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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03782207
Other study ID # MO40653
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 7, 2019
Est. completion date July 31, 2026

Study information

Verified date January 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 of routine clinical practice.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 3040
Est. completion date July 31, 2026
Est. primary completion date July 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Argentina Hospital Universitario Austral; Hepatología Buenos Aires
Argentina Consultorio Privado Korbenfeld Caba
Argentina Hospital Italiano de Buenos Aires; Hepatología Ciudad Autonoma Buenos Aires
Argentina Lucen S.A. Ciudad Autónoma de Buenos Aires
Argentina Sanatorio Allende Cordoba
Argentina Sanatorio de la Mujer Rosario
Argentina Fundacion Koriza Santa Rosa
Austria Klinikum Klagenfurt; Abteilung für Pulmologie Klagenfurt
Austria Landesklinikum Krems Krems
Austria Salzkammergut-Klinikum Voecklabruck Vöcklabruck
Austria Klinikum Wels-Grieskirchen; Lungenabt. Wels
Belgium AZ St Maarten Campus Leopoldstr Mechelen
Belgium CHU UCL Mont-Godinne Mont-godinne
Belgium AZ Damiaan Oostende
Belgium Sint Trudo Ziekenhuis Sint-Truiden
Brazil Beneficencia Portuguesa de Sao Paulo São Paulo SP
Bulgaria Complex Oncology Center Burgas; Department of medical oncology Burgas
Bulgaria Multiprofile Hospital for Active Treatment Uni Hospital; Department of medicinal oncology Panagyurishte
Bulgaria Umhat Dr Georgi Stranski; Clinic of Chemotherapy Pleven
Bulgaria Complex Oncological Center - Plovdiv, EOOD; Second Internal Department Plovdiv
Bulgaria Complex Oncological Center - Plovdiv, EOOD; Third Internal Department Plovdiv
Bulgaria Complex Oncology Center - Plovdiv First Internal Chemotherapy Department Plovdiv
Bulgaria University Hospital Palmed; Medical Oncology Ward Plovdiv
Bulgaria Complex Oncological Center-Ruse EOOD; Department of Medical Oncology Ruse
Bulgaria MBAL Serdika EOOD Sofia
Bulgaria MHAT SofiaMed; OOD Sofia
Bulgaria Tokuda Hospital; Medical Oncology Department Sofia
Bulgaria UMHAT "Sv. Ivan Rilski", EAD Sofia
Bulgaria Specialized Hospital for Active Cancer Treatment, Dr. Mark Antonov Markov - Varna Ltd Varna
Chile Centro de Estudios Clínicos SAGA Santiago
Colombia Angiografia del Occidente Cali
Colombia Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas Cali
Colombia Clinica ASTORGA Medellin
Colombia Hospital Pablo Tobon Uribe Medellin
Croatia Clinical Hospital Centre Osijek Osijek
Croatia Clinical Hospital Center Sestre Milosrdnice Zagreb
Croatia Clinical Hospital Center Sestre Milosrdnice; Clinic for tumors Zagreb
Croatia Clinical Hospital Centre Zagreb Zagreb
Egypt SUN Oncology center- Alexandria Alexandria
Egypt Air Force Specialized Hospital Cairo
Egypt Barsoum Oncology Center Cairo
Egypt Cairo Oncology Center Cairo
Egypt International Medical Center; Oncology Department Cairo
Egypt Yasser Abdel Kader Private Clinic Cairo
Estonia North Estonia Medical Centre Foundation; Oncology Centre Tallinn
Estonia Tartu Uni Hospital; Hematology - Oncology Clinic Tartu
France Ch Du Pays D Aix; Pneumologie Aix En Provence
France Hopital Prive D Antony; Oncologie Antony
France Hopital Jean Minjoz; Pneumologie Besancon
France Ch De Beziers; Pneumologie Beziers
France Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie Bordeaux
France Ch De Chambery; Pneumologie Chambery
France Hopital Gabriel Montpied; Service de Pneumologie Clermont-ferrand
France Hopital Simone Veil Eaubonne; Hopital De Jour Eaubonne
France Hopital Nord Ouest;Unite 2c Gleize
France Hopital Louis Pasteur; Oncologie Hematologie Le Coudray
France Centre Hospitalier Du Mans; Maladies Respiratoires Le Mans
France Hôpital Privé La Louviere; Pneumologie Lille
France Hopital Dupuytren; Pneumologie Limoges
France Ch Bretagne Sud Site Scorff; Oncologie Medicale Lorient
France Hopital Privé Jean Mermoz; Pneumologie Lyon
France Hopital Europeen Marseille
France Hopital Caremeau; Pneumologie Nimes
France Polyclinique Kenval ; Radiotherapie Oncologie Nimes
France Hopital Cochin; Unite Fonctionnelle D Oncologie Paris
France CH ANNECY - GENEVOIS; Pneumologie Pringy
France Hopital De La Maison Blanche;Maladies Respiratoires Reims
France Clinique Mutualiste L Estuaire; Oncologie Saint Nazaire
France Hopital Nord; Service de Pneumologie Saint Priest En Jarez
France HOPITAL ROBERT PAX; Pneumologie Sarreguemines
France Ch De Saint Quentin; Medecine B14 St Quentin
France Hopital Sainte Musse; Pneumologie Toulon
France Hopital Larrey; Pneumologie Toulouse
France Centre Hospitalier de Valence; Pneumologie Valence
France Service de pneumologie Clinique médico-chirurgicale Tessier Valenciennes Cedex
France Ch Bretagne Atlantique; Pneumologie-Oncologie Vannes
France Hopital Robert Schuman; Pneumologie Vantoux
Hungary Orszagos Koranyi TBC es Pulmonologiai Intezet Budapest
Hungary Semmelweis Egyetem, AOK, Pulmonologiai Klinika Budapest
Hungary Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika Debrecen
Hungary University of Pecs; 1St Department of Medicine Pecs
Hungary Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum Törökbálint
India HCG Cancer Center Ahmedabad Gujarat
India KD Hospital Ahmedabad Gujarat
India Manipal Hospital Bangalore Karnataka
India Postgraduate Institute of Medical Education and Research Chandigarh
India AIG Hospitals Gachibowli Telangana
India Aster Medcity Kochi Kerala
India MVR Cancer Centre and Research Institute Kozhikode Kerala
India Mumbai Oncocare Center; Medical Oncology Mumbai Maharashtra
India Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd) Surat CITY Gujarat
India Mahamana Pandit Madan Mohan Malaviya Cancer Centre-TMC Varanasi Uttar Pradesh
Italy Ospedale Civile SS. Antonio E Biagio DI Alessandria; Oncologia Alessandria Piemonte
Italy Ospedale Oncologico A.Businco; Div. Oncologia Medica II Cagliari Sardegna
Italy Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica Catania Sicilia
Italy Azienda Ospedaliero Universitaria Careggi; Medicina interna ed epatologia Firenze Toscana
Italy Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia Firenze Toscana
Italy IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A Genova Liguria
Italy Ospedale San Salvatore, UOC Oncologia L?Aquila Abruzzo
Italy Presidio Ospedaliero Vito Fazzi; Unita Operativa Di Oncologia Medica Lecce Puglia
Italy Ospedale Mater Salutis; Dept of Oncology Legnago Veneto
Italy Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica Lido Di Camaiore Toscana
Italy Ospedale Di Macerata; Oncologia Macerata Marche
Italy IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica Meldola Emilia-Romagna
Italy Az. Osp. Uni. Ria Policlinico G. Martino; Dept. Di Med. Interna E Terapia Medica - Ii Clinica Medica Messina Sicilia
Italy Asst Grande Ospedale Metropolitano Niguarda; Divisione Medicina Epatologia Padiglione Crespi Milano Lombardia
Italy Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica Milano Lombardia
Italy Ospedale Maggiore Policlinico; U.O.C. di Oncologia Medica Milano Lombardia
Italy A.O. Universitaria Policlinico Di Modena; Oncologia Modena Emilia-Romagna
Italy Az. Osp. Monaldi; 1 Pneumologia Oncologica Napoli Campania
Italy Istituto Nazionale Tumori Fondazione G. Pascale; U.O.C. Oncologia Medica Toraco Polmonare Napoli Campania
Italy Casa di Cura La Maddalena; Oncologia Medica Palermo Sicilia
Italy Grande Ospedale Metropolitano; Oncologia Medica Reggio Calabria Calabria
Italy Ist. Ricovero e Cura a Carattere Scientifico-Centro Rif. Oncologico della Basilica Rionero In Vulture (PZ) Basilicata
Italy Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1 Roma Lazio
Italy Azienda Ospedaliero Universitaria Di Sassari;Oncologia Sassari Sardegna
Italy Ospedale S.S. Trinità Nuovo; Divisione Oncologia Sora Lazio
Italy Ospedale Di Circolo E Fondazione Macchi; Oncologia Medica Varese Lombardia
Italy A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina Verona Veneto
Italy Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza Vicenza Veneto
Kuwait Kuwait Cancer control center Shuwakh Industrial
Lebanon Mount Lebanon Hospital Beirut
Lebanon Saint George Hospital; Haematology-Oncology Beirut
Lebanon Middle East Institute of Health Hospital Bsalim, Mount Lebanon-Metn
Lithuania Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution Kaunas
Lithuania National Cancer Institute; Department of Thoracic Surgery and Oncology Vilnius
Mexico Medica sur Hospital Mexico City Mexico CITY (federal District)
Mexico Clinica Opcion Oncologia S.A. de C.V. Monterrey Nuevo LEON
Mexico Oncare San Pedro Garza García Nuevo LEON
Netherlands Onze Lieve Vrouwe Gasthuis, locatie Oost Amsterdam
Netherlands Catharina ziekenhuis Eindhoven
Netherlands Zaans Medisch Centrum Zaandam
Oman Royal Hospital; Oncology Department Muscat
Oman Sultan Qaboos Comprehensive Cancer Care & Research Center Muscat
Pakistan Aga Khan University; Department of Oncology Karachi Sindh (province)
Pakistan Shaukat Khanum Memorial Cancer Hospital; Department of Oncology Lahore Punjab (province)
Philippines Chinese General Hospital and Medical Center Manila
Philippines San Juan de Dios Hospital;Oncology Unit Pasay
Philippines Lung Center of the Philippines Quezon City
Poland Wojewódzki Szpital Specjalistyczny im. M. Kopernika w ?odzi ?ód?
Poland Beskidzkie Centrum Onkologii - Szpital Miejski im. Jana Pawla II; Klinika Onkologii Bielsko-Bia?a
Poland Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Oddzia? Onkologii Klinicznej Odcinka A Bydgoszcz
Poland Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Oddzia? Onkologii Klinicznej Odcinka B Bydgoszcz
Poland Centrum Pulmonologii i Torakochirurgii; Oddzial Pulmonologiczny z Pododdzialem Chemioterapii Bystra
Poland Wojewodzki Szpital Zespolony; Oddzia? Onkologii Elblag
Poland Centrum Onkologii w Gliwicach; II Klinika Radioterapii i Chemioterapii Gliwice
Poland Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Onkologii Klinicznej Grudzi?dz
Poland Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie Lublin
Poland Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii Otwock
Poland Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii Pozna?
Poland Instytut Gruzlicy i Chorob P?uc Warszawa
Poland Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego; Klinika Onkologii Warszawa
Portugal Hospital Geral; Servico de Pneumologia Coimbra
Portugal Centro Clinico Champalimaud; Unidade de Pulmao Lisboa
Portugal Hospital Pulido Valente; Servico de Pneumologia Lisboa
Portugal Hospital Pedro Hispano; Servico de Oncologia Matosinhos
Portugal Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia Porto
Portugal Hospital CUF Porto; Servico Pneumologia Porto
Portugal CHVNG/E_Unidade 1; Servico de Pneumologia Vila Nova de Gaia
Romania County Hospital Alba; Oncology Alba Iulia
Romania Institutul Clinic Fundeni Bucuresti Bucharest
Romania Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. Octavian Fodor Cluj-Napoca
Romania Spitalul Municipal Ploiesti Ploiesti
Romania Oncomed SRL; Oncologie Timisoara
Russian Federation Arkhangelsk Regional Clinical Oncology Dispensary Arkhangelsk Arhangelsk
Russian Federation ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic Barnaul Altaj
Russian Federation SBIH Kaluga Region Clinical Oncology Dispensary Kaluga
Russian Federation Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic Kazan Tatarstan
Russian Federation Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy Krasnoyarsk Krasnodar
Russian Federation FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF Moscow Moskovskaja Oblast
Russian Federation S-Pb clinical scientific practical center of specialized kinds of medical care (oncological) Saint-Petersburg Sankt Petersburg
Russian Federation EuroCityClinic Sankt-peterburg Sankt Petersburg
Russian Federation Medical Clinic "AB Medical group" Sankt-peterburg Sankt Petersburg
Russian Federation Tver Regional Oncology Clinical Dispensary Tver
Russian Federation Bashkirian Republican Clinical Oncology Dispensary UFA Baskortostan
Serbia Clinical Center of Serbia Belgrade
Singapore National Cancer Centre; Medical Oncology Singapore
Singapore Tan Tock Seng Hospital; Oncology Singapore
Slovenia INSTITUTE OF ONCOLOGY LJUBLJANA; Lung Cancer Unit Ljubljana
Slovenia University Medical Center Ljubljana; Clinical Dept. of Gastroenterology Ljubljana
Slovenia Univerzitetni klini?ni center Maribor; Oddelek za onkologijo Maribor
Spain Complejo Hospitalario Torrecardenas; Servicio de Oncologia Almería Almeria
Spain Hospital Universitario Infanta Cristina; Servicio de Oncologia Badajoz
Spain Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia Barcelona
Spain Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica Barcelona
Spain Complejo Asistencial Universitario De Burgos; Servicio de Oncologia Burgos
Spain Hospital San Pedro De Alcantara; Servicio de Oncologia Caceres
Spain Hospital Clinico de Granada; Servicio de Oncologia Granada
Spain Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia Jaen
Spain Hospital Universitario de Canarias;servicio de Oncologia La Laguna Tenerife
Spain Complejo Asistencial Universitario de Leon; Servicio de Oncologia Leon
Spain Hospital Lucus Augusti; Servicio de Oncologia Lugo
Spain Fundacion Jimenez Diaz; Servicio de Oncologia Madrid
Spain HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia Madrid
Spain Hospital Universitario La Paz; Servicio de Oncologia Madrid
Spain Hospital Universitario Puerta de Hierro; Servicio de Oncologia Majadahonda Madrid
Spain Hospital General de Mataro; Servicio de Oncologia Mataro Barcelona
Spain Complejo Hospitalario de Orense; Servicio de Oncologia Orense
Spain Clinica Universitaria de Navarra; Servicio de Oncologia Pamplona Navarra
Spain Complejo Hospitalario de Navarra; Servicio de Oncologia Pamplona Navarra
Spain Hospital Quiron de Madrid; Servicio de Oncologia Pozuelo de Alarcon Madrid
Spain Corporacio Sanitaria Parc Tauli; Servicio de Oncologia Sabadell Barcelona
Spain Hospital Infanta Sofia; Servico de Oncologia San Sebastian de Los Reyes Madrid
Spain Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia Santa Cruz de Tenerife Tenerife
Spain Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia Santiago de Compostela LA Coruña
Spain Hospital General de Segovia; Servicio de Oncologia Segovia
Spain Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia Sevilla
Spain Hospital Clinico Universitario de Valladolid; Servicio de Oncologia Valladolid
Spain Hospital Universitario Miguel Servet; Servicio Oncologia Zaragoza
United Arab Emirates Tawam Hospital Al Ain
United Kingdom Barnet Hospital; ROYAL FREE LONDON NHS FOUNDATION TRUST Barnet
United Kingdom Royal United Hospital; Oncology Department Bath
United Kingdom Clatterbridge Cancer Centre Bebington
United Kingdom Heartlands Hospital; Department Of Medicine Birmingham
United Kingdom Queen Elizabeth Hospital Birmingham
United Kingdom East Lancashire Hospitals NHS Trust Burnley
United Kingdom Addenbrookes Hospital Cambridge
United Kingdom Velindre Cancer Centre Cardiff
United Kingdom Castle Hill Hospital; The Queens Centre for Oncology and Haematology Cottingham
United Kingdom Royal Surrey County Hospital Guildford
United Kingdom Northwick Park Hospital Harrow
United Kingdom Huddersfield Royal Infirmary; The Learning Centre Huddersfield
United Kingdom Airedale General Hospital; Research Office Ward 12 Keighley
United Kingdom Royal Marsden Hospital Kingston upon Thames
United Kingdom St James Hospital; Dept of Oncology/Hematology Leeds
United Kingdom Charing Cross Hospital London
United Kingdom Guys and St Thomas Hospital London
United Kingdom Hammersmith Hospital; Dept of Oncology London
United Kingdom Queen Elizabeth Hospital London
United Kingdom Royal Free Hospital; Dept of Oncology London
United Kingdom Royal Marsden Hospital - Fulham London
United Kingdom St Bartholomew's Hospital London
United Kingdom St George's Hospital; Oncology London
United Kingdom Maidstone Hospital; Kent Oncology Centre Maidstone
United Kingdom The Christie Manchester
United Kingdom James Cook Hospital Middlesbrough
United Kingdom Freeman Hospital Newcastle upon Tyne
United Kingdom Nottingham City Hospital; Oncology Nottingham
United Kingdom Churchill Hospital Oxford
United Kingdom Royal Preston Hospital Preston
United Kingdom Weston Park Hospital Sheffield
United Kingdom Royal Stoke University Hospital Stoke-on-Trent
United Kingdom Royal Marsden Hospital (Sutton) Sutton
United Kingdom Torbay Hospital; Oncology Department Torquay
United Kingdom Royal Cornwall Hospital Truro
United Kingdom Pinderfields General Hospital Wakefield
United Kingdom Great Western Hospitals NHS Foundation Trust. Wiltshire
United Kingdom New Cross Hospital Wolverhampton
United Kingdom The York Hospital York

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Austria,  Belgium,  Brazil,  Bulgaria,  Chile,  Colombia,  Croatia,  Egypt,  Estonia,  France,  Hungary,  India,  Italy,  Kuwait,  Lebanon,  Lithuania,  Mexico,  Netherlands,  Oman,  Pakistan,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovenia,  Spain,  United Arab Emirates,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary OS at 2 Years Percentage of participants alive 2 years after initiation of atezolizumab treatment. After index date up to 2 years
Secondary 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
Secondary Progression Free Survival (PFS) Time from index date to death or disease progression (PD). Index date up to approximately 6 years
Secondary 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
Secondary Time to Response Time from index date to first objective tumor response, CR or PR. Index date up to approximately 6 years
Secondary 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
Secondary 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
Secondary 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
Secondary 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)
Secondary 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.)
Secondary 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.
Secondary Total Number of Infusions of Atezolizuamb Treatment period until discontinuation (up to approximately 6 years)
Secondary Duration of Treatment With Atezolizumab Index date until date of treatment discontinuation (up to approximately 6 years)
Secondary Time to initiation of the first subsequent cancer-related therapy Up to approximately 6 years
Secondary Percentage of Participants with Adverse Events Up to approximately 6 years
Secondary Number of Lines of Prior and Subsequent Cancer-Related Therapies Up to approximately 6 years
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