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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]

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02409342
First received: April 1, 2015
Last updated: August 1, 2017
Last verified: August 2017
  Purpose
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 Intervention 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
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

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

Secondary Outcome Measures:
  • 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) ]
  • 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) ]
  • 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) ]
  • Percentage of Participants Who are Alive at 1 and 2 Years [ Time Frame: 1 and 2 Years ]
  • 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 ]
  • 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 ]
  • 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 ]
  • TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) [ Time Frame: Baseline up to approximately 58 months ]

Other Outcome Measures:
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]

Estimated Enrollment: 555
Actual Study Start Date: July 20, 2015
Estimated Study Completion Date: April 23, 2020
Estimated Primary Completion Date: January 17, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

  Hide Study Locations
Locations
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
University of California San Diego 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 Recruiting
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Georgetown University Medical Center; New Research Building Recruiting
Washington, D.C., District of Columbia, United States, 20057
United States, Florida
Lynn Cancer Institute - West Recruiting
Boca Raton, Florida, United States, 33428
Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
United States, Hawaii
Straub Clinic and Hospital Recruiting
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 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 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 Recruiting
Germantown, Tennessee, United States, 38138
Vanderbilt University Medical Center; Multiple Sclerosis Center Recruiting
Nashville, Tennessee, United States, 37204
United States, Virginia
Hematology Oncology Associates of Fredericksburg, Inc. 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 Recruiting
Salvador, BA, Brazil, 41820-021
Sociedade beneficente de senhoras Hospital Sirio Libanes Recruiting
Brasilia, DF, Brazil, 70200-730
Centro de Pesquisas Clinicas em Oncologia - CPCO Recruiting
Cachoeiro de Itapemirim, ES, Brazil, 29308-014
Santa Casa de Misericordia; de Belo Horizonte Not yet recruiting
Belo Horizonte, MG, Brazil, 30150-221
Instituto Nacional de Cancer - INCa; Oncologia Recruiting
Rio de Janeiro, RJ, Brazil, 20560-120
Associacao Hospital de Caridade Ijui; Departamento De Oncologia Recruiting
Ijui, RS, Brazil, 98700-000
Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia Recruiting
Passo Fundo, RS, Brazil, 99010-260
Irmandade Da Santa Casa de Misericordia de Porto Alegre; Nucleo de Novos Tratamentos em Cancer Recruiting
Porto Alegre, RS, Brazil, 90050-170
Hospital Sao Lucas - PUCRS; Pesquisa Clinica Recruiting
Porto Alegre, RS, Brazil, 90110-270
Hospital Ernesto Dornelles Recruiting
Porto Alegre, RS, Brazil, 90160-092
CliniOnco - Clinica de Oncologia de Porto Alegre; Departamento de Pesquisa Recruiting
Porto Alegre, RS, Brazil, 90430-090
Instituto Joinvilense de Hematologia E Oncologia Recruiting
Joinville, SC, Brazil, 89201-260
Fundacao PIO XII Not yet recruiting
Barretos, SP, Brazil, 14784-400
Hospital Santa Marcelina Not yet recruiting
Sao Paulo, SP, Brazil, 08270-070
Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira Recruiting
São Paulo, SP, Brazil, 01246 000
China
Beijing Hospital Not yet recruiting
Beijing City, China, 100006
Peking Union Medical College Hospital Not yet recruiting
Beijing, China, 100730
Jilin Cancer Hospital Not yet recruiting
Changchun, China, 130012
West China Hospital, Sichuan University Not yet recruiting
Chengdu, China, 610041
Daping Hospital of Third Military Medical University Not yet recruiting
Chongqing, China, 400042
The Second Affiliated Hospital of Dalian Medical University Not yet recruiting
Dalian, China, 116027
The First Affiliated Hospital, Sun Yat-sen University Not yet recruiting
Guangzhou, China, 510080
Harbin Medical University Tumor Hospital Recruiting
Harbin City, China, 150081
The First Affiliated Hospital of Anhui Medical University Not yet 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
Shandong Cancer Hospital Not yet recruiting
Jinan, China, 250117
Shanghai Pulmonary Hospital Not yet recruiting
Shanghai, China, 200433
Union Hospital Tongji Medical College Huazhong University of Science and Technology Not yet recruiting
Wuhan City, China, 430023
Henan Cancer Hospital Not yet recruiting
Zhengzhou, China, 450008
Czechia
Multiscan s.r.o. Terminated
Pardubice, Czechia, 532 03
France
CHU Angers Recruiting
Angers, France, 49933
Hospital d Instructions des Armees Percy Recruiting
Clamart, France, 92141
Hôpital Universitaire Dupuytren Recruiting
Limoges, France, 87042
Clinique Clémentville Recruiting
Montpellier, France, 34070
Centre D'oncologie de Gentilly Not yet recruiting
Nancy, France, 54100
Hopital Tenon Recruiting
Paris, France, 75020
CHU de Bordeaux Not yet recruiting
Pessac, France, 33600
Centre Hospitalier Regional La Reunion Site Felix Guyon Recruiting
Saint Denis Cedex, France, 97405
Hopital d'Instruction des Armees de Begin Not yet recruiting
Saint-Mande, France, 94160
Centre Hospitalier Regional Sud Reunion Recruiting
Saint-pierre, France, 97448
Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll Recruiting
St Brieuc, France, 22027
Centre Paul Strauss Recruiting
Strasbourg, France, 67085
Hopitaux Universitaires de Strasbourg Not yet recruiting
Strasbourg, France, 67091
Germany
Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie Recruiting
Gauting, Germany, 82131
Pius-Hospital Completed
Oldenburg, Germany, 26121
Greece
Sotiria Chest Hospital of Athens Recruiting
Athens, Greece, 11527
Attikon University General Hospital Recruiting
Athens, Greece, 12464
IASO General Hospital of Athens Recruiting
Athens, Greece, 155 62
Metropolitan Hospital Recruiting
Athens, Greece, 18547
Metropolitan Hospital Not yet recruiting
Athens, Greece, 18547
University General Hospital of Larissa Recruiting
Larissa, Greece, 41 110
University General Hospital of Patras Recruiting
Patras, Greece, 265 00
Thermi Clinic Completed
Thermi, Thessaloniki, Greece, 57001
Bioclinic Thessaloniki Recruiting
Thessaloniki, Greece, 546 22
EUROMEDICA General Clinic of Thessaloniki Recruiting
Thessaloniki, Greece, 54645
EUROMEDICA General Clinic of Thessaloniki Not yet recruiting
Thessaloniki, Greece, 54645
Papageorgiou General Hospital of Thessaloniki Recruiting
Thessaloniki, Greece, 564 29
Georgios Papanikolaou General Hosp. of Thessaloniki Recruiting
Thessaloniki, Greece, 57010
Hungary
Uzsoki Utcai Korhaz Recruiting
Budapest, Hungary, 1145
Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz Recruiting
Nyiregyhaza, Hungary, 4400
Pecsi Tudomanyegyetem Recruiting
Pecs, Hungary, 7624
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont Recruiting
Szolnok, Hungary, 5004
Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica Recruiting
Meldola, Emilia-Romagna, Italy, 47014
Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia Recruiting
Rimini, Emilia-Romagna, Italy, 47900
Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B Recruiting
Aviano, Friuli-Venezia Giulia, Italy, 33081
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica Not yet recruiting
Roma, Lazio, Italy, 00128
ASL 3 Genovese Not yet recruiting
Genova, Liguria, Italy, 16125
Asst Papa Giovanni XXIII Recruiting
Bergamo, Lombardia, Italy, 24100
Azienda Ospedaliera Istituti Ospitalieri Recruiting
Cremona, Lombardia, Italy, 26100
Ospedale San Raffaele S.r.l. Recruiting
Milano, Lombardia, Italy, 20132
Istituto Europeo Di Oncologia Recruiting
Milano, Lombardia, Italy, 20141
Azienda Socio Sanitaria Territoriale - ASST di Monza Recruiting
Monza, Lombardia, Italy, 20052
Istituto Nazionale dei Tumori Recruiting
Monza, Lombardia, Italy, 20052
Istituto Clinico Humanitas Recruiting
Rozzano (MI), Lombardia, Italy, 20089
A.O.U. Maggiore della Carità Not yet recruiting
Novara, Piemonte, Italy, 28100
Azienda Ospedaliera Città della Salute e della Scienza di Torino Not yet recruiting
Torino, Piemonte, Italy, 10126
Azienda Ospedaliero-Universitaria "PoliclinicoVittorio Emanuele"- P.O. G. Rodolico; Oncologia Medica Not yet recruiting
Catania, Sicilia, Italy, 95123
Istituto Oncologico Veneto IRCCS Recruiting
Padova, Veneto, Italy, 35128
Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia Recruiting
Verona, Veneto, Italy, 37126
Japan
Aichi Cancer Center Hospital; Respiratory Medicine Recruiting
Aichi, Japan, 464-8681
Nagoya University Hospital; Respiratory Medicine Recruiting
Aichi, Japan, 466-8560
Kyushu University Hospital; Respiratory Recruiting
Fukuoka, Japan, 812-8582
Hokkaido University Hospital Recruiting
Hokkaido, Japan, 060-8648
Institute of Biomedical Research and Innovation Hospital; Integrated Oncology Recruiting
Hyogo, Japan, 650-0047
Hyogo Cancer Center; Thoracic Oncology Recruiting
Hyogo, Japan, 673-8553
Ibaraki Prefectural Central Hospital; Division of respiratory Recruiting
Ibaraki, Japan, 309-1793
Sendai Kousei Hospital; Pulmonary Medicine Recruiting
Miyagi, Japan, 980-0873
Okayama University Hospital; Respiratory and Allergy Medicine Recruiting
Okayama, Japan, 700-8558
Osaka International Cancer Institute; Thoracic Oncology Recruiting
Osaka, Japan, 541-8567
Kansai Medical university Hospital; Thoracic Oncology Recruiting
Osaka, Japan, 573-1191
Osaka Habikino Medical Center Recruiting
Osaka, Japan, 583-8588
Saitama Cancer Center; Thoracic Oncology Recruiting
Saitama, Japan, 362-0806
National Hospital Organization Kinki-Chuo Chest Medical Center 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 Recruiting
Gyeonggi-do, Korea, Republic of, 13620
Chonnam National University Hwasun Hospital Recruiting
Jeollanam-do, Korea, Republic of, 58128
Kangbuk Samsung Hospital Recruiting
Seoul, Korea, Republic of, 03181
Asan Medical Center - PPDS Not yet recruiting
Seoul, Korea, Republic of, 138736
The Catholic University of Korea St. Vincent's Hospital Recruiting
Suwon-si,, Korea, Republic of, 442-723
Poland
Uniwersyteckie Centrum Kliniczne Recruiting
Gdansk, Poland, 80-214
KO-MED Centra Kliniczne LUBLIN Not yet recruiting
Lublin, Poland, 20-362
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie Not yet recruiting
Olsztyn, Poland, 10-357
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy Recruiting
Otwock, Poland, 05-400
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu Recruiting
Poznan, Poland, 60-569
Med.-Polonia Sp. z o.o. NSZOZ Recruiting
Poznan, Poland, 60-693
Szpital Specjalistyczny w Prabutach Sp. z o. o. Not yet recruiting
Prabuty, Poland, 82-550
Romania
County Hospital Alba; Oncology Recruiting
Alba Iulia, Romania, 510073
Teo Health SA - Saint Constantin Hospital Active, not recruiting
Brasov, Romania, 500091
Prof. Dr. I. Chiricuta Institute of Oncology Recruiting
Cluj Napoca, Romania, 400015
Oncology Center Sf. Nectarie Recruiting
Craiova, Romania, 200347
Institutul Regional de Oncologie Iasi; Clinica de Hematologie Recruiting
Iasi, Romania, 700483
Sibiu Emergency Clinical County Hospital 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 Not yet recruiting
Obninsk, Kaluga, Russian Federation, 249036
Moscow City Oncology Hospital #62 Not yet recruiting
Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
Principal Military Clinical Hospital n.a. N.N. Burdenko Recruiting
Moscow, Moskovskaja Oblast, Russian Federation, 105229
Saint Petersburg Clinical Hospital of the Russian Academy of Sciences Recruiting
St. Petersburg, Sankt Petersburg, Russian Federation, 194017
Arkhangelsk Regional Clinical Oncology Dispensary Recruiting
Arkhangelsk, Russian Federation, 163045
Ivanovo Regional Oncology Dispensary Recruiting
Ivanovo, Russian Federation, 153040
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic Not yet recruiting
Kazan, Russian Federation, 420029
Kursk Regional Oncology Centre Recruiting
Kursk, Russian Federation, 305524
Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod Terminated
Nizhny Novgorod, Russian Federation, 603081
Regional Clinical Oncology Center Recruiting
Ryazan, Russian Federation, 390046
City Clinical Oncology Dispensary Not yet recruiting
Saint-Petersburg, Russian Federation, 197022
Mordovia State University Recruiting
Saransk, Russian Federation, 430032
Leningrad Regional Clinical Hospital Recruiting
St Petersburg, Russian Federation, 194291
St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research Recruiting
St Petersburg, Russian Federation, 197089
Volgograd Regional Clinical Oncology Dispensary Recruiting
Volgograd, Russian Federation, 400138
Serbia
Clinical Center of Serbia 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 Recruiting
Belgrade, Serbia, 11000
Clinical Center Kragujevac Recruiting
Kragujevac, Serbia, 34000
Institute of Lung Diseases Vojvodina Recruiting
Sremska Kamenica, Serbia, 21204
Spain
Hospital Universitario Marques de Valdecilla Not yet recruiting
Santander, Cantabria, Spain, 39008
Consorcio Hospitalario Provincial de Castellon Not yet recruiting
Castellon de la Plana, Castellon, Spain, 12002
Hospital Universitario Son Espases Not yet recruiting
Palma de Mallorca, Islas Baleares, Spain, 07010
Hospital Son Llatzer Recruiting
Palma de Mallorca, Islas Baleares, Spain, 07198
Hospital Universitario A Coruña Not yet recruiting
Coruna, La Coruña, Spain, 15006
Hospital Universitario de Canarias Not yet recruiting
S. Cristobal de la Laguna, Tenerife, Spain, 38320
Hospital Universitario Cruces Not yet recruiting
Barakaldo, Vizcaya, Spain, 48903
Hospital Universitario Basurto Not yet recruiting
Bilbao, Vizcaya, Spain, 48013
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Hospital Universitario Vall d'Hebron - PPDS Not yet recruiting
Barcelona, Spain, 08035
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia Recruiting
Barcelona, Spain, 08916
Hospital Universitario Reina Sofia Recruiting
Cordoba, Spain
Hospital General Universitario de Guadalajara Not yet recruiting
Guadalajara, Spain, 19002
Complejo Hospitalario de Jaen Recruiting
Jaen, Spain, 23007
Hospital Universitario La Paz Not yet recruiting
Madrid, Spain, 280146
Hospital Clinico San Carlos; Servicio de Oncologia Not yet recruiting
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre Not yet recruiting
Madrid, Spain, 28041
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain, 41009
Hospital Clinico Universitario de Valencia Not yet recruiting
Valencia, Spain, 46010
Hospital Universitari i Politecnic La Fe de Valencia Recruiting
Valencia, Spain, 46026
Hosp Clinico Univ Lozano Blesa; División De Oncología Médica Recruiting
Zaragoza, Spain, 50009
Hospital Universitario Miguel Servet Not yet recruiting
Zaragoza, Spain, 50009
Thailand
Prince of Songkla University; Department Of Internal Medicine, Faculty Of Medicine Recruiting
Hat Yai, Thailand, 90110
Khon Kaen University Recruiting
Khon Kaen, Thailand, 40002
Chiang Rai Prachanukroh Hospital Recruiting
Muang, Thailand, 57000
Buddhachinnaraj Hospital Recruiting
Phitsanulok, Thailand, 65000
Turkey
Cukurova University Medical Faculty Balcali Hospital Recruiting
Adana, Turkey, 1330
Hacettepe Universitesi Tip Fakultesi Hastanesi; Ic Hastaliklari Anabiim Dali Recruiting
Ankara, Turkey, 06100
Istanbul University Cerrahpasa Medical Faculty 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 Recruiting
Izmir, Turkey, 35110
Inonu University Faculty of Medicine Turgut Ozal Medical Center Recruiting
Malatya, Turkey, 44280
Ukraine
MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council Not yet recruiting
Dnipropetrovsk, Katerynoslav Governorate, Ukraine, 49102
Municipal Noncommercial Institution Regional Center of Oncology Not yet recruiting
Kharkiv, Kharkiv Governorate, Ukraine, 61070
Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2 Not yet recruiting
Ivano-Frankivsk, Kiev Governorate, Ukraine, 76018
Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway Not yet recruiting
Kyiv, Kiev Governorate, Ukraine, 02096
Municipal Institution Odesa Regional Oncology Dispensary Not yet recruiting
Odesa, Kiev Governorate, Ukraine, 65055
Uzhhorod Central City Clinical Hospital Not yet recruiting
Uzhhorod, Kiev Governorate, Ukraine, 88000
Vinnytsya Regional Clinical Oncology Dispensary Not yet recruiting
Vinnytsya, Podolia Governorate, Ukraine, 21029
Transcarpathian Regional Clinical Oncology Dispensary Not yet recruiting
Uzhgorod, Tavria Okruha, Ukraine, 88014
Private Enterprise Private Manufactire Company "Acinus". Not yet recruiting
Kirovograd, Ukraine, 25006
Treatment and Prevention Institution Volyn Regional Oncology Dispensary Not yet recruiting
Lutsk, Ukraine, 43018
Lviv State Oncology Regional Treatment and Diagnostic Centre Not yet recruiting
Lviv, Ukraine, 79031
Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary Not yet recruiting
Sumy, Ukraine, 40005
United Kingdom
Belfast City Hospital Terminated
Belfast, United Kingdom, BT9 7AB
Birmingham Heartlands Hospital Recruiting
Birmingham, United Kingdom, B9 5SS
Colchester General Hospital 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 Recruiting
Manchester, United Kingdom, M20 3BG
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02409342     History of Changes
Other Study ID Numbers: GO29431
2014-003083-21 ( EudraCT Number )
Study First Received: April 1, 2015
Last Updated: August 1, 2017

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Diseases
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

ClinicalTrials.gov processed this record on September 21, 2017