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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 population

Participants diagnosed with early-stage NSCLC following complete resection and platinum-based chemotherapy with PD-L1 expression of \>= 50% on TC, participants diagnosed with metastatic NSCLC with PD-L1 expression of ≥ 50% on TC who have not received prior systemic therapy for metastatic disease, participants diagnosed with ES-SCLC who have not previously been treated, and participants diagnosed with advanced or unresectable HCC who have not received prior systemic therapy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Atezolizumab

    Drug

    Atezolizumab will be administered at the discretion of the treating physician and independently of participation in this study.

Treatment groups

700 Participants
are divided into 4 treatment groups
Group A: Cohort 1: Early Non-small Cell Lung Cancer (NSCLC)1 intervention
Group B: Cohort 2: Metastatic NSCLC1 intervention
Group C: Cohort 3: Extensive stage small cell lung cancer (ES-SCLC)1 intervention
Group D: Cohort 4: Hepatocellular Carcinoma (HCC)1 intervention

Trial outcomes

Primary outcomes

1

Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) Score

Time frame
At Cycle 2 and Cycle 3 (each cycle duration/length is 3 weeks)

Secondary outcomes

1

Overall Survival (OS)

Time frame
Index date up to approximately 3.5 years
2

OS at 2 Years

Time frame
After Index date up to 2 years
3

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Score

Time frame
Baseline or Index date
4

Percentage of Participants With Adverse Events

Time frame
Up to approximately 3.5 years

Other outcomes

Sponsors and contacts

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