A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Recruiting
Observational Study
Lung Cancer, Hepatocellular Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
700 (estimated)
Sponsor
Hoffmann-La Roche · Industry
Who this trial is looking for
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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.
Trial Locations
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Status
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…
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
Contacts
Reference Study ID Number: MO45893 https://forpatients.roche.com/ No attachments to email below.
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
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