Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07284121

RecruitingN/A

Sponsor: Hoffmann-La Roche

Conditions: Lung Cancer, Hepatocellular Carcinoma

Interventions: Atezolizumab

Countries: Austria, Belgium, Bulgaria, Italy, Poland, Romania, Spain, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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
Locations (91)
  • Krems, Austria
  • Linz, Austria
  • Vienna, Austria
  • Wels, Austria
  • Auderghem, Belgium
  • Ghent, Belgium
  • Haine-Saint-Paul, Belgium
  • Liège, Belgium
  • Merksem, Belgium
  • Mont-godinne, Belgium
  • Panagyurishte, Bulgaria
  • Rousse, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Lecce, Apulia, Italy
  • Naples, Campania, Italy
  • Naples, Campania, Italy
  • Modena, Emilia-Romagna, Italy
  • Ravenna, Emilia-Romagna, Italy
  • Rome, Lazio, Italy
  • Rome, Lazio, Italy
  • Genoa, Liguria, Italy
  • Bergamo, Lombardy, Italy
  • Milan, Lombardy, Italy
  • Milan, Lombardy, Italy
  • Milan, Lombardy, Italy
  • Acquaviva Delle Fonti, Piedmont, Italy
  • + 61 more on CT.gov