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 (Actual): 2756

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 16290
    • Hospital Universitario Austral
  • Buenos Aires, Argentina, C1405CUB
    • Lucen S.A.
  • CABA, Argentina, C1426AGE
    • Consultorio Privado Korbenfeld
  • Ciudad Autonoma Buenos Aires, Argentina, C1199ABB
    • Hospital Italiano de Buenos Aires
  • Córdoba, Argentina, X5000JHQ
    • Sanatorio Allende
  • Rosario, Argentina, S2000ORE
    • Sanatorio de la Mujer
  • Santa Rosa, Argentina, 6300
    • Fundacion Koriza
• Austria
  • Klagenfurt, Austria, 9020
    • Klinikum Klagenfurt
  • Krems, Austria, 3500
    • Landesklinikum Krems
  • Vöcklabruck, Austria, 4840
    • Salzkammergut-Klinikum Voecklabruck
  • Wels, Austria, 4600
    • Klinikum Wels-Grieskirchen
• Belgium
  • Brasschaat, Belgium, 2930
    • AZ Klina
  • Mechelen, Belgium, 2800
    • AZ St Maarten Campus Leopoldstr
  • Mont-godinne, Belgium, 5530
    • CHU UCL Mont-Godinne
  • Ostend, Belgium, 8400
    • AZ Oostende
  • Roeselare, Belgium, 8800
    • AZ Delta (Campus Rumbeke)
  • Sint-Truiden, Belgium, 3800
    • Sint Trudo Ziekenhuis
• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01323-900
      • Beneficencia Portuguesa de Sao Paulo
• Bulgaria
  • Burgas, Bulgaria, DUMMY_VALUE
    • Complex Oncology Center Burgas
  • Panagyurishte, Bulgaria, 4500
    • Multiprofile Hospital for Active Treatment Uni Hospital
  • Pleven, Bulgaria, 5800
    • Umhat Dr Georgi Stranski
  • Plovdiv, Bulgaria, 4004
    • Complex Oncological Center - Plovdiv, EOOD
  • Plovdiv, Bulgaria, 4004
    • DDODIU-Plovdiv, EOOD
  • Plovdiv, Bulgaria, 4004
    • Complex Oncology Center - Plovdiv First Internal Chemotherapy Department
  • Plovdiv, Bulgaria, 4001
    • University Hospital Palmed
  • Rousse, Bulgaria, 7000
    • Complex Oncological Center-Ruse EOOD
  • Sofia, Bulgaria, 1431
    • UMHAT "Sv. Ivan Rilski", EAD
  • Sofia, Bulgaria, 1407
    • Tokuda Hospital
  • Sofia, Bulgaria, 1632
    • MBAL Serdika EOOD
  • Sofia, Bulgaria, DUMMY_VALUE
    • MHAT SofiaMed
  • Varna, Bulgaria, 9010
    • Specialized Hospital for Active Cancer Treatment, Dr. Mark Antonov Markov - Varna Ltd
• Chile
  • Santiago, Chile, DUMMY_VALUE
    • Centro de Estudios Clínicos SAGA
• Colombia
  • Cali, Colombia, 760045
    • Angiografia del Occidente
  • Cali, Colombia, DUMMY_VALUE
    • Fundacion Clinica Valle del Lili
  • Medellín, Colombia, 050034
    • Hospital Pablo Tobón Uribe
  • Medellín, Colombia, 50010
    • Clinica ASTORGA
• Croatia
  • Osijek, Croatia, 31000
    • Clinical Hospital Centre Osijek
  • Split, Croatia, 21000
    • Klinicki bolnicki centar Split
  • Zagreb, Croatia, 10000
    • Clinical Hospital Centre Zagreb
  • Zagreb, Croatia, 10000
    • Clinical Hospital Center Sestre Milosrdnice
• Egypt
  • Alexandria, Egypt, DUMMY_VALUE
    • SUN Oncology center- Alexandria
  • Cairo, Egypt, 11391
    • Yasser Abdel Kader Private Clinic
  • Cairo, Egypt, DUMMY_VALUE
    • Air Force Specialized Hospital
  • Cairo, Egypt, DUMMY_VALUE
    • Barsoum Oncology Center
  • Cairo, Egypt, DUMMY_VALUE
    • Cairo Oncology Center
  • Cairo, Egypt, DUMMY_VALUE
    • International Medical Center
• Estonia
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation
  • Tartu, Estonia, 51014
    • Tartu Uni Hospital
• France
  • Agen, France, 47000
    • Clinique Du Docteur Calabet
  • Aix-en-Provence, France, 13616
    • CH du Pays d Aix
  • Amiens, France, 80090
    • Clinique de L'Europe
  • Angers, France, 49933
    • Centre Hospitalier Uni Ire
  • Antony, France, 92166
    • Hopital Prive D Antony
  • Avignon, France, 84902
    • CHG Henri Dufaut médecine interne-onco-hematologie
  • Beauvais, France, 60000
    • CH de BEAUVAIS
  • Besançon, France, 25030
    • Hôpital Jean Minjoz
  • Bordeaux, France, 33077
    • Polyclinique Bordeaux Nord Aquitaine
  • Bordeaux, France, 33030
    • Clinique Tivoli
  • Béziers, France, 34525
    • CH de Béziers
  • Caen, France, 14033
    • Hôpital Côte de Nacre
  • Chambray-lès-Tours, France, 37170
    • Oncologie 37
  • Chambéry, France, 73011
    • Ch De Chambery
  • Clermont-Ferrand, France, 63003
    • Hôpital Gabriel Montpied
  • Compiègne, France, 60321
    • Ch De Compiegne
  • Creil, France, 60109
    • Ch Laennec
  • Dijon, France, 21079
    • Centre Georges François Leclerc
  • Eaubonne, France, 95602
    • Hopital Simone Veil Eaubonne
  • Gap, France, 05007
    • Chi Alpes Du Sud Site De Gap
  • Gleizé, France, 69400
    • Hopital Nord Ouest
  • La Rochelle, France, 17019
    • Ch Saint Louis
  • La Source, France, 45100
    • Hopital La Source
  • Le Coudray, France, 28630
    • Hopital Louis Pasteur
  • Le Mans, France, 72037
    • Centre Hospitalier du Mans
  • Lille, France, 59042
    • Hopital Prive La Louviere
  • Limoges, France, 87042
    • Hopital Dupuytren
  • Lorient, France, 56100
    • Ch Bretagne Sud Site Scorff
  • Lyon, France, 69008
    • Hopital Prive Jean Mermoz
  • Marseille, France, 13003
    • Hôpital Européen
  • Montpellier, France, 34070
    • Clinique Clémentville
  • Montpellier, France, 34298
    • Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque
  • Mulhouse, France, 68070
    • Hopital Emile Muller
  • Nîmes, France, 30029
    • Hopital Caremeau
  • Nîmes, France, 30900
    • Polyclinique KenVal
  • Paris, France, 75014
    • Hôpital Cochin
  • Paris, France, 75005
    • Institut Curie
  • Paris, France, 75908
    • Hopital Europeen Georges Pompidou
  • Pau, France, 64046
    • Centre Hospitalier
  • Perpignan, France, 66000
    • Centre Catalan D' Oncologie
  • Pringy, France, 74374
    • Ch Annecy - Genevois
  • Reims, France, 51092
    • Hopital De La Maison Blanche
  • Saint-Nazaire, France, 44606
    • Clinique Mutualiste L Estuaire
  • Saint-Priest-en-Jarez, France, 42770
    • Hopital Nord
  • Saint-Quentin, France, 02321
    • CH de Saint Quentin
  • Sarreguemines, France, DUMMY_VALUE
    • Hopital Robert Pax
  • Toulon, France, 83056
    • Hopital Sainte Musse
  • Toulouse, France, 31059
    • Hopital Larrey
  • Valence, France, 26000
    • Centre Hospitalier de Valence
  • Valenciennes, France, 59326
    • Service de pneumologie Clinique médico-chirurgicale Tessier
  • Vannes, France, 56017
    • CH Bretagne Atlantique
  • Vantoux, France, 57070
    • Hopital Robert Schuman
• Hungary
  • Budapest, Hungary, 1121
    • Orszagos Koranyi Tbc es Pulmonologiai Intezet
  • Budapest, Hungary, 1125
    • Semmelweis Egyetem, AOK, Pulmonologiai Klinika
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika
  • Pécs, Hungary, 7623
    • University of Pecs
  • Törökbálint, Hungary, 2045
    • Református Pulmonológiai Centrum
• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380060
      • HCG cancer center
    • Surat, 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
      • MOC Cancer Care & Research Centre
  • Telangana
    • Gachibowli, Telangana, India, 500032
      • AIG Hospitals
• Italy
  • Abruzzo
    • L’Aquila, Abruzzo, Italy, 67100
      • Ospedale San Salvatore, UOC Oncologia
  • Calabria
    • Reggio Calabria, Calabria, Italy, 89133
      • Grande Ospedale Metropolitano
  • Campania
    • Napoli, Campania, Italy, 80131
      • Istituto Nazionale Tumori Fondazione G. Pascale
    • Napoli, Campania, Italy, 80131
      • Az. Osp. Monaldi
  • Emilia-Romagna
    • Modena, Emilia-Romagna, Italy, 41100
      • A.O. Universitaria Policlinico Di Modena
  • Lazio
    • Rome, Lazio, Italy, 00152
      • Azienda Ospedaliera San Camillo Forlanini
    • Sora, Lazio, Italy, 03039
      • Ospedale S.S. Trinità Nuovo
  • Liguria
    • Genoa, Liguria, Italy, 16132
      • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST)
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Ospedale Maggiore Policlinico
    • Milan, Lombardy, Italy, 20142
      • Asst Santi Paolo E Carlo
    • Milan, Lombardy, Italy, 20162
      • ASST Grande Ospedale Metropolitano Niguarda
    • Varese, Lombardy, Italy, 21100
      • Ospedale di Circolo e Fondazione Macchi
  • Piedmont
    • Alessandria, Piedmont, Italy, 15100
      • Ospedale Civile SS. Antonio E Biagio DI Alessandria
  • Sardinia
    • Cagliari, Sardinia, Italy, 09121
      • Ospedale Oncologico A.Businco
    • Sassari, Sardinia, Italy, 07100
      • Azienda Ospedaliero Universitaria di Sassari
  • Sicily
    • Catania, Sicily, Italy, 95122
      • Az Ospedaliera Nuovo Garibaldi Quartiere Nesima
    • Messina, Sicily, Italy, 98124
      • Az. Osp. Uni. Ria Policlinico G. Martino
  • The Marches
    • Macerata, The Marches, Italy, 62100
      • Ospedale Di Macerata
  • Tuscany
    • Florence, Tuscany, Italy, 50134
      • Azienda Ospedaliero-Universitaria Careggi
    • Florence, Tuscany, Italy, 50134
      • Azienda Ospedaliero Universitaria Careggi
    • Lido di Camaiore, Tuscany, Italy, 55043
      • Ospedale Nuovo Della Versilia
  • Veneto
    • Verona, Veneto, Italy, 37134
      • A.O.U. Integrata Verona - Policlinico G.B. Rossi
    • Vicenza, Veneto, Italy, 36100
      • Azienda ULSS 8 Berica
• Kuwait
  • Kuwait City, Kuwait, DUMMY_VALUE
    • Kuwait Cancer control center
  • Shuwakh Industrial, Kuwait, 70653
    • Kuwait Cancer control center
• Lebanon
  • Beirut, Lebanon, 166378
    • Saint George 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, LT-08660
    • National Cancer Institute
• Mexico
  • Mexico CITY (federal District)
    • Mexico City, Mexico CITY (federal District), Mexico, 14050
      • Medica sur Hospital
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64000
      • Clinica Opcion Oncologia S.A. de C.V.
    • San Pedro Garza García, Nuevo León, Mexico, 66220
      • Oncare
• Netherlands
  • Amsterdam, Netherlands, 1091 AC
    • Onze Lieve Vrouwe Gasthuis, locatie Oost
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis
  • Leeuwarden, Netherlands, 8934 AD
    • Medisch Centrum Leeuwarden
  • Zaandam, Netherlands, 1502 DV
    • Zaans Medisch Centrum
• Oman
  • Muscat, Oman, 111
    • Royal Hospital
  • Muscat, Oman, DUMMY_VALUE
    • Sultan Qaboos Comprehensive Cancer Care & Research Center
• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • Shaukat Khanum Memorial Cancer Hospital
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • Aga Khan University
• Poland
  • ?ód?, Poland, 93-513
    • Wojewódzki Szpital Specjalistyczny im. M. Kopernika w ?odzi
  • ?ód?, Poland, 91-520
    • WZZOZ Centrum Leczenia Chorob Pluc i Rehabilitacji
  • Bielsko-Bia?a, Poland, 43-300
    • Beskidzkie Centrum Onkologii - Szpital Miejski im. Jana Pawla II
  • Bydgoszcz, Poland, 85-796
    • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
  • Bystra, Poland, 43-360
    • Centrum Pulmonologii i Torakochirurgii
  • Elblag, Poland, 82-300
    • Wojewodzki Szpital Zespolony
  • Grudzi?dz, Poland, 86-300
    • Regionalny Szpital Specjalistyczny im. W. Bieganskiego
  • Lublin, Poland, 20-954
    • Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
  • Olsztyn, Poland, 10-357
    • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
  • Otwock, Poland, 05-400
    • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
  • Późna, Poland, 60-569
    • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu
  • Warsaw, Poland, 01-138
    • Instytut Gruzlicy i Chorob P?uc
  • Warsaw, Poland, 02-091
    • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
  • Wroc?aw, Poland, 53-439
    • Dolno?L?Skie Centrum Onkologii, Pulmonologii I Hematologii
• Portugal
  • Coimbra, Portugal, 3041-801
    • Hospital Geral
  • Lisbon, Portugal, 1400-038
    • Centro Clinico Champalimaud
  • Lisbon, Portugal, 1796-001
    • Hospital Pulido Valente
  • Matosinhos Municipality, Portugal, 4454-509
    • Hospital Pedro Hispano
  • Porto, Portugal, 4100-180
    • Hospital CUF Porto
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto ? Hospital de Santo António
  • Vila Nova de Gaia, Portugal, 4434-502
    • CHVNG/E_Unidade 1
• Romania
  • Bucharest, Romania, 022328
    • Institutul Clinic Fundeni Bucuresti
  • Cluj-Napoca, Romania, 400162
    • Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor
• Russia
  • Kaluga, Russia, 248007
    • SBIH Kaluga Region Clinical Oncology Dispensary
  • Tver', Russia, 170008
    • Tver Regional Oncology Clinical Dispensary
  • Altayskiy Kray
    • Barnaul, Altayskiy Kray, Russia, 656049
      • Altai Regional Oncological Center
  • Arhangelsk
    • Arkhangelsk, Arhangelsk, Russia, 163045
      • Arkhangelsk Regional Clinical Oncology Dispensary
  • Bashkortostan Republic
    • Ufa, Bashkortostan Republic, Russia, 450054
      • Bashkirian Republican Clinical Oncology Dispensary
  • Krasnodarskiy Kray
    • Krasnoyarsk, Krasnodarskiy Kray, Russia, 660133
      • Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky
  • Moscow Oblast
    • Moscow, Moscow Oblast, Russia, 115478
      • FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 196006
      • Medical Clinic "AB Medical group"
    • Saint Petersburg, Sankt-Peterburg, Russia, 197758
      • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
    • Saint Petersburg, Sankt-Peterburg, Russia, 197022
      • EuroCityClinic
  • Tatarstan Republic
    • Kazan', Tatarstan Republic, Russia, 420029
      • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
• Singapore
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Institute of Oncology Ljubljana
  • Ljubljana, Slovenia, 1000
    • University Medical Center Ljubljana
  • Maribor, Slovenia, 2000
    • Univerzitetni klini?ni center Maribor
• Spain
  • Badajoz, Spain, 06080
    • Hospital Universitario Infanta Cristina
  • Barcelona, Spain, 08041
    • Hospital De La Santa Creu I Sant Pau
  • Barcelona, Spain, 08028
    • Hospital Universitari Dexeus - Grupo Quironsalud
  • Burgos, Spain, 09006
    • Complejo Asistencial Universitario de Burgos
  • Cáceres, Spain, 10003
    • Hospital San Pedro de Alcantara
  • Granada, Spain, 18006
    • Hospital Clinico de Granada
  • Jaén, Spain, 23007
    • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico
  • León, Spain, 24071
    • Complejo Asistencial Universitario de Leon
  • Lugo, Spain, 27003
    • Hospital Lucus Augusti
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28222
    • Hospital Universitario Puerta de Hierro
  • Madrid, Spain, 28223
    • Hospital Quiron de Madrid
  • Madrid, Spain, 28050
    • Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal
  • Ourense, Spain, 32005
    • Complejo Hospitalario de Orense
  • Segovia, Spain, 40002
    • Hospital General de Segovia
  • Seville, Spain, 41014
    • Hospital Univ. Nuestra Señora de Valme
  • Valladolid, Spain, 47005
    • Hospital Clinico Universitario de Valladolid
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
  • Almeria
    • Almería, Almeria, Spain, 04009
      • Complejo Hospitalario Torrecárdenas
  • Balearic Islands
    • Palma de Mallorca, Balearic Islands, Spain, 07014
      • Hospital Universitario Son Espases
  • Barcelona
    • Mataró, Barcelona, Spain, 08304
      • Hospital General de Mataro
    • Sabadell, Barcelona, Spain, 08208
      • Corporacio Sanitaria Parc Tauli
  • LA Coruna
    • Santiago de Compostela, LA Coruna, Spain, 15706
      • Complejo Hospitalario Universitario de Santiago (CHUS)
  • Madrid
    • San Sebastián de los Reyes, Madrid, Spain, 28702
      • Hospital Infanta Sofía
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Complejo Hospitalario de Navarra
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universitaria De Navarra
  • Tenerife
    • San Cristóbal de La Laguna, Tenerife, Spain, 38320
      • Hospital Universitario de Canarias
    • Santa Cruz de Tenerife, Tenerife, Spain, 38010
      • Complejo Hospitalario Nuestra Señora de la Candelaria
• United Arab Emirates
  • Al Ain City, United Arab Emirates, 15258
    • Tawam Hospital
• United Kingdom
  • Barnet, United Kingdom, EN5 3DJ
    • Barnet Hospital
  • Bath, United Kingdom, BA1 3NG
    • Royal United Hospital
  • Bebington, United Kingdom, CH63 4JY
    • Clatterbridge Cancer Centre
  • Birmingham, United Kingdom, B15 2TH
    • Queen Elizabeth Hospital
  • Birmingham, United Kingdom, B9 5SS
    • Heartlands Hospital
  • 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
  • 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
  • Keighley, United Kingdom, BD20 6TD
    • Airedale General Hospital
  • Kingston upon Thames, United Kingdom, KT2 7QB
    • Royal Marsden Hospital
  • Leeds, United Kingdom, LS9 7TF
    • St James Hospital
  • London, United Kingdom, SE1 9RT
    • Guys and St Thomas Hospital
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital
  • London, United Kingdom, SW17 0QT
    • St George's Hospital
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital
  • London, United Kingdom, EC1A 7BE
    • St Bartholomew's Hospital
  • London, United Kingdom, W12 OHS
    • Hammersmith Hospital
  • London, United Kingdom, SE18 4QH
    • Queen Elizabeth Hospital
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital - Fulham
  • Maidstone, United Kingdom, ME16 0FS
    • Maidstone Hospital
  • 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
  • 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
  • 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: 14 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): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

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