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A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02367794
First received: February 13, 2015
Last updated: June 12, 2017
Last verified: June 2017
  Purpose
This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.

Condition Intervention Phase
Squamous Non-Small Cell Lung Cancer Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody Drug: Carboplatin Drug: Nab-Paclitaxel Drug: Paclitaxel 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, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Tumor Gene Expression (tGE) Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 30 months after first participant enrolled ]
  • PFS as Determined by the Investigator Using RECIST v1.1 in the Intent-to-Treat (ITT) Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 30 months after first participant enrolled ]
  • Overall Survival (OS) in the ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after first participant enrolled ]

Secondary Outcome Measures:
  • OS in the tGE Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • PFS as Determined by the Investigator Using RECIST v1.1 in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 30 months after first participant enrolled ]
  • PFS as Determined by the Investigator Using RECIST v1.1 in the TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 30 months after first participant enrolled ]
  • OS in the TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • OS in the TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1 in the tGE Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • Duration of Response as Determined by the Investigator Using RECIST v1.1 in the tGE Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • Duration of Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • Percentage of Participants Alive at 1 and 2 Years in the tGE Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: 1 and 2 years ]
  • Percentage of Participants Alive at 1 and 2 Years in the ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: 1 and 2 years ]
  • Time to Deterioration(TTD) in Patient-reported Lung Cancer Symptoms Using European Organisation for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core (QLQ-C30) Subscales in the tGE Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • TTD in Patient-reported Lung Cancer Symptoms Using EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Subscales in the tGE Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after the first participant enrolled ]
  • TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-LC13 Symptom Subscales in the ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after the first participant enrolled ]
  • Change from Baseline in Patient-reported Lung Cancer Symptoms Score using the Symptoms in Lung Cancer (SILC) Scale Symptom Severity Score in the tGE Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 39 months after first participant enrolled ]
  • Change from Baseline in Patient-reported Lung Cancer Symptoms Score using the SILC Scale Symptom Severity Score in the ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 39 months after first participant enrolled ]
  • PFS as Determined by the Investigator Using RECIST v1.1 in the TC2/3 or IC2/3 Population (Arm A vs Arm B) [ Time Frame: Up to approximately 30 months after first participant enrolled ]
  • PFS as Determined by the Investigator Using RECIST v1.1 in the TC1/2/3 or IC1/2/3 Population (Arm A vs Arm B) [ Time Frame: Up to approximately 30 months after first participant enrolled ]
  • OS in the TC2/3 or IC2/3 Population (Arm A vs Arm B) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • OS in the TC1/2/3 or IC1/2/3 Population (Arm A vs Arm B) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • Percentage of Participants With Adverse Events [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • Percentage of Participants with Anti-therapeutic Antibody (ATA) Response to Atezolizumab [ Time Frame: Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle thereafter (up to 39 months), at treatment discontinuation (up to 39 months), and at 120 days after the last dose of atezolizumab (up to approximately 39 months, each cycle is 21 days) ]
    The predose samples will be collected on the same day of treatment administration.

  • Maximum Observed Serum Atezolizumab Concentration (Cmax) [ Time Frame: Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle up to 39 months; 30 minutes postdose on Day 1 of Cycles 1 and 3; at treatment discontinuation (up to 39 months), and at 120 days after last dose of atezolizumab (up to 39 months, each cycle is 21 days) ]
    The predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.

  • Minimum Observed Serum Atezolizumab Concentration (Cmin) [ Time Frame: Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle thereafter (up to 39 months), at treatment discontinuation (up to 39 months), and at 120 days after the last dose of atezolizumab (up to approximately 39 months, each cycle is 21 days) ]
    The predose samples will be collected on the same day of treatment administration.

  • Plasma Concentrations for Paclitaxel [ Time Frame: Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 180 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days) ]
  • Plasma Concentrations for Nab-Paclitaxel [ Time Frame: Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days) ]
  • Plasma Concentrations for Carboplatin [ Time Frame: Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 15 to 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days) ]

Estimated Enrollment: 1025
Actual Study Start Date: June 11, 2015
Estimated Study Completion Date: February 15, 2023
Estimated Primary Completion Date: January 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Atezolizumab + Paclitaxel + Carboplatin
The induction phase of the study will consist of four or six cycles; atezolizumab, paclitaxel, and carboplatin will be administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration is as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experience no further clinical benefit at any time during the induction phase will discontinue all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants will begin maintenance therapy with atezolizumab. Atezolizumab will be continued as long as there is a clinical benefit to the participant.
Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody
Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle.
Other Name: Tecentriq
Drug: Carboplatin
Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.
Drug: Paclitaxel
Paclitaxel 200 mg/m^2 IV on Day 1 of each 21-day cycle for 4 or 6 cycles. Participants of Asian race/ethnicity will be administered paclitaxel 175 mg/m^2 IV.
Experimental: Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin
The induction phase of the study will consist of four or six cycles; atezolizumab and carboplatin will be administered on Day 1 of each 21-day cycle. Nab-Paclitaxel will be administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration is as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experience no further clinical benefit at any time during the induction phase will discontinue all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants will begin maintenance therapy with atezolizumab. Atezolizumab will be continued as long as there is a clinical benefit to the participant.
Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody
Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle.
Other Name: Tecentriq
Drug: Carboplatin
Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.
Drug: Nab-Paclitaxel
Nab-paclitaxel 100 milligrams per meter squared (mg/m^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles.
Active Comparator: Arm C: Nab-Paclitaxel + Carboplatin
The induction phase of the study will consist of four or six cycles; carboplatin will be administered on Day 1 of each 21-day cycle, nab-paclitaxel will be administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration is as follows: nab-paclitaxel, then carboplatin. Participants who experience disease progression at any time during the induction phase will discontinue all study treatment. In the maintenance phase, participants will receive best supportive care.
Drug: Carboplatin
Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.
Drug: Nab-Paclitaxel
Nab-paclitaxel 100 milligrams per meter squared (mg/m^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles.

  Eligibility

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

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC
  • Previously obtained archival tumor tissue or tissue obtained from biopsy at screening
  • Measurable disease as defined by RECIST v1.1
  • Adequate hematologic and end organ function

Exclusion Criteria:

  • Active or untreated central nervous system (CNS) metastasis
  • 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 Computed Tomography (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 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), 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: NCT02367794

  Hide Study Locations
Locations
United States, Arizona
Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224
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
Kaiser Permanente Oakland Medical Center
Oakland, California, United States, 94611
Kaiser Permanente Medical Center - Roseville
Roseville, California, United States, 95661
Kaiser Permanente - Sacramento Medical Center and Medical Offices
Sacramento, California, United States, 95825
Southern CA Permanente Med Grp
San Diego, California, United States, 92120
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
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, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, Connecticut
Danbury Hospital
Danbury, Connecticut, United States, 06810
United States, Florida
Holy Cross Hospital Inc
Fort Lauderdale, Florida, United States, 33308
SCRI Florida Cancer Specialists South
Fort Myers, Florida, United States, 33916
University of Miami Medical Center
Miami, Florida, United States, 33136
Florida Cancer Specialists
Palm Beach Gardens, Florida, United States, 33410
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States, 34952
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
Saint Petersburg, Florida, United States, 33705
SCRI Florida Cancer Specialists East
Tallahassee, Florida, United States, 32308
United States, Georgia
University Cancer & Blood Center, LLC
Athens, Georgia, United States, 30607
Northwest Georgia Oncology Centers P.C.
Carlton, Georgia, United States, 30117
Suburban Hematology / Oncology Associates
Lawrenceville, Georgia, United States, 30046
Central Georgia Cancer Care PC
Macon, Georgia, United States, 31201
Southeastern Regional Medical Center, Inc.
Newnan, Georgia, United States, 30265
United States, Hawaii
University of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Joliet Oncology-Hematology; Associates, Ltd.
Joliet, Illinois, United States, 60435
Loyola University Med Center
Maywood, Illinois, United States, 60153
Oncology Specialists, S.C.
Park Ridge, Illinois, United States, 60068
Quincy Medical Group
Quincy, Illinois, United States, 62301
Southern Illinois University, Simmons Cancer Institute
Springfield, Illinois, United States, 62794
United States, Indiana
Fort Wayne Med Oncology & Hematology Inc
Fort Wayne, Indiana, United States, 46845
United States, Iowa
Hematology-Oncology; Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
Siouxland Hematology/Oncology
Sioux City, Iowa, United States, 51101
United States, Kentucky
ARH Regional Medical Center
Hazard, Kentucky, United States, 41701
Lahey Clinic Med Ctr
Lexington, Kentucky, United States, 02421
Norton Cancer Institute
Louisville, Kentucky, United States, 40402
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maine
New England Cancer Specialists
Scarborough, Maine, United States, 04074
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Southcoast Health System; Southcoast Centers For Cancer Care
Fairhaven, Massachusetts, United States, 02719
United States, Michigan
St. Joseph Mercy Health System
Ann Arbor, Michigan, United States, 48106
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
St. Luke's Regional Cancer Center
Duluth, Minnesota, United States, 55805
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, Montana
Billings Clinic
Billings, Montana, United States, 59102
United States, Nevada
Va Sierra Nevada Health Care System
Reno, Nevada, United States, 89502
United States, New Jersey
Regional Cancer Care Associates
Cherry Hill, New Jersey, United States, 08003
Valley Hospital; Oncology Research
Paramus, New Jersey, United States, 07652
Regional Cancer Care Associates LLC
Sewell, New Jersey, United States, 08080
United States, New York
Clinical Research Alliance
Lake Success, New York, United States, 11042
Monter Cancer Center
Lake Success, New York, United States, 11042
United States, North Carolina
W.G. Bill Hefner VA Medical Center
Salisbury, North Carolina, United States
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45203-0542
Mark H. Zangmeister Center
Columbus, Ohio, United States, 43219
Oncology Hematology Care, Inc.
Hamilton, Ohio, United States, 45103
Mercy St Anne Hospital
Toledo, Ohio, United States, 43623
United States, Oregon
Bend Memorial Clinic
Bend, Oregon, United States, 97701
St. Charles Medical Center Bend; Cancer Care Of The Cascades
Bend, Oregon, United States, 97701
Oregon Health & Science Uni
Portland, Oregon, United States, 97239
United States, Pennsylvania
St. Luke's Cancer Care Associates
Bethlehem, Pennsylvania, United States, 18015
Maryland Oncology Hematology (Lanham) - USOR
Gettysburg, Pennsylvania, United States, 17325
Pinnacle Health
Harrisburg, Pennsylvania, United States, 17110
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17607
Allegheny Cancer Center
Pittsburgh, Pennsylvania, United States, 15212
Univ of Pittsburgh Medical Ctr
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States, 37404
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37920
United States, Texas
SCRI The Center For Cancer and Blood Disorders
Denton, Texas, United States, 76210
Longview Cancer Center
Longview, Texas, United States, 75601
Cancer Care Network of South Texas - SAT & BC
San Antonio, Texas, United States, 78217
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Virginia Cancer Institute
Richmond, Virginia, United States, 23226
Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24014
United States, Washington
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
Medical Oncology Associates
Spokane, Washington, United States, 99208
United States, West Virginia
West Virginia University; Mary Babb Randolph Can Ctr
Morgantown, West Virginia, United States, 26506
Argentina
Instituto Alexander Fleming
Buenos Aires, Argentina, 1426
Fundacion Sanatorio Guemes
Buenos Aires, Argentina, C1180AAX
Fundacion Investigar
Caba, Argentina, C1025ABI
Sanatorio Allende
Cordoba, Argentina, X5000JHQ
Instituto Medico Rio Cuarto
Córdoba, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, Argentina, F5300COE
Clínica Pergamino
Pergamino, Argentina, 2700
COIBA
Provincia de Buenos Aires, Argentina, B1884BBF
Hospital Provincial del Centenario
Rosario, Argentina, 2000
Sanatorio Britanico
Rosario, Argentina, 2000
Fundacion Koriza
Santa Rosa, Argentina, 6300
Centro de Investigacion; Clinica - Clinica Viedma S.A.
Viedma, Argentina, R8500ACE
Australia, New South Wales
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Prince of Wales Hospital; Oncology
Randwick, New South Wales, Australia, 2031
Nepean Cancer Care Centre
Sydney, New South Wales, Australia, 2747
Calvary Mater Newcastle; Medical Oncology
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Icon Cancer Care South Brisbane
South Brisbane, Queensland, Australia, 4101
Townsville Hospital
Townsville, Queensland, Australia, 4810
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Tasmania
Launceston General Hospital
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Frankston Hospital
Frankston, Victoria, Australia, 3199
Austin Health
Heidelberg, Victoria, Australia, 3084
Cabrini Hospital Malvern
Malvern, Victoria, Australia, 3144
The Alfred Hospital
Prahan, Victoria, Australia, 3181
Sunshine Hospital
St Albans, Victoria, Australia, 3021
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Austria
Paracelsus Medizinische Privatuniversität
Salzburg, Austria, 5020
Klinikum Wels-Grieskirchen
Wels, Austria, 4600
Belgium
Cliniques Universitaires St-Luc
Bruxelles, Belgium, 1200
CHU Sart-Tilman
Liège, Belgium, 4000
Clinique Ste-Elisabeth
Namur, Belgium, 5000
Werken Glorieux VZW
Ronse, Belgium, 9600
GasthuisZusters Antwerpen
Wilrijk, Belgium, 2610
Brazil
Cetus Hospital Dia Oncologia
Belo Horizonte, MG, Brazil, 30150-270
Cenantron - Centro Avancado de Tratamento Oncologico
Belo Horizonte, MG, Brazil, 30150-320
Instituto Do Cancer Delondrina; Unidade De Pesquisa Clinica
Londrina, PR, Brazil, 86 015 520
Liga Norte Riograndense Contra O Câncer
Natal, RN, Brazil, 59040150
IPCEM; Instituto de Pesquisa de Estudos Multicêntricos
Caxias do Sul, RS, Brazil, 95070-560
Hospital Bruno Born
Lajeado, RS, Brazil, 95900-000
Hospital das Clinicas - UFRGS
Porto Alegre, RS, Brazil, 90035-003
Hospital Mae de Deus
Porto Alegre, RS, Brazil, 90470-340
Fundação Pio XII Hospital de Câncer de Barretos
Barretos, SP, Brazil, 14784-400
Instituto Ribeirãopretano de Combate Ao Câncer; Centro Especializado De Oncologia
Ribeirão Preto, SP, Brazil, 14015-130
Hospital de Base de Sao Jose do Rio Preto
Sao Jose do Rio Preto, SP, Brazil, 15090-000
Fundacao Antonio Prudente
Sao Paulo, SP, Brazil, 01509-900
UNIFESP Universidade Federal de Sao Paulo EPM
São Paulo, SP, Brazil, 04020-050
Bulgaria
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
Plovdiv, Bulgaria, 4000
Multiprofile Hospital for Active Treatment Serdika EOOD
Sofia, Bulgaria, 1303
Military Medical Academy - MHAT - Sofia
Sofia, Bulgaria, 1606
Specialized Hospital for Active Treatment of Oncology Diseases - Sofia city chemotherapy Department
Sofia, Bulgaria, 1784
Canada, Ontario
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada, L4M 6M2
William Osler Health Centre
Etobicoke, Ontario, Canada, M9V 1R8
Lakeridge Health Center
Oshawa, Ontario, Canada, L1J 2J2
Canada, Quebec
Cite de La Sante de Laval; Hemato-Oncologie
Laval, Quebec, Canada, H7M 3L9
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, Canada, H1T 2M4
Hôpital du Sacré-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
St-Jerome Medical Research Inc
St. Jerome, Quebec, Canada, J7Z 5T3
Chile
Clinica Santa Maria
Santiago, Chile, 0
Health & Care SPA
Santiago, Chile, 7500006
Hospital Clinico de La Universidad de Chile J.J.A.; Oncologia
Santiago, Chile, 8380456
Instituto Clínico Oncolo gico del Sur
Temuco, Chile, 4810469
France
Centre Georges François Leclerc
Dijon, France, 21000
CHU de Grenoble
Grenoble, France, 38043
Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd
Le Mans, France, 72000
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
Lyon, France, 69008
Clinique Clémentville
Montpellier, France, 34070
Hopital de La Source
Orleans, France, 45067
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Hopital de Pontchaillou; Service de Pneumologie
Rennes, France, 35033
Service de Pneumologie Centre Hospitalier Régional La Réunion Site Felix Guyon
Saint Denis Cedex, France, 97405
Centre Hospitalier Regional Sud Reunion; Service de Pneumologie
Saint Pierre, France, 97448
CH de Saint Quentin
Saint Quentin, France, 2100
Hôpital d'Instruction des Armées de Sainte Anne; Service Pharmacie Essais Cliniques
Toulon Cedex 9, France, 83800
Germany
Hämatologisch-onkologische Praxis Dr. med. - Brudler, - Heinrich, - Bangerter
Augsburg, Germany, 86150
Charite - Universitätsmedizin Berlin
Berlin, Germany, 10117
Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie
Bielefeld, Germany, 33611
Augusta Kranken-Anstalt gGmbH
Bochum, Germany, 44791
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, Germany, 01307
St. Elisabethen Krankenhaus
Frankfurt am Main, Germany, 60487
Franziskus-Hospital Harderberg
Georgsmarienhutte, Germany, 49124
Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie
Gerlingen, Germany, 70839
LungenClinic Großhansdorf
Großhansdorf, Germany, 22927
Krankenhaus Martha-Maria; Halle-Dolau gGmbH
Halle, Germany, 06120
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Asklepios Klinik Harburg
Hamburg, Germany, 21075
Hämato-Onkologie Hamburg
Hamburg, Germany, 21075
Lungenklinik Hemer
Hemer, Germany, 58675
Universität Des Saarlandes; Klinik für Innere Medizin V
Homburg, Germany, 66421
Fachklinik für Lungenerkrankungen
Immenhausen, Germany, 34376
Kliniken der Stadt Koln gGmbH
Koln, Germany, 51109
Klinik Loewenstein gGmbH; Onk & Pal
Loewenstein, Germany, 74245
Johannes Wesling Klinikum Minden
Minden, Germany, 32429
Universitätsklinikum Münster; Pädiatrische Hämatologie und Onkologie
Munster, Germany, 48149
Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie
München, Germany, 81925
Krankenhaus Barmherzige Bruder Regensburg
Regensburg, Germany, 93049
Klinikum der Universität Regensburg
Regensburg, Germany, 93053
Stiftung Mathias-Spital Rheine
Rheine, Germany, 48431
Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie
Villingen-Schwenningen, Germany, 78052
Israel
Soroka Medical Center
Beer Sheva, Israel, 8410101
Assaf Harofeh Medical Center
Beer Yaakov, Israel, 70300
Hadassah University Hospital - Ein Kerem
Jerusalem, Israel, 9112001
Meir Medical Center; Oncology
Kfar-Saba, Israel, 4428164
Galilee Medical Center
Nahariya, Israel, 22100
Rabin Medical Center
Petah Tikva, Israel, 4941492
Chaim Sheba Medical Center; Oncology Dept
Ramat Gan, Israel, 5262100
Rambam Health Corporation; Oncology Institute
Rambam, Israel, 3525408
Kaplan Medical Center
Rehovot, Israel, 76100
Tel Aviv Sourasky Medical Ctr; Oncology
Tel Aviv, Israel, 6423906
Italy
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
Avellino, Campania, Italy, 83100
AORN A Cardarelli
Napoli, Campania, Italy, 80131
Azienda Ospedaliero Universitaria Seconda Università degli Studi di Napoli; Farmacia Centralizzata
Napoli, Campania, Italy, 80131
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Napoli, Campania, Italy, 80131
Azienda Ospedaliera San Camillo Forlanini
Roma, Lazio, Italy, 00151
ASL 3 Genovese; DSM
Genova, Liguria, Italy, 16147
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardia, Italy, 27100
A.O.U. Maggiore della Carità
Novara, Piemonte, Italy, 28100
IRCCS Giovanni Paolo II Istituto Oncologico
Bari, Puglia, Italy, 70124
Policlinico Vittorio Emanuele
Catania, Sicilia, Italy, 95123
Ospedale Civile - Livorno
Livorno, Toscana, Italy, 57124
Azienda Ospedaliero Universitaria Pisana
Pisa, Toscana, Italy, 56100
Ospedale Silvestrini
Perugia, Umbria, Italy, 06122
Japan
Aichi Cancer Center Hospital; Respiratory Medicine
Aichi, Japan, 464-8681
Nagoya University Hospital; Respiratory Medicine
Aichi, Japan, 466-8560
National Cancer Center Hospital East; Thoracic Oncology
Chiba, Japan, 277-8577
National Hospital Organization Shikoku Cancer Center; Internal Medicine
Ehime, Japan, 791-0280
National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine
Fukuoka, Japan, 810-8563
Kyushu University Hospital; Respiratory
Fukuoka, Japan, 812-8582
Institute of Biomedical Research and Innovation Hospital; Integrated Oncology
Hyogo, Japan, 650-0047
National Hospital Organization Himeji Medical Center
Hyogo, Japan, 670-8520
Hyogo Cancer Center; Thoracic Oncology
Hyogo, Japan, 673-8553
Ibaraki Prefectural Central Hospital; Division of respiratory
Ibaraki, Japan, 309-1793
Kanagawa Cancer Center;Thoracic Oncology
Kanagawa, Japan, 241-8515
Kyoto University Hospital, Respiratory Medicine
Kyoto, Japan, 606-8507
Sendai Kousei Hospital; Pulmonary Medicine
Miyagi, Japan, 980-0873
Niigata University Medical & Dental Hospital; Respiratory Medicine and Infectious Disease
Niigata, Japan, 951-8520
Okayama University Hospital; Respiratory and Allergy Medicine
Okayama, Japan, 700-8558
Osaka International Cancer Institute; Thoracic Oncology
Osaka, Japan, 541-8567
Osaka City Uni Hospital; Respiratory Medicine
Osaka, Japan, 545-8586
Kansai Medical university Hospital; Thoracic Oncology
Osaka, Japan, 573-1191
Osaka Habikino Medical Center
Osaka, Japan, 583-8588
Saitama Cancer Center; Thoracic Oncology
Saitama, Japan, 362-0806
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai-shi, Japan, 591-8555
Shizuoka Cancer Center; Thoracic Oncology
Shizuoka, Japan, 411-8777
National Cancer Center Hospital; Thoracic Medical Oncology
Tokyo, Japan, 104-0045
Tokyo Medical University Hospital; Dept of Surgery
Tokyo, Japan, 160-0023
Latvia
Riga East Clinical University Hospital Latvian Oncology Centre
Riga, Latvia, LV-1079
Pauls Stradins Clinical University Hospital
Riga, Latvia, LV1002
Lithuania
National Cancer Institute
Vilnius, Lithuania, 08660
Mexico
Centro Universitario Contra El Cancer
Monterrey, Mexico, 64020
Cancerología
Queretaro, Mexico, 76090
Netherlands
VU Medisch Centrum; VU University Medical Center
Amsterdam, Netherlands, 1007 MB
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands, 1066 CX
Amphia Ziekenhuis; Afdeling Longziekten
Breda, Netherlands, 4818 CK
Ziekenhuis Gelderse Vallei
EDE, Netherlands, 6716 RP
Catharina Hospital; Afdeling Longgeneeskunde en Tuberculose
Eindhoven, Netherlands, 5623 EJ
Spaarne Gasthuis; Spaarne Ziekenhuis
Hoofddorp, Netherlands, 2134 TM
Maastricht University Medical Center
Maastricht, Netherlands, 6229 HX
St. Antonius Ziekenhuis; R&D Long
Nieuwegein, Netherlands, 3435 CM
Peru
Centro Medico Monte Carmelo
Arequipa, Peru, 04001
Centro Especializado de Enfermedades Neoplásicas
Arequipa, Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, Peru, 34
Hospital Nacional Guillermo Almenara Irigoyen ESSALUD
Lima, Peru, Lima 13
Instituto Regional de Enfermedades Neoplásicas Del Norte
Trujillo, Peru, 12345
Portugal
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra, Portugal, 3000-602
IPO de Lisboa; Servico de Pneumologia
Lisboa, Portugal, 1099-023
Hospital Pulido Valente; Servico de Pneumologia
Lisboa, Portugal, 1796-001
Centro Hospitalar do Porto - Hospital de Santo António
Porto, Portugal, 4099-001
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
Porto, Portugal, 4200-072
Hospital de Sao Joao; Servico de Pneumologia
Porto, Portugal, 4200
Russian Federation
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
Russian Oncology Research Center n.a. N.N. Blokhin
Moscow, Russian Federation, 115478
Clinical Oncology Dispensary
Omsk, Russian Federation, 644013
City Clinical Oncology Dispensary
Saint-Petersburg, Russian Federation, 197022
Russian Medical Military Academy n.a. S.M. Kirov; Thoracic Surgery Department
St. Petersburg, Russian Federation, 194044
Volgograd Regional Clinical Oncology Dispensary
Volgograd, Russian Federation, 400138
Singapore
National University Hospital
Singapore, Singapore, 119074
National Cancer Centre
Singapore, Singapore, 169610
Slovakia
Univerzitna nemocnica Bratislava
Bratislava, Slovakia, 813 69
Narodny onkologicky ustav
Bratislava, Slovakia, 833 01
POKO Poprad s.r.o.
Poprad, Slovakia, 058 01
Spain
Instituto Catalan de Oncologia de Hospitalet (ICO); Servicio de Farmacia
L'Hospitalet de Llobregat, Barcelona, Spain, 08007
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, Spain, 08208
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Santander, Cantabria, Spain, 39008
Hospital Universitario Son Espases
Palma De Mallorca, Islas Baleares, Spain, 07014
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain, 15006
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
Hospital Nuestra Senora de Valme
Seville, Sevilla, Spain, 41014
Hospital Universitario de Canarias
S. Cristobal de la Laguna, Tenerife, Spain, 38320
Hospital del Mar
Barcelona, Spain, 08003
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, Spain, 08041
Hospital Universitario Reina Sofia
Cordoba, Spain
Hospital Lucus Augusti; Servicio de Oncologia
Lugo, Spain, 27003
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, Spain, 28007
Hospital Universitario La Paz
Madrid, Spain, 280146
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, Spain, 28034
Fundación Jimenez Díaz
Madrid, Spain, 28040
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Madrid, Spain, 28050
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Switzerland
Universitatsspital Bern; Klinik und Poliklinik fur Medizinische Onkologie
Bern, Switzerland, 3010
Taiwan
Changhua Christian Hospital; Hematology-Oncology
Changhua, 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
China Medical University Hospital
Taichung, Taiwan, 40447
Taichung Veterans General Hospital
Taichung, Taiwan, 407
Taipei Veterans General Hospital
Taipei, Taiwan, 00112
National Taiwan Uni Hospital
Taipei, Taiwan, 100
Mackay Memorial Hospital
Taipei, Taiwan, 104
Cheng Hsin General Hospital
Taipei, Taiwan, 112
Tri-Service General Hospital
Taipei, Taiwan, 11490
Chang Gung Medical Foundation Linkou Branch
Taoyuan City, Taiwan, 333
Ukraine
Municipal Noncommercial Institution Regional Center of Oncology; Chemotherapy Department #1
Kharkiv, Kharkiv Governorate, Ukraine, 61070
Vinnytsya Regional Clinical Oncology Dispensary
Vinnytsya, Podolia Governorate, Ukraine, 21029
Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary; Surgery Department #1
Chernivtsi, Ukraine, 58013
Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology
Dnipropetrovsk, Ukraine, 49102
SI Institute of Medical Radiology n.a. S.P. Hryhoriev of NAMS of Ukraine
Kharkiv, Ukraine, 61024
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department
Kryvyi Rih, Ukraine, 50048
Treatment and Prevention Institution Volyn Regional Oncology Dispensary
Lutsk, Ukraine, 43018
Lviv State Oncology Regional Treatment and Diagnostic Centre
Lviv, Ukraine, 79031
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
Uzhgorod Central City Clinical Hospital
Uzhhorod, Ukraine
MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology
Zaporizhzhya, Ukraine, 69040
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02367794     History of Changes
Other Study ID Numbers: GO29437
2014-003208-59 ( EudraCT Number )
Study First Received: February 13, 2015
Last Updated: June 12, 2017

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2017