A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Recruiting · NCT07284121 · Observational (researchers observe without assigning treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
60 locations listed.
- Complejo Hospitalario Universitario de Albacete - Albacete, Spain
- Hospital General de Alicante;servicio de digestivo - Alicante, Spain
- Hospital General Univ. de Alicante - Alicante, Spain
- CHIREC - Auderghem, Belgium
- Hospital de Badajoz - Badajoz, Spain
- Hospital Clinic I Provincial - Barcelona, Spain
- Hospital de la Santa Creu i Sant Pau - Barcelona, Spain
- University Hospitals Birmingham NHS Foundation Trust - Birmingham, United Kingdom
- Spitalul Clinic de Urgenta Prof. Dr. Agrippa Ionescu - Bucharest, Romania
- Institut Oncologic Prof. Dr. Alexandru Trestioreanu - Bucharest, Romania
- Institutul Clinic Fundeni Bucuresti - Bucharest, Romania
- Hospital General de Ciudad Real - Ciudad Real, Spain
- Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. Octavian Fodor - Cluj-Napoca, Romania
- Spitalul Clinic Jude?ean de Urgen?? Sfântul Apostol Andrei Galati;oncology - Galati, Romania
- AZ Sint Lucas (Sint Lucas) - Ghent, Belgium
- Hospital Universitario San Cecilio - Granada, Spain
- Hospital General Universitario de Guadalajara - Guadalajara, Spain
- Royal Surrey County Hospital - Guildford, United Kingdom
- CHU HELORA - Hôpital de la Louvière - Site Jolimont - Haine-Saint-Paul, Belgium
- Institutul Regional de Oncologie Iasi - Iași, Romania
- Narodowy Instytut Onkologii - Panstwowy Instytut Badawczy, Oddzia? w Krakowie - Krakow, Poland
- Landesklinikum Krems - Krems, Austria
- Leeds Teaching Hosp NHS Trust - Leeds, United Kingdom
- Ordensklinikum Linz Elisabethinen - Linz, Austria
- CHC MontLégia - Liège, Belgium
- Uniwersytecki Szpital Kliniczny nr 4 w Lublinie - Lublin, Poland
- ZNA Jan Palfijn - Merksem, Belgium
- James Cook University Hospital - Middlesbrough, United Kingdom
- CHU UCL Mont-Godinne - Mont-godinne, Belgium
- Hospital General Universitario J.M Morales Meseguer - Murcia, Spain
- Hospital Virgen de Arrixaca;servicio de digestivo - Murcia, Spain
- James Paget University Hospitals NHS Foundation Trust - Norfolk, United Kingdom
- Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie - Olsztyn, Poland
- Multiprofile Hospital for Active Treatment Uni Hospital - Panagyurishte, Bulgaria
- Spitalul Municipal Ploiesti - Ploieşti, Romania
- Complejo Hospitalario de Pontevedra - Pontevedra, Spain
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu - Poznan, Poland
- Complex Oncological Center-Ruse EOOD - Rousse, Bulgaria
- Spitalul Judetean de Urgenta Satu Mare - Satu Mare, Romania
- Hospital Virgen del Rocio;Servicio de digestivo - Seville, Spain
- Tokuda Hospital - Sofia, Bulgaria
- UMHAT "Sv. Ivan Rilski", EAD - Sofia, Bulgaria
- UMHAT Tsaritsa Yoanna - ISUL - Sofia, Bulgaria
- MBAL Serdika EOOD - Sofia, Bulgaria
- MHAT SofiaMed - Sofia, Bulgaria
- Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka - Słupsk, Poland
- Oncomed SRL - Timișoara, Romania
- Hospital de Toledo;Servicio de digestivo - Toledo, Spain
- Hospital de Toledo;servicio de oncologia - Toledo, Spain
- NU-MED Centrum Diagnostyki i Terapii Onkologicznej - Tomaszów Mazowiecki, Poland
- Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia - Valencia, Spain
- Hospital Clinico Universitario de Valladolid - Valladolid, Spain
- Hospital Clinico Universitario Valladolid - Valladolid, Spain
- Krankenhaus Nord - Klinik Floridsdorf - Vienna, Austria
- Klinikum Wels-Grieskirchen - Wels, Austria
- Hospital Universitario Miguel Servet - Zaragoza, Spain
- Complejo Hospitalario Torrecardenas - Almería, Almeria, Spain
- Presidio Ospedaliero Vito Fazzi - Lecce, Apulia, Italy
- Hospital Son Espases - Palma de Mallorca, Balearic Islands, Spain
- Hospital Sant Joan de Deu de Manresa;Servicio oncologia - Manresa, Barcelona, Spain
Showing 60 of 92 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →