A Study With Prospective Data Collection Only to Investigate The Outcome and Safety of ATEZOLIZUMAB in NSCLC and HCC Patients Treated In Routine Clinical Practice
- Conditions
- Health Condition 1: C220- Liver cell carcinomaHealth Condition 2: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2023/01/048804
- Lead Sponsor
- F HoffmanLa Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Confirmed diagnosis for which atezolizumab is locally approved
2. Patient is prescribed atezolizumab therapy for the first time
3. Decision to prescribe atezolizumab must be made and documented prior to inclusion into the study and must follow local clinical practice
4. Patient is 18 years or older at the index date
5. Patient has signed an informed consent form
6. Initiation of atezolizumab is not more than 28 days before signing informed consent. In countries where enrollment is only allowed after starting treatment, enrollment must be preceded by the administration of the first cycle of atezolizumab
1. Treatment with atezolizumab for an indication that is not included in the study cohorts
2. Concomitant anti-cancer therapy at the time of starting atezolizumab on the index date, as per locally approved SmPC
3. Treatment with atezolizumab as part of a clinical trial or as compassionate use as part of an access or compassionate use program
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate overall survival (OS) at two years and at the end of the study. <br/ ><br>Timepoint: Timepoint - 2 years & End of study <br/ ><br>
- Secondary Outcome Measures
Name Time Method Exploratory outcome- <br/ ><br>1. PD-L1 testing, type, status, result <br/ ><br>2. Health care resource utilization and cost <br/ ><br>3. Cost of non-health care outcomes <br/ ><br>Timepoint: upto 6 years;Safety Outcome- <br/ ><br>Incidence, seriousness, severity and relatedness of all AEs <br/ ><br>Timepoint: upto 6 years;Secondary Outcome- <br/ ><br>Time to loss of clinical benefit - TTLCB, Progression-free survival - PFS, Objective response rate - ORR, Time to response, Duration of response - DoR, Disease control rate - DCR, Duration of DCR, EQ-5D questionnaire evaluation, Patient characteristics, Study site characteristics, Characteristics of atezolizumab treatment, and prior/subsequent cancer-related therapies <br/ ><br>Timepoint: upto 6 years