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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03782207
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment
Urothelial Carcinoma Non-Small Cell Lung Cancer Small Cell Lung Cancer Drug: Atezolizumab

Detailed Description:
The study will be split into separate cohorts based on the approved indications for atezolizumab treatment, excluding cisplatin ineligible patients 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.

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Study Type : Observational
Estimated Enrollment : 2400 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : February 7, 2019
Estimated Primary Completion Date : June 2, 2025
Estimated Study Completion Date : June 2, 2025


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

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

Cohort 4 (ES-SCLC LOT1)
Participants diagnosed with extensive stage (ES) small cell lung cancer (SCLC) not previously treated.
Drug: Atezolizumab
Atezolizumab will be administered at the discretion of the treating physician per local guidelines and independently of participation in this study.
Other Name: Tecentriq




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Index date up to approximately 5 years ]
    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.

  2. OS at 2 Years [ Time Frame: After index date up to 2 years ]
    Percentage of participants alive 2 years after initiation of atezolizumab treatment.


Secondary Outcome Measures :
  1. Time to Loss of Clinical Benefit (TTLCB) [ Time Frame: Index date up to approximately 5 years ]
    Time from the index date to loss of clinical benefit as assessed by the treating physician.

  2. Progression Free Survival (PFS) [ Time Frame: Index date up to approximately 5 years ]
    Time from index date to death or disease progression (PD).

  3. Objective Response Rate (ORR) [ Time Frame: After index date up to approximately 5 years ]
    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.

  4. Time to Response [ Time Frame: Index date up to approximately 5 years ]
    Time from index date to first objective tumor response, CR or PR.

  5. Duration of Response (DoR) [ Time Frame: Index date up to approximately 5 years ]
    Time from first documentation of CR or PR (whichever occurs first) after index until death or PD.

  6. Disease Control Rate (DCR) [ Time Frame: From 12 weeks after index date up to approximately 5 years ]
    Percentage of participants who have achieved CR, PR and stable disease at least 12 weeks after the index date.

  7. Duration of DCR [ Time Frame: After index date up to approximately 5 years ]
    Time from first documentation of CR, PR or stable disease (whichever occurs first) after index until death or PD.

  8. EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Score [ Time Frame: Index date or after ICF signature, and approx. at 6, 12, and 24 weeks of treatment; and at the first visit after atezolizumab discontinuation, then at 3 months, 6 months and every 12 months thereafter until end of study (study planned duration 5 years) ]
    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).

  9. WPAI-GH Score [ Time Frame: Index date or after ICF signature, and approx. at 6, 12, and 24 weeks of treatment; and at the first visit after atezolizumab discontinuation, then at 3 months, 6 months and every 12 months thereafter until end of study (study planned duration 5 years) ]
    Work Productivity and Activity Impairment Questionnaire General Health V2.0 (WPAI-GH) during and after atezolizumab treatment will be used to assess the ability to work. The WPAI-GH is a standardized questionnaire used to measure the impact of health on work performance. From the WPAI-GH, absenteeism (the percentage of work time missed), presenteeism (the percentage of time when working that productivity is impaired), overall work impairment (a combination of absenteeism and presenteeism), and total activity impairment (the percentage of impairment in daily activities) can be measured.

  10. Number of Paricipants with Disease Stage TNM and IUCC [ Time Frame: At index date (Index date is the date of administration of the first ever dose of atezolizumab for each patient.) ]
  11. Number of Participants at Each Level of Karnofsky or ECOG Performance Status [ Time Frame: At index date (Index date is the date of administration of the first ever dose of atezolizumab for each patient. ]
  12. Total Number of Infusions of Atezolizuamb [ Time Frame: Treatment period until discontinuation (up to approximately 5 years) ]
  13. Duration of Treatment With Atezolizumab [ Time Frame: Index date until date of treatment discontinuation (up to approximately 5 years) ]
  14. Time to initiation of subsequent cancer-related therapies [ Time Frame: Up to approximately 5 years ]
  15. Percentage of Participants with Adverse Events [ Time Frame: Up to approximately 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants diagnosed with la/mUC previously treated with platinum-containing chemotherapy, and participants diagnosed with la/m non-small cell lung cancer (NSCLC) after prior chemotherapy.
Criteria

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).
  • Patient is prescribed atezolizumab therapy for the first time.
  • Decision to prescribe 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 and TNBC 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 an access or compassionate use program.
  • Patients not receiving atezolizumab, but a biosimilar or non-original biologic.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782207


Contacts
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Contact: Reference Study ID Number: MO40653 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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Argentina
Inst. Alexander Fleming; Oncology Dept Not yet recruiting
Buenos Aires, Argentina, C1426ANZ
Consultorio Privado Korbenfeld Recruiting
Caba, Argentina, C1426AGE
Lucen S.A. Recruiting
Ciudad Autónoma de Buenos Aires, Argentina, C1405CUB
Sanatorio de la Mujer Not yet recruiting
Rosario, Argentina, S2000ORE
Sanatorio Parque; Oncology Not yet recruiting
Salta, Argentina, 4400
Fundacion Koriza Recruiting
Santa Rosa, Argentina, 6300
Austria
Klinikum Klagenfurt; Abteilung für Pulmologie Not yet recruiting
Klagenfurt, Austria, 9020
Landesklinikum Krems Recruiting
Krems, Austria, 3500
Salzkammergut-Klinikum Voecklabruck Recruiting
Vöcklabruck, Austria, 4840
Klinikum Wels-Grieskirchen; Lungenabt. Recruiting
Wels, Austria, 4600
Wilhelminenspital; Ii. Medizinische Abt. Not yet recruiting
Wien, Austria, 1160
Belgium
AZ KLINA Not yet recruiting
Brasschaat, Belgium, 2930
AZ Maria Middelares Withdrawn
Gent, Belgium, 9000
AZ St Maarten Campus Leopoldstr Not yet recruiting
Mechelen, Belgium, 2800
CHU UCL Mont-Godinne Recruiting
Mont-godinne, Belgium, 5530
AZ Damiaan Not yet recruiting
Oostende, Belgium, 8400
AZ Delta (Campus Wilgenstraat) Recruiting
Roeselare, Belgium, 8800
Sint Trudo Ziekenhuis Not yet recruiting
Sint-Truiden, Belgium, 3800
Bulgaria
Multiprofile Hospital for Active Treatment Uni Hospital; Department of medicinal oncology Recruiting
Panagyurishte, Bulgaria
Umhat Dr Georgi Stranski; Clinic of Chemotherapy Recruiting
Pleven, Bulgaria, 5800
University Hospital Palmed; Medical Oncology Ward Recruiting
Plovdiv, Bulgaria, 4001
Complex Oncological Center - Plovdiv, EOOD; Third Internal Department Recruiting
Plovdiv, Bulgaria, 4004
Complex Oncology Center - Plovdiv First Internal Chemotherapy Department Recruiting
Plovdiv, Bulgaria, 4004
Multi profiled Hospital for active treatment Park Hospital; Department of medicinal oncology Not yet recruiting
Plovdiv, Bulgaria
Complex Oncological Center-Ruse EOOD; Department of Medical Oncology Recruiting
Ruse, Bulgaria, 7000
UMHAT "Sv. Ivan Rilski", EAD Recruiting
Sofia, Bulgaria, 1431
MBAL Serdika EOOD Recruiting
Sofia, Bulgaria, 1632
MHAT SofiaMed; OOD Recruiting
Sofia, Bulgaria
Colombia
Clinica del Country Not yet recruiting
Bogota, Colombia, 11001
France
Clinique Du Docteur Calabet; Cromg Recruiting
Agen, France, 47000
Ch Du Pays D Aix; Pneumologie Recruiting
Aix En Provence, France, 13616
Clinique de l'Europe Recruiting
Amiens, France, 80090
Centre Hospitalier Uni Ire; Pneumology Recruiting
Angers, France, 49933
Hopital Prive D Antony; Oncologie Recruiting
Antony, France, 92166
CHG Henri Dufaut médecine interne-onco-hematologie Recruiting
Avignon, France, 84902
CH de Beauvais Recruiting
Beauvais, France, 60000
Hopital Jean Minjoz; Pneumologie Recruiting
Besancon, France, 25030
Ch De Beziers; Pneumologie Recruiting
Beziers, France, 34525
Clinique Tivoli; Chimiotherapie Radiotherapie Recruiting
Bordeaux, France, 33030
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie Recruiting
Bordeaux, France, 33077
Hopital Cote De Nacre; Pneumologie Recruiting
Caen, France, 14000
Ch De Chambery; Pneumologie Recruiting
Chambery, France, 73011
Oncologie 37; Bureau Recruiting
Chambray Les Tours, France, 37170
Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne Recruiting
Clermont-ferrand, France, 63003
Hopital Gabriel Montpied; Service de Pneumologie Recruiting
Clermont-ferrand, France, 63003
Ch De Compiegne; Pneumologie Recruiting
Compiegne, France, 60321
Ch Laennec; Pneumologie Recruiting
Creil, France, 60109
Centre Georges Francois Leclerc; Oncologie 3 Recruiting
Dijon, France, 21079
Hopital Simone Veil Eaubonne; Hopital De Jour Recruiting
Eaubonne, France, 95602
Chi Alpes Du Sud Site De Gap; Pneumologie Recruiting
GAP, France, 05007
Hopital Nord Ouest;Unite 2c Recruiting
Gleize, France, 69400
Ch Saint Louis; Pneumologie Recruiting
La Rochelle, France, 17019
Hopital La Source; Pneumologie Recruiting
La Source, France, 45100
Hopital Louis Pasteur; Oncologie Hematologie Recruiting
Le Coudray, France, 28630
Hopital Louis Pasteur; Pneumologie Recruiting
Le Coudray, France, 28630
Centre Hospitalier Du Mans; Maladies Respiratoires Recruiting
Le Mans, France, 72000
Hôpital Privé La Louviere; Pneumologie Recruiting
Lille, France, 59042
Hopital Dupuytren; Pneumologie Recruiting
Limoges, France, 87042
Ch Bretagne Sud Site Scorff; Oncologie Medicale Recruiting
Lorient, France, 56100
Hopital Privé Jean Mermoz; Pneumologie Recruiting
Lyon, France, 69008
Hopital Europeen Recruiting
Marseille, France, 13003
Clinique Clementville; Hopital De Jour Recruiting
Montpellier, France, 34070
Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie Recruiting
Montpellier, France, 34298
Hopital Emile Muller;Pneumologie Recruiting
Mulhouse, France, 68070
Hopital Caremeau; Pneumologie Recruiting
Nimes, France, 30029
Polyclinique Kenval ; Radiotherapie Oncologie Recruiting
Nimes, France, 30900
Institut Curie Recruiting
Paris, France, 75005
Hopital Cochin; Unite Fonctionnelle D Oncologie Not yet recruiting
Paris, France, 75014
Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale Recruiting
Paris, France, 75908
Centre Hospitalier; Pneumologie Recruiting
PAU, France, 64046
Centre Catalan D' Oncologie Recruiting
Perpignan, France, 66000
Chu La Miletrie; Pneumologie Withdrawn
Poitiers, France, 86021
CH ANNECY - GENEVOIS; Pneumologie Recruiting
Pringy, France, 74374
Hopital De La Maison Blanche;Maladies Respiratoires Recruiting
Reims, France, 51092
Clinique Mutualiste L Estuaire; Oncologie Recruiting
Saint Nazaire, France, 44606
Hopital Nord; Service de Pneumologie Recruiting
Saint Priest En Jarez, France, 42770
HOPITAL ROBERT PAX; Pneumologie Recruiting
Sarreguemines, France
Ch De Saint Quentin; Medecine B14 Recruiting
St Quentin, France, 02321
Hopital Sainte Musse; Pneumologie Recruiting
Toulon, France, 83056
Hopital Larrey; Pneumologie Recruiting
Toulouse, France, 31059
Clinique Pasteur; Oncologie Medicale Recruiting
Toulouse, France, 31076
Centre Hospitalier de Valence; Pneumologie Recruiting
Valence, France, 26000
Service de pneumologie Clinique médico-chirurgicale Tessier Recruiting
Valenciennes Cedex, France, 59326
Ch Bretagne Atlantique; Pneumologie-Oncologie Recruiting
Vannes, France, 56017
Hopital Robert Schuman; Pneumologie Recruiting
Vantoux, France, 57070
Hungary
Semmelweis Egyetem, AOK, Pulmonologiai Klinika Not yet recruiting
Budapest, Hungary, 1083
Orszagos Koranyi TBC es Pulmonologiai Intezet Recruiting
Budapest, Hungary, 1121
Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika Recruiting
Debrecen, Hungary, 4032
University of Pecs; 1St Department of Medicine Recruiting
Pecs, Hungary, 7623
Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum Recruiting
Törökbálint, Hungary, 2045
Israel
Soroka Medical Center; Oncology Dept Not yet recruiting
Beer Sheva, Israel, 8410100
Rambam Medical Center; Oncology Not yet recruiting
Haifa, Israel, 3109601
Chaim Sheba Medical Center; Oncology Dept Not yet recruiting
Ramat Gan, Israel, 52620-00
Italy
Ist. Ricovero e Cura a Carattere Scientifico-Centro Rif. Oncologico della Basilica Recruiting
Rionero In Vulture (PZ), Basilicata, Italy, 85028
Grande Ospedale Metropolitano; Oncologia Medica Recruiting
Reggio Calabria, Calabria, Italy, 89133
Az. Osp. Monaldi; 1 Pneumologia Oncologica Recruiting
Napoli, Campania, Italy, 80131
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica Recruiting
Meldola, Emilia-Romagna, Italy, 47014
A.O. Universitaria Policlinico Di Modena; Oncologia Recruiting
Modena, Emilia-Romagna, Italy, 41100
Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1 Recruiting
Roma, Lazio, Italy, 00152
Ospedale Mater Salutis; Dept of Oncology Recruiting
Legnago, Lombardia, Italy, 37045
Ospedale Maggiore Policlinico; U.O.C. di Oncologia Medica Recruiting
Milano, Lombardia, Italy, 20122
Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica Recruiting
Milano, Lombardia, Italy, 20142
Ospedale Di Circolo E Fondazione Macchi; Oncologia Medica Recruiting
Varese, Lombardia, Italy, 21100
Presidio Ospedaliero Vito Fazzi; Unita Operativa Di Oncologia Medica Recruiting
Lecce, Puglia, Italy, 73044
Ospedale Oncologico A.Businco; Div. Oncologia Medica II Recruiting
Cagliari, Sardegna, Italy, 09121
Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica Recruiting
Catania, Sicilia, Italy, 95122
Casa di Cura La Maddalena; Oncologia Medica Recruiting
Palermo, Sicilia, Italy, 90146
Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia Recruiting
Firenze, Toscana, Italy, 50134
Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica Recruiting
Lido Di Camaiore, Toscana, Italy, 55043
Ospedale Di Bolzano; Dept. Di Oncologia Recruiting
Bolzano, Trentino-Alto Adige, Italy, 39100
Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza Recruiting
Vicenza, Veneto, Italy, 36100
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Public Institution Recruiting
Kaunas, Lithuania, 50009
National Cancer Institute; Department of Thoracic Surgery and Oncology Recruiting
Vilnius, Lithuania, LT-08660
Netherlands
Onze Lieve Vrouwe Gasthuis, locatie Oost Recruiting
Amsterdam, Netherlands, 1091 AC
Wilhelmina Ziekenhuis Assen Withdrawn
Assen, Netherlands, 9401 RK
Deventer ziekenhuis Recruiting
Deventer, Netherlands, 7416 SE
Catharina ziekenhuis Recruiting
Eindhoven, Netherlands, 5623 EJ
Medisch Centrum Leeuwarden Recruiting
Leeuwarden, Netherlands, 8934 AD
Maasstadziekenhuis Withdrawn
Rotterdam, Netherlands, 3079 DZ
Diakonessenhuis Recruiting
Utrecht, Netherlands, 3582 KE
Zaans Medisch Centrum Recruiting
Zaandam, Netherlands, 1502 DV
Philippines
San Juan de Dios Hospital;Oncology Unit Not yet recruiting
Pasay, Philippines, 1300
Poland
Centrum Pulmonologii i Torakochirurgii; Oddzial Pulmonologiczny z Pododdzialem Chemioterapii Not yet recruiting
Bystra, Poland, 43-360
Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii Recruiting
Gdansk, Poland, 80-219
Centrum Onkologii w Gliwicach; II Klinika Radioterapii i Chemioterapii Recruiting
Gliwice, Poland, 44-101
Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Onkologii Klinicznej Recruiting
Grudziądz, Poland, 86-300
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie Recruiting
Lublin, Poland, 20-954
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii Recruiting
Otwock, Poland, 05-400
SK Przemienienia Panskiego UM im.K.Marcinkowskiego Recruiting
Poznan, Poland, 60-569
Wojskowy Instytut Medyczny Recruiting
Warszawa, Poland, 04-141
Dolnoslaskie Centrum Onkologii; VII Onkologia Kliniczna Not yet recruiting
Wroclaw, Poland, 53-439
Portugal
Hospital Geral; Servico de Pneumologia Not yet recruiting
Coimbra, Portugal, 3041-801
Centro Clinico Champalimaud; Unidade de Pulmao Recruiting
Lisboa, Portugal, 1400-038
Hospital Pulido Valente; Servico de Pneumologia Not yet recruiting
Lisboa, Portugal, 1796-001
Hospital Pedro Hispano; Servico de Oncologia Recruiting
Matosinhos, Portugal, 4454-509
Centro Hospitalar do Porto - Hospital de Santo António; Oncologia Not yet recruiting
Porto, Portugal, 4099-001
Hospital CUF Porto; Servico Pneumologia Recruiting
Porto, Portugal, 4100-180
CHVNG/E_Unidade 1; Servico de Pneumologia Not yet recruiting
Vila Nova De Gaia, Portugal, 4434-502
Romania
County Hospital Alba; Oncology Not yet recruiting
Alba Iulia, Romania, 510073
Centrul Medical Focus; Oncologie medicala Not yet recruiting
Bucharest, Romania, 021389
University Clinical Emergency Hospital Bucharest Not yet recruiting
Bucharest, Romania
Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti Not yet recruiting
Bucuresti, Romania, 022328
Sanador Medical Center; Medical Oncology Withdrawn
Bucuresti, Romania
Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta Not yet recruiting
Constanta, Romania, 900591
Institutul Regional de Oncologie Iasi Not yet recruiting
Iasi, Romania, 700483
Spitalul Municipal Ploiesti Not yet recruiting
Ploiesti, Romania, 100337
Oncomed SRL; Oncologie Not yet recruiting
Timisoara, Romania, 300239
Oncocenter Timisoara Not yet recruiting
Timişoara, Romania, 300166
Slovenia
INSTITUTE OF ONCOLOGY LJUBLJANA; Lung Cancer Unit Recruiting
Ljubljana, Slovenia, 1000
Univerzitetni klinični center Maribor; Oddelek za onkologijo Recruiting
Maribor, Slovenia, 2000
Spain
Complejo Hospitalario Torrecardenas; Servicio de Oncologia Withdrawn
Almería, Almeria, Spain, 04009
Complejo Hospitalario Torrecardenas; Servicio de Oncologia Recruiting
Almería, Almeria, Spain, 04009
Hospital General de Mataro; Servicio de Oncologia Recruiting
Mataro, Barcelona, Spain, 08304
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia Recruiting
Sabadell, Barcelona, Spain, 08208
Hospital Universitario Son Espases; Servicio de Oncologia Recruiting
Palma De Mallorca, Islas Baleares, Spain, 07014
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia Recruiting
Santiago de Compostela, LA Coruña, Spain, 15706
Hospital Universitario Puerta de Hierro; Servicio de Oncologia Recruiting
Majadahonda, Madrid, Spain, 28222
Clinica Universitaria de Navarra; Servicio de Oncologia Recruiting
Pamplona, Navarra, Spain, 31008
Complejo Hospitalario de Navarra; Servicio de Oncologia Recruiting
Pamplona, Navarra, Spain, 31008
Hospital Universitario de Canarias;servicio de Oncologia Recruiting
La Laguna, Tenerife, Spain, 38320
Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia Recruiting
Santa Cruz de Tenerife, Tenerife, Spain, 38010
Hospital Universitario Infanta Cristina; Servicio de Oncologia Recruiting
Badajoz, Spain, 06080
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia Recruiting
Barcelona, Spain, 08041
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia Withdrawn
Barcelona, Spain, 08041
Complejo Asistencial Universitario De Burgos; Servicio de Oncologia Recruiting
Burgos, Spain, 09006
Hospital San Pedro De Alcantara; Servicio de Oncologia Recruiting
Caceres, Spain, 10003
Hospital Generla de Ciudad Real; Servicio de Oncologia Withdrawn
Ciudad Real, Spain, 13005
Hospital General Universitario de Guadalajara; Servicio de Oncologia Withdrawn
Guadalajara, Spain, 19002
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia Recruiting
Jaen, Spain, 23007
Hospital Lucus Augusti; Servicio de Oncologia Recruiting
Lugo, Spain, 27003
Hospital Universitario La Paz; Servicio de Oncologia Not yet recruiting
Madrid, Spain, 28046
Hospital Universitario La Paz; Servicio de Oncologia Recruiting
Madrid, Spain, 28046
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia Recruiting
Madrid, Spain, 28050
Hospital Quiron de Madrid; Servicio de Oncologia Recruiting
Madrid, Spain, 28223
Complejo Hospitalario de Orense; Servicio de Oncologia Recruiting
Orense, Spain, 32005
Hospital General de Segovia; Servicio de Oncologia Recruiting
Segovia, Spain, 40002
Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia Recruiting
Sevilla, Spain, 41014
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia Withdrawn
Toledo, Spain, 45004
Hospital Clinico Universitario de Valladolid; Servicio de Oncologia Recruiting
Valladolid, Spain, 47005
Hospital Universitario Miguel Servet; Servicio Oncologia Recruiting
Zaragoza, Spain, 50009
United Arab Emirates
NMC Speciality Hospital Not yet recruiting
Abu Dhabi, United Arab Emirates
Tawam Hospital Not yet recruiting
Al Ain, United Arab Emirates, 15258
United Kingdom
Barnet Hospital; ROYAL FREE LONDON NHS FOUNDATION TRUST Not yet recruiting
Barnet, United Kingdom, EN5 3DJ
Royal United Hospital; Oncology Department Recruiting
Bath, United Kingdom, BA1 3NG
Clatterbridge Cancer Centre Recruiting
Bebington, United Kingdom, CH63 4JY
Heartlands Hospital; Department Of Medicine Recruiting
Birmingham, United Kingdom, B9 5SS
East Lancashire Hospitals NHS Trust Recruiting
Burnley, United Kingdom, BB10 2PQ
Velindre Cancer Centre Recruiting
Cardiff, United Kingdom, CF14 2TL
Royal Surrey County Hospital Recruiting
Guildford, United Kingdom, GU2 7XX
Northwick Park Hospital Not yet recruiting
Harrow, United Kingdom, HA1 3UJ
Huddersfield Royal Infirmary; The Learning Centre Recruiting
Huddersfield, United Kingdom, HD3 3EA
Airedale General Hospital; Research Office Ward 12 Recruiting
Keighley, United Kingdom, BD20 6TD
Royal Marsden Hospital Recruiting
Kingston upon Thames, United Kingdom, KT2 7QB
St Bartholomew's Hospital Recruiting
London, United Kingdom, EC1A 7BE
Queen Elizabeth Hospital Recruiting
London, United Kingdom, SE18 4QH
St George's Hospital; Oncology Recruiting
London, United Kingdom, SW17 0QT
Royal Marsden Hospital - Fulham Recruiting
London, United Kingdom, SW3 6JJ
Charing Cross Hospital Recruiting
London, United Kingdom, W6 8RF
Maidstone Hospital; Kent Oncology Centre Recruiting
Maidstone, United Kingdom, ME16 0FS
Freeman Hospital Recruiting
Newcastle upon Tyne, United Kingdom, NE7 7DN
Nottingham City Hospital; Oncology Recruiting
Nottingham, United Kingdom, NG5 1PB
Churchill Hospital Recruiting
Oxford, United Kingdom, OX3 7LJ
Royal Preston Hospital Recruiting
Preston, United Kingdom, PR2 9HT
Scunthorpe General Hospital Recruiting
Scunthorpe, United Kingdom, DN15 7BH
Weston Park Hospital Not yet recruiting
Sheffield, United Kingdom, S10 2SJ
Royal Stoke University Hospital Recruiting
Stoke on Trent, United Kingdom, ST4 6QG
Royal Marsden Hospital (Sutton) Recruiting
Sutton, United Kingdom, SM2 5PT
Torbay Hospital; Oncology Department Recruiting
Torquay, United Kingdom, TQ27AA
Royal Cornwall Hospital Recruiting
Truro, United Kingdom, TR1 3LQ
Pinderfields General Hospital Recruiting
Wakefield, United Kingdom, WF1 4DG
Great Western Hospitals NHS Foundation Trust. Recruiting
Wiltshire, United Kingdom, SN3 6BB
New Cross Hospital Recruiting
Wolverhampton, United Kingdom, WV10 0QP
The York Hospital Recruiting
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03782207    
Other Study ID Numbers: MO40653
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Transitional Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs