A Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice

Sponsor
Hoffmann-La Roche
Study ID
NCT03782207
Status
Active Not Recruiting

Conditions

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 per local guidelines and independently of participation in this study.

Study Details

This is a non-interventional, multi-country, multi-centre, multiple cohort prospective study, with retrospective collection of prior medical/treatment history data from medical records, designed to assess the real-world outcomes and safety of atezolizumab for indications in the existing label in the real world setting of routine clinical practice.

Key Dates

Start date
Feb 7, 2019
Status verified
Jan 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
2,756 participants (actual)

Arms

  • Arm: Cohort 1 (UC LOT2+later lines[LOT2+] & platinum eligible LOT1)
    Participants diagnosed with locally advanced or metastatic Urothelial Cancer previously treated with platinum-containing chemotherapy. Enrollment is closed.
  • Arm: Cohort 2 (NSCLC LOT2 plus later lines [LOT2+])
    Participants diagnosed with Locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) after prior chemotherapy. Participants with epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK)-positive tumor mutations should also have received targeted therapy. Enrollment closed.
  • Arm: Cohort 3 (NSCLC LOT1 plus EGFR+/ALK+ LOT2+)
    EMA: Participants diagnosed with locally advanced/metastatic non-squamous NSCLC not previously treated. Participants with EGFR-activating mutations or ALK-positive tumor mutations should have received at least one line of targeted therapy. FDA: for the treatment of adult participants with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Participants with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ. Enrollment is closed.
  • Arm: Cohort 4 (ES-SCLC LOT1)
    Participants diagnosed with extensive stage (ES) small cell lung cancer (SCLC) not previously treated. Enrollment is closed.
  • Arm: Cohort 5 (NSCLC LOT1)
    Participants diagnosed with metastatic Non-Small Cell Lung cancer with high PD-L1 expression, previously untreated.
  • Arm: Cohort 6 (HCC LOT1)
    Participants diagnosed with unresectable locally advanced or metastatic hepatocellular carcinoma previously untreated with systemic therapy.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Index date up to approximately 6 years ]

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