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 — DRUG
    Atezolizumab 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 NSCLC
    Participants 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)