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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab will be administered at the discretion of the treating physician and independently of participation in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) Score | At Cycle 2 and Cycle 3 (each cycle duration/length is 3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Index date up to approximately 3.5 years | |
| OS at 2 Years | After Index date up to 2 years | |
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Score |
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Inclusion Criteria:
Participants must have one of the following confirmed diagnoses for which atezolizumab is approved in the local SmPC:
Should not have received > 4 prior cycles of IV Atezolizumab
Exclusion Criteria:
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Participants diagnosed with early-stage NSCLC following complete resection and platinum-based chemotherapy with PD-L1 expression of >= 50% on TC, participants diagnosed with metastatic NSCLC with PD-L1 expression of ≥ 50% on TC who have not received prior systemic therapy for metastatic disease, participants diagnosed with ES-SCLC who have not previously been treated, and participants diagnosed with advanced or unresectable HCC who have not received prior systemic therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: MO45893 https://forpatients.roche.com/ | Contact | 888-662-6728 (U.S. and Canada) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landesklinikum Krems | Recruiting | Krems | 3500 | Austria | ||
| Ordensklinikum Linz Elisabethinen |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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|
| Baseline or Index date |
| Percentage of Participants With Adverse Events | Up to approximately 3.5 years |
| Recruiting |
| Linz |
| 4020 |
| Austria |
| Krankenhaus Nord - Klinik Floridsdorf | Recruiting | Vienna | 1210 | Austria |
| Klinikum Wels-Grieskirchen | Recruiting | Wels | 4600 | Austria |
| CHIREC | Recruiting | Auderghem | 1160 | Belgium |
| AZ Sint Lucas (Sint Lucas) | Recruiting | Ghent | 9000 | Belgium |
| CHU HELORA - Hôpital de la Louvière - Site Jolimont | Recruiting | Haine-Saint-Paul | 7100 | Belgium |
| CHC MontLégia | Recruiting | Liège | 4000 | Belgium |
| ZNA Jan Palfijn | Recruiting | Merksem | 2170 | Belgium |
| CHU UCL Mont-Godinne | Recruiting | Mont-godinne | 5530 | Belgium |
| Multiprofile Hospital for Active Treatment Uni Hospital | Recruiting | Panagyurishte | 4500 | Bulgaria |
| Complex Oncological Center-Ruse EOOD | Recruiting | Rousse | 7000 | Bulgaria |
| Tokuda Hospital | Recruiting | Sofia | 1407 | Bulgaria |
| UMHAT "Sv. Ivan Rilski", EAD | Recruiting | Sofia | 1431 | Bulgaria |
| UMHAT Tsaritsa Yoanna - ISUL | Recruiting | Sofia | 1527 | Bulgaria |
| MBAL Serdika EOOD | Recruiting | Sofia | 1632 | Bulgaria |
| MHAT SofiaMed | Recruiting | Sofia | 1797 | Bulgaria |
| Presidio Ospedaliero Vito Fazzi | Recruiting | Lecce | Apulia | 73044 | Italy |
| AORN Ospedali dei Colli Ospedale Monaldi | Recruiting | Naples | Campania | 80131 | Italy |
| Az. Osp. Cardarelli | Recruiting | Naples | Campania | 80131 | Italy |
| A.O. Universitaria Policlinico Di Modena | Recruiting | Modena | Emilia-Romagna | 41100 | Italy |
| Ospedale Provinciale Santa Maria Delle Croci | Recruiting | Ravenna | Emilia-Romagna | 48100 | Italy |
| Policlinico Universitario Agostino Gemelli | Recruiting | Rome | Lazio | 00168 | Italy |
| Università Campus Bio-Medico di Roma | Recruiting | Rome | Lazio | 128 | Italy |
| IRCCS AOU San Martino - IST | Recruiting | Genoa | Liguria | 16132 | Italy |
| Cliniche Gavazzeni SpA Humanitas Gavazzeni | Recruiting | Bergamo | Lombardy | 24125 | Italy |
| Fondazione IRCCS Ospedale Maggiore Policlinico | Recruiting | Milan | Lombardy | 20122 | Italy |
| Ospedale Maggiore Policlinico | Recruiting | Milan | Lombardy | 20122 | Italy |
| Asst Santi Paolo E Carlo | Recruiting | Milan | Lombardy | 20142 | Italy |
| Ente Ecclesiastico Ospedale Generale Regionale F Miulli | Recruiting | Acquaviva Delle Fonti | Piedmont | 70021 | Italy |
| A.O.U. Maggiore della Carità | Recruiting | Novara | Piedmont | 28100 | Italy |
| Azienda Ospedaliero Universitaria Di Sassari | Recruiting | Sassari | Sardinia | 07100 | Italy |
| Humanitas Istituto Clinico Catanese S.p.A | Recruiting | Misterbianco (CT) | Sicily | 95045 | Italy |
| A.O.U. Policlinico Paolo Giaccone | Recruiting | Palermo | Sicily | 90100 | Italy |
| Casa di Cura La Maddalena | Recruiting | Palermo | Sicily | 90146 | Italy |
| Azienda Sanitaria Territoriale Pesaro Urbino (AST PU) - Ospedale Santa Croce;UOC Oncologia - Stabilimento di Fano | Recruiting | Fano (PU) | The Marches | 61032 | Italy |
| Ospedale Santa Chiara | Recruiting | Trento | Trentino-Alto Adige | 38100 | Italy |
| Ospedale dell'Angelo | Recruiting | Mestre | Veneto | 30174 | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona | Recruiting | Verona | Veneto | 37126 | Italy |
| Narodowy Instytut Onkologii - Panstwowy Instytut Badawczy, Oddzia? w Krakowie | Recruiting | Krakow | 31-115 | Poland |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie | Recruiting | Lublin | 20-954 | Poland |
| Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie | Recruiting | Olsztyn | 10-357 | Poland |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu | Recruiting | Poznan | 60-569 | Poland |
| Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka | Recruiting | Słupsk | 76-200 | Poland |
| NU-MED Centrum Diagnostyki i Terapii Onkologicznej | Recruiting | Tomaszów Mazowiecki | 97-200 | Poland |
| Institut Oncologic Prof. Dr. Alexandru Trestioreanu | Recruiting | Bucharest | 022328 | Romania |
| Institutul Clinic Fundeni Bucuresti | Recruiting | Bucharest | 022328 | Romania |
| Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. Octavian Fodor | Recruiting | Cluj-Napoca | 400162 | Romania |
| Spitalul Clinic Jude?ean de Urgen?? Sfântul Apostol Andrei Galati;oncology | Recruiting | Galati | 800578 | Romania |
| Institutul Regional de Oncologie Iasi | Recruiting | Iași | 700483 | Romania |
| Spitalul Municipal Ploiesti | Recruiting | PloieÅŸti | 107071 | Romania |
| Spitalul Judetean de Urgenta Satu Mare | Recruiting | Satu Mare | 440055 | Romania |
| Oncomed SRL | Recruiting | Timișoara | 300239 | Romania |
| Complejo Hospitalario Torrecardenas | Recruiting | AlmerÃa | Almeria | 04009 | Spain |
| Hospital Son Espases | Recruiting | Palma de Mallorca | Balearic Islands | 7120 | Spain |
| Hospital Sant Joan de Deu de Manresa;Servicio oncologia | Recruiting | Manresa | Barcelona | 08243 | Spain |
| Hospital Universitario Puerto Real | Recruiting | Puerto Real | Cadiz | 11510 | Spain |
| Hospital Universitario Mancha Centro (Alcázar de San Juan);Servicio de digestivo | Recruiting | Alcázar de San Juan | Ciudad REAL | 13600 | Spain |
| Hospital Universitario Mancha Centro (Alcázar de San Juan);Servicio de oncologÃa | Recruiting | Alcázar de San Juan | Ciudad REAL | 13600 | Spain |
| Complejo Hospitalario Universitario de Santiago (CHUS) | Recruiting | Santiago de Compostela | LA Coruna | 15706 | Spain |
| Hospital Univ. Central de Asturias | Recruiting | Oviedo | Principality of Asturias | 33006 | Spain |
| Hospital Univ. Central de Asturias | Recruiting | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Universitari Sant Joan de Reus | Recruiting | Reus | Tarragona | 43204 | Spain |
| Complejo Hospitalario Nuestra Señora de la Candelaria | Recruiting | Santa Cruz de Tenerife | Tenerife | 38010 | Spain |
| Hospital Universitario de Canarias | Recruiting | Santa Cruz de Tenerife | Tenerife | 38320 | Spain |
| Hospital de Cruces | Recruiting | Barakaldo | Vizcaya | 48903 | Spain |
| Hospital de Cruces | Recruiting | Bilbao | Vizcaya | 48903 | Spain |
| Complejo Hospitalario Universitario de Albacete | Recruiting | Albacete | 02006 | Spain |
| Hospital General de Alicante;servicio de digestivo | Recruiting | Alicante | 03010 | Spain |
| Hospital General Univ. de Alicante | Recruiting | Alicante | 3010 | Spain |
| Hospital de Badajoz | Recruiting | Badajoz | 06080 | Spain |
| Hospital Clinic I Provincial | Recruiting | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | 08041 | Spain |
| Hospital General de Ciudad Real | Recruiting | Ciudad Real | 13005 | Spain |
| Hospital Universitario San Cecilio | Recruiting | Granada | 18016 | Spain |
| Hospital General Universitario de Guadalajara | Recruiting | Guadalajara | 19002 | Spain |
| Hospital General Universitario J.M Morales Meseguer | Recruiting | Murcia | 30008 | Spain |
| Hospital Virgen de Arrixaca;servicio de digestivo | Recruiting | Murcia | 30120 | Spain |
| Complejo Hospitalario de Pontevedra | Recruiting | Pontevedra | 36002 | Spain |
| Hospital Virgen del Rocio;Servicio de digestivo | Recruiting | Seville | 41013 | Spain |
| Hospital de Toledo;Servicio de digestivo | Recruiting | Toledo | 45007 | Spain |
| Hospital de Toledo;servicio de oncologia | Recruiting | Toledo | 47007 | Spain |
| Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia | Recruiting | Valencia | 46015 | Spain |
| Hospital Clinico Universitario de Valladolid | Recruiting | Valladolid | 47003 | Spain |
| Hospital Clinico Universitario Valladolid | Recruiting | Valladolid | 47005 | Spain |
| Hospital Universitario Miguel Servet | Recruiting | Zaragoza | 50009 | Spain |
| University Hospitals Birmingham NHS Foundation Trust | Recruiting | Birmingham | B15 2TH | United Kingdom |
| Royal Surrey County Hospital | Recruiting | Guildford | GU2 7XX | United Kingdom |
| Leeds Teaching Hosp NHS Trust | Recruiting | Leeds | LS9 7TF | United Kingdom |
| James Cook University Hospital | Recruiting | Middlesbrough | TS4 3BW | United Kingdom |
| James Paget University Hospitals NHS Foundation Trust | Recruiting | Norfolk | NR31 6LA | United Kingdom |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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