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

August 17, 2017 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

485

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to data cut-off date 24 June 2016 (approximately 5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to data cut-off date 24 June 2016 (approximately 5 years)
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.
Up to data cut-off date 24 June 2016 (approximately 5 years)
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.
Up to data cut-off date 24 June 2016 (approximately 5 years)
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.
Up to data cut-off date 24 June 2016 (approximately 5 years)
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.
Up to data cut-off date 24 June 2016 (approximately 5 years)
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.
Up to data cut-off date 24 June 2016 (approximately 5 years)
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.
Month 6, 12, 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2011

Primary Completion (Actual)

June 25, 2016

Study Completion (Actual)

June 25, 2016

Study Registration Dates

First Submitted

May 9, 2011

First Submitted That Met QC Criteria

May 9, 2011

First Posted (Estimate)

May 10, 2011

Study Record Updates

Last Update Posted (Actual)

September 18, 2017

Last Update Submitted That Met QC Criteria

August 17, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MO22097
  • 2010-022645-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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