Carcinoma, Non-Small Cell Lung, Hepatocellular Carcinoma, Small Cell Lung Carcinoma, Triple Negative Breast Carcinoma, Urothelial Carcinoma
Conditions
Brief summary
This Phase 4, prospective, multicenter, non-interventional, regulatory post-marketing surveillance study will collect information on the the safety and effectiveness of atezolizumab under the clinical practice, and update the drug label approved by the MFDS in Korea.
Interventions
DRUGAtezolizumab
Participants will receive atezolizumab as per the local label and standard of care at physician's discretion.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participants who are administered with atezolizumab for the locally approved indications
Exclusion criteria
* Participants with a known hypersensitivity to atezolizumab or to any of the excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Approximately 6 years |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Complete Response (CR) Assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Approximately 6 years |
| Percentage of Participants With Partial Response (PR) Assessed per RECIST 1.1 | Approximately 6 years |
| Percentage of Participants With Stable Disease (SD) Assessed per RECIST 1.1 | Approximately 6 years |
| Percentage of Participants With Progressive Disease (PD) Assessed per RECIST 1.1 | Approximately 6 years |
Countries
South Korea
Outcome results
None listed