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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 : Active, not recruiting
First Posted : April 6, 2015
Last Update Posted : January 9, 2019
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)
Actual Enrollment : 572 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: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (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: From the first occurrence of a complete response (CR) or partial response (PR), whichever occurs first, until the first date that progressive disease or death is documented, whichever occurs first (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 ]
  9. OS in Participants with PD-L1 Expression [ Time Frame: From randomization to death from any cause (maximum up to approximately 58 months) ]
  10. Investigator-Assessed PFS in Participants with PD-L1 Expression According to RECIST v1.1 [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 58 months) ]
  11. OS in Participants with Blood Tumor Mutational Burden (bTMB) [ Time Frame: From randomization to death from any cause (maximum up to approximately 58 months) ]
  12. Investigator-Assessed PFS in Participants with bTMB According to RECIST v1.1 [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (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


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Locations
United States, California
City of Hope
Duarte, California, United States, 91010
University of California San Diego
La Jolla, California, United States, 92093
Va Greater Los Angeles Healthcare System
Sepulveda, California, United States, 91343
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Georgetown University Medical Center; New Research Building
Washington, District of Columbia, United States, 20057
United States, Florida
Lynn Cancer Institute - West
Boca Raton, Florida, United States, 33428
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Hawaii
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
United States, Illinois
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Bay Hematology Oncology
Easton, Maryland, United States, 21601
United States, New York
Beth Israel Cancer Center
New York, New York, United States, 10011
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, Oregon
Oregon Health & Science Uni
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Tennessee
Wellmont Cancer Institute
Bristol, Tennessee, United States, 37620
Sarah Cannon Cancer Center
Germantown, Tennessee, United States, 38138
Vanderbilt University Medical Center; Multiple Sclerosis Center
Nashville, Tennessee, United States, 37204
United States, Virginia
Hematology Oncology Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, United States, 22408
United States, Washington
VA Puget Sound Health Care Sys
Seattle, Washington, United States, 98108
United States, West Virginia
West Virginia University Hospital
Morgantown, West Virginia, United States, 26506
Brazil
Oncovida
Salvador, BA, Brazil, 41820-021
Sociedade beneficente de senhoras Hospital Sirio Libanes
Brasilia, DF, Brazil, 70200-730
Centro de Pesquisas Clinicas em Oncologia - CPCO
Cachoeiro de Itapemirim, ES, Brazil, 29308-014
Santa Casa de Misericordia; de Belo Horizonte
Belo Horizonte, MG, Brazil, 30150-221
Instituto Nacional de Cancer - INCa; Oncologia
Rio de Janeiro, RJ, Brazil, 20560-120
Associacao Hospital de Caridade Ijui; Departamento De Oncologia
Ijui, RS, Brazil, 98700-000
Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia
Passo Fundo, RS, Brazil, 99010-260
Irmandade Da Santa Casa de Misericordia de Porto Alegre; Nucleo de Novos Tratamentos em Cancer
Porto Alegre, RS, Brazil, 90050-170
Hospital Sao Lucas - PUCRS; Pesquisa Clinica
Porto Alegre, RS, Brazil, 90110-270
Hospital Ernesto Dornelles
Porto Alegre, RS, Brazil, 90160-092
CliniOnco - Clinica de Oncologia de Porto Alegre; Departamento de Pesquisa
Porto Alegre, RS, Brazil, 90430-090
Instituto Joinvilense de Hematologia E Oncologia
Joinville, SC, Brazil, 89201-260
Fundacao PIO XII
Barretos, SP, Brazil, 14784-400
Hospital Santa Marcelina
Sao Paulo, SP, Brazil, 08270-070
Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira
São Paulo, SP, Brazil, 01246 000
China
Beijing Hospital
Beijing City, China, 100006
West China Hospital, Sichuan University
Chengdu, China, 610041
The Second Affiliated Hospital of Dalian Medical University
Dalian, China, 116027
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China, 510080
Harbin Medical University Tumor Hospital
Harbin City, China, 150081
The First Affiliated Hospital of Anhui Medical University
Hefei, China, 230022
Affiliated Drum Tower Hospital of Nanjing University Medical School; Nanjing Shi
Jiangsu Sheng, China, 210008
Qilu Hospital
Jinan City, China, 250012
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan City, China, 430023
Henan Cancer Hospital
Zhengzhou, China, 450008
France
CHU Angers
Angers, France, 49933
Hospital d Instructions des Armees Percy
Clamart, France, 92141
Hôpital Universitaire Dupuytren
Limoges, France, 87042
Clinique Clémentville
Montpellier, France, 34070
Centre D'oncologie de Gentilly
Nancy, France, 54100
Hopital Tenon
Paris, France, 75020
CHU de Bordeaux
Pessac, France, 33600
Centre Hospitalier Regional La Reunion Site Felix Guyon
Saint Denis Cedex, France, 97405
Hopital d'Instruction des Armees de Begin
Saint-Mande, France, 94160
Centre Hospitalier Regional Sud Reunion
Saint-pierre, France, 97448
Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll
St Brieuc, France, 22027
Centre Paul Strauss
Strasbourg, France, 67085
Hopitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Germany
Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie
Gauting, Germany, 82131
Pius-Hospital
Oldenburg, Germany, 26121
Greece
Sotiria Chest Hospital of Athens
Athens, Greece, 11527
Attikon University General Hospital
Athens, Greece, 12464
IASO General Hospital of Athens
Athens, Greece, 155 62
Metropolitan Hospital
Athens, Greece, 18547
University General Hospital of Larissa
Larissa, Greece, 41 110
University General Hospital of Patras
Patras, Greece, 265 00
Thermi Clinic
Thermi, Thessaloniki, Greece, 57001
Bioclinic Thessaloniki
Thessaloniki, Greece, 546 22
EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department
Thessaloniki, Greece, 54645
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, Greece, 564 29
Georgios Papanikolaou General Hosp. of Thessaloniki
Thessaloniki, Greece, 57010
Hungary
Uzsoki Utcai Korhaz
Budapest, Hungary, 1145
Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz
Nyiregyhaza, Hungary, 4400
Pecsi Tudomanyegyetem
Pecs, Hungary, 7624
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont
Szolnok, Hungary, 5004
Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, Italy, 47014
Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia
Rimini, Emilia-Romagna, Italy, 47900
Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B
Aviano, Friuli-Venezia Giulia, Italy, 33081
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
Roma, Lazio, Italy, 00128
ASL 3 Genovese
Genova, Liguria, Italy, 16125
Asst Papa Giovanni XXIII
Bergamo, Lombardia, Italy, 24100
Azienda Ospedaliera Istituti Ospitalieri
Cremona, Lombardia, Italy, 26100
Ospedale San Raffaele S.r.l.
Milano, Lombardia, Italy, 20132
Istituto Europeo Di Oncologia
Milano, Lombardia, Italy, 20141
Azienda Socio Sanitaria Territoriale - ASST di Monza
Monza, Lombardia, Italy, 20052
Istituto Nazionale dei Tumori
Monza, Lombardia, Italy, 20052
Istituto Clinico Humanitas
Rozzano (MI), Lombardia, Italy, 20089
A.O.U. Maggiore della Carità
Novara, Piemonte, Italy, 28100
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, Piemonte, Italy, 10126
Azienda Ospedaliero-Universitaria "PoliclinicoVittorio Emanuele"- P.O. G. Rodolico; Oncologia Medica
Catania, Sicilia, Italy, 95123
Istituto Oncologico Veneto IRCCS
Padova, Veneto, Italy, 35128
Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia
Verona, Veneto, Italy, 37126
Japan
Aichi Cancer Center Hospital; Respiratory Medicine
Aichi, Japan, 464-8681
Nagoya University Hospital; Respiratory Medicine
Aichi, Japan, 466-8560
Kyushu University Hospital; Respiratory
Fukuoka, Japan, 812-8582
Hokkaido University Hospital
Hokkaido, Japan, 060-8648
Kobe City Medical Center General Hospital; Respiratory Medicine
Hyogo, Japan, 650-0047
Hyogo Cancer Center; Thoracic Oncology
Hyogo, Japan, 673-8558
Ibaraki Prefectural Central Hospital; Division of respiratory
Ibaraki, Japan, 309-1793
Sendai Kousei Hospital; Pulmonary Medicine
Miyagi, Japan, 980-0873
Okayama University Hospital; Respiratory and Allergy Medicine
Okayama, Japan, 700-8558
Osaka International Cancer Institute; Thoracic Oncology
Osaka, Japan, 541-8567
Kansai Medical university Hospital; Thoracic Oncology
Osaka, Japan, 573-1191
Osaka Habikino Medical Center
Osaka, Japan, 583-8588
Saitama Cancer Center; Thoracic Oncology
Saitama, Japan, 362-0806
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai-shi, Japan, 591-8555
National Cancer Center Hospital; Thoracic Medical Oncology
Tokyo, Japan, 104-0045
Tokyo Medical University Hospital; Dept of Surgery
Tokyo, Japan, 160-0023
Korea, Republic of
Seoul National University Bundang Hospital
Gyeonggi-do, Korea, Republic of, 13620
Chonnam National University Hwasun Hospital
Jeollanam-do, Korea, Republic of, 58128
Kangbuk Samsung Hospital
Seoul, Korea, Republic of, 03181
Asan Medical Center - PPDS
Seoul, Korea, Republic of, 138736
The Catholic University of Korea St. Vincent's Hospital
Suwon-si,, Korea, Republic of, 442-723
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-214
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie
Olsztyn, Poland, 10-357
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock, Poland, 05-400
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan, Poland, 60-569
Med.-Polonia Sp. z o.o. NSZOZ
Poznan, Poland, 60-693
Romania
County Hospital Alba; Oncology
Alba Iulia, Romania, 510073
Teo Health SA - Saint Constantin Hospital
Brasov, Romania, 500091
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj Napoca, Romania, 400015
Oncology Center Sf. Nectarie
Craiova, Romania, 200347
Institutul Regional de Oncologie Iasi; Clinica de Hematologie
Iasi, Romania, 700483
Sibiu Emergency Clinical County Hospital
Sibiu, Romania, 550245
Oncomed SRL
Timisoara, Romania, 300239
Oncocenter Clinical Oncology
Timişoara, Romania, 300210
Russian Federation
Federal State Institution Medical Radiology Research Center
Obninsk, Kaluga, Russian Federation, 249036
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
Principal Military Clinical Hospital n.a. N.N. Burdenko
Moscow, Moskovskaja Oblast, Russian Federation, 105229
Saint Petersburg Clinical Hospital of the Russian Academy of Sciences
St. Petersburg, Sankt Petersburg, Russian Federation, 194017
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, Russian Federation, 163045
Ivanovo Regional Oncology Dispensary
Ivanovo, Russian Federation, 153040
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
Kazan, Russian Federation, 420029
Kursk Regional Oncology Centre
Kursk, Russian Federation, 305524
Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod
Nizhny Novgorod, Russian Federation, 603081
Regional Clinical Oncology Center
Ryazan, Russian Federation, 390046
City Clinical Oncology Dispensary
Saint-Petersburg, Russian Federation, 197022
Mordovia State University
Saransk, Russian Federation, 430032
Leningrad Regional Clinical Hospital
St Petersburg, Russian Federation, 194291
St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research
St Petersburg, Russian Federation, 197089
Volgograd Regional Clinical Oncology Dispensary
Volgograd, Russian Federation, 400138
Serbia
Clinical Center of Serbia
Belgrade, Serbia, 11000
Clinical Hospital Center Bezanijska kosa; Clinic for Oncology
Belgrade, Serbia, 11000
Institute for Oncology and Radiology of Serbia; Medical Oncology
Belgrade, Serbia, 11000
Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Institute of Lung Diseases Vojvodina
Sremska Kamenica, Serbia, 21204
Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona, Barcelona, Spain, 08916
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Consorcio Hospitalario Provincial de Castellon
Castellon de la Plana, Castellon, Spain, 12002
Hospital Universitario Son Espases
Palma de Mallorca, Islas Baleares, Spain, 07010
Hospital Son Llatzer
Palma de Mallorca, Islas Baleares, Spain, 07198
Hospital Universitario A Coruña
Coruna, LA Coruña, Spain, 15006
Hospital Universitario de Canarias
S. Cristobal De La Laguna, Tenerife, Spain, 38320
Hospital Universitario Cruces
Barakaldo, Vizcaya, Spain, 48903
Hospital Universitario Basurto
Bilbao, Vizcaya, Spain, 48013
Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Spain, 08035
Hospital Universitario Reina Sofia
Cordoba, Spain, 14004
Hospital General Universitario de Guadalajara
Guadalajara, Spain, 19002
Complejo Hospitalario de Jaen
Jaen, Spain, 23007
Hospital Universitario La Paz
Madrid, Spain, 280146
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46026
Hosp Clinico Univ Lozano Blesa; División De Oncología Médica
Zaragoza, Spain, 50009
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Thailand
Prince of Songkla University; Department Of Internal Medicine, Faculty Of Medicine
Hat Yai, Thailand, 90110
Khon Kaen University
Khon Kaen, Thailand, 40002
Chiang Rai Prachanukroh Hospital
Muang, Thailand, 57000
Buddhachinnaraj Hospital
Phitsanulok, Thailand, 65000
Turkey
Cukurova University Medical Faculty Balcali Hospital
Adana, Turkey, 1330
Hacettepe Universitesi Tip Fakultesi Hastanesi; Ic Hastaliklari Anabiim Dali
Ankara, Turkey, 06100
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey, 34000
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, Turkey, 35100
Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
Izmir, Turkey, 35110
Inonu University Faculty of Medicine Turgut Ozal Medical Center
Malatya, Turkey, 44280
Ukraine
MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council
Dnipropetrovsk, Katerynoslav Governorate, Ukraine, 49102
Municipal Noncommercial Institution Regional Center of Oncology
Kharkiv, Kharkiv Governorate, Ukraine, 61070
Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2
Ivano-Frankivsk, KIEV Governorate, Ukraine, 76018
Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway
Kyiv, KIEV Governorate, Ukraine, 02096
Municipal Institution Odesa Regional Oncology Dispensary
Odesa, KIEV Governorate, Ukraine, 65055
Municipal Institution Podilskiy Regional Center of Oncology; Department of Chemotherapy
Vinnytsia, Podolia Governorate, Ukraine, 21029
Transcarpathian Regional Clinical Oncology Dispensary
Uzhgorod, Tavria Okruha, Ukraine, 88014
Private Enterprise Private Manufacturing Company Acinus
Kirovograd, Ukraine, 25006
Treatment and Prevention Institution Volyn Regional Oncology Dispensary
Lutsk, Ukraine, 43018
Lviv State Oncology Regional Treatment and Diagnostic Centre
Lviv, Ukraine, 79031
Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
Sumy, Ukraine, 40005
United Kingdom
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Colchester General Hospital
Colchester, Essex, United Kingdom, CO4 5JL
Diana Princess of Wales Hosp.
Grimsby, United Kingdom, DN33 2BA
Barts Health NHS Trust
London, United Kingdom, E1 2ES
Sarah Cannon Research Institute
London, United Kingdom, W1G 6AD
Christie Hospital
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: January 9, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Atezolizumab
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