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A Study of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower150)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02366143
First received: February 12, 2015
Last updated: June 9, 2017
Last verified: June 2017
  Purpose
This randomized, open-label study will evaluate the safety and efficacy of atezolizumab in combination with carboplatin + paclitaxel with or without bevacizumab compared with treatment with carboplatin + paclitaxel + bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants will be randomized in a 1:1:1 ratio to Arm A (Atezolizumab + Carboplatin + Paclitaxel), Arm B (Atezolizumab + Carboplatin + Paclitaxel + Bevacizumab), or Arm C (Carboplatin + Paclitaxel + Bevacizumab).

Condition Intervention Phase
Non-Small Cell Lung Cancer Drug: Atezolizumab Drug: Bevacizumab Drug: Carboplatin Drug: Paclitaxel Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-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) for 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: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • PFS as Determined by the Investigator Using RECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • PFS as Determined by the Investigator Using RECIST v1.1 for Intent-to-Treat (ITT) Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • Overall Survival (OS) for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until death (up to approximately 44 months) ]
  • OS for ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until death (up to approximately 44 months) ]

Secondary Outcome Measures:
  • Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 for ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using RECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using RECIST v1.1 for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 for ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • DOR as Determined by the Investigator Using RECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • DOR as Determined by the Investigator Using RECIST v1.1 for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • Time to Response (TTR) as Determined by the Investigator Using RECIST v1.1 for ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • TTR as Determined by the Investigator Using ECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • TTR as Determined by the Investigator Using RECIST v1.1 for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • Time in Response (TIR) as Determined by the Investigator Using RECIST v1.1 for ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • TIR as Determined by the Investigator Using RECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • TIR as Determined by the Investigator Using RECIST v1.1 for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • PFS as Determined by the Independent Review Facility Using RECIST v1.1 for ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • PFS as Determined by the Independent Review Facility Using RECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • PFS as Determined by the Independent Review Facility Using RECIST v1.1 for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • Percentage of Participants Who are Alive at Year 1 and 2 [ Time Frame: Year 1 and 2 ]
  • Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms as Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score for ITT Population [ Time Frame: Baseline up to approximately 44 months ]
    The comparison for EORTC QLQ-C30 score will be done as Arm A vs Arm C, and Arm B vs Arm C.

  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC QLQ-C30 Score for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 44 months ]
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC QLQ-C30 Score for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 44 months ]
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score for ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 44 months ]
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC QLQ-LC13 Score for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 44 months ]
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC QLQ-LC13 Score for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 44 months ]
  • Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale for ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 44 months ]
  • Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the SILC Scale for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 44 months ]
  • Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the SILC Scale for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 44 months ]
  • PFS as Determined by the Investigator using RECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm B) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • PFS as Determined by the Investigator Using RECIST v1.1 for TC2/3 or IC2/3 Population (Arm A vs Arm B) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • PFS as Determined by the Investigator Using RECIST v1.1 for ITT Population (Arm A vs Arm B) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • OS for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm B) [ Time Frame: Baseline until death (up to approximately 44 months) ]
  • OS for ITT Population (Arm A vs Arm B) [ Time Frame: Baseline until death (up to approximately 44 months) ]
  • Maximum Observed Serum Concentration (Cmax) of Atezolizumab [ Time Frame: Arm A and B: Predose on Day (D) 1 of Cycle (Cy) 1,2,3,4,8,16 & every 8 cycles thereafter (1 Cy=21 days), 0.5 hours (h) post-infusion on D1 of Cy1,3, at treatment discontinuation & at 120 days after last atezolizumab dose (up to approximately 44 months) ]
    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 Concentration (Cmin) of Atezolizumab Prior to Infusion [ Time Frame: Arm A and B: Predose (same day of treatment administration) on D1 of Cy1,2,3,4,8,16 and every 8 cycles thereafter (1 Cy=21 days), at treatment discontinuation and at 120 days after last atezolizumab dose (up to approximately 44 months) ]
  • Plasma Concentrations for Carboplatin [ Time Frame: Arm A, B and C: Predose (same day of treatment administration), 5-10 minutes before end of carboplatin infusion, 1 h after carboplatin infusion (infusion duration=15 to 30 minutes) on D1 of Cy1,3 (1Cy=21 days) ]
  • Plasma Concentrations for Paclitaxel [ Time Frame: Arm A, B and C: Predose (same day of treatment administration), 5-10 minutes before end of paclitaxel infusion, 1 h after paclitaxel infusion (infusion duration=3 h) on D1 of Cy1,3 (1Cy=21 days) ]
  • Cmax of Bevacizumab [ Time Frame: Arm B and C: Predose (same day of treatment administration), 0.5 h after bevacizumab infusion (infusion duration=30 to 90 minutes) on D1 of Cy1,3 (1 Cy=21 days), at bevacizumab discontinuation (up to approximately 44 months) ]
  • Cmin of Bevacizumab [ Time Frame: Arm B and C: Predose (same day of treatment administration) on D1 of Cy1,3 (1 Cy=21 days), at bevacizumab discontinuation (up to approximately 44 months) ]
  • Percentage of Participants With Adverse Events [ Time Frame: Baseline up to approximately 44 months ]
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab [ Time Frame: Arm A and B: Predose (same day of treatment administration) on D1 of Cy1,2,3,4,8,16, and every 8 cycles thereafter (1 Cy=21 days), at treatment discontinuation and at 120 days after last atezolizumab dose (up to approximately 44 months) ]

Enrollment: 1202
Actual Study Start Date: March 31, 2015
Estimated Study Completion Date: July 15, 2018
Estimated Primary Completion Date: November 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A (Atezolizumab + Paclitaxel + Carboplatin)
Participants will receive intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants will receive IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Drug: Atezolizumab
Atezolizumab will be administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until loss of clinical benefit.
Other Name: MPDL3280A, Tecentriq
Drug: Carboplatin
Carboplatin will be administered at area under the concentration-time curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.
Drug: Paclitaxel
Paclitaxel will be administered as IV infusion at a dose of 200 milligrams per square meter (mg/m^2) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.
Experimental: Arm B (Atezolizumab + Bevacizumab + Paclitaxel + Carboplatin)
Participants will receive IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants will receive IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Drug: Atezolizumab
Atezolizumab will be administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until loss of clinical benefit.
Other Name: MPDL3280A, Tecentriq
Drug: Bevacizumab
Bevacizumab will be administered as IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle until progressive disease, unacceptable toxicity, or death.
Drug: Carboplatin
Carboplatin will be administered at area under the concentration-time curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.
Drug: Paclitaxel
Paclitaxel will be administered as IV infusion at a dose of 200 milligrams per square meter (mg/m^2) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.
Active Comparator: Arm C (Bevacizumab + Paclitaxel + Carboplatin)
Participants will receive IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants will receive IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Drug: Bevacizumab
Bevacizumab will be administered as IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle until progressive disease, unacceptable toxicity, or death.
Drug: Carboplatin
Carboplatin will be administered at area under the concentration-time curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.
Drug: Paclitaxel
Paclitaxel will be administered as IV infusion at a dose of 200 milligrams per square meter (mg/m^2) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.

  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, Stage IV non-squamous NSCLC
  • Participants with no prior treatment for Stage IV non-squamous NSCLC
  • Known PD-L1 status as determined by immunohistochemistry (IHC) assay performed on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
  • Measurable disease as defined by RECIST v1.1
  • Adequate hematologic and end organ function

Exclusion Criteria:

Cancer-Specific Exclusions:

  • Active or untreated central nervous system (CNS) metastases
  • 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

General Medical Exclusions:

  • 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
  • Severe infection within 4 weeks prior to randomization
  • Significant cardiovascular disease

Exclusion Criteria Related to Medications:

  • Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti-PD-L1 therapeutic antibodies
  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: NCT02366143

  Hide Study Locations
Locations
United States, Arizona
Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224
Arizona Oncology Associates
Flagstaff, Arizona, United States, 86001
Premiere Oncology
Scottsdale, Arizona, United States, 85258
United States, California
Compassionate Cancer Care Medical Group, Inc
Corona, California, United States, 92882
Marin Cancer Care Inc
Greenbrae, California, United States, 94904
Scripps Health
La Jolla, California, United States, 92037
Chao Family Comprehensive Cancer Center UCI
Orange, California, United States, 92868
Southern CA Permanente Med Grp
San Diego, California, United States, 92120
VA San Diego Healthcare System
San Diego, California, United States, 92161
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
Kaiser Permanente
Lonetree, Colorado, United States, 80124
United States, Connecticut
Danbury Hospital
Danbury, Connecticut, United States, 06810
Yale Cancer Center
New Haven, Connecticut, United States, 06520
United States, Florida
University Cancer Institute
Boynton Beach, Florida, United States, 33426
Holy Cross Hospital Inc
Fort Lauderdale, Florida, United States, 33308
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
Mayo Clinic-Jacksonville
Jacksonville, Florida, United States, 32224
Cancer Specialists of North Florida - Baptist South
Jacksonville, Florida, United States, 32258
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States, 34952
United States, Georgia
Piedmont Cancer Institute, PC
Atlanta, Georgia, United States, 30318
Central Georgia Cancer Care PC
Macon, Georgia, United States, 31201
United States, Hawaii
Straub Clinic & Hospital; Oncology
Honolulu, Hawaii, United States, 96813
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Univ of Chicago
Chicago, Illinois, United States, 60637
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Oncology Specialists, S.C.
Park Ridge, Illinois, United States, 60068
United States, Iowa
Hematology-Oncology; Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
United States, Kentucky
Norton Cancer Institute
Louisville, Kentucky, United States, 40402
United States, Maine
New England Cancer Specialists
Scarborough, Maine, United States, 04074
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States, 21044
Frederick Memorial Health System
Frederick, Maryland, United States, 21701
United States, Michigan
St. Joseph Mercy Health System
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
St. Luke's Regional Cancer Center
Duluth, Minnesota, United States, 55805
Park Nicolett - Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States, 55426
United States, Missouri
St. Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Mercy; Chub O'Reilly Cancer Center
Springfield, Missouri, United States, 65804
United States, Montana
Billings Clinic
Billings, Montana, United States, 59102
Montana Cancer Specialists
Missoula, Montana, United States, 59802
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89014
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
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Canton-Potsdam Hospital
Potsdam, New York, United States, 13676
Montefiore Medical Center
The Bronx, New York, United States, 10467
United States, North Carolina
First Health of the Carolinas
Pinehurst, North Carolina, United States, 28374
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45203-0542
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
Willamette Valley Cancer Insitute and Research Center
Springfield, Oregon, United States, 97477
United States, Pennsylvania
St. Luke's Cancer Care Associates
Bethlehem, Pennsylvania, United States, 18015
Allegheny Cancer Center
Pittsburgh, Pennsylvania, United States, 15212
Univ of Pittsburgh Medical Ctr
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Charleston Hematology Oncology
Charleston, South Carolina, United States, 29414
Carolina Blood and Cancer Care
Lancaster, South Carolina, United States, 29720
United States, Tennessee
West Clinic
Germantown, Tennessee, United States, 38138
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37920
United States, Texas
Houston Methodist Cancer Center
Houston, Texas, United States, 77030
Longview Cancer Center
Longview, Texas, United States, 75601
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Tyler Hematololgy Oncology, PA
Tyler, Texas, United States, 75701
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
MultiCare Regional Cancer Center - Auburn
Auburn, Washington, United States, 98002-4117
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
Virginia Mason Medical Center
Seattle, Washington, United States, 98111
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
Centro Medico Austral
Buenos Aires, Argentina, 1019
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
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
Australia, Queensland
Prince Charles Hospital; Department of Medical Oncology
Chermside, Queensland, Australia, 4032
Townsville Hospital
Townsville, Queensland, Australia, 4810
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Adelaide Cancer Centre
Kurralta Park, South Australia, Australia, 5037
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
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
CHU de Liège
Liège, Belgium, 4000
Clinique Ste-Elisabeth
Namur, Belgium, 5000
Brazil
Cetus Hospital Dia Oncologia
Belo Horizonte, MG, Brazil, 30150-270
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 Mae de Deus
Porto Alegre, RS, Brazil, 90470-340
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil
Hospital de Cancer 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
MHAT Serdika, EOOD
Sofia, Bulgaria, 1303
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
Sofia, Bulgaria, 1527
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
Lakeridge Health Center
Oshawa, Ontario, Canada, L1J 2J2
Sault Area Hospitals
Sault Ste Marie, Ontario, Canada, P6A 2C4
Chile
Clinica Santa Maria
Santiago, Chile, 0
Health & Care SPA
Santiago, Chile, 7500006
Instituto Clínico Oncolo gico del Sur
Temuco, Chile, 4810469
France
Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
Bordeaux, France, 33076
Centre Georges François Leclerc
Dijon, France, 21000
CHU de Grenoble
Grenoble, France, 38043
Centre Jean Bernard Clinique Victor Hugo
Le Mans, France, 72015
Hôpital Saint Joseph
Marseille, France, 13008
Hopital Nord AP-HM
Marseille, France, 13015
Hôpital Européen Georges Pompidou
Paris, France, 75908
CHU de Bordeaux
Pessac, France, 33600
Service de Pneumologie Centre Hospitalier Régional La Réunion Site Felix Guyon
Saint Denis Cedex, France, 97405
CH de Saint Quentin
Saint Quentin, France, 2100
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
Toulon, France, 83000
Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie
Toulon, France, 83000
Hôpital Larrey;Université Paul Sabatier
Toulouse, France, 31059
Hopital Paul Brousse; Service de Cancerologie
Villejuif, France, 94800
Germany
Zentralklinikum Augsburg
Augsburg, Germany, 86156
Klinikum Bayreuth GmbH
Bayreuth, Germany, 95445
Helios Klinikum Emil von Behring GmbH
Berlin, Germany, 14165
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
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
Lungenklinik Hemer
Hemer, Germany, 58675
Universität Des Saarlandes; Klinik für Innere Medizin V
Homburg, Germany, 66421
Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz
Koln, Germany, 51109
Klinik Loewenstein gGmbH; Onk & Pal
Loewenstein, Germany, 74245
Klinikum Bogenhausen
München, Germany, 81925
Krankenhaus Barmherzige Bruder Regensburg
Regensburg, Germany, 93049
Klinikum der Universität Regensburg
Regensburg, Germany, 93053
Stiftung Mathias-Spital Rheine
Rheine, Germany, 48431
Italy
AORN A Cardarelli
Napoli, Campania, Italy, 80131
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
Roma, Lazio, Italy, 00128
Azienda Ospedaliera San Camillo Forlanini
Roma, Lazio, Italy, 00151
Università Cattolica Del S Cuore
Roma, Lazio, Italy, 00168
Istituto Nazionale per la Ricerca sul Cancro di Genova
Genova, Liguria, Italy, 16132
ASL 3 Genovese; DSM
Genova, Liguria, Italy, 16147
A.O.U. Maggiore della Carità
Novara, Piemonte, Italy, 28100
Azienda Unita Sanitaria Locale N1 Sassari; Unita Operativa Di Oncologia Medica
Sassari, Sardegna, Italy, 07100
Policlinico Vittorio Emanuele
Catania, Sicilia, Italy, 95123
Ospedale Versilia
Lido Di Camaiore, Toscana, Italy, 55043
Ospedale Civile - Livorno
Livorno, Toscana, Italy, 57124
Azienda Ospedaliero Universitaria Pisana; Unita Operativa Medica
Pisa, Toscana, Italy, 56126
Japan
National Hospital Organization Shikoku Cancer Center
Ehime, Japan, 791-0280
National Hospital Organization Kyushu Medical Center
Fukuoka, Japan, 810-8563
NHO Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Kurume University Hospital
Fukuoka, Japan, 830-0011
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Japan, 236-0051
Kitasato University Hospital
Kanagawa, Japan, 252-0375
Kyoto University Hospital
Kyoto, Japan, 606-8507
Miyagi Cancer Center
Miyagi, Japan, 981-1293
Niigata Cancer Center Hospital
Niigata-shi, Japan, 951-8566
Osaka City University Hospital
Osaka, Japan, 545-8586
National Hospital Organization Toneyama National Hospital
Osaka, Japan, 560-8552
Toranomon Hospital
Tokyo, Japan, 105-8470
Center Hospital of the National Center for Global Health and Medicine
Tokyo, Japan, 162-8655
Kyorin University Hospital
Tokyo, Japan, 181-8611
Wakayama Medical University Hospital
Wakayama, Japan, 641-8510
Latvia
Riga East Clinical University Hospital Latvian Oncology Centre
Riga, Latvia, LV-1079
Pauls Stradins Clinical University Hospital
Riga, Latvia, LV1002
Lithuania
PI Republican Siauliai Hosp.; Oncology Clinic
Siauliai, Lithuania, LT-76307
National Cancer Institute
Vilnius, Lithuania, 08660
Mexico
Centro Universitario Contra El Cancer
Monterrey, Mexico, 64020
Cancerologia de Queretaro
Queretaro, Mexico, 76090
Centro Hemato Oncologico Privado; Oncologia
Toluca, Mexico, 50080
Netherlands
Jeroen Bosch Ziekenhuis
'S Hertogenbosch, Netherlands, 5223 GZ
NWZ, location Alkmaar
Alkmaar, Netherlands, 1815 JD
VU Medisch Centrum
Amsterdam, Netherlands, NL 1007 MB
Tergooiziekenhuizen
Blaricum, Netherlands, 1261 AN
Amphia Ziekenhuis; Afdeling Longziekten
Breda, Netherlands, 4818 CK
Ziekenhuis Gelderse Vallei
EDE, Netherlands, 6716 RP
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
Erasmus MC; Afdeling Longziekten
Rotterdam, Netherlands, 3000 CA
Maasstad ziekenhuis
Rotterdam, Netherlands, 3078 HT
Zuyderland Medisch Centrum
Sittard-Geleen, Netherlands, 6162 BG
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3584 CX
Gelre Ziekenhuizen, Zutphen
Zutphen, Netherlands, 7207 AE
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
Hospital Distrital de Faro, Pneumologia
Faro, Portugal, 8000-386
Instituto Portugues Oncologia de Lisboa Francisco Gentil EPE
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
Evromedservis LCC
Pushkin, Russian Federation, 196603
Dorozhnaya clinical hospital
Rostov-na-donu, Russian Federation, 344011
City Clinical Oncology Dispensary
Saint-Petersburg, Russian Federation, 197022
Russian Medical Military Academy n.a. S.M. Kirov
St. Petersburg, Russian Federation, 194044
Volgograd Regional Clinical Oncology Dispensary
Volgograd, Russian Federation, 400138
Singapore
National Cancer Centre; Medical Oncology
Singapore, Singapore, 169610
Slovakia
Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov; Nemocnicna lekaren
Bardejov, Slovakia, 085 01
Onkologicky ustav sv. Alzbety, s.r.o.
Bratislava, Slovakia, 812 50
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
Santander, Cantabria, Spain, 39008
Hospital Universitario Son Espases
Palma De Mallorca, Islas Baleares, Spain, 07014
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
Complejo Hospitalario U. de Ourense
Ourense, Orense, Spain, 32005
Hospital Lluis Alcanyis De Xativa
Xativa, Valencia, Spain, 46800
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 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
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid, Spain, 28040
Hospital Universitario Fundación Jimenez Díaz
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario HM Sanchinarro-CIOCC
Madrid, Spain, 28050
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Switzerland
Universitatsspital Bern
Bern, Switzerland, 3010
Kantonsspital Baselland
Bruderholz, Switzerland, 4101
Luzerner Kantonsspital Sursee
Luzern, Switzerland, 6000
Kantonsspital St. Gallen; Onkologie/Hämatologie
St. Gallen, Switzerland, 9007
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
National Cheng Kung Univ Hosp
Tainan, Taiwan, 00704
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
Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2
Ivano-Frankivsk, Kiev Governorate, Ukraine, 76018
Vinnytsya Regional Clinical Oncology Dispensary
Vinnytsya, Podolia Governorate, Ukraine, 21029
Chernivtsi Regional Clinical Oncology Dispensary
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
Kyiv City Clinical Oncological Center
Kyiv, Ukraine, 03115
Volyn Regional Oncology Dispensary
Lutsk, Ukraine, 43018
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: NCT02366143     History of Changes
Other Study ID Numbers: GO29436
2014-003207-30 ( EudraCT Number )
Study First Received: February 12, 2015
Last Updated: June 9, 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
Bevacizumab
Carboplatin
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunologic Factors

ClinicalTrials.gov processed this record on September 21, 2017