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

RECRUITING

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

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

NCT07284121•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (85)

Landesklinikum Krems

Krems, Austria

Ordensklinikum Linz Elisabethinen

Linz, Austria

Krankenhaus Nord - Klinik Floridsdorf

Vienna, Austria

Klinikum Wels-Grieskirchen

Wels, Austria

AZ Sint Lucas (Sint Lucas)

Ghent, Belgium

CHU HELORA - Hôpital de la Louvière - Site Jolimont

Haine-Saint-Paul, Belgium

CHU UCL Mont-Godinne

Mont-godinne, Belgium

Multiprofile Hospital for Active Treatment Uni Hospital

Panagyurishte, Bulgaria

Complex Oncological Center-Ruse EOOD

Rousse, Bulgaria

Tokuda Hospital

Sofia, Bulgaria

Key Dates

Start Date

July 17, 2025

Primary Completion Date

March 31, 2027

Completion Date

December 31, 2028

Last Updated

February 27, 2026

Enrollment

700

ESTIMATED participants

Conditions

Lung Cancer, Hepatocellular Carcinoma

Interventions

Atezolizumab

DRUG

Contacts

Reference Study ID Number: MO45893 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. and Canada)global-roche-genentech-trials@gene.com