AzTrials
AzTrials

Urothelial CarcinomaIMrealNCT03782207

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

An observational study of Urothelial Carcinoma and Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 257 sites in 30 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab
How many people
2,756 participants
Where
257 sitesin 30 countries
Study dates
7 Feb 2019to 31 Jul 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

257 sites in 30 countries.

257 sites in 30 countries

France52 sites

  • Clinique Du Docteur Calabet

    Agen, 47000

  • Ch Du Pays D Aix

    Aix-en-Provence, 13616

  • Clinique de l'Europe

    Amiens, 80090

  • Centre Hospitalier Uni Ire

    Angers, 49933

  • Hopital Prive D Antony

    Antony, 92166

  • CHG Henri Dufaut médecine interne-onco-hematologie

    Avignon, 84902

  • CH de Beauvais

    Beauvais, 60000

  • Hopital Jean Minjoz

    Besançon, 25030

  • Ch De Beziers

    Béziers, 34525

  • Clinique Tivoli

    Bordeaux, 33030

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33077

  • Hopital Cote De Nacre

    Caen, 14033

  • Ch De Chambery

    Chambéry, 73011

  • Oncologie 37

    Chambray-lès-Tours, 37170

  • Hopital Gabriel Montpied

    Clermont-Ferrand, 63003

  • Ch De Compiegne

    Compiègne, 60321

  • Ch Laennec

    Creil, 60109

  • Centre Georges Francois Leclerc

    Dijon, 21079

  • Hopital Simone Veil Eaubonne

    Eaubonne, 95602

  • Chi Alpes Du Sud Site De Gap

    Gap, 05007

  • Hopital Nord Ouest

    Gleizé, 69400

  • Ch Saint Louis

    La Rochelle, 17019

  • Hopital La Source

    La Source, 45100

  • Hopital Louis Pasteur

    Le Coudray, 28630

  • Centre Hospitalier Du Mans

    Le Mans, 72037

  • Hôpital Privé La Louviere

    Lille, 59042

  • Hopital Dupuytren

    Limoges, 87042

  • Ch Bretagne Sud Site Scorff

    Lorient, 56100

  • Hopital Privé Jean Mermoz

    Lyon, 69008

  • Hopital Europeen

    Marseille, 13003

  • Clinique Clementville

    Montpellier, 34070

  • Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque

    Montpellier, 34298

  • Hopital Emile Muller

    Mulhouse, 68070

  • Hopital Caremeau

    Nîmes, 30029

  • Polyclinique Kenval

    Nîmes, 30900

  • Institut Curie

    Paris, 75005

  • Hopital Cochin

    Paris, 75014

  • Hopital Europeen Georges Pompidou

    Paris, 75908

  • Centre Hospitalier

    Pau, 64046

  • Centre Catalan D' Oncologie

    Perpignan, 66000

  • Ch Annecy - Genevois

    Pringy, 74374

  • Hopital De La Maison Blanche

    Reims, 51092

  • Clinique Mutualiste L Estuaire

    Saint-Nazaire, 44606

  • Hopital Nord

    Saint-Priest-en-Jarez, 42770

  • Ch De Saint Quentin

    Saint-Quentin, 02321

  • Hopital Robert Pax

    Sarreguemines, DUMMY_VALUE

  • Hopital Sainte Musse

    Toulon, 83056

  • Hopital Larrey

    Toulouse, 31059

  • Centre Hospitalier de Valence

    Valence, 26000

  • Service de pneumologie Clinique médico-chirurgicale Tessier

    Valenciennes, 59326

  • Ch Bretagne Atlantique

    Vannes, 56017

  • Hopital Robert Schuman

    Vantoux, 57070

Other trials in France

United Kingdom39 sites

  • Barnet Hospital

    Barnet, EN5 3DJ

  • Royal United Hospital

    Bath, BA1 3NG

  • Clatterbridge Cancer Centre

    Bebington, CH63 4JY

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Heartlands Hospital

    Birmingham, B9 5SS

  • East Lancashire Hospitals NHS Trust

    Burnley, BB10 2PQ

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

  • Castle Hill Hospital

    Cottingham, HU16 5JG

  • Royal Surrey County Hospital

    Guildford, GU2 7XX

  • Northwick Park Hospital

    Harrow, HA1 3UJ

  • Huddersfield Royal Infirmary

    Huddersfield, HD3 3EA

  • Airedale General Hospital

    Keighley, BD20 6TD

  • Royal Marsden Hospital

    Kingston upon Thames, KT2 7QB

  • St James Hospital

    Leeds, LS9 7TF

  • St Bartholomew's Hospital

    London, EC1A 7BE

  • Royal Free Hospital

    London, NW3 2QG

  • Guys and St Thomas Hospital

    London, SE1 9RT

  • Queen Elizabeth Hospital

    London, SE18 4QH

  • St George's Hospital

    London, SW17 0QT

  • Royal Marsden Hospital - Fulham

    London, SW3 6JJ

  • Hammersmith Hospital

    London, W12 OHS

  • Charing Cross Hospital

    London, W6 8RF

  • Maidstone Hospital

    Maidstone, ME16 0FS

  • The Christie

    Manchester, M20 4BX

  • James Cook Hospital

    Middlesbrough, TS4 3BW

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Churchill Hospital

    Oxford, OX3 7LJ

  • Royal Preston Hospital

    Preston, PR2 9HT

  • Weston Park Hospital

    Sheffield, S10 2SJ

  • Royal Stoke University Hospital

    Stoke-on-Trent, ST4 6QG

  • Royal Marsden Hospital (Sutton)

    Sutton, SM2 5PT

  • Torbay Hospital

    Torquay, TQ27AA

  • Royal Cornwall Hospital

    Truro, TR1 3LQ

  • Pinderfields General Hospital

    Wakefield, WF1 4DG

  • Great Western Hospitals NHS Foundation Trust.

    Wiltshire, SN3 6BB

  • New Cross Hospital

    Wolverhampton, WV10 0QP

  • The York Hospital

    York, YO31 8HE

Other trials in United Kingdom

Spain28 sites

  • Complejo Hospitalario Torrecardenas

    Almería, Almeria, 04009

  • Hospital Universitario Infanta Cristina

    Badajoz, 06080

  • Hospital Universitari Dexeus - Grupo Quironsalud

    Barcelona, 08028

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Complejo Asistencial Universitario De Burgos

    Burgos, 09006

  • Hospital San Pedro De Alcantara

    Cáceres, 10003

  • Hospital Clinico de Granada

    Granada, 18006

  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico

    Jaén, 23007

  • Complejo Asistencial Universitario de Leon

    León, 24071

  • Hospital Lucus Augusti

    Lugo, 27003

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro

    Madrid, 28222

  • Hospital Quiron de Madrid

    Madrid, 28223

  • Hospital General de Mataro

    Mataró, Barcelona, 08304

  • Complejo Hospitalario de Orense

    Ourense, 32005

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07014

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320

  • Hospital Infanta Sofia

    San Sebastián de los Reyes, Madrid, 28702

  • Complejo Hospitalario Nuestra Señora de la Candelaria

    Santa Cruz de Tenerife, Tenerife, 38010

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    Santiago de Compostela, LA Coruna, 15706

  • Hospital General de Segovia

    Segovia, 40002

  • Hospital Univ. Nuestra Señora de Valme

    Seville, 41014

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47005

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Italy23 sites

  • Ospedale Civile SS. Antonio E Biagio DI Alessandria

    Alessandria, Piedmont, 15100

  • Ospedale Oncologico A.Businco

    Cagliari, Sardinia, 09121

  • Az Ospedaliera Nuovo Garibaldi Quartiere Nesima

    Catania, Sicily, 95122

  • Azienda Ospedaliero Universitaria Careggi

    Florence, Tuscany, 50134

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, Tuscany, 50134

  • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST)

    Genoa, Liguria, 16132

  • Ospedale San Salvatore, UOC Oncologia

    L’Aquila, Abruzzo, 67100

  • Ospedale Nuovo Della Versilia

    Lido di Camaiore, Tuscany, 55043

  • Az. Osp. Uni. Ria Policlinico G. Martino

    Messina, Sicily, 98124

  • Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122

  • Asst Santi Paolo E Carlo

    Milan, Lombardy, 20142

  • Asst Grande Ospedale Metropolitano Niguarda

    Milan, Lombardy, 20162

  • A.O. Universitaria Policlinico Di Modena

    Modena, Emilia-Romagna, 41100

  • Az. Osp. Monaldi

    Naples, Campania, 80131

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, Campania, 80131

  • Ospedale Di Macerata

    Province of Macerata, The Marches, 62100

  • Grande Ospedale Metropolitano

    Reggio Calabria, Calabria, 89133

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, Lazio, 00152

  • Azienda Ospedaliero Universitaria Di Sassari

    Sassari, Sardinia, 07100

  • Ospedale S.S. Trinità Nuovo

    Sora, Lazio, 03039

  • Ospedale Di Circolo E Fondazione Macchi

    Varese, Lombardy, 21100

  • A.O.U. Integrata Verona - Policlinico G.B. Rossi

    Verona, Veneto, 37134

  • Azienda ULSS 8 Berica

    Vicenza, Veneto, 36100

Other trials in Italy

Poland14 sites

  • WZZOZ Centrum Leczenia Chorob Pluc i Rehabilitacji

    ?ód?, 91-520

  • Wojewódzki Szpital Specjalistyczny im. M. Kopernika w ?odzi

    ?ód?, 93-513

  • Beskidzkie Centrum Onkologii - Szpital Miejski im. Jana Pawla II

    Bielsko-Bia?a, 43-300

  • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka

    Bydgoszcz, 85-796

  • Centrum Pulmonologii i Torakochirurgii

    Bystra, 43-360

  • Wojewodzki Szpital Zespolony

    Elblag, 82-300

  • Regionalny Szpital Specjalistyczny im. W. Bieganskiego

    Grudzi?dz, 86-300

  • Uniwersytecki Szpital Kliniczny nr 4 w Lublinie

    Lublin, 20-954

  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

    Olsztyn, 10-357

  • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy

    Otwock, 05-400

  • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu

    Późna, 60-569

  • Instytut Gruzlicy i Chorob P?uc

    Warsaw, 01-138

  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

    Warsaw, 02-091

  • Dolno?L?Skie Centrum Onkologii, Pulmonologii I Hematologii

    Wroc?aw, 53-439

Other trials in Poland

Bulgaria13 sites

  • Complex Oncology Center Burgas

    Burgas, DUMMY_VALUE

  • Multiprofile Hospital for Active Treatment Uni Hospital

    Panagyurishte, 4500

  • Umhat Dr Georgi Stranski

    Pleven, 5800

  • University Hospital Palmed

    Plovdiv, 4001

  • Complex Oncological Center - Plovdiv, EOOD

    Plovdiv, 4004

  • Complex Oncology Center - Plovdiv First Internal Chemotherapy Department

    Plovdiv, 4004

  • DDODIU-Plovdiv, EOOD

    Plovdiv, 4004

  • Complex Oncological Center-Ruse EOOD

    Rousse, 7000

  • Tokuda Hospital

    Sofia, 1407

  • UMHAT "Sv. Ivan Rilski", EAD

    Sofia, 1431

  • MBAL Serdika EOOD

    Sofia, 1632

  • MHAT SofiaMed

    Sofia, 1797

  • Specialized Hospital for Active Cancer Treatment, Dr. Mark Antonov Markov - Varna Ltd

    Varna, 9010

Other trials in Bulgaria

Russia11 sites

  • Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk, Arhangelsk, 163045

  • Altai Regional Oncological Center

    Barnaul, Altayskiy Kray, 656049

  • SBIH Kaluga Region Clinical Oncology Dispensary

    Kaluga, 248007

  • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

    Kazan', Tatarstan Republic, 420029

  • Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky

    Krasnoyarsk, Krasnodarskiy Kray, 660133

  • FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

    Moscow, Moscow Oblast, 115478

  • Medical Clinic "AB Medical group"

    Saint Petersburg, Sankt-Peterburg, 196006

  • EuroCityClinic

    Saint Petersburg, Sankt-Peterburg, 197022

  • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

    Saint Petersburg, Sankt-Peterburg, 197758

  • Tver Regional Oncology Clinical Dispensary

    Tver', 170008

  • Bashkirian Republican Clinical Oncology Dispensary

    Ufa, Bashkortostan Republic, 450054

Other trials in Russia

Argentina7 sites

  • Hospital Universitario Austral

    Buenos Aires, 16290

  • Lucen S.A.

    Buenos Aires, C1405CUB

  • Consultorio Privado Korbenfeld

    CABA, C1426AGE

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma Buenos Aires, C1199ABB

  • Sanatorio Allende

    Córdoba, X5000JHQ

  • Sanatorio de la Mujer

    Rosario, S2000ORE

  • Fundacion Koriza

    Santa Rosa, 6300

Other trials in Argentina

India7 sites

  • HCG Cancer Center

    Ahmedabad, Gujarat, 380060

  • Manipal Hospital

    Bangalore, Karnataka, 560017

  • AIG Hospitals

    Gachibowli, Telangana, 500032

  • Aster Medcity

    Kochi, Kerala, 682027

  • MVR Cancer Centre and Research Institute

    Kozhikode, Kerala, 673601

  • MOC Cancer Care & Research Centre

    Mumbai, Maharashtra, 400056

  • Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd)

    Surat, Gujarat, 395007

Other trials in India

Portugal7 sites

  • Hospital Geral

    Coimbra, 3041-801

  • Centro Clinico Champalimaud

    Lisbon, 1400-038

  • Hospital Pulido Valente

    Lisbon, 1796-001

  • Hospital Pedro Hispano

    Matosinhos Municipality, 4454-509

  • Centro Hospitalar do Porto ? Hospital de Santo António

    Porto, 4099-001

  • Hospital CUF Porto

    Porto, 4100-180

  • CHVNG/E_Unidade 1

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Belgium6 sites

  • AZ KLINA

    Brasschaat, 2930

  • AZ St Maarten Campus Leopoldstr

    Mechelen, 2800

  • CHU UCL Mont-Godinne

    Mont-godinne, 5530

  • AZ Oostende

    Ostend, 8400

  • AZ Delta (Campus Rumbeke)

    Roeselare, 8800

  • Sint Trudo Ziekenhuis

    Sint-Truiden, 3800

Other trials in Belgium

Egypt6 sites

  • SUN Oncology center- Alexandria

    Alexandria, DUMMY_VALUE

  • Yasser Abdel Kader Private Clinic

    Cairo, 11391

  • Air Force Specialized Hospital

    Cairo, DUMMY_VALUE

  • Barsoum Oncology Center

    Cairo, DUMMY_VALUE

  • Cairo Oncology Center

    Cairo, DUMMY_VALUE

  • International Medical Center

    Cairo, DUMMY_VALUE

Other trials in Egypt

Hungary5 sites

  • Orszagos Koranyi TBC es Pulmonologiai Intezet

    Budapest, 1121

  • Semmelweis Egyetem, AOK, Pulmonologiai Klinika

    Budapest, 1125

  • Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

    Debrecen, 4032

  • University of Pecs

    Pécs, 7623

  • Református Pulmonológiai Centrum

    Törökbálint, 2045

Other trials in Hungary

Austria4 sites

  • Klinikum Klagenfurt

    Klagenfurt, 9020

  • Landesklinikum Krems

    Krems, 3500

  • Salzkammergut-Klinikum Voecklabruck

    Vöcklabruck, 4840

  • Klinikum Wels-Grieskirchen

    Wels, 4600

Other trials in Austria

Colombia4 sites

  • Angiografia del Occidente

    Cali, 760045

  • Fundacion Clinica Valle del Lili

    Cali, DUMMY_VALUE

  • Hospital Pablo Tobon Uribe

    Medellín, 050034

  • Clinica ASTORGA

    Medellín, 50010

Other trials in Colombia

Croatia4 sites

  • Clinical Hospital Centre Osijek

    Osijek, 31000

  • Klinicki Bolnicki Centar Split

    Split, 21000

  • Clinical Hospital Center Sestre Milosrdnice

    Zagreb, 10000

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000

Other trials in Croatia

Netherlands4 sites

  • Onze Lieve Vrouwe Gasthuis, locatie Oost

    Amsterdam, 1091 AC

  • Catharina ziekenhuis

    Eindhoven, 5623 EJ

  • Frisius MC Leeuwarden

    Leeuwarden, 8934 AD

  • Zaans Medisch Centrum

    Zaandam, 1502 DV

Other trials in Netherlands

Slovenia3 sites

  • Institute of Oncology Ljubljana

    Ljubljana, 1000

  • University Medical Center Ljubljana

    Ljubljana, 1000

  • Univerzitetni klini?ni center Maribor

    Maribor, 2000

Other trials in Slovenia

Estonia2 sites

  • North Estonia Medical Centre Foundation

    Tallinn, 13419

  • Tartu Uni Hospital

    Tartu, 51014

Other trials in Estonia

Kuwait2 sites

  • Kuwait Cancer control center

    Kuwait City, DUMMY_VALUE

  • Kuwait Cancer control center

    Shuwakh Industrial, 70653

Other trials in Kuwait

Lebanon2 sites

  • Saint George Hospital

    Beirut, 166378

  • Middle East Institute of Health Hospital

    Bsalim, Mount Lebanon-Metn, 2624 0000

Other trials in Lebanon

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution

    Kaunas, 50009

  • National Cancer Institute

    Vilnius, LT-08660

Other trials in Lithuania

Mexico2 sites

  • Medica sur Hospital

    Mexico City, Mexico CITY (federal District), 14050

  • Clinica Opcion Oncologia S.A. de C.V.

    Monterrey, Nuevo León, 64000

Other trials in Mexico

Oman2 sites

  • Royal Hospital

    Muscat, 111

  • Sultan Qaboos Comprehensive Cancer Care & Research Center

    Muscat, DUMMY_VALUE

Other trials in Oman

Pakistan2 sites

  • Aga Khan University

    Karachi, Sindh, 74800

  • Shaukat Khanum Memorial Cancer Hospital

    Lahore, Punjab Province, 54000

Other trials in Pakistan

Romania2 sites

  • Institutul Clinic Fundeni Bucuresti

    Bucharest, 022328

  • Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. Octavian Fodor

    Cluj-Napoca, 400162

Other trials in Romania

Brazil1 site

  • Beneficencia Portuguesa de Sao Paulo

    São Paulo, São Paulo, 01323-900

Other trials in Brazil

Chile1 site

  • Centro de Estudios Clínicos SAGA

    Santiago, DUMMY_VALUE

Other trials in Chile

Singapore1 site

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

United Arab Emirates1 site

  • Tawam Hospital

    Al Ain City, 15258

Other trials in United Arab Emirates

About this study

Official title: 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.

Read the 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.

Being tested
Atezolizumab
Medical subject headings
Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab will be administered at the discretion of the treating physician per local guidelines and independently of participation in this study.

Study groups in NCT03782207
Study groupRoleWhat they receive
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.
Receives: Drug: Atezolizumab
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.
Receives: Drug: Atezolizumab
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.
Receives: Drug: Atezolizumab
Cohort 4 (ES-SCLC LOT1)Participants diagnosed with extensive stage (ES) small cell lung cancer (SCLC) not previously treated. Enrollment is closed.
Receives: Drug: Atezolizumab
Cohort 5 (NSCLC LOT1)Participants diagnosed with metastatic Non-Small Cell Lung cancer with high PD-L1 expression, previously untreated.
Receives: Drug: Atezolizumab
Cohort 6 (HCC LOT1)Participants diagnosed with unresectable locally advanced or metastatic hepatocellular carcinoma previously untreated with systemic therapy.
Receives: Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Index date up to approximately 6 years

  2. OS at 2 Years

    Percentage of participants alive 2 years after initiation of atezolizumab treatment.

    Measured: After index date up to 2 years

Secondary outcomes (15)

  1. Time to Loss of Clinical Benefit (TTLCB)

    Time from the index date to loss of clinical benefit as assessed by the treating physician.

    Measured: Index date up to approximately 6 years

  2. Progression Free Survival (PFS)

    Time from index date to death or disease progression (PD).

    Measured: Index date up to approximately 6 years

  3. 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.

    Measured: After index date up to approximately 6 years

  4. Time to Response

    Time from index date to first objective tumor response, CR or PR.

    Measured: Index date up to approximately 6 years

  5. Duration of Response (DoR)

    Time from first documentation of CR or PR (whichever occurs first) after index until death or PD.

    Measured: Index date up to approximately 6 years

  6. Disease Control Rate (DCR)

    Percentage of participants who have achieved CR, PR and stable disease at least 12 weeks after the index date.

    Measured: From 12 weeks after index date up to approximately 6 years

  7. Duration of DCR

    Time from first documentation of CR, PR or stable disease (whichever occurs first) after index until death or PD.

    Measured: After index date up to approximately 6 years

  8. 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).

    Measured: 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)

  9. Number of Paricipants with Disease Stage TNM and IUCC

    Measured: At index date (Index date is the date of administration of the first ever dose of atezolizumab for each patient.)

  10. Number of Participants at Each Level of Karnofsky or ECOG Performance Status

    Measured: At index date (Index date is the date of administration of the first ever dose of atezolizumab for each patient.

  11. Total Number of Infusions of Atezolizuamb

    Measured: Treatment period until discontinuation (up to approximately 6 years)

  12. Duration of Treatment With Atezolizumab

    Measured: Index date until date of treatment discontinuation (up to approximately 6 years)

  13. Time to initiation of the first subsequent cancer-related therapy

    Measured: Up to approximately 6 years

  14. Percentage of Participants with Adverse Events

    Measured: Up to approximately 6 years

  15. Number of Lines of Prior and Subsequent Cancer-Related Therapies

    Measured: Up to approximately 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2018
  2. Study start7 Feb 2019
  3. Primary completion31 Jul 2026
  4. Study completion31 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,756 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03782207
Sponsor's protocol ID
MO40653
Acronym
IMreal
Status last verified
Aug 2026
First submitted
28 Nov 2018
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Urothelial Carcinoma and Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 257 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 257 sites in France, United Kingdom, Spain, Italy, Poland and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Index date up to approximately 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03782207.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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