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Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02486718
Recruitment Status : Active, not recruiting
First Posted : July 1, 2015
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Atezolizumab Drug: Cisplatin Drug: Vinorelbine Drug: Docetaxel Drug: Gemcitabine Drug: Pemetrexed Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer
Actual Study Start Date : October 31, 2015
Estimated Primary Completion Date : November 26, 2020
Estimated Study Completion Date : December 17, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Atezolizumab
Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed [non-squamous cell NSCLC only]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: Participants will receive atezolizumab 1200 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles and will undergo periodic chest X-ray and CT scan.
Drug: Atezolizumab
Participants will receive atezolizumab (1200 mg IV) Q3W for 16 cycles (cycle length=21 days).
Other Name: MPDL3280A; TECENTRIQ

Drug: Cisplatin
Participants will receive cisplatin 75 milligrams per square meter (mg/m^2) IV on Day 1 of up to four 21-day cycles.

Drug: Vinorelbine
Participants will receive vinorelbine 30 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles.

Drug: Docetaxel
Participants will receive docetaxel 75 mg/m^2 IV on Day 1 of each of the four 21-day cycles.

Drug: Gemcitabine
Participants will receive gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles.

Drug: Pemetrexed
Participants will receive pemetrexed 500 mg/m^2 IV on Day 1 of each of the four 21-day cycles. Pemetrexed will be administered only in participants with non-squamous cell NSCLC.

Active Comparator: Best Supportive Care
Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed [non-squamous cell NSCLC only]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: After enrollment phase participants will receive only the best supportive care and will undergo periodic chest X-ray and CT scan.
Drug: Cisplatin
Participants will receive cisplatin 75 milligrams per square meter (mg/m^2) IV on Day 1 of up to four 21-day cycles.

Drug: Vinorelbine
Participants will receive vinorelbine 30 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles.

Drug: Docetaxel
Participants will receive docetaxel 75 mg/m^2 IV on Day 1 of each of the four 21-day cycles.

Drug: Gemcitabine
Participants will receive gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles.

Drug: Pemetrexed
Participants will receive pemetrexed 500 mg/m^2 IV on Day 1 of each of the four 21-day cycles. Pemetrexed will be administered only in participants with non-squamous cell NSCLC.




Primary Outcome Measures :
  1. Disease-Free Survival (DFS), Assessed Using Computed Tomography (CT)/Magnetic Resonance Imaging (MRI)/X-Ray [ Time Frame: From randomization to the date of first recurrence of NSCLC, occurrence of new primary NSCLC, or death from any cause, whichever occurs first (up to approximately 131 months) ]
    DFS will be assessed by the investigator in PD-L1-selected populations within the Stage II-IIIA subpopulation, in all randomized Stage II-IIIA participants, and in the intent-to-treat (ITT) population.


Secondary Outcome Measures :
  1. Overall Survival (OS) in the ITT Population [ Time Frame: Baseline up to death from any cause (up to approximately 131 months) ]
  2. Percentage of Participants Who are Disease-Free at Year 3, Assessed Using CT/MRI/X-Ray [ Time Frame: Year 3 ]
    DFS rates will be measured in the PD-L1-selected populations within the Stage II-IIIA subpopulation, in all randomized participants with Stage II-IIIA NSCLC, and in the ITT population.

  3. Percentage of Participants Who are Disease-Free at Year 5, Assessed Using CT/MRI/X-Ray [ Time Frame: Year 5 ]
    DFS rates will be measured in the PD-L1-selected populations within the Stage II-IIIA subpopulation, in all randomized participants with Stage II-IIIA NSCLC, and in the ITT population.

  4. DFS Within Selected Populations [ Time Frame: From randomization to the date of first recurrence of NSCLC, occurrence of new primary NSCLC, or death from any cause, whichever occurs first (up to approximately 67 months) ]
    DFS rates will be measured within the PD-L1-selected populations in the evaluable Stage II-IIIA subpopulation and within the evaluable ITT population.

  5. Percentage of Participants with Adverse Events [ Time Frame: Baseline up to approximately 131 months ]
  6. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab [ Time Frame: Predose (Hour 0) on Day (D) 1 of Cycles (Cy) 1, 2, 3, 4, 8, 16 (Cy length=21 days), at treatment discontinuation (TD) (up to 12 months), 120 days after last atezolizumab administration (up to 16 months) ]
  7. Maximum Plasma Concentration (Cmax) of Atezolizumab [ Time Frame: Post-infusion on Day 1 of Cycle 1 (cy length = 21 days) ]
  8. Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab [ Time Frame: Prior to infusion on D1 of Cy2, 3, 4, 8, 16 (Cy length = 21 days), and at study termination (up to approximately 131 months) ]


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
Criteria

Inclusion Criteria:

Inclusion Criteria for Enrollment Phase

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histological or cytological diagnosis of Stage IB (tumors greater than or equal to [>/=] 4 centimeters [cm])-IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC (per the Union Internationale Contre le Cancer staging system (UICC)/American Joint Committee on Cancer staging system (AJCC) staging system, 7th edition; Detterbeck et al. 2009)
  • Participants must have had complete resection of NSCLC 4-12 weeks (>/=28 days and less than or equal to [</=] 84 days) prior to enrollment and must be adequately recovered from surgery
  • If mediastinoscopy was not performed preoperatively, it is required that, at a minimum, mediastinal lymph node systematic sampling will have occurred. Systematic sampling is defined as removal of at least one representative lymph node at specified levels. MLND entails resection of all lymph nodes at those same levels. For a right thoracotomy, sampling or MLND is required at levels 4 and 7 and for a left thoracotomy, levels 5 and/or 6 and 7. Exceptions will be granted if there is clear documentation in the operative report or in a separately submitted addendum by the surgeon of exploration of the required lymph node areas, the participant will be considered eligible if no lymph nodes are found in those areas; if participants have documented N2 disease in one level (per the UICC/AJCC staging system, 7th edition; Detterbeck et al. 2009), not all levels need to be sampled; if the preoperative staging imaging results (contrast computed tomography [CT] and positron emission tomography [PET] scans) do not suggest evidence of disease in the mediastinum, the participant will be considered eligible if N2 nodal sampling is not performed per surgeon's decision
  • Eligible to receive a cisplatin-based chemotherapy regimen
  • Adequate hematologic and end-organ function
  • Women who are not postmenopausal (>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of cisplatin-based chemotherapy

Inclusion Criteria for Randomized Phase - Women who are not postmenopausal (>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of atezolizumab or BSC

Exclusion Criteria:

Exclusion Criteria for Enrollment Phase

  • Illness or condition that may interfere with a participant's capacity to understand, follow, and/or comply with study procedures
  • Pregnant and lactating women
  • Treatment with prior systemic chemotherapy: Chemotherapy for early stage of malignancy with curative intent, provided that the last dose received was more than 5 years prior to enrollment and low-dose chemotherapy for non-malignant conditions may be allowed upon approval by the Medical Monitor
  • Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years before enrollment
  • Treatment with any other investigational agent with therapeutic intent within 28 days prior to enrollment
  • Participants with hearing impairment
  • Known sensitivity to any component of the chemotherapy regimen the participant will be assigned to, or to mannitol
  • Prior treatment with cluster of differentiation (CD) 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti programmed death ligand 1 (PD-L1) therapeutic antibodies
  • Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS greater than [>] 90 percent [%]) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
  • History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
  • Positive test for human immunodeficiency virus (HIV)
  • Participants with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C
  • Active tuberculosis
  • Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within the previous 3 months, unstable arrhythmias, or unstable angina
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • Prior allogeneic bone marrow transplantation or solid organ transplant
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
  • Known tumor PD-L1 expression status as determined by an immunohistochemistry (IHC) assay from other clinical studies (e.g., participants whose PD-L1 expression status was determined during screening for entry into a study with anti-PD-1 or anti-PD-L1 antibodies but were not eligible are excluded)

Specific Exclusions for Pemetrexed Treatment

- Participants with squamous cell histology

Exclusion Criteria for Randomized Phase

  • Signs or symptoms of infection within 14 days prior to randomization (severe infection within 28 days prior to randomization), including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Received therapeutic oral or intravenous (IV) antibiotics within 14 days prior to randomization
  • Major surgical procedure within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study
  • Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live attenuated vaccine will be required during the study
  • Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to randomization: Prior treatment with cancer vaccines is allowed
  • Treatment with systemic corticosteroids or other immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 14 days prior to randomization

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): NCT02486718


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Locations
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United States, Arizona
Ironwood Cancer & Research Ctr
Mesa, Arizona, United States, 85206
Premiere Oncology
Scottsdale, Arizona, United States, 85258
United States, Arkansas
Uni of Arkansas For Medical Sciences
Little Rock, Arkansas, United States, 72205
Highlands Oncology Group
Rogers, Arkansas, United States, 72758
United States, California
Southern California Permanente Medical Group Bellflower
Bellflower, California, United States, 90706
Compassionate Cancer Care Medical Group, Inc
Corona, California, United States, 92882
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California, United States, 92008
Marin Cancer Care Inc
Greenbrae, California, United States, 94904
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Kaiser Permanente Oakland Medical Center
Oakland, California, United States, 94611
Chao Family Comprehensive Cancer Center; UC Irvine Medical Center
Orange, California, United States, 92868
Stanford University
Palo Alto, California, United States, 94305
Kaiser Permanente Medical Center - Roseville
Roseville, California, United States, 95661
Kaiser Permanente - Sacramento Medical Center and Medical Offices
Sacramento, California, United States, 95825
Kaiser Permanente - San Francisco Medical Center
San Francisco, California, United States, 94115
Kaiser Permanente - San Jose Medical Center
San Jose, California, United States, 95119
Kaiser Permanente - San Leandro Medical Center
San Leandro, California, United States, 94577
Kaiser Permanente - Santa Clara
Santa Clara, California, United States, 95051
University of California Los Angeles
Santa Monica, California, United States, 90404
Va Greater Los Angeles Healthcare System
Sepulveda, California, United States, 91343
Kaiser Permanente - South San Francisco
South San Francisco, California, United States, 94080
Kaiser Permanente; Oncology Clinical Trials
Vallejo, California, United States, 94589
Kaiser Permanente - Walnut Creek
Walnut Creek, California, United States, 94596
United States, Connecticut
Praxair Cancer Center at Danbury Hospital
Danbury, Connecticut, United States, 06810
Eastern Connecticut Hematology and Oncology Associates; (ECHO)
Norwich, Connecticut, United States, 06360
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
Lynn Cancer Institute - West
Boca Raton, Florida, United States, 33428
University of Miami School of Medicine - Sylvester at Deerfield
Deerfield Beach, Florida, United States, Suite 200
Holy Cross Hospital Inc
Fort Lauderdale, Florida, United States, 33308
Florida Cancer Specialists-Broadway, Fort Myers
Fort Myers, Florida, United States, 33908
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Florida Hospital
Orlando, Florida, United States, 32803
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States, 34952
SCRI Florida Cancer Specialists North; Research Office North Region.
Saint Petersburg, Florida, United States, 33705
SCRI Florida Cancer Specialists East
Tallahassee, Florida, United States, 32308
United States, Georgia
University Cancer & Blood Center, LLC; Research
Athens, Georgia, United States, 30607
Northwest Georgia Oncology Centers P.C.
Carrollton, Georgia, United States, 30117
Central Georgia Cancer Care PC
Macon, Georgia, United States, 31201
Lewis Hall Singletary Oncology Center
Thomasville, Georgia, United States, 31792
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Joliet Oncology-Hematology; Associates, Ltd.
Joliet, Illinois, United States, 60435
Oncology Specialists, S.C.
Park Ridge, Illinois, United States, 60068
Illinois Cancer Care
Peoria, Illinois, United States, 61615
Quincy Medical Group; Canc Ctr at Blessing Hosp
Quincy, Illinois, United States, 62301
Southern Illinois University, Simmons Cancer Institute
Springfield, Illinois, United States, 62794
United States, Iowa
Siouxland Hematology - Oncology Associates LLP
Sioux City, Iowa, United States, 51101
United States, Kentucky
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
Baptist Health Louisville
Louisville, Kentucky, United States, 40207
United States, Maine
New England Cancer Specialists
Scarborough, Maine, United States, 04074
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States, 21044
Frederick Memorial Hospital
Frederick, Maryland, United States, 21701
United States, Massachusetts
VA Boston Healthcare System; Hematology and Oncology
Boston, Massachusetts, United States, 2130
United States, Michigan
St. Joseph Mercy Health System
Ann Arbor, Michigan, United States, 48106
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States, 49503
United States, Mississippi
Hematology and Oncology Associates at Bridgepoint
Tupelo, Mississippi, United States, 38801
United States, Missouri
St. Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
United States, Nebraska
Southeast Nebraska Cancer Ctr
Lincoln, Nebraska, United States, 68510
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89014
United States, New Jersey
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
Hematology Oncology Associates of Northern New Jersey
Florham Park, New Jersey, United States, 07932
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Morristown Medical Center
Morristown, New Jersey, United States, 07962
Valley Hospital; Oncology Research
Paramus, New Jersey, United States, 07652
Regional Cancer Care Associates LLC
Sewell, New Jersey, United States, 08080
Overlook Medical Center; Medical Diagnostic Associates
Summit, New Jersey, United States, 07901
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Clinical Research Alliance
Lake Success, New York, United States, 11042
Weill Cornell Medical College
New York, New York, United States, 10065
United States, North Carolina
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
First Health of the Carolinas
Pinehurst, North Carolina, United States, 28374
W.G. Bill Hefner VA Medical Center
Salisbury, North Carolina, United States
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45203-0542
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Oncology Hematology Care - SCRI
Cincinnati, Ohio, United States, 45242
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Mark H. Zangmeister Center
Columbus, Ohio, United States, 43219
United States, Oregon
Bend Memorial Clinic
Bend, Oregon, United States, 97701
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
St. Luke's Cancer Care Associates
Bethlehem, Pennsylvania, United States, 18015
Pinnacle Health
Harrisburg, Pennsylvania, United States, 17110
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Greenville Health System
Greenville, South Carolina, United States, 29605
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
University Oncology Associates
Chattanooga, Tennessee, United States, 37403
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States, 37404
Sarah Cannon Cancer Center
Germantown, Tennessee, United States, 38138
United States, Texas
SCRI The Center For Cancer and Blood Disorders
Denton, Texas, United States, 76210
Houston Methodist Cancer Center
Houston, Texas, United States, 77030
United States, Virginia
Wellmont Medical Associates
Bristol, Virginia, United States, 24201
Hematology Oncology Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, United States, 22408
Virginia Cancer Institute
Richmond, Virginia, United States, 23226
United States, Washington
MultiCare Regional Cancer Center - Auburn
Auburn, Washington, United States, 98002-4117
Providence Everett Med Ctr
Everett, Washington, United States, 98201
VA Puget Sound Health Care Sys
Seattle, Washington, United States, 98108
Swedish Medical Center
Seattle, Washington, United States, 98122
Australia, Queensland
Townsville Hospital
Townsville, Queensland, Australia, 4810
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Adelaide Cancer Centre
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
Cabrini Hospital Malvern
Malvern, Victoria, Australia, 3144
Belgium
UZ Brussel
Brussel, Belgium, 1090
Cliniques Universitaires St-Luc
Bruxelles, Belgium, 1200
CHU Sart-Tilman
Liège, Belgium, 4000
Canada, Ontario
Toronto East General Hospital
East York, Ontario, Canada, M4C 3E7
William Osler Health Centre
Etobicoke, Ontario, Canada, M9V 1R8
Canada, Quebec
Cite de La Sante de Laval; Hemato-Oncologie
Laval, Quebec, Canada, H7M 3L9
China
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Beijing, China, 100021
Beijing Cancer Hospital
Beijing, China, 100142
Chinese People's Liberation Army (PLA) General Hospital (301 Hospital)
Beijing, China, 100853
Affiliated Hospital of Guangdong Medical University
Guangdong, China, 524023
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China, 510120
Zhejiang Cancer Hospital
Hangzhou, China, 310022
Anhui Province Cancer Hospital
Hefei, China, 12345
Shanghai Chest Hospital
Shanghai, China, 200000
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Liaoning Provincial Cancer Hospital
Shengyang, China, 110042
First Hospital of China Medical University
Shenyang, China, 110001
First Affiliated Hospital of Soochow University
Suzhou, China, 215006
France
Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne
Clermont-ferrand, France, 63003
Hôpital Universitaire Dupuytren
Limoges, France, 87042
Centre Hospitalier Bretagne Sud
Lorient, France, 56100
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
Lyon, France, 69008
Hôpital Saint Joseph; Oncologie Medicale
Marseille, France, 13285
Centre Hospitalier de Mont de Marsan - Hopital Layne
Mont De Marsan, France, 40024
Clinique Clémentville
Montpellier, France, 34070
Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie
Montpellier, France, 34298
Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique
Nantes, France, 44805
Centre Hospitalier Regional Sud Reunion; Service de Pneumologie
Saint Pierre, France, 97448
Hopital d'Instruction des Armees de Begin
Saint-Mande, France, 94160
Centre Hospitalier de Saint-Quentin; Pharmacie-URCC
Saint-Quentin, France, 02321
Centre Paul Strauss
Strasbourg, France, 67085
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
Toulon, France, 83000
Hopital d Instruction des Armees de Sainte Anne
Toulon, France, 83041
Germany
Evang. Lungenklinik Berlin Klinik für Pneumologie
Berlin, Germany, 13125
Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie
Bielefeld, Germany, 33611
Augusta Kranken-Anstalt gGmbH
Bochum, Germany, 44791
Stadtisches Klinikum Braunschweig
Braunschweig, Germany, 38114
Klinikum Chemnitz gGmbH
Chemnitz, Germany, 09116
Helios Klinikum Erfurt
Erfurt, Germany, 99089
Krankenhaus Nordwest
Frankfurt am Main, Germany, 60488
LungenClinic Großhansdorf GmbH
Großhansdorf, Germany, 22927
Krankenhaus Martha-Maria; Halle-Dolau gGmbH
Halle, Germany, 06120
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Asklepios Klinik Harburg
Hamburg, Germany, 21075
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Thoraxklinik Heidelberg gGmbH
Heidelberg, Germany, 69126
Lungenklinik Hemer
Hemer, Germany, 58675
Universität Des Saarlandes
Homburg, Germany, 66421
Fachklinik für Lungenerkrankungen
Immenhausen, Germany, 34376
Vincentius-Diakonissen-Kliniken gAG
Karlsruhe, Germany, 76137
Katholisches Klinikum Marienhof
Koblenz Am Rhein, Germany, 56073
Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz
Koln, Germany, 51109
Klinik Loewenstein gGmbH; Onk & Pal
Loewenstein, Germany, 74245
Klinikum Bogenhausen
München, Germany, 81925
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster, Germany, 48149
Pius-Hospital Oldenburg
Oldenburg, Germany, 26121
Krankenhaus Barmherzige Bruder Regensburg
Regensburg, Germany, 93049
Praxis fur Hamatologie und internistische Onkologie
Velbert, Germany, 42551
Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc
Shatin, Hong Kong
Hungary
Semmelweis Egyetem
Budapest, Hungary, 1083
University of Pecs, I st Dept of Internal Medicine
Pecs, Hungary, 7624
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
Szolnok, Hungary, 5000
Tudogyogyintezet Torokbalint
Torokbalint, Hungary, 2045
Israel
Assaf Harofeh Medical Center
Beer Yaakov, Israel, 70300
Rambam Medical Center; Oncology
Haifa, Israel, 3109601
Edith Wolfson Medical Center
Holon, Israel, 58100
Meir Medical Center; Oncology
Kfar-Saba, Israel, 4428164
Rabin Medical Center
Petach Tikva, Israel, 49100
Chaim Sheba Medical Center; Oncology Dept
Ramat Gan, Israel, 52620-00
Kaplan Medical Center
Rehovot, Israel, 7610001
Tel Aviv Sourasky Medical Ctr; Oncology
Tel Aviv, Israel, 6423906
Italy
Ospedale Clinicizzato SS Annunziata
Chieti, Abruzzo, Italy, 66100
Azienda per l'Assistenza Sanitaria N° 5 - Friuli Occidentale; S.C. Oncologia Pordenone
Pordenone, Friuli-Venezia Giulia, Italy, 33170
Policlinico Universitario Campus Biomedico Di Roma; U.O.Oncologia Medica
Roma, Lazio, Italy, 00128
Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia
Rome, Lazio, Italy, 00168
Asst Papa Giovanni XXIII; Oncologia Medica
Bergamo, Lombardia, Italy, 24127
ASST Spedali Civili di Brescia
Brescia, Lombardia, Italy, 25123
Ospedale San Raffaele
Milano, Lombardia, Italy, 20132
Azienda Sanitaria Ospedaliera s. Croce e Carle; Oncologia Medica
Cuneo, Piemonte, Italy, 12100
A.O.U. Maggiore della Carità
Novara, Piemonte, Italy, 28100
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano, Piemonte, Italy, 10043
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, Piemonte, Italy, 10126
Ospedale Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, Puglia, Italy, 71013
Presidio Ospedaliero Centrale
Taranto, Puglia, Italy, 74100
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, Sicilia, Italy, 95123
Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
Palermo, Sicilia, Italy, 90127
Azienda Ospedaliero Universitaria Pisana
Pisa, Toscana, Italy, 56100
Ospedale Santa Chiara; Oncologia Medica
Trento, Trentino-Alto Adige, Italy, 38100
Ospedale Silvestrini
Perugia, Umbria, Italy, 06122
Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia
Verona, Veneto, Italy, 37126
Japan
Aichi Cancer Center Hospital
Aichi, Japan, 464-8681
Nagoya University Hospital
Aichi, Japan, 466-8560
National Cancer Center East
Chiba, Japan, 277-8577
Shikoku Cancer Center
Ehime, Japan, 791-0280
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Hiroshima University Hospital
Hiroshima, Japan, 734-8551
National Hospital Organization Hokkaido Cancer Center
Hokkaido, Japan, 003-0804
Hyogo Cancer Center
Hyogo, Japan, 673-0021
Kanagawa Cancer Center
Kanagawa, Japan, 241-8515
Hospital of the University of Occupational and Environmental Health,Japan
Kitakyushu-shi, Japan, 807-8556
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Kyoto University Hospital
Kyoto, Japan, 606-8507
Sendai Kousei Hospital
Miyagi, Japan, 980-0873
Niigata Cancer Center Hospital
Niigata, Japan, 951-8566
Okayama University Hospital
Okayama, Japan, 700-8558
Saitama Cancer Center
Saitama, Japan, 362-0806
Shizuoka Cancer Center
Shizuoka, Japan, 411-8777
National Cancer Center Hospital
Tokyo, Japan, 104-0045
Toranomon Hospital
Tokyo, Japan, 105-8470
Juntendo University Hospital
Tokyo, Japan, 113-8431
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Tokyo, Japan, 113-8677
Tokyo Medical University Hospital
Tokyo, Japan, 160-0023
Kyorin University Hospital
Tokyo, Japan, 181-8611
Wakayama Medical University Hospital
Wakayama, Japan, 641-8509
Korea, Republic of
Chonnam National University Hwasun Hospital
Jeollanam-do, Korea, Republic of, 58128
The Catholic University of Korea St. Vincent's Hospital
Suwon-si,, Korea, Republic of, 442-723
Netherlands
Jeroen Bosch Ziekenhuis
'S Hertogenbosch, Netherlands, 5223 GZ
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands, 1066 CX
Catharina ziekenhuis
Eindhoven, Netherlands, 5623 EJ
Martini Ziekenhuis
Groningen, Netherlands, 9728 MG
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, Netherlands, 3430 EM
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3584 CX
Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock, Poland, 05-400
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan, Poland, 60-569
Portugal
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra, Portugal, 3000-602
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.; Pneumologia
Lisboa, Portugal, 1099-023
Centro Hospitalar de Lisboa Norte E.P.E - Hospital Pulido Valente
Lisboa, Portugal, 1769-001
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
Porto, Portugal, 4200-072
Hospital de Sao Joao; Servico de Pneumologia
Porto, Portugal, 4200
Romania
Oncology Center Sf. Nectarie
Craiova, Romania, 200347
Institutul Regional de Oncologie Iasi; Clinica de Hematologie
Iasi, Romania, 700483
Russian Federation
Principal Military Clinical Hospital n.a. N.N. Burdenko
Moscow, Moskovskaja Oblast, Russian Federation, 105229
Russian Oncology Research Center n a N N Blokhin
Moscow, Moskovskaja Oblast, Russian Federation, 115478
Scientific Research Institute of Oncology n.a. N.N. Petrov; Department of Oncogynecology
St. Petersburg, Sankt Petersburg, Russian Federation, 197758
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
Kazan, Russian Federation, 420029
Moscow city oncology hospital #62 of Moscow Healthcare Department
Moscow, Russian Federation, 143423
Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod
Nizhny Novgorod, Russian Federation, 603081
City Clinical Hospital #1; Dpt of Oncology
Novosibirsk, Russian Federation, 630047
Evromedservis LCC
Pushkin, Russian Federation, 196603
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
Saint Petersburg, Russian Federation, 197758
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
State Budgetary Institution of Health Volzhskii Regional Clinical Oncology Dispensary #3
Volzhskiy, Russian Federation, 404100
Regional Clinical Oncology Hospital
Yaroslavl, Russian Federation, 150040
Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona, Barcelona, Spain, 08916
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Santander, Cantabria, Spain, 39008
Consorcio Hospitalario Provincial de Castellon
Castellon DE LA Plana/castello DE LA Plana, Castellon, Spain, 12002
Hospital Universitario Son Espases
Palma De Mallorca, Islas Baleares, Spain, 07014
Centro Oncologico de Galicia COG; Medical Oncology
A Coruna, LA Coruña, Spain, 15009
Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia
El Palmar, Murcia, Spain, 30120
Hospital Universitario de Canarias
S. Cristobal De La Laguna, Tenerife, Spain, 38320
Hospital del Mar
Barcelona, Spain, 08003
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
C.H. Regional Reina Sofia
Cordoba, Spain, 14004
Complejo Hospitalario de Jaen
Jaen, Spain, 23007
Hospital Lucus Augusti; Servicio de Oncologia
Lugo, Spain, 27003
Hospital Universitario La Paz
Madrid, Spain, 280146
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, Spain, 28034
Fundación Jimenez Díaz
Madrid, Spain, 28040
Hosp. Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario HM Sanchinarro-CIOCC; Oncología Médica
Madrid, Spain, 28050
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Hospital NisA 9 de Octubre
Valencia, Spain, 46015
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46026
Hosp Clinico Univ Lozano Blesa
Zaragoza, Spain, 50009
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Taiwan
Changhua Christian Hospital
Chang Hua, Taiwan, 500
Kaohsiung Medical University Hospital; Department of Urology
Kaohsiung City, Taiwan, 807
Chi Mei Medical Center Liou Ying Campus
Liuying Township, Taiwan, 736
Chang Gung Memorial Hospital Chiayi
Putzu, Taiwan, 613
Taichung Veterans General Hospital
Taichung, Taiwan, 407
National Taiwan Uni Hospital
Taipei City, Taiwan, 10041
Taipei Veterans General Hospital
Taipei City, Taiwan, 112
Mackay Memorial Hospital
Taipei, Taiwan, 104
Chang Gung Medical Foundation Linkou Branch
Taoyuan City, Taiwan, 333
Ukraine
MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council
Dnipropetrovsk, Katerynoslav Governorate, Ukraine, 49102
Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs
Kharkiv, Kharkiv Governorate, Ukraine, 61070
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
Municipal Institution SubCarpathian ClinicalOncological Centre; Chemotherapy department
Ivano-Frankivsk, Poltava Governorate, Ukraine, 76018
Private Enterprise Private Manufacturing Company Acinus
Kirovograd, Ukraine, 25006
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department
Kryvyi Rih, Ukraine, 50048
Kyiv City Clinical Oncological Center
Kyiv, Ukraine, 03115
Poltava Regional Clinical Oncology Dispensary of Poltava Regional Council; Thoracic department
Poltava, Ukraine, 36011
Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
Sumy, Ukraine, 40005
Transcarpathian Regional Clinical Oncology Dispensary; Chemotherapy Department
Uzhhorod, Ukraine, 88014
MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology
Zaporizhzhya, Ukraine, 69040
United Kingdom
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
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Sarah Cannon Research Institute
London, United Kingdom, W1G 6AD
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02486718     History of Changes
Other Study ID Numbers: GO29527
2014-003205-15 ( EudraCT Number )
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
Layout table for 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
Cisplatin
Docetaxel
Pemetrexed
Atezolizumab
Vinorelbine
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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators