A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Recruiting now
Conditions studied: Lung Cancer, Hepatocellular Carcinoma
In brief
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.
Key facts
- Study ID
- NCT07284121
- Run by
- Hoffmann-La Roche
- People needed
- 700
- Starts
- 2025-07-15
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Ordensklinikum Linz Elisabethinen — Linz, Austria (enrolling)
- Krankenhaus Nord - Klinik Floridsdorf — Vienna, Austria (enrolling)
- Klinikum Wels-Grieskirchen — Wels, Austria (enrolling)
- CHIREC — Auderghem, Belgium (enrolling)
- AZ Sint Lucas (Sint Lucas) — Ghent, Belgium (enrolling)
- CHU HELORA - Hôpital de la Louvière - Site Jolimont — Haine-Saint-Paul, Belgium (enrolling)
- CHC MontLégia — Liège, Belgium (enrolling)
- ZNA Jan Palfijn — Merksem, Belgium (enrolling)
- CHU UCL Mont-Godinne — Mont-godinne, Belgium (enrolling)
- Multiprofile Hospital for Active Treatment Uni Hospital — Panagyurishte, Bulgaria (enrolling)
- Complex Oncological Center-Ruse EOOD — Rousse, Bulgaria (enrolling)
- Tokuda Hospital — Sofia, Bulgaria (enrolling)
- UMHAT "Sv. Ivan Rilski", EAD — Sofia, Bulgaria (enrolling)
- UMHAT Tsaritsa Yoanna - ISUL — Sofia, Bulgaria (enrolling)
- MBAL Serdika EOOD — Sofia, Bulgaria (enrolling)
- MHAT SofiaMed — Sofia, Bulgaria (enrolling)
- Presidio Ospedaliero Vito Fazzi — Lecce, Apulia, Italy (enrolling)
- AORN Ospedali dei Colli Ospedale Monaldi — Naples, Campania, Italy (enrolling)
- Az. Osp. Cardarelli — Naples, Campania, Italy (enrolling)
- A.O. Universitaria Policlinico Di Modena — Modena, Emilia-Romagna, Italy (enrolling)
- Ospedale Provinciale Santa Maria Delle Croci — Ravenna, Emilia-Romagna, Italy (enrolling)
- Policlinico Universitario Agostino Gemelli — Rome, Lazio, Italy (enrolling)
- Università Campus Bio-Medico di Roma — Rome, Lazio, Italy (enrolling)
- IRCCS AOU San Martino - IST — Genoa, Liguria, Italy (enrolling)
- Landesklinikum Krems — Krems, Austria (enrolling)
Full record on ClinicalTrials.gov
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