A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)
NCT ID: NCT01351415
Last Updated: 2017-09-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
485 participants
INTERVENTIONAL
2011-06-25
2016-06-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
Bevacizumab
Participants will receive bevacizumab 7.5 or 15 milligrams per kilogram (mg/kg) intravenously.
Docetaxel
Docetaxel 60 or 75 milligram per meter square (mg/m\^2) on Day 1 every 21 days.
Erlotinib
Erlotinib 150 mg daily taken on an empty stomach at least one hour before or two hours after the ingestion of food.
Pemetrexed
Pemetrexed 500 mg/m\^2 IV over 10 minutes on Day 1 every 21 days.
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).
Docetaxel
Docetaxel 60 or 75 milligram per meter square (mg/m\^2) on Day 1 every 21 days.
Erlotinib
Erlotinib 150 mg daily taken on an empty stomach at least one hour before or two hours after the ingestion of food.
Pemetrexed
Pemetrexed 500 mg/m\^2 IV over 10 minutes on Day 1 every 21 days.
Interventions
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Bevacizumab
Participants will receive bevacizumab 7.5 or 15 milligrams per kilogram (mg/kg) intravenously.
Docetaxel
Docetaxel 60 or 75 milligram per meter square (mg/m\^2) on Day 1 every 21 days.
Erlotinib
Erlotinib 150 mg daily taken on an empty stomach at least one hour before or two hours after the ingestion of food.
Pemetrexed
Pemetrexed 500 mg/m\^2 IV over 10 minutes on Day 1 every 21 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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USA Mitchell Cancer Institute
Mobile, Alabama, United States
Palo Verde Hema/Onc
Glendale, Arizona, United States
Arizona Center for Cancer Care
Glendale, Arizona, United States
Clopton Clinic
Jonesboro, Arkansas, United States
East Valley Hematology ; Oncology Medical Group
Burbank, California, United States
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California, United States
Scripps Clinic; Hematology & Oncology
La Jolla, California, United States
Sutter Cancer Center
Sacramento, California, United States
Coastal Integrative Cancer Care
San Luis Obispo, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
The Hospital of Central CT
New Britain, Connecticut, United States
Eastern Ct Hema/Onco Assoc; Dept of Oncology
Norwich, Connecticut, United States
Lynn Cancer Institute - West
Boca Raton, Florida, United States
Baptist - MD Anderson Cancer Center
Jacksonville, Florida, United States
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
Jacksonville, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Cancer Care Centers of Brevard
Rockledge, Florida, United States
Emory Univ Winship Cancer Inst
Atlanta, Georgia, United States
Summit Cancer Care PC
Savannah, Georgia, United States
Kootenai Cancer Center
Post Falls, Idaho, United States
Alexian Brothers Neurosci Inst
Elk Grove Village, Illinois, United States
Oncology-Evanston Nthwest Healthcare Kellogg Cancer Care Ctr
Evanston, Illinois, United States
Joliet Oncology Hematology Associates, Ltd.
Joliet, Illinois, United States
Cancer Care & Hematology; Specialists of Chicagoland
Niles, Illinois, United States
W. Suburban Ctr for Cncer Care
River Forest, Illinois, United States
St. Francis Medical Group
Indianapolis, Indiana, United States
Oncology Hematology Associates of Southwest Indiana
Newburgh, Indiana, United States
McFarland Clinic
Ames, Iowa, United States
Cancer Center of Kansas
Wichita, Kansas, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Jewish Cancer Care
Louisville, Kentucky, United States
Hematology/Oncology Clinic, LLP
Baton Rouge, Louisiana, United States
Louisiana Oncology Associates
Lafayette, Louisiana, United States
New England Cancer Specialists
Scarborough, Maine, United States
York Hospital
York Village, Maine, United States
Anne Arundel Health System Research Instit-Annapolis Oncology Ctr
Annapolis, Maryland, United States
Tufts Medical Center; Neely Cancer Center
Boston, Massachusetts, United States
Ann Arbor Hematology Oncology
Ann Arbor, Michigan, United States
Henry Ford Hospital; Hematology Oncology
Detroit, Michigan, United States
Cancer & Hematology Center of West Michigan
Grand Rapids, Michigan, United States
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States
St Joseph Oncology
Saint Joseph, Missouri, United States
Heartland CCOP/Missouri Baptist Medical Center
St Louis, Missouri, United States
Stony Brook Univ Cancer Ctr; Medical Oncology Clinic
Stony Brook, New York, United States
Carolina Oncology Specialists, PA - Hickory
Hickory, North Carolina, United States
Aultman Hospital
Canton, Ohio, United States
Mid Ohio Onc Hematology Inc
Columbus, Ohio, United States
Dayton Clinical Oncology Prog
Dayton, Ohio, United States
Signal Point Clinical; Research Center, LLC
Middletown, Ohio, United States
Toledo Hospital; CCOP Toledo
Toledo, Ohio, United States
Bay Area Hospital
Coos Bay, Oregon, United States
St. Lukes Hospital and Health Network
Bethlehem, Pennsylvania, United States
Hematology & Oncology Assoc; North Eastern Pennsylvania
Dunmore, Pennsylvania, United States
St. Mary Medical Center
Langhorne, Pennsylvania, United States
University of Pennsylvania; Radiation Oncology
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Lankenau Hospital
Wynnewood, Pennsylvania, United States
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States
West Clinic
Germantown, Tennessee, United States
University of Tennessee Medical Center Cancer Institute
Knoxville, Tennessee, United States
Unv of TX SW Med Cntr; Hematology/Onc
Dallas, Texas, United States
Delta Hematology/ Oncology Associates
Portsmouth, Virginia, United States
Blue Ridge Cancer Care - Roanoke
Roanoke, Virginia, United States
Medical Oncology Associates
Spokane, Washington, United States
Fox Valley Hema and Onc SC
Appleton, Wisconsin, United States
Gundersen Lutheran
La Crosse, Wisconsin, United States
UNI OF WISCONSIN SCHOOL OF MEDICINE; GI Oncology Research Group, Paul P Carbone Cancer Center
Madison, Wisconsin, United States
Inst. Alexander Fleming; Oncology Dept
Buenos Aires, , Argentina
Centro Oncologico Infinito; Oncologia
La Pampa, , Argentina
Hospital Privado de Comunidad; Oncology
Mar del Plata, , Argentina
Sanatorio Parque de Rosario
Rosario, , Argentina
ISIS Clinica Especializada
Santa Fe, , Argentina
Clínica Viedma
Viedma, Rio Negro, , Argentina
LKH Hohenems; Abteilung für Pulmologie
Hohenems, , Austria
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
Innsbruck, , Austria
Lkh Natters; Abt. Für Atemwegs- & Lungenkrankheiten
Natters, , Austria
A.Ö. LKH; Abt. für Lungenkrankheiten
Steyr, , Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
Vienna, , Austria
Krankenhaus Der Stadt Wien Lainz; V. Medizinische Abt.
Vienna, , Austria
SMZ - Baumgartner Hohe, Pavilion Leopold; 1.Interne Lungenabteilung, Onkologische Tagesklinik
Vienna, , Austria
Klinikum Wels-Grieskirchen; Lungenabt.
Wels, , Austria
Clin. Europe (Ste Elisabeth)
Brussels, , Belgium
Centro de Pesquisa Clínica- Instituto do Câncer do Ceará- ICC
Fortaleza, Ceará, Brazil
Nucleo de Oncologia da Bahia - NOB
Salvador, Bahia, Estado de Bahia, Brazil
Sociedade beneficente de senhoras Hospital Sirio Libanes
Brasília, Federal District, Brazil
Centro de Estudos e Pesquisas Oncologicas - CESPO
Brasília, Federal District, Brazil
Instituto de Câncer de Brasília
Taguatinga, Federal District, Brazil
Clinicas Oncologicas Integradas - COI
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital de Caridade de Ijui; Oncologia
Ijuí, Rio Grande do Sul, Brazil
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, Brazil
Hospital A. C. Camargo; Oncologia
São Paulo, São Paulo, Brazil
Hospital Sao Jose
São Paulo, São Paulo, Brazil
Nordsjællands Hospital, Hillerød, Onkologisk Afdeling
Hillerød, , Denmark
Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
Aix-en-Provence, , France
Centre Francois Baclesse; Oncologie
Caen, , France
Centre Hospitalier Intercommunal; Service de Pneumologie
Créteil, , France
Hopital Nord Ouest;Unite 2c
Gleizé, , France
Centre Oscar Lambret
Lille, , France
Hopital Calmette; Pneumologie
Lille, , France
Hopital Louis Pradel; Cardiologie B
Lyon, , France
Hôpital Saint Joseph; Oncologie Medicale
Marseille, , France
Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique
Marseille, , France
Centre Antoine Lacassagne
Nice, , France
Ch Lyon Sud; Chir Onc Gyne Sct Jules Courmont
Pierre-Bénite, , France
CH Rene Dubos; Oncologie
Pontoise, , France
Ico Rene Gauducheau; Oncologie
Saint-Herblain, , France
Institut de Cancérologie de Loire
Saint-Priest-en-Jarez, , France
Centre Paul Strauss; Oncologie Medicale
Strasbourg, , France
Hia Sainte Anne; Pneumologie
Toulon, , France
Hopital Sainte Musse; Pneumologie
Toulon, , France
Clinique Pasteur; Pneumologie
Toulouse, , France
Chi De La Haute Saone De Vesoul; Pneumologie
Vesoul, , France
Zentralklinik Bad Berka GmbH; Pneumologie
Bad Berka, , Germany
Praxis Dr. med. David Borquez
Bergisch Gladbach, , Germany
Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie
Esslingen am Neckar, , Germany
Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
Frankfurt, , Germany
SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
Gera, , Germany
LungenClinic Großhansdorf
Großhansdorf, , Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I
Halle, , Germany
Universitaetsklinikum des Saarlandes; Innere Medizin V
Homburg/Saar, , Germany
Fachklinik für Lungenerkrankungen
Immenhausen, , Germany
St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie
Karlsruhe, , Germany
Robert-Koch-Klinik; Pneumologie
Leipzig, , Germany
Praxis Christian Geßner
Leipzig, , Germany
Johannes-Wesling-Klinikum Minden; Onkologische Ambulanz / Tagesklinik
Minden, , Germany
Ludwig-Maximilians Uni Klinik Innenstadt; Medizinische Klinik
München, , Germany
Pius-Hospital; Klinik fuer Haematologie und Onkologie
Oldenburg, , Germany
Sotiria Hospital
Athens, , Greece
Metropolitan Hospital; 2Nd Oncology Clinic
Piraeus, , Greece
General Hospital of Thessaloniki Papanikolaou; Uni Pneumonology Dept.
Thessaloniki, , Greece
Diavalkaniko Hospital
Thessaloniki, , Greece
Citta Ospedaliera; Divisione Oncologia Medica
Avellino, Campania, Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A
Napoli, Campania, Italy
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
Rome, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1
Rome, Lazio, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genoa, Liguria, Italy
Az. Osp. Di Busto P.O. Di Saronno; U.O. Di Oncologia Medica
Saronno, Lombardy, Italy
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
Pisa, Tuscany, Italy
Aichi Cancer Center Hospital; Respiratory Medicine
Aichi, , Japan
National Cancer Center Hospital East; Thoracic Oncology
Chiba, , Japan
National Hospital Organization Shikoku Cancer Center; Thoracic Oncology
Ehime, , Japan
National Hospital Organization Kyushu Cancer Center, Thoracic Oncology
Fukuoka, , Japan
Hyogo Cancer Center; Thoracic Oncology
Hyōgo, , Japan
Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine
Kanagawa, , Japan
Yokohama Municipal Citizen'S Hospital; Respiratory
Kanagawa, , Japan
Miyagi Cancer Center; Respiratory Medicine
Miyagi, , Japan
Okayama University Hospital; Respiratory and Allergy Medicine
Okayama, , Japan
OSAKA CITY GENERAL HOSPITAL;Medical Oncology
Osaka, , Japan
Osaka International Cancer Institute; Thoracic Oncology
Osaka, , Japan
Shizuoka Cancer Center; Thoracic Oncology
Shizuoka, , Japan
National Cancer Center Hospital; Thoracic Medical Oncology
Tokyo, , Japan
The Cancer Institute Hospital of JFCR, Respiratory Medicine
Tokyo, , Japan
American University of Beirut - Medical Center
Beirut, , Lebanon
Hotel Dieu de France; Oncology
Beirut, , Lebanon
Middle East Inst. of Health; Oncology
Beirut, , Lebanon
Centenario Hospital Miguel Hidalgo
Aguascalientes, , Mexico
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
Mexico City, , Mexico
Amphia Ziekenhuis; Afdeling Longziekten
Breda, , Netherlands
Catharina Ziekenhuis; Dept of Lung Diseases
Eindhoven, , Netherlands
Ziekenhuis St Jansdal; Dept of Lung Diseases
Harderwijk, , Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
Antonius Ziekenhuis; Dept of Lung Diseases
Nieuwegein, , Netherlands
Leyenburg Hospital; Pulmonology
The Hague, , Netherlands
College of Medicine & Sciences, Sultan Qaboos University Hospital
Muscat, , Oman
Fnsp Fdr Banska Bystrica; Dep of Pneumology&Ftizeology
Banská Bystrica, , Slovakia
FNsP Bratislava, Nemocnica Ruzinov
Bratislava, , Slovakia
Vychodoslovensky onkologicky ustav
Košice, , Slovakia
Inst. of Tb & Respiratory Diseases; Dep. of Oncology
Nitra, , Slovakia
Hospital de Cruces; Servicio de Oncologia
Barakaldo, Vizcaya, Spain
Hospital General Univ. de Alicante; Servicio de Oncologia
Alicante, , Spain
Centro Oncologico MD Anderson International Espana
Madrid, , Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, , Spain
Hospital Universitario Dr. Peset; Servicio de Oncologia
Valencia, , Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, , Spain
Tawam Hospital; Medical Oncology Department
Al Ain City, , United Arab Emirates
Countries
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References
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Gridelli C, de Castro Carpeno J, Dingemans AC, Griesinger F, Grossi F, Langer C, Ohe Y, Syrigos K, Thatcher N, Das-Gupta A, Truman M, Donica M, Smoljanovic V, Bennouna J. Safety and Efficacy of Bevacizumab Plus Standard-of-Care Treatment Beyond Disease Progression in Patients With Advanced Non-Small Cell Lung Cancer: The AvaALL Randomized Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):e183486. doi: 10.1001/jamaoncol.2018.3486. Epub 2018 Dec 13.
Takeda M, Yamanaka T, Seto T, Hayashi H, Azuma K, Okada M, Sugawara S, Daga H, Hirashima T, Yonesaka K, Urata Y, Murakami H, Saito H, Kubo A, Sawa T, Miyahara E, Nogami N, Nakagawa K, Nakanishi Y, Okamoto I. Bevacizumab beyond disease progression after first-line treatment with bevacizumab plus chemotherapy in advanced nonsquamous non-small cell lung cancer (West Japan Oncology Group 5910L): An open-label, randomized, phase 2 trial. Cancer. 2016 Apr 1;122(7):1050-9. doi: 10.1002/cncr.29893. Epub 2016 Feb 1.
Gridelli C, Bennouna J, de Castro J, Dingemans AM, Griesinger F, Grossi F, Rossi A, Thatcher N, Wong EK, Langer C. Randomized phase IIIb trial evaluating the continuation of bevacizumab beyond disease progression in patients with advanced non-squamous non-small-cell lung cancer after first-line treatment with bevacizumab plus platinum-based chemotherapy: treatment rationale and protocol dynamics of the AvaALL (MO22097) trial. Clin Lung Cancer. 2011 Nov;12(6):407-11. doi: 10.1016/j.cllc.2011.05.002. Epub 2011 Jun 25.
Other Identifiers
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2010-022645-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MO22097
Identifier Type: -
Identifier Source: org_study_id