Lung Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

485

Study ID:

NCT01351415

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 176 Locations for this study

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USA Mitchell Cancer Institute
Mobile Alabama, 36688, United States
Palo Verde Hema/Onc
Glendale Arizona, 85304, United States
Arizona Center for Cancer Care
Glendale Arizona, 85306, United States
Clopton Clinic
Jonesboro Arkansas, 72401, United States
East Valley Hematology ; Oncology Medical Group
Burbank California, 91505, United States
California Cancer Associates for Research & Excellence, Inc.
Encinitas California, 92008, United States
Scripps Clinic; Hematology & Oncology
La Jolla California, 92037, United States
Sutter Cancer Center
Sacramento California, 95816, United States
Coastal Integrative Cancer Care
San Luis Obispo California, 93401, United States
Innovative Clinical Research Institute
Whittier California, 90603, United States
The Hospital of Central CT
New Britain Connecticut, 06050, United States
Eastern Ct Hema/Onco Assoc; Dept of Oncology
Norwich Connecticut, 06360, United States
Lynn Cancer Institute - West
Boca Raton Florida, 33428, United States
Baptist - MD Anderson Cancer Center
Jacksonville Florida, 32207, United States
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
Jacksonville Florida, 32256, United States
Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Cancer Care Centers of Brevard
Rockledge Florida, 32955, United States
Emory Univ Winship Cancer Inst
Atlanta Georgia, 30322, United States
Summit Cancer Care PC
Savannah Georgia, 31405, United States
Kootenai Cancer Center
Post Falls Idaho, 83854, United States
Alexian Brothers Neurosci Inst
Elk Grove Village Illinois, 60007, United States
Oncology-Evanston Nthwest Healthcare Kellogg Cancer Care Ctr
Evanston Illinois, 60201, United States
Joliet Oncology Hematology Associates, Ltd.
Joliet Illinois, 60435, United States
Cancer Care & Hematology; Specialists of Chicagoland
Niles Illinois, 60714, United States
W. Suburban Ctr for Cncer Care
River Forest Illinois, 60305, United States
St. Francis Medical Group
Indianapolis Indiana, 46237, United States
Oncology Hematology Associates of Southwest Indiana
Newburgh Indiana, 47630, United States
McFarland Clinic
Ames Iowa, 50010, United States
Cancer Center of Kansas
Wichita Kansas, 67214, United States
University of Kentucky Medical Center
Lexington Kentucky, 40536, United States
Jewish Cancer Care
Louisville Kentucky, 40245, United States
Hematology/Oncology Clinic, LLP
Baton Rouge Louisiana, 70809, United States
Louisiana Oncology Associates
Lafayette Louisiana, 70508, United States
New England Cancer Specialists
Scarborough Maine, 04074, United States
York Hospital
York Maine, 03909, United States
Anne Arundel Health System Research Instit-Annapolis Oncology Ctr
Annapolis Maryland, 21401, United States
Tufts Medical Center; Neely Cancer Center
Boston Massachusetts, 02111, United States
Ann Arbor Hematology Oncology
Ann Arbor Michigan, 48106, United States
Henry Ford Hospital; Hematology Oncology
Detroit Michigan, 48202, United States
Cancer & Hematology Center of West Michigan
Grand Rapids Michigan, 49546, United States
Metro-Minnesota CCOP
Saint Louis Park Minnesota, 55416, United States
St Joseph Oncology
Saint Joseph Missouri, 64507, United States
Heartland CCOP/Missouri Baptist Medical Center
Saint Louis Missouri, 63131, United States
Stony Brook Univ Cancer Ctr; Medical Oncology Clinic
Stony Brook New York, 11794, United States
Carolina Oncology Specialists, PA - Hickory
Hickory North Carolina, 28602, United States
Aultman Hospital
Canton Ohio, 44710, United States
Mid Ohio Onc Hematology Inc
Columbus Ohio, 43219, United States
Dayton Clinical Oncology Prog
Dayton Ohio, 45420, United States
Signal Point Clinical; Research Center, LLC
Middletown Ohio, 45042, United States
Toledo Hospital; CCOP Toledo
Toledo Ohio, 43617, United States
Bay Area Hospital
Coos Bay Oregon, 97420, United States
St. Lukes Hospital and Health Network
Bethlehem Pennsylvania, 18015, United States
Hematology & Oncology Assoc; North Eastern Pennsylvania
Dunmore Pennsylvania, 18512, United States
St. Mary Medical Center
Langhorne Pennsylvania, 19047, United States
University of Pennsylvania; Radiation Oncology
Philadelphia Pennsylvania, 19104, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Temple University Hospital
Philadelphia Pennsylvania, 19140, United States
Lankenau Hospital
Wynnewood Pennsylvania, 19096, United States
Memorial Hospital of Rhode Island
Pawtucket Rhode Island, 02860, United States
West Clinic
Germantown Tennessee, 38138, United States
University of Tennessee Medical Center Cancer Institute
Knoxville Tennessee, 37920, United States
Unv of TX SW Med Cntr; Hematology/Onc
Dallas Texas, 75390, United States
Delta Hematology/ Oncology Associates
Portsmouth Virginia, 23704, United States
Blue Ridge Cancer Care - Roanoke
Roanoke Virginia, 24014, United States
Medical Oncology Associates
Spokane Washington, 99208, United States
Fox Valley Hema and Onc SC
Appleton Wisconsin, 54915, United States
Gundersen Lutheran
La Crosse Wisconsin, 54601, United States
UNI OF WISCONSIN SCHOOL OF MEDICINE; GI Oncology Research Group, Paul P Carbone Cancer Center
Madison Wisconsin, 53792, United States
Inst. Alexander Fleming; Oncology Dept
Buenos Aires , C1426, Argentina
Centro Oncologico Infinito; Oncologia
La Pampa , 6300, Argentina
Hospital Privado de Comunidad; Oncology
Mar Del Plata , 7600, Argentina
Sanatorio Parque de Rosario
Rosario , S2000, Argentina
ISIS Clinica Especializada
Santa Fe , 03000, Argentina
Clínica Viedma
Viedma, Rio Negro , 8500, Argentina
LKH Hohenems; Abteilung für Pulmologie
Hohenems , 6845, Austria
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
Innsbruck , 6020, Austria
Lkh Natters; Abt. Für Atemwegs- & Lungenkrankheiten
Natters , 6161, Austria
A.Ö. LKH; Abt. für Lungenkrankheiten
Steyr , 4400, Austria
Klinikum Wels-Grieskirchen; Lungenabt.
Wels , 4600, Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
Wien , 1090, Austria
Krankenhaus Der Stadt Wien Lainz; V. Medizinische Abt.
Wien , 1130, Austria
SMZ - Baumgartner Hohe, Pavilion Leopold; 1.Interne Lungenabteilung, Onkologische Tagesklinik
Wien , 1140, Austria
Clin. Europe (Ste Elisabeth)
Bruxelles , 1180, Belgium
Nucleo de Oncologia da Bahia - NOB
Salvador, Bahia BA, 40170, Brazil
Centro de Pesquisa Clínica- Instituto do Câncer do Ceará- ICC
Fortaleza CE, 60125, Brazil
Sociedade beneficente de senhoras Hospital Sirio Libanes
Brasilia DF, 70200, Brazil
Centro de Estudos e Pesquisas Oncologicas - CESPO
Brasilia DF, 70390, Brazil
Instituto de Câncer de Brasília
Taguatinga DF, 72110, Brazil
Clinicas Oncologicas Integradas - COI
Rio de Janeiro RJ, 22793, Brazil
Hospital de Caridade de Ijui; Oncologia
Ijui RS, 98700, Brazil
Clinica de Neoplasias Litoral
Itajai SC, 88301, Brazil
Hospital A. C. Camargo; Oncologia
Sao Paulo SP, 01509, Brazil
Hospital Sao Jose
São Paulo SP, CEP 0, Brazil
Nordsjællands Hospital, Hillerød, Onkologisk Afdeling
Hillerod , 3400, Denmark
Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
Aix En Provence , 13617, France
Centre Francois Baclesse; Oncologie
Caen , 14076, France
Centre Hospitalier Intercommunal; Service de Pneumologie
Creteil , 94010, France
Hopital Nord Ouest;Unite 2c
Gleize , 69400, France
Centre Oscar Lambret
Lille , 59020, France
Hopital Calmette; Pneumologie
Lille , 59037, France
Hopital Louis Pradel; Cardiologie B
Lyon , 69394, France
Hôpital Saint Joseph; Oncologie Medicale
Marseille , 13285, France
Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique
Marseille , 13915, France
Centre Antoine Lacassagne
Nice , 06189, France
Ch Lyon Sud; Chir Onc Gyne Sct Jules Courmont
Pierre Benite , 69310, France
CH Rene Dubos; Oncologie
Pontoise , 95300, France
Ico Rene Gauducheau; Oncologie
Saint Herblain , 44805, France
Institut de Cancérologie de Loire
St-Priest-En-Jarez , 42271, France
Centre Paul Strauss; Oncologie Medicale
Strasbourg , 67065, France
Hia Sainte Anne; Pneumologie
Toulon , 83041, France
Hopital Sainte Musse; Pneumologie
Toulon , 83056, France
Clinique Pasteur; Pneumologie
Toulouse , 31076, France
Chi De La Haute Saone De Vesoul; Pneumologie
Vesoul , 70014, France
Zentralklinik Bad Berka GmbH; Pneumologie
Bad Berka , 99437, Germany
Praxis Dr. med. David Borquez
Bergisch Gladbach , 51465, Germany
Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie
Esslingen , 73730, Germany
Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
Frankfurt , 60488, Germany
SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
Gera , 07548, Germany
LungenClinic Großhansdorf
Großhansdorf , 22927, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I
Halle (Saale) , 06120, Germany
Universitaetsklinikum des Saarlandes; Innere Medizin V
Homburg/Saar , 66421, Germany
Fachklinik für Lungenerkrankungen
Immenhausen , 34376, Germany
St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie
Karlsruhe , 76137, Germany
Robert-Koch-Klinik; Pneumologie
Leipzig , 04207, Germany
Praxis Christian Geßner
Leipzig , 04357, Germany
Johannes-Wesling-Klinikum Minden; Onkologische Ambulanz / Tagesklinik
Minden , 32429, Germany
Ludwig-Maximilians Uni Klinik Innenstadt; Medizinische Klinik
Muenchen , 80336, Germany
Pius-Hospital; Klinik fuer Haematologie und Onkologie
Oldenburg , 26121, Germany
Sotiria Hospital
Athens , 11527, Greece
Metropolitan Hospital; 2Nd Oncology Clinic
Piraeus , 185 4, Greece
General Hospital of Thessaloniki Papanikolaou; Uni Pneumonology Dept.
Thessaloniki , 570 1, Greece
Diavalkaniko Hospital
Thessaloniki , 57001, Greece
Citta Ospedaliera; Divisione Oncologia Medica
Avellino Campania, 83100, Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A
Napoli Campania, 80131, Italy
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
Roma Lazio, 00128, Italy
Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1
Roma Lazio, 00152, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genova Liguria, 16132, Italy
Az. Osp. Di Busto P.O. Di Saronno; U.O. Di Oncologia Medica
Saronno Lombardia, 21047, Italy
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
Pisa Toscana, 56124, Italy
Aichi Cancer Center Hospital; Respiratory Medicine
Aichi , 464-8, Japan
National Cancer Center Hospital East; Thoracic Oncology
Chiba , 277-8, Japan
National Hospital Organization Shikoku Cancer Center; Thoracic Oncology
Ehime , 791-0, Japan
National Hospital Organization Kyushu Cancer Center, Thoracic Oncology
Fukuoka , 811-1, Japan
Hyogo Cancer Center; Thoracic Oncology
Hyogo , 673-8, Japan
Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine
Kanagawa , 236-0, Japan
Yokohama Municipal Citizen'S Hospital; Respiratory
Kanagawa , 240-8, Japan
Miyagi Cancer Center; Respiratory Medicine
Miyagi , 981-1, Japan
Okayama University Hospital; Respiratory and Allergy Medicine
Okayama , 700-8, Japan
OSAKA CITY GENERAL HOSPITAL;Medical Oncology
Osaka , 534-0, Japan
Osaka International Cancer Institute; Thoracic Oncology
Osaka , 541-8, Japan
Shizuoka Cancer Center; Thoracic Oncology
Shizuoka , 411-8, Japan
National Cancer Center Hospital; Thoracic Medical Oncology
Tokyo , 104-0, Japan
The Cancer Institute Hospital of JFCR, Respiratory Medicine
Tokyo , 135-8, Japan
American University of Beirut - Medical Center
Beirut , 11-23, Lebanon
Hotel Dieu de France; Oncology
Beirut , 16830, Lebanon
Middle East Inst. of Health; Oncology
Beirut , , Lebanon
Centenario Hospital Miguel Hidalgo
Aguascalientes , 20230, Mexico
Hospital Central Sur de Alta Especialidad Petróleos Mexicanos
Mexico City , 14140, Mexico
Centro Médico Abc the American British Cowdray Medical Center, I.A.P. - Centro de Cáncer
Mexico City , , Mexico
Amphia Ziekenhuis; Afdeling Longziekten
Breda , 4818 , Netherlands
Leyenburg Hospital; Pulmonology
Den Haag , 2504 , Netherlands
Catharina Ziekenhuis; Dept of Lung Diseases
Eindhoven , 5623 , Netherlands
Ziekenhuis St Jansdal; Dept of Lung Diseases
Harderwijk , 3844 , Netherlands
Academisch Ziekenhuis Maastricht
Maastricht , 6202 , Netherlands
Antonius Ziekenhuis; Dept of Lung Diseases
Nieuwegein , 3435 , Netherlands
College of Medicine & Sciences, Sultan Qaboos University Hospital
Muscat , P.O B, Oman
Fnsp Fdr Banska Bystrica; Dep of Pneumology&Ftizeology
Banska Bystrica , 975 1, Slovakia
FNsP Bratislava, Nemocnica Ruzinov
Bratislava , 826 0, Slovakia
Vychodoslovensky onkologicky ustav
Kosice , 04001, Slovakia
Inst. of Tb & Respiratory Diseases; Dep. of Oncology
Nitra , 949 8, Slovakia
Hospital de Cruces; Servicio de Oncologia
Barakaldo Vizcaya, 48903, Spain
Hospital General Univ. de Alicante; Servicio de Oncologia
Alicante , 3010, Spain
Centro Oncologico MD Anderson International Espana
Madrid , 28033, Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid , 28040, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid , 28046, Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia , 46010, Spain
Hospital Universitario Dr. Peset; Servicio de Oncologia
Valencia , 46017, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza , 50009, Spain
Tawam Hospital; Medical Oncology Department
Al Ain , 15258, United Arab Emirates

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

485

Study ID:

NCT01351415

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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