About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Participants diagnosed with early-stage NSCLC following complete resection and platinum-based chemotherapy with PD-L1 expression of \>= 50% on TC, participants diagnosed with metastatic NSCLC with PD-L1 expression of ≥ 50% on TC who have not received prior systemic therapy for metastatic disease, participants diagnosed with ES-SCLC who have not previously been treated, and participants diagnosed with advanced or unresectable HCC who have not received prior systemic therapy.
Trial design
Cohort
Prospective
Treatments tested in this trial
Atezolizumab
DrugAtezolizumab will be administered at the discretion of the treating physician and independently of participation in this study.
Treatment groups
Trial outcomes
Primary outcomes
Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) Score
Secondary outcomes
Overall Survival (OS)
OS at 2 Years
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Score
Percentage of Participants With Adverse Events
Sponsors and contacts
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