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A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01351415
First Posted: May 10, 2011
Last Update Posted: September 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This open-label, randomized, multicenter study will evaluate the efficacy and safety of bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants with advanced non-squamous NSCLC. Participants will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with bevacizumab plus a platinum doublet-containing therapy and a minimum of two cycles of bevacizumab maintenance treatment prior to PD. Participants will be randomly assigned to one of two treatment arms to receive either bevacizumab plus SOC treatment or SOC treatment alone.

Condition Intervention Phase
Non-Squamous Non-Small Cell Lung Cancer Drug: Bevacizumab Drug: Docetaxel Drug: Erlotinib Drug: Pemetrexed Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Phase IIIb Trial Evaluating the Efficacy and Safety of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression of Disease (PD) in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) After First Line Treatment With Bevacizumab Plus a Platinum Doublet-containing Chemotherapy

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Up to data cut-off date 24 June 2016 (approximately 5 years) ]
    Overall survival (OS) was defined as the time from the date of randomization at first progression of disease to the date of death, regardless of the cause of death.


Secondary Outcome Measures:
  • Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: Up to data cut-off date 24 June 2016 (approximately 5 years) ]
    PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PFS2 is defined as the time between randomization at PD1 and the date of PD2 or death, whichever occurs first. PFS3 is defined as the time between PD2 and the date of PD3 or death, whichever occurs first.

  • Percentage of Participants With Objective Response According to RECIST v1.1 [ Time Frame: Up to data cut-off date 24 June 2016 (approximately 5 years) ]
    The objective response is defined as complete response (CR) or partial response (PR) assessed according to the RECIST v.1.1 criteria with baseline tumour assessment as the reference. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.

  • Percentage of Participants With Disease Control According to RECIST v1.1 [ Time Frame: Up to data cut-off date 24 June 2016 (approximately 5 years) ]
    The disease control rate is defined as CR or PR or stable disease (SD) assessed according to the RECIST v.1.1 criteria with baseline tumour assessment as the reference. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started for target lesions and the persistence of 1 or more non-target lesions.

  • Duration of Response (DoR) According to RECIST v1.1 [ Time Frame: Up to data cut-off date 24 June 2016 (approximately 5 years) ]
    Duration of response is defined as the time that measurement criteria are met for objective response (CR/PR) (whichever status is recorded first) until the first date of progression or death is documented. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than < 10 mm. PR was defined as greater than or equal to ≥30 % decrease in sum of longest diameter of target lesions in reference to baseline sum longest diameter.

  • Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to data cut-off date 24 June 2016 (approximately 5 years) ]
    An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.

  • Time to Progression (TTP) According to RECIST v1.1 [ Time Frame: Up to data cut-off date 24 June 2016 (approximately 5 years) ]
    The time to progression was defined as the time from baseline until disease progression as determined by the RECIST v1.1. TTP2 is defined as the interval between the day of randomization at PD1 and PD2. TTP3 is defined as the interval between the day of PD2 and PD3. PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

  • Percentage of Participants Who Are Alive at Month 6, 12, and 18 [ Time Frame: Month 6, 12, 18 ]
    Percentage of participants who were alive at Month 6, 12 and 18 were reported.


Enrollment: 485
Actual Study Start Date: June 25, 2011
Study Completion Date: June 25, 2016
Primary Completion Date: June 25, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab + Standard of Care
Participants will receive bevacizumab on Day 1 of every 21-days cycle along with standard of care (Erlotinib or Docetaxel or Pemetrexed) as second line treatment, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
Drug: Bevacizumab
Participants will receive bevacizumab 7.5 or 15 milligrams per kilogram (mg/kg) intravenously.
Other Name: Avastin
Drug: Docetaxel
Docetaxel 60 or 75 milligram per meter square (mg/m^2) on Day 1 every 21 days.
Drug: Erlotinib
Erlotinib 150 mg daily taken on an empty stomach at least one hour before or two hours after the ingestion of food.
Drug: Pemetrexed
Pemetrexed 500 mg/m^2 IV over 10 minutes on Day 1 every 21 days.
Active Comparator: Standard of Care
Participants will receive investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
Drug: Docetaxel
Docetaxel 60 or 75 milligram per meter square (mg/m^2) on Day 1 every 21 days.
Drug: Erlotinib
Erlotinib 150 mg daily taken on an empty stomach at least one hour before or two hours after the ingestion of food.
Drug: Pemetrexed
Pemetrexed 500 mg/m^2 IV over 10 minutes on Day 1 every 21 days.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Histologically or cytologically confirmed non-squamous NSCLC
  • Documented progression of disease (locally recurrent or metastatic) per investigator assessment following first-line treatment with 4-6 cycles of Bevacizumab plus a platinum doublet-containing chemotherapy regimen and a minimum of 2 cycles of Bevacizumab (monotherapy) maintenance treatment prior to first progression of disease
  • No treatment interruption of Bevacizumab treatment greater than 2 consecutive cycles (42 days) between the start of first-line treatment to start of Cycle 1 of second line treatment
  • Randomization within 4 weeks of progression of disease
  • At least one unidimensionally measurable lesion meeting RECIST v1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Participants with adequate hematological, liver, and renal function
  • Female participants must not be pregnant or breast-feeding. Female participants of childbearing potential and fertile male participants must agree to use a highly effective contraceptive during the trial and for a period of at least 6 months following the last administration of trial drug(s)

Exclusion Criteria:

  • Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
  • Epidermal growth factor receptor (EGFR)-mutation-positive disease according to local laboratory testing
  • History of hemoptysis greater than or equal to (>/=) grade 2 within 3 months of randomization
  • History or evidence of inherited bleeding diathesis or coagulopathy with a risk of bleeding and active gastrointestinal bleeding
  • Major cardiac disease
  • Treatment with any other investigational agent within 28 days prior to randomization
  • Known hypersensitivity to bevacizumab or any of its excipients, or any SOC drugs foreseen
  • Malignancy other than NSCLC within 5 years prior to randomization and evidence of any other disease that contraindicates the use of an investigational or SOC drug
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351415


  Hide Study Locations
Locations
United States, Alabama
USA Mitchell Cancer Institute
Mobile, Alabama, United States, 36688
United States, Arizona
Palo Verde Hema/Onc
Glendale, Arizona, United States, 85304
Arizona Center for Cancer Care
Glendale, Arizona, United States, 85306
United States, Arkansas
Clopton Clinic
Jonesboro, Arkansas, United States, 72401
United States, California
East Valley Hematology ; Oncology Medical Group
Burbank, California, United States, 91505
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California, United States, 92008
Scripps Clinic; Hematology & Oncology
La Jolla, California, United States, 92037-1027
Sutter Cancer Center
Sacramento, California, United States, 95816
Coastal Integrative Cancer Care
San Luis Obispo, California, United States, 93401
Innovative Clinical Research Institute
Whittier, California, United States, 90603
United States, Connecticut
The Hospital of Central CT
New Britain, Connecticut, United States, 06050
Eastern Ct Hema/Onco Assoc; Dept of Oncology
Norwich, Connecticut, United States, 06360
United States, Florida
Lynn Cancer Institute - West
Boca Raton, Florida, United States, 33428
Baptist - MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
Jacksonville, Florida, United States, 32256
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Cancer Care Centers of Brevard
Rockledge, Florida, United States, 32955
United States, Georgia
Emory Univ Winship Cancer Inst
Atlanta, Georgia, United States, 30322
Summit Cancer Care PC
Savannah, Georgia, United States, 31405
United States, Idaho
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
United States, Illinois
Alexian Brothers Neurosci Inst
Elk Grove Village, Illinois, United States, 60007
Oncology-Evanston Nthwest Healthcare Kellogg Cancer Care Ctr
Evanston, Illinois, United States, 60201
Joliet Oncology Hematology Associates, Ltd.
Joliet, Illinois, United States, 60435
Cancer Care & Hematology; Specialists of Chicagoland
Niles, Illinois, United States, 60714
W. Suburban Ctr for Cncer Care
River Forest, Illinois, United States, 60305
United States, Indiana
St. Francis Medical Group
Indianapolis, Indiana, United States, 46237
Oncology Hematology Associates of Southwest Indiana
Newburgh, Indiana, United States, 47630
United States, Iowa
McFarland Clinic
Ames, Iowa, United States, 50010
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214-3728
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Jewish Cancer Care
Louisville, Kentucky, United States, 40245
United States, Louisiana
Hematology/Oncology Clinic, LLP
Baton Rouge, Louisiana, United States, 70809
Louisiana Oncology Associates
Lafayette, Louisiana, United States, 70508
United States, Maine
New England Cancer Specialists
Scarborough, Maine, United States, 04074
York Hospital
York, Maine, United States, 03909
United States, Maryland
Anne Arundel Health System Research Instit-Annapolis Oncology Ctr
Annapolis, Maryland, United States, 21401
United States, Massachusetts
Tufts Medical Center; Neely Cancer Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Ann Arbor Hematology Oncology
Ann Arbor, Michigan, United States, 48106
Henry Ford Hospital; Hematology Oncology
Detroit, Michigan, United States, 48202
Cancer & Hematology Center of West Michigan
Grand Rapids, Michigan, United States, 49546
United States, Minnesota
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
St Joseph Oncology
Saint Joseph, Missouri, United States, 64507
Heartland CCOP/Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
United States, New York
Stony Brook Univ Cancer Ctr; Medical Oncology Clinic
Stony Brook, New York, United States, 11794-9447
United States, North Carolina
Carolina Oncology Specialists, PA - Hickory
Hickory, North Carolina, United States, 28602
United States, Ohio
Aultman Hospital
Canton, Ohio, United States, 44710
Mid Ohio Onc Hematology Inc
Columbus, Ohio, United States, 43219
Dayton Clinical Oncology Prog
Dayton, Ohio, United States, 45420
Signal Point Clinical; Research Center, LLC
Middletown, Ohio, United States, 45042
Toledo Hospital; CCOP Toledo
Toledo, Ohio, United States, 43617
United States, Oregon
Bay Area Hospital
Coos Bay, Oregon, United States, 97420
United States, Pennsylvania
St. Lukes Hospital and Health Network
Bethlehem, Pennsylvania, United States, 18015
Hematology & Oncology Assoc; North Eastern Pennsylvania
Dunmore, Pennsylvania, United States, 18512
St. Mary Medical Center
Langhorne, Pennsylvania, United States, 19047
University of Pennsylvania; Radiation Oncology
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States, 02860
United States, Tennessee
West Clinic
Germantown, Tennessee, United States, 38138
University of Tennessee Medical Center Cancer Institute
Knoxville, Tennessee, United States, 37920
United States, Texas
Unv of TX SW Med Cntr; Hematology/Onc
Dallas, Texas, United States, 75390-9015
United States, Virginia
Delta Hematology/ Oncology Associates
Portsmouth, Virginia, United States, 23704
Blue Ridge Cancer Care - Roanoke
Roanoke, Virginia, United States, 24014
United States, Washington
Medical Oncology Associates
Spokane, Washington, United States, 99208
United States, Wisconsin
Fox Valley Hema and Onc SC
Appleton, Wisconsin, United States, 54915
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
UNI OF WISCONSIN SCHOOL OF MEDICINE; GI Oncology Research Group, Paul P Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Argentina
Inst. Alexander Fleming; Oncology Dept
Buenos Aires, Argentina, C1426ANZ
Centro Oncologico Infinito; Oncologia
La Pampa, Argentina, 6300
Hospital Privado de Comunidad; Oncology
Mar Del Plata, Argentina, 7600
Sanatorio Parque de Rosario
Rosario, Argentina, S2000DSV
ISIS Clinica Especializada
Santa Fe, Argentina, 03000
Clínica Viedma
Viedma, Rio Negro, Argentina, 8500
Austria
LKH Hohenems; Abteilung für Pulmologie
Hohenems, Austria, 6845
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
Innsbruck, Austria, 6020
Lkh Natters; Abt. Für Atemwegs- & Lungenkrankheiten
Natters, Austria, 6161
A.Ö. LKH; Abt. für Lungenkrankheiten
Steyr, Austria, 4400
Klinikum Wels-Grieskirchen; Lungenabt.
Wels, Austria, 4600
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
Wien, Austria, 1090
Krankenhaus Der Stadt Wien Lainz; V. Medizinische Abt.
Wien, Austria, 1130
SMZ - Baumgartner Hohe, Pavilion Leopold; 1.Interne Lungenabteilung, Onkologische Tagesklinik
Wien, Austria, 1140
Belgium
Clin. Europe (Ste Elisabeth)
Bruxelles, Belgium, 1180
Brazil
Nucleo de Oncologia da Bahia - NOB
Salvador, Bahia, BA, Brazil, 40170-380
Centro de Pesquisa Clínica- Instituto do Câncer do Ceará- ICC
Fortaleza, CE, Brazil, 60125-120
Sociedade beneficente de senhoras Hospital Sirio Libanes
Brasilia, DF, Brazil, 70200-730
Centro de Estudos e Pesquisas Oncologicas - CESPO
Brasilia, DF, Brazil, 70390-150
Instituto de Câncer de Brasília
Taguatinga, DF, Brazil, 72110-980
Clinicas Oncologicas Integradas - COI
Rio de Janeiro, RJ, Brazil, 22793-080
Hospital de Caridade de Ijui; Oncologia
Ijui, RS, Brazil, 98700-000
Clinica de Neoplasias Litoral
Itajai, SC, Brazil, 88301-220
Hospital A. C. Camargo; Oncologia
Sao Paulo, SP, Brazil, 01509-010
Hospital Sao Jose
São Paulo, SP, Brazil, CEP 01321-001
Denmark
Nordsjællands Hospital, Hillerød, Onkologisk Afdeling
Hillerod, Denmark, 3400
France
Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
Aix En Provence, France, 13617
Centre Francois Baclesse; Oncologie
Caen, France, 14076
Centre Hospitalier Intercommunal; Service de Pneumologie
Creteil, France, 94010
Hopital Nord Ouest;Unite 2c
Gleize, France, 69400
Centre Oscar Lambret
Lille, France, 59020
Hopital Calmette; Pneumologie
Lille, France, 59037
Hopital Louis Pradel; Cardiologie B
Lyon, France, 69394
Hôpital Saint Joseph; Oncologie Medicale
Marseille, France, 13285
Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique
Marseille, France, 13915
Centre Antoine Lacassagne
Nice, France, 06189
Ch Lyon Sud; Chir Onc Gyne Sct Jules Courmont
Pierre Benite, France, 69310
CH Rene Dubos; Oncologie
Pontoise, France, 95300
Ico Rene Gauducheau; Oncologie
Saint Herblain, France, 44805
Institut de Cancérologie de Loire
St-Priest-En-Jarez, France, 42271
Centre Paul Strauss; Oncologie Medicale
Strasbourg, France, 67065
Hia Sainte Anne; Pneumologie
Toulon, France, 83041
Hopital Sainte Musse; Pneumologie
Toulon, France, 83056
Clinique Pasteur; Pneumologie
Toulouse, France, 31076
Chi De La Haute Saone De Vesoul; Pneumologie
Vesoul, France, 70014
Germany
Zentralklinik Bad Berka GmbH; Pneumologie
Bad Berka, Germany, 99437
Praxis Dr. med. David Borquez
Bergisch Gladbach, Germany, 51465
Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie
Esslingen, Germany, 73730
Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
Frankfurt, Germany, 60488
SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
Gera, Germany, 07548
LungenClinic Großhansdorf
Großhansdorf, Germany, 22927
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I
Halle (Saale), Germany, 06120
Universitaetsklinikum des Saarlandes; Innere Medizin V
Homburg/Saar, Germany, 66421
Fachklinik für Lungenerkrankungen
Immenhausen, Germany, 34376
St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie
Karlsruhe, Germany, 76137
Robert-Koch-Klinik; Pneumologie
Leipzig, Germany, 04207
Praxis Christian Geßner
Leipzig, Germany, 04357
Johannes-Wesling-Klinikum Minden; Onkologische Ambulanz / Tagesklinik
Minden, Germany, 32429
Ludwig-Maximilians Uni Klinik Innenstadt; Medizinische Klinik
Muenchen, Germany, 80336
Pius-Hospital; Klinik fuer Haematologie und Onkologie
Oldenburg, Germany, 26121
Greece
Sotiria Hospital
Athens, Greece, 11527
Metropolitan Hospital; 2Nd Oncology Clinic
Piraeus, Greece, 185 47
General Hospital of Thessaloniki Papanikolaou; Uni Pneumonology Dept.
Thessaloniki, Greece, 570 10
Diavalkaniko Hospital
Thessaloniki, Greece, 57001
Italy
Citta Ospedaliera; Divisione Oncologia Medica
Avellino, Campania, Italy, 83100
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A
Napoli, Campania, Italy, 80131
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
Roma, Lazio, Italy, 00128
Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1
Roma, Lazio, Italy, 00152
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genova, Liguria, Italy, 16132
Az. Osp. Di Busto P.O. Di Saronno; U.O. Di Oncologia Medica
Saronno, Lombardia, Italy, 21047
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
Pisa, Toscana, Italy, 56124
Japan
Aichi Cancer Center Hospital; Respiratory Medicine
Aichi, Japan, 464-8681
National Cancer Center Hospital East; Thoracic Oncology
Chiba, Japan, 277-8577
National Hospital Organization Shikoku Cancer Center; Thoracic Oncology
Ehime, Japan, 791-0280
National Hospital Organization Kyushu Cancer Center, Thoracic Oncology
Fukuoka, Japan, 811-1395
Hyogo Cancer Center; Thoracic Oncology
Hyogo, Japan, 673-8553
Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine
Kanagawa, Japan, 236-0051
Yokohama Municipal Citizen'S Hospital; Respiratory
Kanagawa, Japan, 240-8555
Miyagi Cancer Center; Respiratory Medicine
Miyagi, Japan, 981-1293
Okayama University Hospital; Respiratory and Allergy Medicine
Okayama, Japan, 700-8558
OSAKA CITY GENERAL HOSPITAL;Medical Oncology
Osaka, Japan, 534-0021
Osaka International Cancer Institute; Thoracic Oncology
Osaka, Japan, 541-8567
Shizuoka Cancer Center; Thoracic Oncology
Shizuoka, Japan, 411-8777
National Cancer Center Hospital; Thoracic Medical Oncology
Tokyo, Japan, 104-0045
The Cancer Institute Hospital of JFCR, Respiratory Medicine
Tokyo, Japan, 135-8550
Lebanon
American University of Beirut - Medical Center
Beirut, Lebanon, 11-236
Hotel Dieu de France; Oncology
Beirut, Lebanon, 16830
Middle East Inst. of Health; Oncology
Beirut, Lebanon
Mexico
Centenario Hospital Miguel Hidalgo
Aguascalientes, Mexico, 20230
Hospital Central Sur de Alta Especialidad Petróleos Mexicanos
Mexico City, Mexico, 14140
Centro Médico Abc the American British Cowdray Medical Center, I.A.P. - Centro de Cáncer
Mexico City, Mexico
Netherlands
Amphia Ziekenhuis; Afdeling Longziekten
Breda, Netherlands, 4818 CK
Leyenburg Hospital; Pulmonology
Den Haag, Netherlands, 2504 LN
Catharina Ziekenhuis; Dept of Lung Diseases
Eindhoven, Netherlands, 5623 EJ
Ziekenhuis St Jansdal; Dept of Lung Diseases
Harderwijk, Netherlands, 3844 DG
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6202 AZ
Antonius Ziekenhuis; Dept of Lung Diseases
Nieuwegein, Netherlands, 3435 CM
Oman
College of Medicine & Sciences, Sultan Qaboos University Hospital
Muscat, Oman, P.O Box 35
Slovakia
Fnsp Fdr Banska Bystrica; Dep of Pneumology&Ftizeology
Banska Bystrica, Slovakia, 975 17
FNsP Bratislava, Nemocnica Ruzinov
Bratislava, Slovakia, 826 06
Vychodoslovensky onkologicky ustav
Kosice, Slovakia, 04001
Inst. of Tb & Respiratory Diseases; Dep. of Oncology
Nitra, Slovakia, 949 88
Spain
Hospital de Cruces; Servicio de Oncologia
Barakaldo, Vizcaya, Spain, 48903
Hospital General Univ. de Alicante; Servicio de Oncologia
Alicante, Spain, 3010
Centro Oncologico MD Anderson International Espana
Madrid, Spain, 28033
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, Spain, 28040
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, Spain, 28046
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, Spain, 46010
Hospital Universitario Dr. Peset; Servicio de Oncologia
Valencia, Spain, 46017
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, Spain, 50009
United Arab Emirates
Tawam Hospital; Medical Oncology Department
Al Ain, United Arab Emirates, 15258
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01351415     History of Changes
Other Study ID Numbers: MO22097
2010-022645-14 ( EudraCT Number )
First Submitted: May 9, 2011
First Posted: May 10, 2011
Results First Submitted: June 20, 2017
Results First Posted: September 18, 2017
Last Update Posted: September 18, 2017
Last Verified: August 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
Bevacizumab
Docetaxel
Erlotinib Hydrochloride
Pemetrexed
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors