interventional, multi-center, multicohort observational program that collects primary patient-reported data on satisfaction and health-related quality of life alongside routine effectiveness and safety outcomes for subcutaneous Atezolizumab. Participants receive Atezolizumab per local approved labeling for specific indications (various stages of NSCLC, ES-SCLC, or advanced/unresectable HCC) and continue standard clinical care. The study captures real-world experience across participating sites, with limits on prior intravenous Atezolizumab exposure and exclusion of concurrent systemic anticancer therapy at initiation. Data will be used to describe patient experience, HRQoL, and routine-use safety and effectiveness signals rather than to change treatment.
Why it matters
Potential benefit: If successful, the study could show that subcutaneous Atezolizumab delivers comparable safety and tumor control while improving patient satisfaction and quality of life in routine practice.
How similar studies have gone: Large randomized trials have established the effectiveness and safety of intravenous atezolizumab in these cancers, and early work on subcutaneous formulations and real-world patient-reported outcome programs shows feasibility though evidence is less extensive.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Universitätsklinikum Krems
Krems, Austria Recruiting -
Ordensklinikum Linz Elisabethinen
Linz, Austria Recruiting -
Krankenhaus Nord - Klinik Floridsdorf
Vienna, Austria Recruiting -
Klinikum Wels-Grieskirchen
Wels, Austria Recruiting -
Chirec
Auderghem, Belgium Recruiting -
AZ Sint Lucas (Sint Lucas)
Ghent, Belgium Recruiting
Show 44 more locations
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CHU HELORA - Hôpital de la Louvière - Site Jolimont
Haine-Saint-Paul, Belgium Recruiting -
CHC MontLégia
Liège, Belgium Recruiting -
ZNA Jan Palfijn
Merksem, Belgium Recruiting -
CHU UCL Mont-Godinne
Mont-godinne, Belgium Recruiting -
Multiprofile Hospital for Active Treatment Uni Hospital
Panagyurishte, Bulgaria Recruiting -
Complex Oncological Center-Ruse EOOD
Rousse, Bulgaria Recruiting -
Tokuda Hospital
Sofia, Bulgaria Recruiting -
UMHAT "Sv. Ivan Rilski", EAD
Sofia, Bulgaria Recruiting -
UMHAT Tsaritsa Yoanna - ISUL
Sofia, Bulgaria Recruiting -
MBAL Serdika EOOD
Sofia, Bulgaria Recruiting -
MHAT SofiaMed
Sofia, Bulgaria Recruiting -
Presidio Ospedaliero Vito Fazzi
Lecce, Apulia, Italy Recruiting -
AORN Ospedali dei Colli Ospedale Monaldi
Naples, Campania, Italy Recruiting -
Az. Osp. Cardarelli
Naples, Campania, Italy Recruiting -
A.O. Universitaria Policlinico Di Modena
Modena, Emilia-Romagna, Italy Recruiting -
Ospedale Provinciale Santa Maria Delle Croci
Ravenna, Emilia-Romagna, Italy Recruiting -
Policlinico Universitario Agostino Gemelli
Rome, Lazio, Italy Recruiting -
Università Campus Bio-Medico di Roma
Rome, Lazio, Italy Recruiting -
IRCCS AOU San Martino - IST
Genoa, Liguria, Italy Recruiting -
Cliniche Gavazzeni SpA Humanitas Gavazzeni
Bergamo, Lombardy, Italy Recruiting -
Fondazione IRCCS Ospedale Maggiore Policlinico
Milan, Lombardy, Italy Recruiting -
Ospedale Maggiore Policlinico
Milan, Lombardy, Italy Recruiting -
Asst Santi Paolo E Carlo
Milan, Lombardy, Italy Recruiting -
Ente Ecclesiastico Ospedale Generale Regionale F Miulli
Acquaviva Delle Fonti, Piedmont, Italy Recruiting -
A.O.U. Maggiore della Carità
Novara, Piedmont, Italy Recruiting -
Azienda Ospedaliero Universitaria Di Sassari
Sassari, Sardinia, Italy Recruiting -
Humanitas Istituto Clinico Catanese S.p.A
Misterbianco (CT), Sicily, Italy Recruiting -
A.O.U. Policlinico Paolo Giaccone
Palermo, Sicily, Italy Recruiting -
Casa di Cura La Maddalena
Palermo, Sicily, Italy Recruiting -
Azienda Sanitaria Territoriale Pesaro Urbino (AST PU) - Ospedale Santa Croce;UOC Oncologia - Stabilimento di Fano
Fano (PU), The Marches, Italy Recruiting -
Ospedale Santa Chiara
Trento, Trentino-Alto Adige, Italy Recruiting -
Ospedale dell'Angelo
Mestre, Veneto, Italy Recruiting -
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Veneto, Italy Recruiting -
Narodowy Instytut Onkologii - Panstwowy Instytut Badawczy, Oddzia? w Krakowie
Krakow, Poland Recruiting -
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
Lublin, Poland Recruiting -
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
Olsztyn, Poland Recruiting -
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan, Poland Recruiting -
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
Słupsk, Poland Recruiting -
NU-MED Centrum Diagnostyki i Terapii Onkologicznej
Tomaszów Mazowiecki, Poland Recruiting -
Spitalul Clinic de Urgenta Prof. Dr. Agrippa Ionescu
Bucharest, Romania Recruiting -
Institut Oncologic Prof. Dr. Alexandru Trestioreanu
Bucharest, Romania Recruiting -
Institutul Clinic Fundeni Bucuresti
Bucharest, Romania Recruiting -
Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. Octavian Fodor
Cluj-Napoca, Romania Recruiting -
Spitalul Clinic Jude?ean de Urgen?? Sfântul Apostol Andrei Galati;oncology
Galati, Romania Recruiting
+42 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Reference Study ID Number: MO45893 https://forpatients.roche.com/ No attachments to email below.
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.