A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice

Roche

Status: Enrolling

Conditions: Lung Cancer, Hepatocellular Carcinoma

Treatments: Drug: Atezolizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT07284121

MO45893

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have one of the following confirmed diagnoses for which atezolizumab is approved in the local SmPC:

  • Early stage NSCLC following complete resection and platinum-based chemotherapy with a high risk of recurrence and PD-L1 expression on ≥ 50% of TC and with no EGFR-mutant or ALK-positive NSCLC
  • Metastatic stage NSCLC with PD-L1 expression on ≥ 50% TC or ≥ 10% tumor infiltrating immune cells (IC) and with no EGFR-mutant or ALK-positive NSCLC not previously treated
  • Extensive-stage small cell lung cancer (ES-SCLC) not previously treated
  • Advanced or unresectable HCC not previously treated with systemic therapy

• Should not have received > 4 prior cycles of IV Atezolizumab

Exclusion criteria

• Not receiving treatment with Atezolizumab according to standard of care and in line with the current SmPC or local labelling
• Receiving concomitant systemic anticancer therapy at the time of initiation of Atezolizumab or an Atezolizumab-containing regimen for treatment of the same disease, as per label
• Receiving treatment with Atezolizumab as part of a clinical trial, pre-approval access program, compassionate use program, expanded use program, post-trial access program, or continued access program
• Unwilling to complete questionnaires related to treatment satisfaction and treatment-related quality of life

Trial design

700 participants in 4 patient groups

Cohort 1: Early Non-small Cell Lung Cancer (NSCLC)

Description:

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).

Treatment:

Drug: Atezolizumab

Cohort 2: Metastatic NSCLC

Description:

Participants diagnosed with metastatic NSCLC with PD-L1 expression of \>= 50% on TC who have not received prior systemic therapy for metastatic disease.

Treatment:

Drug: Atezolizumab

Cohort 3: Extensive stage small cell lung cancer (ES-SCLC)

Description:

Participants diagnosed with ES-SCLC who have not previously been treated.

Treatment:

Drug: Atezolizumab

Cohort 4: Hepatocellular Carcinoma (HCC)

Description:

Participants diagnosed with advanced or unresectable HCC who have not received prior systemic therapy.

Treatment:

Drug: Atezolizumab