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Atezolizumab subcutaneous: patient satisfaction, effectiveness, and safety in routine care

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

Observational Hoffmann-La Roche · NCT07284121

This will see if subcutaneous Atezolizumab given in routine care is satisfying, helpful, and safe for people with certain types of lung cancer or advanced liver cancer.

Quick facts

Study typeObservational
Enrollment700 (estimated)
Ages18 Years and up
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionsatezolizumab, chemotherapy
Locations88 sites (Krems and 87 other locations)
Trial IDNCT07284121 on ClinicalTrials.gov

What this trial studies

This is a non-interventional, multi-center, multicohort observational program that collects primary patient-reported data on satisfaction and health-related quality of life alongside routine effectiveness and safety outcomes for subcutaneous Atezolizumab. Participants receive Atezolizumab per local approved labeling for specific indications (various stages of NSCLC, ES-SCLC, or advanced/unresectable HCC) and continue standard clinical care. The study captures real-world experience across participating sites, with limits on prior intravenous Atezolizumab exposure and exclusion of concurrent systemic anticancer therapy at initiation. Data will be used to describe patient experience, HRQoL, and routine-use safety and effectiveness signals rather than to change treatment.

Who should consider this trial

Good fit: Ideal candidates are people with an approved indication for Atezolizumab (specific NSCLC subtypes, ES-SCLC, or advanced/unresectable HCC) who are starting subcutaneous Atezolizumab per local labeling and have not received more than four prior IV Atezolizumab cycles.

Not a fit: Patients whose tumors or molecular profiles are not covered by local labeling (for example EGFR-mutant or ALK-positive NSCLC where Atezolizumab is not indicated), those receiving concurrent systemic anticancer therapy at Atezolizumab initiation, or those with more than four prior IV Atezolizumab cycles are unlikely to gain benefit from participating.

Why it matters

Potential benefit: If successful, the study could show that subcutaneous Atezolizumab delivers comparable safety and tumor control while improving patient satisfaction and quality of life in routine practice.

How similar studies have performed: Large randomized trials have established the effectiveness and safety of intravenous atezolizumab in these cancers, and early work on subcutaneous formulations and real-world patient-reported outcome programs shows feasibility though evidence is less extensive.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Krems and 87 other locations

+38 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lung Cancer, Hepatocellular Carcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.