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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]

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02486718
First received: June 4, 2015
Last updated: June 16, 2017
Last verified: June 2017
  Purpose
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 Intervention Phase
Non-Small Cell Lung Cancer Drug: Atezolizumab Drug: Cisplatin Drug: Vinorelbine Drug: Docetaxel Drug: Gemcitabine Drug: Pemetrexed Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • DFS, Assessed Using Computed Tomography (CT)/Magnetic Resonance Imaging (MRI)/X-Ray in in Stage IB-IIIA (Intent-to-Treat [ITT]) Population [ 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, Assessed Using CT/MRI/X-Ray in Stage II-IIIA and PD-L1-Selected Subpopulation [ 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) ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Baseline up to death from any cause (up to approximately 131 months) ]
  • Percentage of Participants Who are Disease-Free at Year 3, Assessed Using CT/MRI/X-Ray [ Time Frame: Year 3 ]
  • Percentage of Participants Who are Disease-Free at Year 5, Assessed Using CT/MRI/X-Ray [ Time Frame: Year 5 ]
  • Percentage of Participants with Adverse Events [ Time Frame: Baseline up to approximately 131 months ]
  • 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) ]
  • Maximum Plasma Concentration (Cmax) of Atezolizumab [ Time Frame: Predose (Hour 0) on D1 of Cy1,2,3,4,8,16 (Cy length=21 days), 30 minutes after end of infusion (infusion over 60 minutes) on Cy1D1, at TD (up to 12 months), 120 days after last atezolizumab administration (up to 16 months) ]
  • Minimum Serum Concentration (Cmin) at Steady-State of Atezolizumab [ Time Frame: Predose (Hour 0) on D1 of Cy2, 3, 4, 8, 16 (Cy length = 21 days), at TD (up to 12 months) ]

Estimated Enrollment: 1127
Actual Study Start Date: October 31, 2015
Estimated Study Completion Date: September 25, 2026
Estimated Primary Completion Date: September 25, 2026 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 each of the 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 each of the 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 28 days prior to randomization 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
  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: NCT02486718

Contacts
Contact: Reference Study ID Number: GO29527 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, Arizona
Ironwood Cancer & Research Ctr Recruiting
Mesa, Arizona, United States, 85206
Premiere Oncology Recruiting
Scottsdale, Arizona, United States, 85258
United States, Arkansas
Uni of Arkansas For Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Highlands Oncology Group Recruiting
Rogers, Arkansas, United States, 72758
United States, California
Southern California Permanente Medical Group Bellflower Recruiting
Bellflower, California, United States, 90706
Compassionate Cancer Care Medical Group, Inc Recruiting
Corona, California, United States, 92882
California Cancer Associates for Research & Excellence, Inc. Recruiting
Encinitas, California, United States, 92008
Marin Cancer Care Inc Recruiting
Greenbrae, California, United States, 94904
Cedars Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
Kaiser Permanente Oakland Medical Center Recruiting
Oakland, California, United States, 94611
Chao Family Comprehensive Cancer Center; UC Irvine Medical Center Recruiting
Orange, California, United States, 92868
Stanford University Not yet recruiting
Palo Alto, California, United States, 94305
Kaiser Permanente Medical Center - Roseville Recruiting
Roseville, California, United States, 95661
Kaiser Permanente - Sacramento Medical Center and Medical Offices Recruiting
Sacramento, California, United States, 95825
Kaiser Permanente - San Francisco Medical Center Recruiting
San Francisco, California, United States, 94115
Kaiser Permanente - San Jose Medical Center Recruiting
San Jose, California, United States, 95119
Kaiser Permanente - San Leandro Medical Center Recruiting
San Leandro, California, United States, 94577
Kaiser Permanente - Santa Clara Recruiting
Santa Clara, California, United States, 95051
University of California Los Angeles Not yet recruiting
Santa Monica, California, United States, 90404
Va Greater Los Angeles Healthcare System Not yet recruiting
Sepulveda, California, United States, 91343
Kaiser Permanente - South San Francisco Recruiting
South San Francisco, California, United States, 94080
Kaiser Permanente; Oncology Clinical Trials Recruiting
Vallejo, California, United States, 94589
Kaiser Permanente - Walnut Creek Recruiting
Walnut Creek, California, United States, 94596
United States, Connecticut
Praxair Cancer Center at Danbury Hospital Active, not recruiting
Danbury, Connecticut, United States, 06810
Eastern Connecticut Hematology and Oncology Associates; (ECHO) Recruiting
Norwich, Connecticut, United States, 06360
United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, D.C., District of Columbia, United States, 20007
United States, Florida
Lynn Cancer Institute - West Recruiting
Boca Raton, Florida, United States, 33428
University of Miami School of Medicine - Sylvester at Deerfield Recruiting
Deerfield Beach, Florida, United States, Suite 200
Holy Cross Hospital Inc Recruiting
Fort Lauderdale, Florida, United States, 33308
Florida Cancer Specialists-Broadway, Fort Myers Recruiting
Fort Myers, Florida, United States, 33908
Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Hematology Oncology Associates of the Treasure Coast Recruiting
Port Saint Lucie, Florida, United States, 34952
SCRI Florida Cancer Specialists North; Research Office North Region. Recruiting
Saint Petersburg, Florida, United States, 33705
SCRI Florida Cancer Specialists East Recruiting
Tallahassee, Florida, United States, 32308
United States, Georgia
University Cancer & Blood Center, LLC Recruiting
Athens, Georgia, United States, 30607
Northwest Georgia Oncology Centers P.C. Recruiting
Carlton, Georgia, United States, 30117
Central Georgia Cancer Care PC Recruiting
Macon, Georgia, United States, 31201
Lewis Hall Singletary Oncology Center Recruiting
Thomasville, Georgia, United States, 31792
United States, Illinois
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426
Joliet Oncology-Hematology; Associates, Ltd. Recruiting
Joliet, Illinois, United States, 60435
Oncology Specialists, S.C. Recruiting
Park Ridge, Illinois, United States, 60068
Illinois Cancer Care Recruiting
Peoria, Illinois, United States, 61615
Quincy Medical Group; Canc Ctr at Blessing Hosp Recruiting
Quincy, Illinois, United States, 62301
Southern Illinois University, Simmons Cancer Institute Recruiting
Springfield, Illinois, United States, 62794
United States, Iowa
Siouxland Hematology - Oncology Associates LLP Recruiting
Sioux City, Iowa, United States, 51101
United States, Kentucky
Baptist Health Louisville Recruiting
Louisville, Kentucky, United States, 40207
Norton Cancer Institute Active, not recruiting
Louisville, Kentucky, United States, 40402
United States, Maine
New England Cancer Specialists Recruiting
Scarborough, Maine, United States, 04074
United States, Maryland
Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20814
Maryland Oncology Hematology, P.A. Recruiting
Columbia, Maryland, United States, 21044
Frederick Memorial Hospital Recruiting
Frederick, Maryland, United States, 21701
United States, Massachusetts
VA Boston Healthcare System; Hematology and Oncology Not yet recruiting
Boston, Massachusetts, United States, 2130
United States, Michigan
St. Joseph Mercy Health System Terminated
Ann Arbor, Michigan, United States, 48106
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Cancer and Hematology Centers of Western Michigan Recruiting
Grand Rapids, Michigan, United States, 49503
United States, Mississippi
Hematology and Oncology Associates at Bridgepoint Recruiting
Tupelo, Mississippi, United States, 38801
United States, Missouri
St. Luke's Cancer Institute Recruiting
Kansas City, Missouri, United States, 64111
United States, Nebraska
Southeast Nebraska Cancer Ctr Recruiting
Lincoln, Nebraska, United States, 68510
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Henderson, Nevada, United States, 89014
United States, New Jersey
Englewood Hospital and Medical Center Recruiting
Englewood, New Jersey, United States, 07631
Saint Barnabas Medical Center Not yet recruiting
Livingston, New Jersey, United States, 07039
Valley Hospital; Oncology Research Recruiting
Paramus, New Jersey, United States, 07652
Regional Cancer Care Associates LLC Active, not recruiting
Sewell, New Jersey, United States, 08080
Regional Cancer Care Associates LLC Recruiting
Sewell, New Jersey, United States, 08080
Atlantic Health Cancer Center Recruiting
Summit, New Jersey, United States, 07902
United States, New York
Clinical Research Alliance Recruiting
Lake Success, New York, United States, 11042
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Montefiore Medical Center Recruiting
The Bronx, New York, United States, 10467
United States, North Carolina
Presbyterian Hospital Recruiting
Charlotte, North Carolina, United States, 28204
First Health of the Carolinas Not yet recruiting
Pinehurst, North Carolina, United States, 28374
W.G. Bill Hefner VA Medical Center Recruiting
Salisbury, North Carolina, United States
United States, Ohio
University Hospitals of Cleveland Recruiting
Beechwood, Ohio, United States, 44122
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45203-0542
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Oncology Hematology Care - SCRI Recruiting
Cincinnati, Ohio, United States, 45242
Mark H. Zangmeister Center Recruiting
Columbus, Ohio, United States, 43219
United States, Oregon
Bend Memorial Clinic Terminated
Bend, Oregon, United States, 97701
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
St. Luke's Cancer Care Associates Recruiting
Bethlehem, Pennsylvania, United States, 18015
Pinnacle Health Recruiting
Harrisburg, Pennsylvania, United States, 17110
Lancaster General Hospital Recruiting
Lancaster, Pennsylvania, United States, 17607
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
United States, South Carolina
Greenville Health System Recruiting
Greenville, South Carolina, United States, 29605
Spartanburg Regional Medical Center Terminated
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
University Oncology Associates Recruiting
Chattanooga, Tennessee, United States, 37403
SCRI Tennessee Oncology Chattanooga Recruiting
Chattanooga, Tennessee, United States, 37404
Sarah Cannon Cancer Center Recruiting
Germantown, Tennessee, United States, 38138
United States, Texas
SCRI The Center For Cancer and Blood Disorders Recruiting
Denton, Texas, United States, 76210
Houston Methodist Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Wellmont Medical Associates Recruiting
Bristol, Virginia, United States, 24201
Hematology Oncology Associates of Fredericksburg, Inc. Recruiting
Fredericksburg, Virginia, United States, 22408
Virginia Cancer Institute Terminated
Richmond, Virginia, United States, 23226
United States, Washington
MultiCare Regional Cancer Center - Auburn Recruiting
Auburn, Washington, United States, 98002-4117
Providence Everett Med Ctr Recruiting
Everett, Washington, United States, 98201
VA Puget Sound Health Care Sys Recruiting
Seattle, Washington, United States, 98108
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Australia, Queensland
Townsville Hospital Recruiting
Townsville, Queensland, Australia, 4810
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Adelaide Cancer Centre Terminated
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
Cabrini Hospital Malvern Recruiting
Malvern, Victoria, Australia, 3144
Belgium
UZ Brussel Not yet recruiting
Brussel, Belgium, 1090
Cliniques Universitaires St-Luc Recruiting
Bruxelles, Belgium, 1200
CHU Sart-Tilman Recruiting
Liège, Belgium, 4000
Canada, Ontario
Toronto East General Hospital Not yet recruiting
East York, Ontario, Canada, M4C 3E7
William Osler Health Centre Recruiting
Etobicoke, Ontario, Canada, M9V 1R8
Canada, Quebec
Cite de La Sante de Laval; Hemato-Oncologie Recruiting
Laval, Quebec, Canada, H7M 3L9
China
Cancer Institute and Hospital Chinese Academy of Medical Sciences Not yet recruiting
Beijing, China, 100021
Beijing Cancer Hospital Not yet recruiting
Beijing, China, 100142
Chinese People's Liberation Army (PLA) General Hospital (301 Hospital) Not yet recruiting
Beijing, China, 100853
Affiliated Hospital of Guangdong Medical University Not yet recruiting
Guangdong, China, 524023
Guangdong General Hospital Not yet recruiting
Guangzhou City, China, 510080
Sun Yet-sen University Cancer Center Not yet recruiting
Guangzhou, China, 510060
The First Affiliated Hospital of Guangzhou Medical University Not yet recruiting
Guangzhou, China, 510120
Zhejiang Cancer Hospital Not yet recruiting
Hangzhou, China, 310022
Anhui Province Cancer Hospital Not yet recruiting
Hefei, China, 12345
Jiangsu Province Hospital Not yet recruiting
Nanjing, China, 210036
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China, 200032
Shanghai Pulmonary Hospital Not yet recruiting
Shanghai, China, 200433
Liaoning Provincial Cancer Hospital Not yet recruiting
Shengyang, China, 110042
The First Hospital of China Medical University Not yet recruiting
Shenyang, China, 110001
First Affiliated Hospital of Soochow University Not yet recruiting
Suzhou, China, 215006
France
Hôpital Universitaire Dupuytren Recruiting
Limoges, France, 87042
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes Recruiting
Lyon, France, 69008
Hôpital Saint Joseph; Oncologie Medicale Recruiting
Marseille, France, 13285
Centre Hospitalier de Mont de Marsan - Hopital Layne Recruiting
Mont De Marsan, France, 40024
Clinique Clémentville Recruiting
Montpellier, France, 34070
Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique Recruiting
Nantes, France, 44805
Centre Hospitalier Regional Sud Reunion; Service de Pneumologie Recruiting
Saint Pierre, France, 97448
Hopital d'Instruction des Armees de Begin Recruiting
Saint-Mande, France, 94160
Centre Hospitalier de Saint-Quentin; Pharmacie-URCC Recruiting
Saint-Quentin, France, 02321
Centre Paul Strauss Recruiting
Strasbourg, France, 67085
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer Recruiting
Toulon, France, 83000
Hopital d Instruction des Armees de Sainte Anne Recruiting
Toulon, France, 83041
Germany
Evang. Lungenklinik Berlin Klinik für Pneumologie Recruiting
Berlin, Germany, 13125
Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie Recruiting
Bielefeld, Germany, 33611
Augusta Kranken-Anstalt gGmbH Recruiting
Bochum, Germany, 44791
Stadtisches Klinikum Braunschweig Not yet recruiting
Braunschweig, Germany, 38114
Krankenhaus Nordwest Recruiting
Frankfurt am Main, Germany, 60488
LungenClinic Großhansdorf Recruiting
Großhansdorf, Germany, 22927
Krankenhaus Martha-Maria; Halle-Dolau gGmbH Recruiting
Halle, Germany, 06120
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Asklepios Klinik Harburg Recruiting
Hamburg, Germany, 21075
Thoraxklinik Heidelberg gGmbH Recruiting
Heidelberg, Germany, 69126
Lungenklinik Hemer Recruiting
Hemer, Germany, 58675
Universitätsklinikum des Saarlandes Recruiting
Homburg/Saar, Germany, 66421
Fachklinik für Lungenerkrankungen Recruiting
Immenhausen, Germany, 34376
Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz Recruiting
Koln, Germany, 51109
Klinik Loewenstein gGmbH; Onk & Pal Recruiting
Loewenstein, Germany, 74245
Klinikum Bogenhausen Recruiting
München, Germany, 81925
Gemeinschaftspraxis für Hämatologie und Onkologie Not yet recruiting
Münster, Germany, 48149
Pius-Hospital Recruiting
Oldenburg, Germany, 26121
Krankenhaus Barmherzige Bruder Regensburg Recruiting
Regensburg, Germany, 93049
Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc Recruiting
Shatin, Hong Kong
Hungary
Semmelweis Egyetem Recruiting
Budapest, Hungary, 1083
University of Pecs, I st Dept of Internal Medicine Recruiting
Pecs, Hungary, 7624
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int. Recruiting
Szolnok, Hungary, 5000
Tudogyogyintezet Torokbalint Recruiting
Torokbalint, Hungary, 2045
Israel
Assaf Harofeh Medical Center Recruiting
Beer Yaakov, Israel, 70300
Rambam Medical Center; Oncology Recruiting
Haifa, Israel, 4959381
Edith Wolfson Medical Center Recruiting
Holon, Israel, 58100
Meir Medical Center; Oncology Recruiting
Kfar-Saba, Israel, 4428164
Rabin Medical Center Recruiting
Petach Tikva, Israel, 49100
Chaim Sheba Medical Center; Oncology Dept Recruiting
Ramat Gan, Israel, 5262100
Kaplan Medical Center Recruiting
Rehovot, Israel, 76100
Tel Aviv Sourasky Medical Ctr; Oncology Recruiting
Tel Aviv, Israel, 6423906
Italy
Ospedale Clinicizzato SS Annunziata Recruiting
Chieti, Abruzzo, Italy, 66100
Azienda per l'Assistenza Sanitaria N° 5 - Friuli Occidentale; S.C. Oncologia Pordenone Recruiting
Pordenone, Friuli-Venezia Giulia, Italy, 33170
Policlinico Universitario Campus Biomedico Di Roma; U.O.Oncologia Medica Recruiting
Roma, Lazio, Italy, 00128
Asst Papa Giovanni XXIII; Oncologia Medica Recruiting
Bergamo, Lombardia, Italy, 24128
ASST Spedali Civili di Brescia Recruiting
Brescia, Lombardia, Italy, 25123
Ospedale San Raffaele Recruiting
Milano, Lombardia, Italy, 20132
Azienda Sanitaria Ospedaliera s. Croce e Carle; Oncologia Medica Recruiting
Cuneo, Piemonte, Italy, 12100
A.O.U. Maggiore della Carità Recruiting
Novara, Piemonte, Italy, 28100
Azienda Sanitaria Ospedaliera S Luigi Gonzaga Recruiting
Orbassano, Piemonte, Italy, 10043
Azienda Ospedaliera Città della Salute e della Scienza di Torino Recruiting
Torino, Piemonte, Italy, 10126
Presidio Ospedaliero Centrale Recruiting
Taranto, Puglia, Italy, 74100
Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi Recruiting
Palermo, Sicilia, Italy, 90127
Azienda Ospedaliero Universitaria Pisana Recruiting
Pisa, Toscana, Italy, 56100
Ospedale Santa Chiara; Oncologia Medica Recruiting
Trento, Trentino-Alto Adige, Italy, 38100
Ospedale Silvestrini Active, not recruiting
Perugia, Umbria, Italy, 06122
Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia Recruiting
Verona, Veneto, Italy, 37126
Japan
Aichi Cancer Center Hospital Recruiting
Aichi, Japan, 464-8681
Nagoya University Hospital Recruiting
Aichi, Japan, 466-8560
Hyogo Cancer Center Recruiting
Akashi, Japan, 673-0021
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital Recruiting
Bunkyo-ku, Japan, 113-8677
National Cancer Center East Not yet recruiting
Chiba, Japan, 277-8577
Kyushu University Hospital Recruiting
Fukuoka, Japan, 812-8582
Hiroshima University Hospital Recruiting
Hiroshima, Japan, 734-8551
National Hospital Organization Hokkaido Cancer Center Recruiting
Hokkaido, Japan, 003-0804
Kanagawa Cancer Center Recruiting
Kanagawa, Japan, 241-8515
Hospital of the University of Occupational and Environmental Health,Japan Recruiting
Kitakyushu-shi, Japan, 807-8556
Kumamoto University Hospital Recruiting
Kumamoto, Japan, 860-8556
Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Shikoku Cancer Center Recruiting
Matsuyama-shi, Japan, 791-0280
Sendai Kousei Hospital Recruiting
Miyagi, Japan, 980-0873
Niigata Cancer Center Hospital Recruiting
Niigata-shi, Japan, 951-8566
Okayama University Hospital Recruiting
Okayama, Japan, 700-8558
Saitama Cancer Center Recruiting
Saitama, Japan, 362-0806
Shizuoka Cancer Center Recruiting
Shizuoka, Japan, 411-8777
National Cancer Center Hospital Recruiting
Tokyo, Japan, 104-0045
Toranomon Hospital Recruiting
Tokyo, Japan, 105-8470
Juntendo University Hospital Recruiting
Tokyo, Japan, 113-8431
Tokyo Medical University Hospital Recruiting
Tokyo, Japan, 160-0023
Kyorin University Hospital Recruiting
Tokyo, Japan, 181-8611
Wakayama Medical University Hospital Recruiting
Wakayama, Japan, 641-8510
Korea, Republic of
Chonnam National University Hwasun Hospital Recruiting
Jeollanam-do, Korea, Republic of, 58128
The Catholic University of Korea St. Vincent's Hospital Recruiting
Suwon-si,, Korea, Republic of, 442-723
Netherlands
Jeroen Bosch Ziekenhuis Recruiting
'S Hertogenbosch, Netherlands, 5223 GZ
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis Terminated
Amsterdam, Netherlands, 1066 CX
Catharina ziekenhuis Recruiting
Eindhoven, Netherlands, 5623 EJ
Martini Ziekenhuis Recruiting
Groningen, Netherlands, 9728 MG
St. Antonius Ziekenhuis Nieuwegein Recruiting
Nieuwegein, Netherlands, 3430 EM
Universitair Medisch Centrum Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy Recruiting
Otwock, Poland, 05-400
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu Recruiting
Poznan, Poland, 60-569
Portugal
Centro Hospitalar E Universitário de Coimbra EPE Recruiting
Coimbra, Portugal, 3000-602
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.; Pneumologia Recruiting
Lisboa, Portugal, 1099-023
Centro Hospitalar de Lisboa Norte E.P.E - Hospital Pulido Valente Recruiting
Lisboa, Portugal, 1769-001
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe Recruiting
Porto, Portugal, 4200-072
Hospital de Sao Joao; Servico de Pneumologia Recruiting
Porto, Portugal, 4200
Romania
Oncology Center Sf. Nectarie Recruiting
Craiova, Romania, 200347
Institutul Regional de Oncologie Iasi; Clinica de Hematologie Recruiting
Iasi, Romania, 700483
Russian Federation
Principal Military Clinical Hospital n.a. N.N. Burdenko Recruiting
Moscow, Moskovskaja Oblast, Russian Federation, 105229
Scientific Research Institute of Oncology n.a. N.N. Petrov; Department of Oncogynecology Not yet recruiting
St. Petersburg, Sankt Petersburg, Russian Federation, 197758
Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod Completed
Nizhny Novgorod, Russian Federation, 603081
City Clinical Hospital #1; Dpt of Oncology Not yet recruiting
Novosibirsk, Russian Federation, 630047
Clinical Oncology Dispensary Not yet recruiting
Omsk, Russian Federation, 644013
Evromedservis LCC Not yet recruiting
Pushkin, Russian Federation, 196603
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology) Recruiting
Saint Petersburg, Russian Federation, 197758
City Clinical Oncology Dispensary 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
State Budgetary Institution of Health Volzhskii Regional Clinical Oncology Dispensary #3 Recruiting
Volzhskiy, Russian Federation, 404100
Spain
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia Recruiting
Santander, Cantabria, Spain, 39008
Hospital Universitario Son Espases Recruiting
Palma De Mallorca, Islas Baleares, Spain, 07014
Hospital Universitario de Canarias Recruiting
S. Cristobal de la Laguna, Tenerife, Spain, 38320
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Hospital Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Hospital Univ Vall d'Hebron; Servicio de Oncologia 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 Lucus Augusti; Servicio de Oncologia Recruiting
Lugo, Spain, 27003
Hospital Universitario La Paz Recruiting
Madrid, Spain, 280146
Hospital Ramon y Cajal; Servicio de Oncologia Recruiting
Madrid, Spain, 28034
Fundación Jimenez Díaz Recruiting
Madrid, Spain, 28040
Hosp. Clinico San Carlos Recruiting
Madrid, Spain, 28040
Hospital Universitario HM Sanchinarro-CIOCC; Oncología Médica Recruiting
Madrid, Spain, 28050
Hospital Clinico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Hospital Universitari i Politecnic La Fe de Valencia Recruiting
Valencia, Spain, 46026
Hosp Clinico Univ Lozano Blesa Recruiting
Zaragoza, Spain, 50009
Hospital Universitario Miguel Servet Recruiting
Zaragoza, Spain, 50009
Taiwan
Changhua Christian Hospital Recruiting
Changhua, Taiwan, 500
Kaohsiung Medical University Hospital; Department of Urology Recruiting
Kaohsiung City, Taiwan, 807
Chi Mei Medical Center Liou Ying Campus Recruiting
Liuying Township, Taiwan, 736
Chang Gung Memorial Hospital Chiayi Recruiting
Putzu, Taiwan, 613
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 407
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 00112
National Taiwan Uni Hospital Recruiting
Taipei, Taiwan, 100
Mackay Memorial Hospital Recruiting
Taipei, Taiwan, 104
Chang Gung Medical Foundation Linkou Branch Recruiting
Taoyuan City, Taiwan, 333
Ukraine
Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology Recruiting
Dnipropetrovsk, Ukraine, 49102
MIHC Kharkiv Regional Clinical Oncology Center; Chemotherapy Department #1 Recruiting
Kharkiv, Ukraine, 61070
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department Recruiting
Kryvyi Rih, Ukraine, 50048
Poltava Regional Clinical Oncology Dispensary of Poltava Regional Council; Thoracic department Terminated
Poltava, Ukraine, 36011
Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary Recruiting
Sumy, Ukraine, 40005
Transcarpathian Regional Clinical Oncology Dispensary; Chemotherapy Department Recruiting
Uzhhorod, Ukraine, 88014
Vinnytsia Regional Council Vinnytsia Regional Clinical Oncological Dispensary; Dpt of Chemotherapy Recruiting
Vinnytsia, Ukraine, 21029
MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology Recruiting
Zaporizhzhya, Ukraine, 69040
United Kingdom
Belfast City Hospital Not yet recruiting
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
Sarah Cannon Research Institute Terminated
London, United Kingdom, W1G 6AD
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02486718     History of Changes
Other Study ID Numbers: GO29527
2014-003205-15 ( EudraCT Number )
Study First Received: June 4, 2015
Last Updated: June 16, 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
Docetaxel
Vinorelbine
Cisplatin
Pemetrexed
Vinblastine
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

ClinicalTrials.gov processed this record on June 23, 2017