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NCT Number: NCT07284121

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

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atezolizumab

Drug

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

Other names: Tecentriq

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

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: MO45893 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S. and Canada)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 16, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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