Lung Cancer, Hepatocellular Carcinoma
Conditions
Brief 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.
Interventions
DRUGAtezolizumab
Atezolizumab will be administered at the discretion of the treating physician and independently of participation in this study.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) Score | At Cycle 2 and Cycle 3 (each cycle duration/length is 3 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | Index date up to approximately 3.5 years |
| OS at 2 Years | After Index date up to 2 years |
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Score | Baseline or Index date |
| Percentage of Participants With Adverse Events | Up to approximately 3.5 years |
Countries
Austria, Belgium, Bulgaria, Italy, Poland, Romania, Spain, United Kingdom
Contacts
CONTACTReference Study ID Number: MO45893 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed