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Trial record 6 of 8 for:    Atezolizumab Lung | Recruiting Studies | Germany

A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]

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ClinicalTrials.gov Identifier: NCT02409342
Recruitment Status : Recruiting
First Posted : April 6, 2015
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.

Condition or disease Intervention/treatment Phase
Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody Drug: Carboplatin Drug: Cisplatin Drug: Gemcitabine Drug: Pemetrexed Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 555 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Open Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With a Platinum Agent (Cisplatin or Carboplatin) in Combination With Either Pemetrexed or Gemcitabine for PD-L1-Selected, Chemotherapy-Naive Patients With Stage IV Non-Squamous Or Squamous Non-Small Cell Lung Cancer
Actual Study Start Date : July 20, 2015
Estimated Primary Completion Date : January 17, 2019
Estimated Study Completion Date : April 23, 2020


Arm Intervention/treatment
Active Comparator: (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
Drug: Carboplatin
Carboplatin will be administered as intravenous infusion at a dose of area under the concentration-time curve (AUC) 6 when given in combination with pemetrexed or at a dose of AUC 5 when given in combination with gemcitabine, every 21 days for 4 or 6 cycles as per local standard of care.

Drug: Cisplatin
Cisplatin will be administered as intravenous infusion at a dose of 75 mg per meter squared (mg/m^2) every 21 days for 4 or 6 cycles as per local standard of care.

Drug: Gemcitabine
Gemcitabine will be administered as intravenous infusion at a dose of 1250 mg/m^2 (in combination with cisplatin) or 1000 mg/m^2 (in combination with carboplatin), on Days 1 and 8 of each 21-day cycle for 4 or 6 cycles as per local standard of care.

Drug: Pemetrexed
Pemetrexed will be administered as intravenous infusion at a dose of 500 mg/m^2 on Day 1 of each 21-day cycle as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).

Experimental: Atezolizumab
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Atezolizumab 1200 milligram (mg) will be administered as intravenous infusion every 21 days until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Other Name: MPDL3280A, RO5541267




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From randomization to death from any cause (maximum up to approximately 58 months) ]

Secondary Outcome Measures :
  1. Progression-free Survival (PFS) Time as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of the Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression (maximum up to approximately 58 months) ]
  2. Percentage of Participants With Objective Response (ORR) as Determined by the Investigator Using RECIST v1.1 [ Time Frame: Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of the Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression (maximum up to approximately 58 months) ]
  3. Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 [ Time Frame: Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of the Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression (maximum up to approximately 58 months) ]
  4. Percentage of Participants Who are Alive at 1 and 2 Years [ Time Frame: 1 and 2 Years ]
  5. Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Score as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score [ Time Frame: Baseline up to approximately 58 months ]
  6. Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score [ Time Frame: Baseline up to approximately 58 months ]
  7. TTD as Assessed Using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (EORTC QLQ-C30) [ Time Frame: Baseline up to approximately 58 months ]
  8. TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) [ Time Frame: Baseline up to approximately 58 months ]

Other Outcome Measures:
  1. Minimum Observed Serum Concentration (Cmin) of Atezolizumab [ Time Frame: Prior to infusion (0 hour) on Day 1 of Cycles 2, 3, 4, 8, 16, and every eighth cycle thereafter, at treatment discontinuation, and at 120 days after the last dose of atezolizumab (maximum up to approximately 58 months) (cycle duration = 21 days) ]
  2. Maximum Observed Serum Concentration (Cmax) of Atezolizumab [ Time Frame: 0 hour (predose) and 30 minutes after atezolizumab infusion on Day 1 (infusion duration = up to 1 hour) ]
  3. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 90 days after the last dose of study treatment (maximum up to approximately 58 months) ]
  4. Percentage of Participants With Anti-therapeutic Antibodies (ATAs) [ Time Frame: Day 1 of Cycles 1, 2, 3, 4, 8, 16, and every eighth cycle thereafter, at treatment discontinuation, and at 120 to 150 days after the last dose of atezolizumab (maximum up to approximately 58 months) (cycle duration = 21 days) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC
  • No prior treatment for Stage IV non-squamous or squamous NSCLC. Participant known to have a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene are excluded from the study
  • Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
  • Adequate hematologic and end-organ function

Exclusion Criteria:

  • Known sensitizing mutation in the EGFR gene or ALK fusion oncogene
  • Active or untreated central nervous system (CNS) metastases as determined by Computed Tomography (CT) or magnetic resonance imaging (MRI) evaluation
  • Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
  • Pregnant or lactating women
  • History of autoimmune disease
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Positive test for Human Immunodeficiency Virus (HIV)
  • Active hepatitis B or hepatitis C
  • Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti PD1, and anti-PD-L1 therapeutic antibody
  • Severe infection within 4 weeks prior to randomization
  • Significant history of cardiovascular disease

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): NCT02409342


Contacts
Contact: Reference Study ID Number: GO29431 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

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Locations
United States, California
City of Hope Terminated
Duarte, California, United States, 91010
University of California San Diego Active, not recruiting
La Jolla, California, United States, 92093
Va Greater Los Angeles Healthcare System Terminated
Sepulveda, California, United States, 91343
United States, Connecticut
Yale Cancer Center Active, not recruiting
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Georgetown University Medical Center; New Research Building Active, not recruiting
Washington, District of Columbia, United States, 20057
United States, Florida
Lynn Cancer Institute - West Active, not recruiting
Boca Raton, Florida, United States, 33428
Mount Sinai Medical Center Terminated
Miami Beach, Florida, United States, 33140
United States, Hawaii
Straub Clinic and Hospital Terminated
Honolulu, Hawaii, United States, 96813
United States, Illinois
Ingalls Memorial Hospital Terminated
Harvey, Illinois, United States, 60426
United States, Maryland
University of Maryland Greenebaum Cancer Center Active, not recruiting
Baltimore, Maryland, United States, 21201
Bay Hematology Oncology Terminated
Easton, Maryland, United States, 21601
United States, New York
Beth Israel Cancer Center Terminated
New York, New York, United States, 10011
SUNY Upstate Medical University Terminated
Syracuse, New York, United States, 13210
United States, Oregon
Oregon Health & Science Uni Active, not recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Terminated
Hershey, Pennsylvania, United States, 17033
United States, Tennessee
Wellmont Cancer Institute Terminated
Bristol, Tennessee, United States, 37620
Sarah Cannon Cancer Center Active, not recruiting
Germantown, Tennessee, United States, 38138
Vanderbilt University Medical Center; Multiple Sclerosis Center Completed
Nashville, Tennessee, United States, 37204
United States, Virginia
Hematology Oncology Associates of Fredericksburg, Inc. Active, not recruiting
Fredericksburg, Virginia, United States, 22408
United States, Washington
VA Puget Sound Health Care Sys Active, not recruiting
Seattle, Washington, United States, 98108
United States, West Virginia
West Virginia University Hospital Terminated
Morgantown, West Virginia, United States, 26506
Brazil
Oncovida Active, not recruiting
Salvador, BA, Brazil, 41820-021
Sociedade beneficente de senhoras Hospital Sirio Libanes Active, not recruiting
Brasilia, DF, Brazil, 70200-730
Centro de Pesquisas Clinicas em Oncologia - CPCO Active, not recruiting
Cachoeiro de Itapemirim, ES, Brazil, 29308-014
Santa Casa de Misericordia; de Belo Horizonte Active, not recruiting
Belo Horizonte, MG, Brazil, 30150-221
Instituto Nacional de Cancer - INCa; Oncologia Active, not recruiting
Rio de Janeiro, RJ, Brazil, 20560-120
Associacao Hospital de Caridade Ijui; Departamento De Oncologia Active, not recruiting
Ijui, RS, Brazil, 98700-000
Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia Active, not recruiting
Passo Fundo, RS, Brazil, 99010-260
Irmandade Da Santa Casa de Misericordia de Porto Alegre; Nucleo de Novos Tratamentos em Cancer Active, not recruiting
Porto Alegre, RS, Brazil, 90050-170
Hospital Sao Lucas - PUCRS; Pesquisa Clinica Active, not recruiting
Porto Alegre, RS, Brazil, 90110-270
Hospital Ernesto Dornelles Active, not recruiting
Porto Alegre, RS, Brazil, 90160-092
CliniOnco - Clinica de Oncologia de Porto Alegre; Departamento de Pesquisa Active, not recruiting
Porto Alegre, RS, Brazil, 90430-090
Instituto Joinvilense de Hematologia E Oncologia Active, not recruiting
Joinville, SC, Brazil, 89201-260
Fundacao PIO XII Active, not recruiting
Barretos, SP, Brazil, 14784-400
Hospital Santa Marcelina Active, not recruiting
Sao Paulo, SP, Brazil, 08270-070
Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira Active, not recruiting
São Paulo, SP, Brazil, 01246 000
China
Beijing Hospital Recruiting
Beijing City, China, 100006
West China Hospital, Sichuan University Not yet recruiting
Chengdu, China, 610041
The Second Affiliated Hospital of Dalian Medical University Not yet recruiting
Dalian, China, 116027
The First Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, China, 510080
Harbin Medical University Tumor Hospital Recruiting
Harbin City, China, 150081
The First Affiliated Hospital of Anhui Medical University Recruiting
Hefei, China, 230022
Affiliated Drum Tower Hospital of Nanjing University Medical School; Nanjing Shi Not yet recruiting
Jiangsu Sheng, China, 210008
Qilu Hospital Not yet recruiting
Jinan City, China, 250012
Shanghai Pulmonary Hospital Recruiting
Shanghai, China, 200433
Union Hospital Tongji Medical College Huazhong University of Science and Technology Active, not recruiting
Wuhan City, China, 430023
Henan Cancer Hospital Not yet recruiting
Zhengzhou, China, 450008
Czechia
Multiscan s.r.o. Withdrawn
Pardubice, Czechia, 532 03
France
CHU Angers Active, not recruiting
Angers, France, 49933
Hospital d Instructions des Armees Percy Active, not recruiting
Clamart, France, 92141
Hôpital Universitaire Dupuytren Active, not recruiting
Limoges, France, 87042
Clinique Clémentville Active, not recruiting
Montpellier, France, 34070
Centre D'oncologie de Gentilly Active, not recruiting
Nancy, France, 54100
Hopital Tenon Active, not recruiting
Paris, France, 75020
CHU de Bordeaux Not yet recruiting
Pessac, France, 33600
Centre Hospitalier Regional La Reunion Site Felix Guyon Active, not recruiting
Saint Denis Cedex, France, 97405
Hopital d'Instruction des Armees de Begin Active, not recruiting
Saint-Mande, France, 94160
Centre Hospitalier Regional Sud Reunion Active, not recruiting
Saint-pierre, France, 97448
Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll Active, not recruiting
St Brieuc, France, 22027
Centre Paul Strauss Active, not recruiting
Strasbourg, France, 67085
Hopitaux Universitaires de Strasbourg Active, not recruiting
Strasbourg, France, 67091
Germany
Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie Active, not recruiting
Gauting, Germany, 82131
Pius-Hospital Active, not recruiting
Oldenburg, Germany, 26121
Greece
Sotiria Chest Hospital of Athens Active, not recruiting
Athens, Greece, 11527
Attikon University General Hospital Active, not recruiting
Athens, Greece, 12464
IASO General Hospital of Athens Active, not recruiting
Athens, Greece, 155 62
Metropolitan Hospital Active, not recruiting
Athens, Greece, 18547
University General Hospital of Larissa Active, not recruiting
Larissa, Greece, 41 110
University General Hospital of Patras Active, not recruiting
Patras, Greece, 265 00
Thermi Clinic Completed
Thermi, Thessaloniki, Greece, 57001
Bioclinic Thessaloniki Active, not recruiting
Thessaloniki, Greece, 546 22
EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department Active, not recruiting
Thessaloniki, Greece, 54645
Papageorgiou General Hospital of Thessaloniki Active, not recruiting
Thessaloniki, Greece, 564 29
Georgios Papanikolaou General Hosp. of Thessaloniki Active, not recruiting
Thessaloniki, Greece, 57010
Hungary
Uzsoki Utcai Korhaz Active, not recruiting
Budapest, Hungary, 1145
Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz Active, not recruiting
Nyiregyhaza, Hungary, 4400
Pecsi Tudomanyegyetem Active, not recruiting
Pecs, Hungary, 7624
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont Active, not recruiting
Szolnok, Hungary, 5004
Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica Active, not recruiting
Meldola, Emilia-Romagna, Italy, 47014
Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia Active, not recruiting
Rimini, Emilia-Romagna, Italy, 47900
Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B Active, not recruiting
Aviano, Friuli-Venezia Giulia, Italy, 33081
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica Active, not recruiting
Roma, Lazio, Italy, 00128
ASL 3 Genovese Active, not recruiting
Genova, Liguria, Italy, 16125
Asst Papa Giovanni XXIII Active, not recruiting
Bergamo, Lombardia, Italy, 24100
Azienda Ospedaliera Istituti Ospitalieri Active, not recruiting
Cremona, Lombardia, Italy, 26100
Ospedale San Raffaele S.r.l. Active, not recruiting
Milano, Lombardia, Italy, 20132
Istituto Europeo Di Oncologia Active, not recruiting
Milano, Lombardia, Italy, 20141
Azienda Socio Sanitaria Territoriale - ASST di Monza Active, not recruiting
Monza, Lombardia, Italy, 20052
Istituto Nazionale dei Tumori Active, not recruiting
Monza, Lombardia, Italy, 20052
Istituto Clinico Humanitas Active, not recruiting
Rozzano (MI), Lombardia, Italy, 20089
A.O.U. Maggiore della Carità Active, not recruiting
Novara, Piemonte, Italy, 28100
Azienda Ospedaliera Città della Salute e della Scienza di Torino Active, not recruiting
Torino, Piemonte, Italy, 10126
Azienda Ospedaliero-Universitaria "PoliclinicoVittorio Emanuele"- P.O. G. Rodolico; Oncologia Medica Active, not recruiting
Catania, Sicilia, Italy, 95123
Istituto Oncologico Veneto IRCCS Active, not recruiting
Padova, Veneto, Italy, 35128
Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia Active, not recruiting
Verona, Veneto, Italy, 37126
Japan
Aichi Cancer Center Hospital; Respiratory Medicine Active, not recruiting
Aichi, Japan, 464-8681
Nagoya University Hospital; Respiratory Medicine Recruiting
Aichi, Japan, 466-8560
Kyushu University Hospital; Respiratory Active, not recruiting
Fukuoka, Japan, 812-8582
Hokkaido University Hospital Completed
Hokkaido, Japan, 060-8648
Kobe City Medical Center General Hospital; Respiratory Medicine Active, not recruiting
Hyogo, Japan, 650-0047
Hyogo Cancer Center; Thoracic Oncology Active, not recruiting
Hyogo, Japan, 673-8553
Ibaraki Prefectural Central Hospital; Division of respiratory Active, not recruiting
Ibaraki, Japan, 309-1793
Sendai Kousei Hospital; Pulmonary Medicine Active, not recruiting
Miyagi, Japan, 980-0873
Okayama University Hospital; Respiratory and Allergy Medicine Recruiting
Okayama, Japan, 700-8558
Osaka International Cancer Institute; Thoracic Oncology Active, not recruiting
Osaka, Japan, 541-8567
Kansai Medical university Hospital; Thoracic Oncology Active, not recruiting
Osaka, Japan, 573-1191
Osaka Habikino Medical Center Active, not recruiting
Osaka, Japan, 583-8588
Saitama Cancer Center; Thoracic Oncology Active, not recruiting
Saitama, Japan, 362-0806
National Hospital Organization Kinki-Chuo Chest Medical Center Active, not recruiting
Sakai-shi, Japan, 591-8555
National Cancer Center Hospital; Thoracic Medical Oncology Active, not recruiting
Tokyo, Japan, 104-0045
Tokyo Medical University Hospital; Dept of Surgery Recruiting
Tokyo, Japan, 160-0023
Korea, Republic of
Seoul National University Bundang Hospital Active, not recruiting
Gyeonggi-do, Korea, Republic of, 13620
Chonnam National University Hwasun Hospital Active, not recruiting
Jeollanam-do, Korea, Republic of, 58128
Kangbuk Samsung Hospital Active, not recruiting
Seoul, Korea, Republic of, 03181
Asan Medical Center - PPDS Recruiting
Seoul, Korea, Republic of, 138736
The Catholic University of Korea St. Vincent's Hospital Terminated
Suwon-si,, Korea, Republic of, 442-723
Poland
Uniwersyteckie Centrum Kliniczne Active, not recruiting
Gdansk, Poland, 80-214
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie Active, not recruiting
Olsztyn, Poland, 10-357
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy Active, not recruiting
Otwock, Poland, 05-400
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu Active, not recruiting
Poznan, Poland, 60-569
Med.-Polonia Sp. z o.o. NSZOZ Active, not recruiting
Poznan, Poland, 60-693
Romania
County Hospital Alba; Oncology Terminated
Alba Iulia, Romania, 510073
Teo Health SA - Saint Constantin Hospital Active, not recruiting
Brasov, Romania, 500091
Prof. Dr. I. Chiricuta Institute of Oncology Active, not recruiting
Cluj Napoca, Romania, 400015
Oncology Center Sf. Nectarie Active, not recruiting
Craiova, Romania, 200347
Institutul Regional de Oncologie Iasi; Clinica de Hematologie Recruiting
Iasi, Romania, 700483
Sibiu Emergency Clinical County Hospital Active, not recruiting
Sibiu, Romania, 550245
Oncomed SRL Recruiting
Timisoara, Romania, 300239
Oncocenter Clinical Oncology Recruiting
Timişoara, Romania, 300210
Russian Federation
Federal State Institution Medical Radiology Research Center Recruiting
Obninsk, Kaluga, Russian Federation, 249036
Moscow City Oncology Hospital #62 Active, not recruiting
Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
Principal Military Clinical Hospital n.a. N.N. Burdenko Active, not recruiting
Moscow, Moskovskaja Oblast, Russian Federation, 105229
Saint Petersburg Clinical Hospital of the Russian Academy of Sciences Active, not recruiting
St. Petersburg, Sankt Petersburg, Russian Federation, 194017
Arkhangelsk Regional Clinical Oncology Dispensary Active, not recruiting
Arkhangelsk, Russian Federation, 163045
Ivanovo Regional Oncology Dispensary Active, not recruiting
Ivanovo, Russian Federation, 153040
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic Active, not recruiting
Kazan, Russian Federation, 420029
Kursk Regional Oncology Centre Active, not recruiting
Kursk, Russian Federation, 305524
Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod Terminated
Nizhny Novgorod, Russian Federation, 603081
Regional Clinical Oncology Center Active, not recruiting
Ryazan, Russian Federation, 390046
City Clinical Oncology Dispensary Terminated
Saint-Petersburg, Russian Federation, 197022
Mordovia State University Active, not recruiting
Saransk, Russian Federation, 430032
Leningrad Regional Clinical Hospital Active, not recruiting
St Petersburg, Russian Federation, 194291
St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research Active, not recruiting
St Petersburg, Russian Federation, 197089
Volgograd Regional Clinical Oncology Dispensary Active, not recruiting
Volgograd, Russian Federation, 400138
Serbia
Clinical Center of Serbia Active, not recruiting
Belgrade, Serbia, 11000
Clinical Hospital Center Bezanijska kosa; Clinic for Oncology Active, not recruiting
Belgrade, Serbia, 11000
Institute for Oncology and Radiology of Serbia; Medical Oncology Active, not recruiting
Belgrade, Serbia, 11000
Clinical Center Kragujevac Active, not recruiting
Kragujevac, Serbia, 34000
Institute of Lung Diseases Vojvodina Active, not recruiting
Sremska Kamenica, Serbia, 21204
Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia Active, not recruiting
Badalona, Barcelona, Spain, 08916
Hospital Universitario Marques de Valdecilla Active, not recruiting
Santander, Cantabria, Spain, 39008
Consorcio Hospitalario Provincial de Castellon Active, not recruiting
Castellon de la Plana, Castellon, Spain, 12002
Hospital Universitario Son Espases Active, not recruiting
Palma de Mallorca, Islas Baleares, Spain, 07010
Hospital Son Llatzer Active, not recruiting
Palma de Mallorca, Islas Baleares, Spain, 07198
Hospital Universitario A Coruña Active, not recruiting
Coruna, LA Coruña, Spain, 15006
Hospital Universitario de Canarias Active, not recruiting
S. Cristobal De La Laguna, Tenerife, Spain, 38320
Hospital Universitario Cruces Active, not recruiting
Barakaldo, Vizcaya, Spain, 48903
Hospital Universitario Basurto Active, not recruiting
Bilbao, Vizcaya, Spain, 48013
Hospital del Mar Active, not recruiting
Barcelona, Spain, 08003
Hospital Universitario Vall d'Hebron - PPDS Active, not recruiting
Barcelona, Spain, 08035
Hospital Universitario Reina Sofia Active, not recruiting
Cordoba, Spain, 14004
Hospital General Universitario de Guadalajara Active, not recruiting
Guadalajara, Spain, 19002
Complejo Hospitalario de Jaen Active, not recruiting
Jaen, Spain, 23007
Hospital Universitario La Paz Active, not recruiting
Madrid, Spain, 280146
Hospital Clinico San Carlos; Servicio de Oncologia Active, not recruiting
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre Active, not recruiting
Madrid, Spain, 28041
Hospital Universitario Virgen Macarena Active, not recruiting
Sevilla, Spain, 41009
Hospital Clinico Universitario de Valencia Active, not recruiting
Valencia, Spain, 46010
Hospital Universitari i Politecnic La Fe de Valencia Active, not recruiting
Valencia, Spain, 46026
Hosp Clinico Univ Lozano Blesa; División De Oncología Médica Active, not recruiting
Zaragoza, Spain, 50009
Hospital Universitario Miguel Servet Active, not recruiting
Zaragoza, Spain, 50009
Thailand
Prince of Songkla University; Department Of Internal Medicine, Faculty Of Medicine Active, not recruiting
Hat Yai, Thailand, 90110
Khon Kaen University Active, not recruiting
Khon Kaen, Thailand, 40002
Chiang Rai Prachanukroh Hospital Active, not recruiting
Muang, Thailand, 57000
Buddhachinnaraj Hospital Completed
Phitsanulok, Thailand, 65000
Turkey
Cukurova University Medical Faculty Balcali Hospital Active, not recruiting
Adana, Turkey, 1330
Hacettepe Universitesi Tip Fakultesi Hastanesi; Ic Hastaliklari Anabiim Dali Active, not recruiting
Ankara, Turkey, 06100
Istanbul University Cerrahpasa Medical Faculty Active, not recruiting
Istanbul, Turkey, 34000
Ege Universitesi Tip Fakultesi Hastanesi Recruiting
Izmir, Turkey, 35100
Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi Active, not recruiting
Izmir, Turkey, 35110
Inonu University Faculty of Medicine Turgut Ozal Medical Center Active, not recruiting
Malatya, Turkey, 44280
Ukraine
MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council Active, not recruiting
Dnipropetrovsk, Katerynoslav Governorate, Ukraine, 49102
Municipal Noncommercial Institution Regional Center of Oncology Active, not recruiting
Kharkiv, Kharkiv Governorate, Ukraine, 61070
Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2 Active, not recruiting
Ivano-Frankivsk, KIEV Governorate, Ukraine, 76018
Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway Active, not recruiting
Kyiv, KIEV Governorate, Ukraine, 02096
Municipal Institution Odesa Regional Oncology Dispensary Active, not recruiting
Odesa, KIEV Governorate, Ukraine, 65055
Municipal Institution Podilskiy Regional Center of Oncology; Department of Chemotherapy Active, not recruiting
Vinnytsia, Podolia Governorate, Ukraine, 21029
Transcarpathian Regional Clinical Oncology Dispensary Active, not recruiting
Uzhgorod, Tavria Okruha, Ukraine, 88014
Private Enterprise Private Manufacturing Company Acinus Active, not recruiting
Kirovograd, Ukraine, 25006
Treatment and Prevention Institution Volyn Regional Oncology Dispensary Active, not recruiting
Lutsk, Ukraine, 43018
Lviv State Oncology Regional Treatment and Diagnostic Centre Active, not recruiting
Lviv, Ukraine, 79031
Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary Active, not recruiting
Sumy, Ukraine, 40005
United Kingdom
Belfast City Hospital Terminated
Belfast, United Kingdom, BT9 7AB
Birmingham Heartlands Hospital Active, not recruiting
Birmingham, United Kingdom, B9 5SS
Colchester General Hospital Active, not recruiting
Colchester, Essex, United Kingdom, CO4 5JL
Diana Princess of Wales Hosp. Recruiting
Grimsby, United Kingdom, DN33 2BA
Barts Health NHS Trust Not yet recruiting
London, United Kingdom, E1 2ES
Sarah Cannon Research Institute Terminated
London, United Kingdom, W1G 6AD
Christie Hospital Active, not recruiting
Manchester, United Kingdom, M20 3BG
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02409342     History of Changes
Other Study ID Numbers: GO29431
2014-003083-21 ( EudraCT Number )
First Posted: April 6, 2015    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Atezolizumab
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Cisplatin
Carboplatin
Pemetrexed
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors