A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT07284121
- Status
- Recruiting
Conditions
- Lung Cancer, Hepatocellular Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Atezolizumab — DRUGAtezolizumab will be administered at the discretion of the treating physician and independently of participation in this study.
Study Details
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.
Key Dates
- Start date
- Jul 15, 2025
- Status verified
- May 2026
- Primary completion
- Mar 31, 2027
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 700 participants (estimated)
Arms
- Arm: Cohort 1: Early Non-small Cell Lung Cancer (NSCLC)Participants diagnosed with early-stage NSCLC following complete resection and platinum-based chemotherapy with Programmed Cell-Death Ligand 1 (PD-L1) expression of \>= 50% on Tumor Cell (TC).
- Arm: Cohort 2: Metastatic NSCLCParticipants diagnosed with metastatic NSCLC with PD-L1 expression of \>= 50% on TC who have not received prior systemic therapy for metastatic disease.
- Arm: Cohort 3: Extensive stage small cell lung cancer (ES-SCLC)Participants diagnosed with ES-SCLC who have not previously been treated.
- Arm: Cohort 4: Hepatocellular Carcinoma (HCC)Participants diagnosed with advanced or unresectable HCC who have not received prior systemic therapy.
Primary Outcome Measure
Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) Score [ Time Frame: At Cycle 2 and Cycle 3 (each cycle duration/length is 3 weeks) ]
Central Contacts
- Reference Study ID Number: MO45893 https://forpatients.roche.com/888-662-6728 (U.S. and Canada)