A Non-Interventional, Multicenter, Multicohort Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Subcutaneous Atezolizumab in Participants Treated in Routine Clinical Practice
Status: Recruiting
Location: See all (57) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Austria
Landesklinikum Krems
RECRUITING
Krems
Ordensklinikum Linz Elisabethinen
RECRUITING
Linz
Klinikum Wels-Grieskirchen
RECRUITING
Wels
Bulgaria
Multiprofile Hospital for Active Treatment Uni Hospital
RECRUITING
Panagyurishte
Complex Oncological Center-Ruse EOOD
RECRUITING
Rousse
Italy
Ente Ecclesiastico Ospedale Generale Regionale F Miulli
RECRUITING
Acquaviva Delle Fonti
Humanitas Gavazzeni
RECRUITING
Bergamo
Azienda Sanitaria Territoriale Pesaro Urbino (AST PU) - Ospedale Santa Croce;UOC Oncologia - Stabilimento di Fano
RECRUITING
Fano (pu)
IRCCS AOU San Martino - IST
RECRUITING
Genoa
Presidio Ospedaliero Vito Fazzi
RECRUITING
Lecce
Asst Santi Paolo E Carlo
RECRUITING
Milan
Fondazione IRCCS Ospedale Maggiore Policlinico
RECRUITING
Milan
Ospedale Maggiore Policlinico
RECRUITING
Milan
Humanitas Istituto Clinico Catanese S.p.A
RECRUITING
Misterbianco (ct)
A.O. Universitaria Policlinico Di Modena
RECRUITING
Modena
A.O.U. Maggiore della Carità
RECRUITING
Novara
A.O.U. Policlinico Paolo Giaccone
RECRUITING
Palermo
Casa di Cura La Maddalena
RECRUITING
Palermo
Azienda Ospedaliero Universitaria Di Sassari
RECRUITING
Sassari
Ospedale Santa Chiara
RECRUITING
Trento
Azienda Ospedaliera Universitaria Integrata Verona
RECRUITING
Verona
Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
RECRUITING
Poznan
NU-MED Centrum Diagnostyki i Terapii Onkologicznej
RECRUITING
Tomaszów Mazowiecki
Romania
Institutul Clinic Fundeni Bucuresti
RECRUITING
Bucharest
Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. Octavian Fodor
RECRUITING
Cluj-napoca
Spitalul Clinic Jude?ean de Urgen?? Sfântul Apostol Andrei Galati;oncology
RECRUITING
Galati
Institutul Regional de Oncologie Iasi
RECRUITING
Iași
Spitalul Municipal Ploiesti
RECRUITING
Ploieşti
Spitalul Judetean de Urgenta Satu Mare
RECRUITING
Satu Mare
Oncomed SRL
RECRUITING
Timișoara
Spain
Hospital General de Alicante;servicio de digestivo
RECRUITING
Alicante
Hospital General Univ. de Alicante
RECRUITING
Alicante
Complejo Hospitalario Torrecardenas
RECRUITING
Almería
Hospital de Badajoz
RECRUITING
Badajoz
Hospital Clinic I Provincial
RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital de Cruces
RECRUITING
Bilbao
Hospital General de Ciudad Real
RECRUITING
Ciudad Real
Hospital Universitario San Cecilio
RECRUITING
Granada
Hospital General Universitario de Guadalajara
RECRUITING
Guadalajara
Hospital Sant Joan de Deu de Manresa;Servicio oncologia
RECRUITING
Manresa
Hospital General Universitario J.M Morales Meseguer
RECRUITING
Murcia
Hospital Virgen de Arrixaca;servicio de digestivo
RECRUITING
Murcia
Hospital Univ. Central de Asturias
RECRUITING
Oviedo
Hospital Univ. Central de Asturias
RECRUITING
Oviedo
Hospital Universitario Puerto Real
RECRUITING
Puerto Real
Hospital Universitari Sant Joan de Reus
RECRUITING
Reus
Complejo Hospitalario Nuestra Señora de la Candelaria
RECRUITING
Santa Cruz De Tenerife
Hospital Universitario de Canarias
RECRUITING
Santa Cruz De Tenerife
Complejo Hospitalario Universitario de Santiago (CHUS)
RECRUITING
Santiago De Compostela
Hospital Virgen del Rocio;Servicio de digestivo
RECRUITING
Seville
Hospital de Toledo;Servicio de digestivo
RECRUITING
Toledo
Hospital de Toledo;servicio de oncologia
RECRUITING
Toledo
Hospital Clinico Universitario de Valladolid
RECRUITING
Valladolid
Hospital Clínico Universitario Valladolid;servicio de digestivo
RECRUITING
Valladolid
Hospital Universitario de Cruces;servicio de digestivo
RECRUITING
Vizcaya
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Contact Information
Primary
Reference Study ID Number: MO45893 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: 2025-07-17
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 700
Treatments
Cohort 1: Early Non-small Cell Lung Cancer (NSCLC)
Participants diagnosed with early-stage NSCLC following complete resection and platinum-based chemotherapy with Programmed Cell-Death Ligand 1 (PD-L1) expression of \>= 50% on Tumor Cell (TC).
Cohort 2: Metastatic NSCLC
Participants diagnosed with metastatic NSCLC with PD-L1 expression of \>= 50% on TC who have not received prior systemic therapy for metastatic disease.
Cohort 3: Extensive stage small cell lung cancer (ES-SCLC)
Participants diagnosed with ES-SCLC who have not previously been treated.
Cohort 4: Hepatocellular Carcinoma (HCC)
Participants diagnosed with advanced or unresectable HCC who have not received prior systemic therapy.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche