Clinical trial Recruiting at 92 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment700 (estimated)
SponsorHoffmann-La Roche
Industry-sponsored
Drugs / interventionsatezolizumab, chemotherapy
Locations92 sites (Krems and 91 other locations)
StatusRecruiting
StartedJuly 15, 2025
Main results expectedMarch 31, 2027
Study endsDecember 31, 2028
Registry record updatedNovember 6, 2026
Trial IDNCT07284121 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.