A Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice (IMreal)

A Non-Interventional, Multicenter, Multiple Cohort Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice

This is a non-interventional, multi-country, multi-centre, multiple cohort prospective study, with retrospective collection of prior medical/treatment history data from medical records, designed to assess the real-world outcomes and safety of atezolizumab for indications in the existing label in the real world setting of routine clinical practice.

Study Overview

• Status: Active, not recruiting
• Conditions: Small Cell Lung Cancer; Hepatocellular Carcinoma; Non-Small Cell Lung Cancer; Urothelial Carcinoma
• Intervention / Treatment: Drug: Atezolizumab

Detailed Description

The study will be split into separate cohorts based on the approved indications for atezolizumab treatment, excluding cisplatin ineligible participants receiving atezolizumab as first line of therapy (LOT1) for locally advanced/metastatic urothelial cancer (locally advanced/metastatic UC). The study may be amended for inclusion of new cohorts as these are approved in the participating countries. Participants will be included into each cohort based on their indication for receiving atezolizumab.

• Study Type: Observational
• Enrollment (Estimated): 3040

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: MO40653 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. and Canada); Email: global-roche-genentech-trials@gene.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, 16290
    • Hospital Universitario Austral; Hepatología
  • Caba, Argentina, C1426AGE
    • Consultorio Privado Korbenfeld
  • Ciudad Autonoma Buenos Aires, Argentina, C1199ABB
    • Hospital Italiano de Buenos Aires; Hepatología
  • Ciudad Autónoma de Buenos Aires, Argentina, C1405CUB
    • Lucen S.A.
  • Cordoba, Argentina, X5000JHQ
    • Sanatorio Allende
  • Rosario, Argentina, S2000ORE
    • Sanatorio de la Mujer
  • Santa Rosa, Argentina, L6304BOC
    • Fundacion Koriza
• Austria
  • Klagenfurt, Austria, 9020
    • Klinikum Klagenfurt; Abteilung für Pulmologie
  • Krems, Austria, 3500
    • Landesklinikum Krems
  • Vöcklabruck, Austria, 4840
    • Salzkammergut-Klinikum Voecklabruck
  • Wels, Austria, 4600
    • Klinikum Wels-Grieskirchen; Lungenabt.
• Belgium
  • Mechelen, Belgium, 2800
    • AZ St Maarten Campus Leopoldstr
  • Mont-godinne, Belgium, 5530
    • CHU UCL Mont-Godinne
  • Oostende, Belgium, 8400
    • AZ Damiaan
  • Sint-Truiden, Belgium, 3800
    • Sint Trudo Ziekenhuis
• Brazil
  • SP
    • São Paulo, SP, Brazil, 01321-00
      • Beneficencia Portuguesa de Sao Paulo
• Bulgaria
  • Burgas, Bulgaria
    • Complex Oncology Center Burgas; Department of medical oncology
  • Panagyurishte, Bulgaria, 4500
    • Multiprofile Hospital for Active Treatment Uni Hospital; Department of medicinal oncology
  • Pleven, Bulgaria, 5800
    • Umhat Dr Georgi Stranski; Clinic of Chemotherapy
  • Plovdiv, Bulgaria, 4004
    • Complex Oncology Center - Plovdiv First Internal Chemotherapy Department
  • Plovdiv, Bulgaria, 4001
    • University Hospital Palmed; Medical Oncology Ward
  • Plovdiv, Bulgaria, 4004
    • Complex Oncological Center - Plovdiv, EOOD; Second Internal Department
  • Plovdiv, Bulgaria, 4004
    • Complex Oncological Center - Plovdiv, EOOD; Third Internal Department
  • Ruse, Bulgaria, 7000
    • Complex Oncological Center-Ruse EOOD; Department of Medical Oncology
  • Sofia, Bulgaria, 1431
    • UMHAT "Sv. Ivan Rilski", EAD
  • Sofia, Bulgaria, 1407
    • Tokuda Hospital; Medical Oncology Department
  • Sofia, Bulgaria, 1632
    • MBAL Serdika EOOD
  • Sofia, Bulgaria
    • MHAT SofiaMed; OOD
  • Varna, Bulgaria, 9010
    • Specialized Hospital for Active Cancer Treatment, Dr. Mark Antonov Markov - Varna Ltd
• Chile
  • Santiago, Chile, 7500653
    • Centro de Estudios Clinicos SAGA
• Colombia
  • Cali, Colombia
    • Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas
  • Cali, Colombia, 760045
    • Angiografia del Occidente
  • Medellin, Colombia, 050034
    • Hospital Pablo Tobon Uribe
  • Medellin, Colombia, 50010
    • Clinica ASTORGA
• Croatia
  • Osijek, Croatia, 31000
    • Clinical Hospital Centre Osijek
  • Zagreb, Croatia, 10000
    • Clinical Hospital Centre Zagreb
  • Zagreb, Croatia, 10000
    • Clinical Hospital Center Sestre Milosrdnice
  • Zagreb, Croatia, 10000
    • Clinical Hospital Center Sestre Milosrdnice; Clinic for tumors
• Egypt
  • Alexandria, Egypt
    • SUN Oncology center- Alexandria
  • Cairo, Egypt
    • Air Force Specialized Hospital
  • Cairo, Egypt
    • Cairo Oncology Center
  • Cairo, Egypt, 11391
    • Yasser Abdel Kader Private Clinic
  • Cairo, Egypt
    • Barsoum Oncology Center
  • Cairo, Egypt
    • International Medical Center; Oncology Department
• Estonia
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation; Oncology Centre
  • Tartu, Estonia, 51014
    • Tartu Uni Hospital; Hematology - Oncology Clinic
• France
  • Aix En Provence, France, 13616
    • Ch Du Pays D Aix; Pneumologie
  • Antony, France, 92166
    • Hopital Prive D Antony; Oncologie
  • Besancon, France, 25030
    • Hopital Jean Minjoz; Pneumologie
  • Beziers, France, 34525
    • Ch De Beziers; Pneumologie
  • Bordeaux, France, 33077
    • Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
  • Chambery, France, 73011
    • Ch De Chambery; Pneumologie
  • Clermont-ferrand, France, 63003
    • Hopital Gabriel Montpied; Service de Pneumologie
  • Eaubonne, France, 95602
    • Hopital Simone Veil Eaubonne; Hopital De Jour
  • Gleize, France, 69400
    • Hopital Nord Ouest;Unite 2c
  • Le Coudray, France, 28630
    • Hopital Louis Pasteur; Oncologie Hematologie
  • Le Mans, France, 72000
    • Centre Hospitalier Du Mans; Maladies Respiratoires
  • Lille, France, 59042
    • Hôpital Privé La Louviere; Pneumologie
  • Limoges, France, 87042
    • Hopital Dupuytren; Pneumologie
  • Lorient, France, 56100
    • Ch Bretagne Sud Site Scorff; Oncologie Medicale
  • Lyon, France, 69008
    • Hopital Privé Jean Mermoz; Pneumologie
  • Marseille, France, 13003
    • Hôpital Européen
  • Nimes, France, 30900
    • Polyclinique Kenval ; Radiotherapie Oncologie
  • Nimes, France, 30029
    • Hopital Caremeau; Pneumologie
  • Paris, France, 75014
    • Hopital Cochin; Unite Fonctionnelle D Oncologie
  • Pringy, France, 74374
    • CH ANNECY - GENEVOIS; Pneumologie
  • Reims, France, 51092
    • Hopital De La Maison Blanche;Maladies Respiratoires
  • Saint Nazaire, France, 44606
    • Clinique Mutualiste L Estuaire; Oncologie
  • Saint Priest En Jarez, France, 42770
    • Hopital Nord; Service de Pneumologie
  • Sarreguemines, France
    • HOPITAL ROBERT PAX; Pneumologie
  • St Quentin, France, 02321
    • Ch De Saint Quentin; Medecine B14
  • Toulon, France, 83056
    • Hopital Sainte Musse; Pneumologie
  • Toulouse, France, 31059
    • Hopital Larrey; Pneumologie
  • Valence, France, 26000
    • Centre Hospitalier de Valence; Pneumologie
  • Valenciennes Cedex, France, 59326
    • Service de pneumologie Clinique médico-chirurgicale Tessier
  • Vannes, France, 56017
    • Ch Bretagne Atlantique; Pneumologie-Oncologie
  • Vantoux, France, 57070
    • Hopital Robert Schuman; Pneumologie
• Hungary
  • Budapest, Hungary, 1121
    • Orszagos Koranyi Tbc es Pulmonologiai Intezet
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem, AOK, Pulmonologiai Klinika
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika
  • Pecs, Hungary, 7623
    • University of Pecs; 1St Department of Medicine
  • Törökbálint, Hungary, 2045
    • Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum
• India
  • Chandigarh, India, 160012
    • Postgraduate Institute of Medical Education and Research
  • Gujarat
    • Ahmedabad, Gujarat, India, 380060
      • HCG cancer center
    • Ahmedabad, Gujarat, India, 382421
      • KD Hospital
    • Surat CITY, Gujarat, India, 395007
      • Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd)
  • Karnataka
    • Bangalore, Karnataka, India, 560017
      • Manipal Hospital
  • Kerala
    • Kochi, Kerala, India, 682027
      • Aster Medcity
    • Kozhikode, Kerala, India, 673601
      • MVR Cancer Centre and Research Institute
  • Maharashtra
    • Mumbai, Maharashtra, India, 400056
      • Mumbai Oncocare Center; Medical Oncology
  • Telangana
    • Gachibowli, Telangana, India, 500032
      • AIG Hospitals
  • Uttar Pradesh
    • Varanasi, Uttar Pradesh, India, 221005
      • Mahamana Pandit Madan Mohan Malaviya Cancer Centre-TMC
• Italy
  • Abruzzo
    • L?Aquila, Abruzzo, Italy, 67100
      • Ospedale San Salvatore, UOC Oncologia
  • Basilicata
    • Rionero In Vulture (PZ), Basilicata, Italy, 85028
      • Ist. Ricovero e Cura a Carattere Scientifico-Centro Rif. Oncologico della Basilica
  • Calabria
    • Reggio Calabria, Calabria, Italy, 89133
      • Grande Ospedale Metropolitano; Oncologia Medica
  • Campania
    • Napoli, Campania, Italy, 80131
      • Az. Osp. Monaldi; 1 Pneumologia Oncologica
    • Napoli, Campania, Italy, 80131
      • Istituto Nazionale Tumori Fondazione G. Pascale; U.O.C. Oncologia Medica Toraco Polmonare
  • Emilia-Romagna
    • Meldola, Emilia-Romagna, Italy, 47014
      • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
    • Modena, Emilia-Romagna, Italy, 41124
      • A.O. Universitaria Policlinico Di Modena; Oncologia
  • Lazio
    • Roma, Lazio, Italy, 00152
      • Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1
    • Sora, Lazio, Italy, 03039
      • Ospedale S.S. Trinità Nuovo; Divisione Oncologia
  • Liguria
    • Genova, Liguria, Italy, 16132
      • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
  • Lombardia
    • Milano, Lombardia, Italy, 20142
      • Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica
    • Milano, Lombardia, Italy, 20122
      • Ospedale Maggiore Policlinico; U.O.C. di Oncologia Medica
    • Milano, Lombardia, Italy, 20162
      • Asst Grande Ospedale Metropolitano Niguarda; Divisione Medicina Epatologia Padiglione Crespi
    • Varese, Lombardia, Italy, 21100
      • Ospedale Di Circolo E Fondazione Macchi; Oncologia Medica
  • Marche
    • Macerata, Marche, Italy, 62100
      • Ospedale Di Macerata; Oncologia
  • Piemonte
    • Alessandria, Piemonte, Italy, 15100
      • Ospedale Civile SS. Antonio E Biagio DI Alessandria; Oncologia
  • Puglia
    • Lecce, Puglia, Italy, 73044
      • Presidio Ospedaliero Vito Fazzi; Unita Operativa Di Oncologia Medica
  • Sardegna
    • Cagliari, Sardegna, Italy, 09121
      • Ospedale Oncologico A.Businco; Div. Oncologia Medica II
    • Sassari, Sardegna, Italy, 07100
      • Azienda Ospedaliero Universitaria Di Sassari;Oncologia
  • Sicilia
    • Catania, Sicilia, Italy, 95122
      • Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica
    • Messina, Sicilia, Italy, 98124
      • Az. Osp. Uni. Ria Policlinico G. Martino; Dept. Di Med. Interna E Terapia Medica - Ii Clinica Medica
    • Palermo, Sicilia, Italy, 90146
      • Casa di Cura La Maddalena; Oncologia Medica
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
    • Firenze, Toscana, Italy, 50134
      • Azienda Ospedaliero Universitaria Careggi; Medicina interna ed epatologia
    • Lido Di Camaiore, Toscana, Italy, 55043
      • Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica
  • Veneto
    • Legnago, Veneto, Italy, 37045
      • Ospedale Mater Salutis; Dept of Oncology
    • Verona, Veneto, Italy, 37134
      • A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina
    • Vicenza, Veneto, Italy, 36100
      • Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza
• Kuwait
  • Shuwakh Industrial, Kuwait, 70653
    • Kuwait Cancer control center
• Lebanon
  • Beirut, Lebanon, 166378
    • Saint George Hospital; Haematology-Oncology
  • Beirut, Lebanon, 1107 2090
    • Mount Lebanon Hospital
  • Bsalim, Mount Lebanon-Metn, Lebanon, 2624 0000
    • Middle East Institute of Health Hospital
• Lithuania
  • Kaunas, Lithuania, 50009
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution
  • Vilnius, Lithuania, 08660
    • National Cancer Institute; Department of Thoracic Surgery and Oncology
• Mexico
  • Mexico CITY (federal District)
    • Mexico City, Mexico CITY (federal District), Mexico, 14050
      • Medica sur Hospital
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, 64000
      • Clinica Opcion Oncologia S.A. de C.V.
    • San Pedro Garza García, Nuevo LEON, Mexico, 66220
      • Oncare
• Netherlands
  • Amsterdam, Netherlands, 1091 AC
    • Onze Lieve Vrouwe Gasthuis, locatie Oost
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis
  • Zaandam, Netherlands, 1502 DV
    • Zaans Medisch Centrum
• Oman
  • Muscat, Oman, 111
    • Royal Hospital; Oncology Department
  • Muscat, Oman
    • Sultan Qaboos Comprehensive Cancer Care & Research Center
• Pakistan
  • Punjab (province)
    • Lahore, Punjab (province), Pakistan, 54000
      • Shaukat Khanum Memorial Cancer Hospital; Department of Oncology
  • Sindh (province)
    • Karachi, Sindh (province), Pakistan, 74800
      • Aga Khan University; Department of Oncology
• Philippines
  • Manila, Philippines, 1014
    • Chinese General Hospital and Medical Center
  • Pasay, Philippines, 1300
    • San Juan de Dios Hospital;Oncology Unit
  • Quezon City, Philippines, 1104
    • Lung Center of the Philippines
• Poland
  • ?ód?, Poland, 93-513
    • Wojewódzki Szpital Specjalistyczny im. M. Kopernika w ?odzi
  • Bielsko-Bia?a, Poland, 43-300
    • Beskidzkie Centrum Onkologii - Szpital Miejski im. Jana Pawla II; Klinika Onkologii
  • Bydgoszcz, Poland, 85-796
    • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Oddzia? Onkologii Klinicznej Odcinka A
  • Bydgoszcz, Poland, 85-796
    • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Oddzia? Onkologii Klinicznej Odcinka B
  • Bystra, Poland, 43-360
    • Centrum Pulmonologii i Torakochirurgii; Oddzial Pulmonologiczny z Pododdzialem Chemioterapii
  • Elblag, Poland, 82-300
    • Wojewodzki Szpital Zespolony; Oddzia? Onkologii
  • Gliwice, Poland, 44-101
    • Centrum Onkologii w Gliwicach; II Klinika Radioterapii i Chemioterapii
  • Grudzi?dz, Poland, 86-300
    • Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Onkologii Klinicznej
  • Lublin, Poland, 20-954
    • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
  • Otwock, Poland, 05-400
    • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
  • Pozna?, Poland, 60-569
    • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii
  • Warszawa, Poland, 01-138
    • Instytut Gruzlicy i Chorob P?uc
  • Warszawa, Poland, 02-091
    • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego; Klinika Onkologii
• Portugal
  • Coimbra, Portugal, 3041-801
    • Hospital Geral; Servico de Pneumologia
  • Lisboa, Portugal, 1796-001
    • Hospital Pulido Valente; Servico de Pneumologia
  • Lisboa, Portugal, 1400-038
    • Centro Clinico Champalimaud; Unidade de Pulmao
  • Matosinhos, Portugal, 4454-509
    • Hospital Pedro Hispano; Servico de Oncologia
  • Porto, Portugal, 4100-180
    • Hospital CUF Porto; Servico Pneumologia
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia
  • Vila Nova de Gaia, Portugal, 4434-502
    • CHVNG/E_Unidade 1; Servico de Pneumologia
• Romania
  • Alba Iulia, Romania, 510073
    • County Hospital Alba; Oncology
  • Bucharest, Romania, 022328
    • Institutul Clinic Fundeni Bucuresti
  • Cluj-Napoca, Romania, 400162
    • Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. Octavian Fodor
  • Ploiesti, Romania, 100337
    • Spitalul Municipal Ploiesti
  • Timisoara, Romania, 300239
    • Oncomed SRL; Oncologie
• Russian Federation
  • Kaluga, Russian Federation, 248007
    • SBIH Kaluga Region Clinical Oncology Dispensary
  • Tver, Russian Federation, 170008
    • Tver Regional Oncology Clinical Dispensary
  • Altaj
    • Barnaul, Altaj, Russian Federation, 656049
      • ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic
  • Arhangelsk
    • Arkhangelsk, Arhangelsk, Russian Federation, 163045
      • Arkhangelsk Regional Clinical Oncology Dispensary
  • Baskortostan
    • UFA, Baskortostan, Russian Federation, 450054
      • Bashkirian Republican Clinical Oncology Dispensary
  • Krasnodar
    • Krasnoyarsk, Krasnodar, Russian Federation, 660133
      • Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy
  • Moskovskaja Oblast
    • Moscow, Moskovskaja Oblast, Russian Federation, 115478
      • FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
  • Sankt Petersburg
    • Saint-Petersburg, Sankt Petersburg, Russian Federation, 197758
      • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
    • Sankt-peterburg, Sankt Petersburg, Russian Federation, 196006
      • Medical Clinic "AB Medical group"
    • Sankt-peterburg, Sankt Petersburg, Russian Federation, 197022
      • EuroCityClinic
  • Tatarstan
    • Kazan, Tatarstan, Russian Federation, 420029
      • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
• Singapore
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital; Oncology
  • Singapore, Singapore, 168583
    • National Cancer Centre; Medical Oncology
• Slovenia
  • Ljubljana, Slovenia, 1000
    • INSTITUTE OF ONCOLOGY LJUBLJANA; Lung Cancer Unit
  • Ljubljana, Slovenia, 1000
    • University Medical Center Ljubljana; Clinical Dept. of Gastroenterology
  • Maribor, Slovenia, 2000
    • Univerzitetni klini?ni center Maribor; Oddelek za onkologijo
• Spain
  • Badajoz, Spain, 06080
    • Hospital Universitario Infanta Cristina; Servicio de Oncologia
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  • Barcelona, Spain, 08028
    • Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica
  • Burgos, Spain, 09006
    • Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
  • Caceres, Spain, 10003
    • Hospital San Pedro De Alcantara; Servicio de Oncologia
  • Granada, Spain, 18016
    • Hospital Clinico de Granada; Servicio de Oncologia
  • Jaen, Spain, 23007
    • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
  • Leon, Spain, 24071
    • Complejo Asistencial Universitario de Leon; Servicio de Oncologia
  • Lugo, Spain, 27003
    • Hospital Lucus Augusti; Servicio de Oncologia
  • Madrid, Spain, 28050
    • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz; Servicio de Oncologia
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz; Servicio de Oncologia
  • Orense, Spain, 32005
    • Complejo Hospitalario de Orense; Servicio de Oncologia
  • Segovia, Spain, 40002
    • Hospital General de Segovia; Servicio de Oncologia
  • Sevilla, Spain, 41014
    • Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
  • Valladolid, Spain, 47005
    • Hospital Clinico Universitario de Valladolid; Servicio de Oncologia
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet; Servicio Oncologia
  • Almeria
    • Almería, Almeria, Spain, 04009
      • Complejo Hospitalario Torrecardenas; Servicio de Oncologia
  • Barcelona
    • Mataro, Barcelona, Spain, 08304
      • Hospital General de Mataro; Servicio de Oncologia
    • Sabadell, Barcelona, Spain, 8208
      • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • LA Coruña
    • Santiago de Compostela, LA Coruña, Spain, 15706
      • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro; Servicio de Oncologia
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • Hospital Quiron de Madrid; Servicio de Oncologia
    • San Sebastian de Los Reyes, Madrid, Spain, 28702
      • Hospital Infanta Sofia; Servico de Oncologia
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria de Navarra; Servicio de Oncologia
    • Pamplona, Navarra, Spain, 31008
      • Complejo Hospitalario de Navarra; Servicio de Oncologia
  • Tenerife
    • La Laguna, Tenerife, Spain, 38320
      • Hospital Universitario de Canarias;servicio de Oncologia
    • Santa Cruz de Tenerife, Tenerife, Spain, 38010
      • Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia
• United Arab Emirates
  • Al Ain, United Arab Emirates, 15258
    • Tawam Hospital
• United Kingdom
  • Barnet, United Kingdom, EN5 3DJ
    • Barnet Hospital; ROYAL FREE LONDON NHS FOUNDATION TRUST
  • Bath, United Kingdom, BA1 3NG
    • Royal United Hospital; Oncology Department
  • Bebington, United Kingdom, CH63 4JY
    • Clatterbridge Cancer Centre
  • Birmingham, United Kingdom, B15 2TH
    • Queen Elizabeth Hospital
  • Birmingham, United Kingdom, B9 5SS
    • Heartlands Hospital; Department Of Medicine
  • Burnley, United Kingdom, BB10 2PQ
    • East Lancashire Hospitals NHS Trust
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrookes Hospital
  • Cardiff, United Kingdom, CF14 2TL
    • Velindre Cancer Centre
  • Cottingham, United Kingdom, HU16 5JG
    • Castle Hill Hospital; The Queens Centre for Oncology and Haematology
  • Guildford, United Kingdom, GU2 7XX
    • Royal Surrey County Hospital
  • Harrow, United Kingdom, HA1 3UJ
    • Northwick Park Hospital
  • Huddersfield, United Kingdom, HD3 3EA
    • Huddersfield Royal Infirmary; The Learning Centre
  • Keighley, United Kingdom, BD20 6TD
    • Airedale General Hospital; Research Office Ward 12
  • Kingston upon Thames, United Kingdom, KT2 7QB
    • Royal Marsden Hospital
  • Leeds, United Kingdom, LS9 7TF
    • St James Hospital; Dept of Oncology/Hematology
  • London, United Kingdom, SE1 9RT
    • Guys and St Thomas Hospital
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital; Dept of Oncology
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital
  • London, United Kingdom, EC1M 6BQ
    • St Bartholomew's Hospital
  • London, United Kingdom, SE18 4QH
    • Queen Elizabeth Hospital
  • London, United Kingdom, SW17 0QT
    • St George's Hospital; Oncology
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital - Fulham
  • London, United Kingdom, W12 0HS
    • Hammersmith Hospital; Dept of Oncology
  • Maidstone, United Kingdom, ME16 9QQ
    • Maidstone Hospital; Kent Oncology Centre
  • Manchester, United Kingdom, M20 4BX
    • The Christie
  • Middlesbrough, United Kingdom, TS4 3BW
    • James Cook Hospital
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Freeman Hospital
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham City Hospital; Oncology
  • Oxford, United Kingdom, OX3 7LJ
    • Churchill Hospital
  • Preston, United Kingdom, PR2 9HT
    • Royal Preston Hospital
  • Sheffield, United Kingdom, S10 2SJ
    • Weston Park Hospital
  • Stoke-on-Trent, United Kingdom, ST4 6QG
    • Royal Stoke University Hospital
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hospital (Sutton)
  • Torquay, United Kingdom, TQ27AA
    • Torbay Hospital; Oncology Department
  • Truro, United Kingdom, TR1 3LQ
    • Royal Cornwall Hospital
  • Wakefield, United Kingdom, WF1 4DG
    • Pinderfields General Hospital
  • Wiltshire, United Kingdom, SN3 6BB
    • Great Western Hospitals NHS Foundation Trust.
  • Wolverhampton, United Kingdom, WV10 0QP
    • New Cross Hospital
  • York, United Kingdom, YO31 8HE
    • The York Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with locally advanced /mUC previously treated with platinum-containing chemotherapy, participants diagnosed with locally advanced/metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, participants diagnosed with extensive-stage small cell lung cancer (ES-SCLC), participants diagnosed with metastatic NSCLC previously untreated,and participants diagnosed with locally unresectable locally advanced or metastatic hepatocellular carcinoma previously untreated with systemic therapy.

Description

Inclusion Criteria:

• Patient must have one of the following confirmed diagnoses for which atezolizumab is locally approved in the SmPC: (1) As monotherapy for the treatment of adult patients with locally advanced/metastatic UC after prior platinum-containing chemotherapy (Cohort 1 LOT2+mUC) or (2) As monotherapy for the treatment of adult patients with locally advanced/metastatic NSCLC after prior chemotherapy. Patients with EGFR activating mutations or ALK-positive tumour mutations should also have received targeted therapy before receiving atezolizumab (Cohort 2 LOT2+NSCLC) or (3) In combination with bevacizumab, paclitaxel and carboplatin for the first line treatment of adult patients with metastatic non-squamous NSCLC. Patients with EGFR activating mutations or ALK- positive tumour mutations should also have received targeted therapy (Cohort 3 LOT1 NSCLC) or (4) In combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (Cohort 4 LOT1 ES-SCLC) or (5) As a monotherapy, for the treatment of metastatic NSCLC with high PD-L1 expression, previously untreated (Cohort 5 LOT1 NSCLC) or (6) In combination with bevacizumab for unresectable locally advanced or metastatic hepatocellular carcinoma previously untreated with systemic therapy (Cohort 6 LOT1 HCC) .
• Patient is administered atezolizumab therapy for the first time.
• Decision to administer atezolizumab must be made and documented prior to inclusion into the study and must follow local clinical practice.

Exclusion Criteria:

• Patients not receiving treatment for a disease with atezolizumab according to standard of care and in line with the current summary of product characteristics (SPC) or local labelling. Cisplatin ineligible patients receiving atezolizumab LOT1 for the treatment of locally advanced/metastatic UC patients will be excluded
• Concomitant anti-cancer therapy at the time of starting atezolizumab on the index date not part of locally approved combination therapy with atezolizumab.
• Treatment with atezolizumab as part of a clinical trial or for compassionate use as part of a pre-approval or compassionate use program.
• Patients not receiving atezolizumab, but a biosimilar or non-original biologic.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1 (UC LOT2+later lines[LOT2+] & platinum eligible LOT1); Participants diagnosed with locally advanced or metastatic Urothelial Cancer previously treated with platinum-containing chemotherapy. Enrollment is closed.	Drug: Atezolizumab; Atezolizumab will be administered at the discretion of the treating physician per local guidelines and independently of participation in this study.; Other Names: Tecentriq
Cohort 2 (NSCLC LOT2 plus later lines [LOT2+]); Participants diagnosed with Locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) after prior chemotherapy. Participants with epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK)-positive tumor mutations should also have received targeted therapy. Enrollment closed.	Drug: Atezolizumab; Atezolizumab will be administered at the discretion of the treating physician per local guidelines and independently of participation in this study.; Other Names: Tecentriq
Cohort 5 (NSCLC LOT1); Participants diagnosed with metastatic Non-Small Cell Lung cancer with high PD-L1 expression, previously untreated.	Drug: Atezolizumab; Atezolizumab will be administered at the discretion of the treating physician per local guidelines and independently of participation in this study.; Other Names: Tecentriq
Cohort 6 (HCC LOT1); Participants diagnosed with unresectable locally advanced or metastatic hepatocellular carcinoma previously untreated with systemic therapy.	Drug: Atezolizumab; Atezolizumab will be administered at the discretion of the treating physician per local guidelines and independently of participation in this study.; Other Names: Tecentriq
Cohort 3 (NSCLC LOT1 plus EGFR+/ALK+ LOT2+); EMA: Participants diagnosed with locally advanced/metastatic non-squamous NSCLC not previously treated. Participants with EGFR-activating mutations or ALK-positive tumor mutations should have received at least one line of targeted therapy. FDA: for the treatment of adult participants with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Participants with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ. Enrollment is closed.	Drug: Atezolizumab; Atezolizumab will be administered at the discretion of the treating physician per local guidelines and independently of participation in this study.; Other Names: Tecentriq
Cohort 4 (ES-SCLC LOT1); Participants diagnosed with extensive stage (ES) small cell lung cancer (SCLC) not previously treated. Enrollment is closed.	Drug: Atezolizumab; Atezolizumab will be administered at the discretion of the treating physician per local guidelines and independently of participation in this study.; Other Names: Tecentriq

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Time from index date until date of death from any cause. Index date is the date of administration of the first ever dose of atezolizumab for each patient.	Index date up to approximately 6 years
OS at 2 Years	Percentage of participants alive 2 years after initiation of atezolizumab treatment.	After index date up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Loss of Clinical Benefit (TTLCB)	Time from the index date to loss of clinical benefit as assessed by the treating physician.	Index date up to approximately 6 years
Progression Free Survival (PFS)	Time from index date to death or disease progression (PD).	Index date up to approximately 6 years
Objective Response Rate (ORR)	Percentage of participants who have a best overall response (BOR) of Complete Response (CR) or Partial Response (PR). BOR for each participant is the best response achieved after the index date prior to initiation of any subsequent treatment.	After index date up to approximately 6 years
Time to Response	Time from index date to first objective tumor response, CR or PR.	Index date up to approximately 6 years
Duration of Response (DoR)	Time from first documentation of CR or PR (whichever occurs first) after index until death or PD.	Index date up to approximately 6 years
Disease Control Rate (DCR)	Percentage of participants who have achieved CR, PR and stable disease at least 12 weeks after the index date.	From 12 weeks after index date up to approximately 6 years
Duration of DCR	Time from first documentation of CR, PR or stable disease (whichever occurs first) after index until death or PD.	After index date up to approximately 6 years
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Score	EQ-5D-5L during and after atezolizumab treatment will be used to assess HRQoL. Scale is from 1-5 (no problems, slight problems, moderate problems, severe problems and extreme problems).	Index date or after ICF signature, & approx. at 6, 12, and 24 weeks of treatment; then at approx. 3 months, 6 months, 12 months, & every 12 months thereafter until end of study (study planned duration up to approximately 6 years)
Number of Paricipants with Disease Stage TNM and IUCC		At index date (Index date is the date of administration of the first ever dose of atezolizumab for each patient.)
Number of Participants at Each Level of Karnofsky or ECOG Performance Status		At index date (Index date is the date of administration of the first ever dose of atezolizumab for each patient.
Total Number of Infusions of Atezolizuamb		Treatment period until discontinuation (up to approximately 6 years)
Duration of Treatment With Atezolizumab		Index date until date of treatment discontinuation (up to approximately 6 years)
Percentage of Participants with Adverse Events		Up to approximately 6 years
Time to initiation of the first subsequent cancer-related therapy		Up to approximately 6 years
Number of Lines of Prior and Subsequent Cancer-Related Therapies		Up to approximately 6 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2019
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: November 28, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Atezolizumab
• Other Study ID Numbers: MO40653

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO