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NCT07284121
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Conditions: Lung Cancer, Hepatocellular Carcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 700
Sponsor: Hoffmann-La Roche
Location: Landesklinikum Krems Krems
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 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
Source: ClinicalTrials.gov (NCT07284121). StuddyBuddy aggregates publicly available trial information.