Recruiting NCT07284121
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Atezolizumab.
- Who it may be relevant to
- Registry conditions: Lung Cancer, Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Belgium, Bulgaria, Italy, Poland +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug Atezolizumab
Atezolizumab will be administered at the discretion of the treating physician and independently of participation in this study.
Primary outcome measures
- Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) Score [Time frame: At Cycle 2 and Cycle 3 (each cycle duration/length is 3 weeks)]
Secondary outcome measures (4)
- Overall Survival (OS) [Time frame: Index date up to approximately 3.5 years]
- OS at 2 Years [Time frame: After Index date up to 2 years]
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Score [Time frame: Baseline or Index date]
- Percentage of Participants With Adverse Events [Time frame: Up to approximately 3.5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 33 centers
- Complejo Hospitalario Torrecardenas — Almería
- Hospital Son Espases — Palma de Mallorca
- Hospital Sant Joan de Deu de Manresa;Servicio oncologia — Manresa
- Hospital Universitario Puerto Real — Puerto Real
- Hospital Universitario Mancha Centro (Alcázar de San Juan);Servicio de digestivo — Alcázar de San Juan
- Hospital Universitario Mancha Centro (Alcázar de San Juan);Servicio de oncología — Alcázar de San Juan
- Complejo Hospitalario Universitario de Santiago (CHUS) — Santiago de Compostela
- Hospital Univ. Central de Asturias — Oviedo
- … and 25 more centers
Italy · 22 centers
- Presidio Ospedaliero Vito Fazzi — Lecce
- AORN Ospedali dei Colli Ospedale Monaldi — Naples
- Az. Osp. Cardarelli — Naples
- A.O. Universitaria Policlinico Di Modena — Modena
- Ospedale Provinciale Santa Maria Delle Croci — Ravenna
- Policlinico Universitario Agostino Gemelli — Rome
- Università Campus Bio-Medico di Roma — Rome
- IRCCS AOU San Martino - IST — Genoa
- … and 14 more centers
Romania · 8 centers
- Institut Oncologic Prof. Dr. Alexandru Trestioreanu — Bucharest
- Institutul Clinic Fundeni Bucuresti — Bucharest
- Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. Octavian Fodor — Cluj-Napoca
- Spitalul Clinic Jude?ean de Urgen?? Sfântul Apostol Andrei Galati;oncology — Galati
- Institutul Regional de Oncologie Iasi — Iași
- Spitalul Municipal Ploiesti — Ploieşti
- Spitalul Judetean de Urgenta Satu Mare — Satu Mare
- Oncomed SRL — Timișoara
Bulgaria · 7 centers
- Multiprofile Hospital for Active Treatment Uni Hospital — Panagyurishte
- Complex Oncological Center-Ruse EOOD — Rousse
- Tokuda Hospital — Sofia
- UMHAT "Sv. Ivan Rilski", EAD — Sofia
- UMHAT Tsaritsa Yoanna - ISUL — Sofia
- MBAL Serdika EOOD — Sofia
- MHAT SofiaMed — Sofia
Belgium · 6 centers
- CHIREC — Auderghem
- AZ Sint Lucas (Sint Lucas) — Ghent
- CHU HELORA - Hôpital de la Louvière - Site Jolimont — Haine-Saint-Paul
- CHC MontLégia — Liège
- ZNA Jan Palfijn — Merksem
- CHU UCL Mont-Godinne — Mont-godinne
Poland · 6 centers
- Narodowy Instytut Onkologii - Panstwowy Instytut Badawczy, Oddzia? w Krakowie — Krakow
- Uniwersytecki Szpital Kliniczny nr 4 w Lublinie — Lublin
- Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie — Olsztyn
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu — Poznan
- Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka — Słupsk
- NU-MED Centrum Diagnostyki i Terapii Onkologicznej — Tomaszów Mazowiecki
United Kingdom · 5 centers
Center list to be confirmed — check the primary protocol.
Austria · 4 centers
- Landesklinikum Krems — Krems
- Ordensklinikum Linz Elisabethinen — Linz
- Krankenhaus Nord - Klinik Floridsdorf — Vienna
- Klinikum Wels-Grieskirchen — Wels
Identifiers
NCT: NCT07284121 · MO45893