A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF- 06439535 PLUS PACLITAXEL-CARBOPLATIN AND BEVACIZUMAB PLUS PACLITAXEL -CARBOPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER.

This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Bevacizumab-Pfizer; Drug: Paclitaxel; Drug: Carboplatin; Drug: Bevacizumab-EU

• Study Type: Interventional
• Enrollment (Actual): 719
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Lismore, New South Wales, Australia, 2480
      • Epic pharmacy
    • Tweed Heads, New South Wales, Australia, 2485
      • The Tweed Hospital
  • Queensland
    • Tugun, Queensland, Australia, 4224
      • Cardiac Services, John Flynn Private Hospital -
    • Tugun, Queensland, Australia, 4224
      • South Coast Radiology, John Flynn Private Hospital
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health - Olivia Newton - John Cancer & Wellness Centre
    • St Albans, Victoria, Australia, 3021
      • Western Health, Sunshine Hospital
• Brazil
  • Rio de Janeiro, Brazil, 22793-080
    • Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca
  • Sao Paulo, Brazil, 01246-000
    • lnstituto do Cancer do Estado de Sao Paulo - Octavio Frias de -
  • Sao Paulo, Brazil, 04039-004
    • Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE/HSPE-FMO
  • Bahia
    • Salvador, Bahia, Brazil, 40050-410
      • Hospital Santa Izabel / Santa Casa de Misericordia da Bahia
  • Ceara
    • Fortaleza, Ceara, Brazil, 60160230
      • Oncoclinic (Clinica de Oncologia e Atendimento de Urgencia Ltda)
  • Minas Gerais
    • Uberlandia, Minas Gerais, Brazil, 38408-150
      • COT - Centro Oncologico do Triangulo Ltda
  • Parana
    • Curitiba, Parana, Brazil, 81520-060
      • Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
  • RIO Grande DO SUL
    • Lajeado, RIO Grande DO SUL, Brazil, 95900-000
      • Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado)
    • Novo Hamburgo, RIO Grande DO SUL, Brazil, 93510-250
      • Oncosinos (Lessa Ferreira Servicos Oncologicos Ltda)
    • Passo Fundo, RIO Grande DO SUL, Brazil, 99010-260
      • Hospital da Cidade de Passo Fundo - HCPF
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90020-090
      • Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90050-170
      • Irmandade da Santa Casa de Misericordia de Porto Alegre - Hospital Santa Rita
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
      • Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia
  • SAO Paulo
    • Sao Jose do Rio Preto, SAO Paulo, Brazil, 15090-000
      • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto -
    • Sorocaba, SAO Paulo, Brazil, 18035-300
      • Instituto de Oncologia de Sorocaba - ONCO Clinicas Especializadas SC Ltda
  • Santa Catarina
    • Joinville, Santa Catarina, Brazil, 89201-260
      • Instituto Joinvillense de Hematologia e Oncologia SS Ltda - Clinica de Hematologia e Oncologia
• Bulgaria
  • Shumen, Bulgaria, 9700
    • Complex Oncological Center Shumen EOOD
• Chile
  • Region DE LA Araucania
    • Temuco, Region DE LA Araucania, Chile, 4810469
      • Instituto Clinico Oncologico del Sur (ICOS)
  • Region Metropolitana
    • Santiago, Region Metropolitana, Chile, 8420383
      • Bradford Hill Centro de Investigaciones Clinicas
    • Santiago, Region Metropolitana, Chile, 8420383
      • Centro Internacional de Estudios Clinicos (CIEC)
    • Santiago, Region Metropolitana, Chile, 8940575
      • Fresenius Kabi Chile, Therapia i.v.
  • Región DE LA Araucanía
    • Temuco, Región DE LA Araucanía, Chile, 4810469
      • Instituto Clinico Oncologico del Sur (ICOS)
  • V Region
    • Vina del Mar, V Region, Chile, 2540364
      • Centro de Investigaciones Clínicas Vina del Mar Ltda.
• Croatia
  • Zagreb, Croatia, 10000
    • University Hospital Centre "Sestre Milosrdnice"
• Czechia
  • Nova Ves pod Plesi, Czechia, 262 04
    • Nemocnice na Plesi s.r.o
  • Novy Jicin, Czechia, 741 01
    • Nemocnice Novy Jicin a.s
  • Novy Jicin, Czechia, 74101
    • Lekarna Agel Novy Jicin
  • Pelhrimov, Czechia, 39338
    • Nemocnice Pelhrimov p.o, Radioterapeuticke oddeleni
  • Pribram, Czechia, 26126
    • Lekarna Oblastni nemocnice Pribram
• France
  • Mont De Marsan Cedex, France, 40024
    • Centre Hospitalier General de Mont de Marsan
  • Montbeliard, France, 25200
    • Centre Hospitalier Montbeliard
  • Nantes Cedex, France, 44277
    • L'hopital prive du Confluent S.A.S.
  • Toulon Cedex 9, France, 83800
    • Hôpital d'Instruction des armées SAINTE ANNE
• Germany
  • Bayreuth, Germany, 95445
    • Klinikum Bayreuth GmbH
  • Berlin, Germany, 13125
    • Evangelische Lungenklinik Berlin
  • Berlin, Germany, 13585
    • Vivantes Klinikum Spandau
  • Berlin, Germany, 13125
    • Viereck-Apotheke
  • Berlin, Germany, 13509
    • Vivantes GmbH Apotheke des Humboldt-Klinikums
  • Braunschweig, Germany, 38114
    • Staedtisches Klinikum Braunschweig gGmbH Apotheke
  • Braunschweig, Germany, 38114
    • Staedtisches Klinikum Braunschweig gGmbH Institut fuer Roentgendiagnostik und Nuklearmedizin
  • Braunschweig, Germany, 38114
    • Staedtisches Klinikum Braunschweig gGmbH
  • Coswig, Germany, 01640
    • Fachkrankenhaus Coswig GmbH
  • Dresden, Germany, 01307
    • Apotheke Johannstadt Sven Ullrich e.K.
  • Esslingen a.N., Germany, 73730
    • Klinikum Esslingen GmbH
  • Frankfurt am Main, Germany, 60322
    • Radiologie Nuklearmedizin Adickesallee
  • Frankfurt am Main, Germany, 60487
    • St. Elisabethen - Krankenhaus
  • Frankfurt am Main, Germany, 60596
    • Sued-Apotheke
  • Gauting, Germany, 82131
    • Asklepios Fachkliniken Muenchen Gauting
  • Groebenzell, Germany, 82194
    • Johannes-Apotheke
  • Halle (Saale), Germany, 06120
    • Krankenhaus Martha-Maria Halle-Doelau gGmbH - Apotheke
  • Halle (Saale), Germany, 06120
    • Krankenhaus Martha-Maria Halle-Doelau gGmbH - Institut fuer Radiologie
  • Halle (Saale), Germany, 06120
    • Krankenhaus Martha-Maria Halle-Doelau gGmbH
  • Hamburg, Germany, 22045
    • Zytoservice Deutschland GmbH
  • Hamburg, Germany, 22087
    • Katholisches Marienkrankenhaus gGmbH
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Hannover, Germany, 30625
    • Institut fuer Diagnostische und Interventionelle Radiologie
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover Zentralapotheke
  • Homburg/Saar, Germany, 66421
    • Universitaetsklinikum des Saarlandes - Klinik fuer Diagnostische und Interventionelle Radiologie
  • Homburg/Saar, Germany, 66421
    • Universitaetsklinikum des Saarlandes - Klinik fuer Innere Medizin V - Pneumologie, Allergologie,
  • Homburg/Saar, Germany, 66421
    • Universitaetsklinikum des Saarlandes, Apotheke
  • Karlsruhe, Germany, 76137
    • Vincentius-Diakonissen-Kliniken gAG Karlsruhe
  • Karlsruhe, Germany, 76137
    • Vincentius-Diakonissen-Kliniken gAG Klinik fuer Diagnostische und Interventionelle Radiologie
  • Karlsruhe, Germany, 76137
    • Vincentius-Diakonissen-Kliniken gAG Zentralapotheke
  • Koblenz, Germany, 56068
    • Institut Fuer Versorgungsforschung In Der Onkologie
  • Koblenz, Germany, 56068
    • Radiologisches Institut Koblenz
  • Koblenz, Germany, 56068
    • Sonnenschein Apotheke
  • Leer, Germany, 26789
    • Onkologie UnterEms
  • Leer, Germany, 26789
    • Hirsch-Apotheke
  • Leipzig, Germany, 04103
    • Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz (ZRN Leipzig)
  • Leipzig, Germany, 04315
    • Arkana Apotheke OHG
  • Leipzig, Germany, 04357
    • POIS Leipzig GbR, Pneumologisch/onkologisch/internistisches Studienzentrum
  • Moers, Germany, 47441
    • Onkologie Moers GbR
  • Neumuenster, Germany, 24534
    • Friedrich-Ebert-Krankenhaus Neumuenster
• Greece
  • Athens, Greece, 11527
    • Univ. of Athens Hosp. of Chest Diseases of Athens ''Sotiria''
  • Athens, Greece, 14564
    • General Oncology Hospital of Kifissia "Ag. Anargiroi"
  • Patras, Greece, 26504
    • University General Hospital of Patras
  • Thessaloniki, Greece, 54645
    • Euromedica General Clinic of Thessaloniki
  • Thessaloniki, Greece, 57001
    • European Inter-Balkan Medical Centre
  • Thessaloniki, Greece, 57001
    • Thermi Clinic S.A
  • Thessaloniki, Greece, 57010
    • Gen.Hospital "G. Papanikolaou"
  • Crete
    • Heraklion, Crete, Greece, 71110
      • University Hospital of Heraklion
• Hungary
  • Budapest, Hungary, 1125
    • Semmelweis Egyetem Klinikai Pulmonologiai Klinikai Gyogyszertar
  • Budapest, Hungary, 1125
    • Semmelweis Egyetem, Pulmonologiai Klinika
  • Deszk, Hungary, 6772
    • Csongrad Megyei Mellkasi Betegsegek Szakkorhaza
  • Farkasgyepu, Hungary, 8582
    • Veszprem Megyei Tudogyogyintezet
  • Gyor, Hungary, 9023
    • Petz Aladar Megyei Oktato Korhaz, Pulmonologiai Osztaly
  • Matrahaza, Hungary, 3233
    • Matrai Gyogyintezet Pulmonologiai Osztaly
  • Szolnok, Hungary, 5000
    • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet, Megyei Onkologiai Kozpont
  • Torokbalint, Hungary, 2045
    • Tudogyogyintezet Torokbalint
  • Zalaegerszeg, Hungary, 8900
    • Zala Megyei Kórház
• India
  • Andhra Pradesh
    • Visakhapatnam, Andhra Pradesh, India, 530 017
      • Mahatma Gandhi Cancer Hospital and Research Institute
  • Karnataka
    • Bangalore, Karnataka, India, 560027
      • Healthcare Global Enterprises Limited
  • Maharashtra
    • Nashik, Maharashtra, India, 422005
      • Shatabdi Super Speciality Hospital
    • Pune, Maharashtra, India, 411004
      • Sahyadri Clinical Research and Development Center (A Unit of Sahayadri hospitals Limited)
    • Pune, Maharashtra, India, 411004
      • Sahyadri Speciality Hospital
  • Rajasthan
    • Jaipur, Rajasthan, India, 302016
      • Institute of Respiratory Diseases, SMS Medical College & Hospital
• Italy
  • BG
    • Treviglio, BG, Italy, 24047
      • UOC Oncologia
  • BS
    • Brescia, BS, Italy, 25124
      • Oncologia Medica, Fondazione Poliambulanza Instituto Ospedaliero
  • CT
    • Catania, CT, Italy, 95123
      • UO Oncologia Medica
  • FC
    • Meldola, FC, Italy, 47014
      • Unita di Oncologia Toracica
  • LU
    • Lido di Camaiore, LU, Italy, 55041
      • UOC di Oncologia Medica
  • RM
    • Roma, RM, Italy, 00152
      • UOSD Pneumologia Oncologica - Padiglione Flaiani
  • SO
    • Sondrio, SO, Italy, 23100
      • S.C. Oncologia Medica-Presidio Ospedaliero Sondrio
  • VR
    • Legnago, VR, Italy, 37045
      • UOC Oncologia Medica
• Japan
  • Fukuoka, Japan, 810-0001
    • Saiseikai Fukuoka General Hospital
  • Kochi, Japan, 780-8077
    • National Hospital Organization Kochi National Hospital
  • Oita, Japan, 870-0263
    • National Hospital Organization Oita Medical Center
  • Okayama, Japan, 700-8607
    • Japanese Red Cross Okayama Hospital
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8545
      • National Hospital Organization Hirosaki National Hospital
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 070-8644
      • National Hospital Organization Asahikawa Medical Center
  • Hyogo
    • Himeji, Hyogo, Japan, 670-8520
      • National Hospital Organization Himeji Medical Center
  • Ibaraki
    • Higashi-ibaraki-gun, Ibaraki, Japan, 311-3193
      • National Hospital Organization Mito Medical Center
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-8641
      • Kanazawa University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 236-0051
      • Kanagawa Cardiovascular and Respiratory Center
  • MIE
    • Tsu, MIE, Japan, 514-1101
      • National Hospital Organization Mie Chuo Medical Center
  • Miyagi
    • Sendai, Miyagi, Japan, 983-8520
      • National Hospital Organization Sendai Medical Center
  • Tokyo
    • Kiyose, Tokyo, Japan, 204-8585
      • National Hospital Organization Tokyo National Hospital
    • Meguro-Ku, Tokyo, Japan, 152-8902
      • National Hospital Organization Tokyo Medical Center
    • Tachikawa, Tokyo, Japan, 190-0014
      • National Hospital Organization Disaster Medical Center
• Korea, Republic of
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St.Mary's Hospital
  • Chungcheongbuk-do
    • Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
      • Chungbuk National University Hospital
  • Gangdong-gu
    • Seoul, Gangdong-gu, Korea, Republic of, 05368
      • VHS Medical Center
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
    • Suwon, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University Hospital
• Malaysia
  • Penang, Malaysia, 10350
    • Penang Adventist Hospital
  • Negeri Sembilan
    • Nilai, Negeri Sembilan, Malaysia, 71800
      • Nilai Medical Centre
  • Penang
    • Tanjung Bungah, Penang, Malaysia, 11200
      • Mount Miriam Cancer Hospital
• Netherlands
  • Arnhem, Netherlands, 6815 AD
    • Rijnstate Ziekenhuis
  • Arnhem, Netherlands, 6815 AD
    • Klinisch Chemisch en Hematologisch Laboratorium (KCHL)
  • Ede, Netherlands, 6716 RP
    • Ziekenhuis de Gelderse Vallei
  • Helmond, Netherlands, 5707 HA
    • Elkerliek Ziekenhuis
• Philippines
  • Cebu
    • Cebu City, Cebu, Philippines, 6000
      • Cebu Doctors' University Hospital
  • Davao DEL SUR
    • Davao City, Davao DEL SUR, Philippines, 8000
      • Davao Doctors Hospital
• Poland
  • Elblag, Poland, 82-300
    • Wojewódzki Szpital Zespolony w Elblągu
  • Lodz, Poland, 93-513
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Kopernika w Lodzi,
  • Olsztyn, Poland, 10-357
    • Samodzielny Publiczny Zespól Gruzlicy i Chorób Pluc w Olsztynie
  • Poznan, Poland, 60-569
    • Wielkopolskie Centrum Pulmonologii i Torakochirurgii im.Eugenii i Janusza Zeylandow
  • Rzeszow, Poland, 35-021
    • MRUKMED. Lekarz Beata Madej Mruk i Partner. Sp. p. Oddzial nr 1 w Rzeszowie
  • Szczecin-Zdunowo, Poland, 70-891
    • Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie Szpital Wojewodzki w
  • Torun, Poland, 87-100
    • Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Obserwacyjno-Zakazny
  • Warszawa, Poland, 02-781
    • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
  • Warszawa, Poland, 04-141
    • Wojskowy Instytut Medyczny, Klinika Onkologii
  • Wodzislaw-Slaski, Poland, 44-300
    • Wojewodzki Szpital Chorob Pluc im. dr Alojzego Pawelca
• Romania
  • Cluj Napoca, Romania, 400058
    • Medisprof
  • Cluj-Napoca, Romania, 400139
    • Spitalul Clinic Municipal
  • Cluj-Napoca, Romania, 400489
    • SC Hiperdia SA
  • Constanta, Romania, 900591
    • Spitalul Clinic Judetean de Urgenta "Sf Apostol Andrei" Constanta Clinica Oncologie Medicala
  • Constanta, Romania, 900663
    • Centrul Medical Pozimed, SC Pozitron Medical Investigation SRL
  • Craiova, Romania, 200347
    • S.C. Centrul de Oncologie Sf. Nectarie S.R.L., Oncologie Medicala
  • Jud Cluj, Romania, 407280
    • Sc Radiotherapy Center Cluj Srl
  • Timisoara, Romania, 300158
    • Hiperdia Timisoara, Cardiologie
  • Timisoara, Romania, 300158
    • Hiperdia Timisoara, Radiologie si imagistica medicala
  • Dolj
    • Craiova, Dolj, Romania, 200352
      • SPAD Imaging International S.R.L
    • Craiova, Dolj, Romania, 200382
      • SC Cardio-Center SRL
  • Jud Dolj
    • Craiova, Jud Dolj, Romania, 200385
      • SC Oncolab SRL, Oncologie
  • Mures
    • Targu-Mures, Mures, Romania, 540136
      • Spitalul Clinic Judetean de Urgenta Targu Mures, Cardiologie
    • Targu-Mures, Mures, Romania, 540141
      • Spitalul Clinic Judetean Mures, radiologie si imagistica medicala
    • Targu-Mures, Mures, Romania, 540141
      • Spitalul Clinic Judetean Mures, sectia Clinica de Oncologie Medicala
  • Timis
    • Timisoara, Timis, Romania, 300166
      • S.C. Oncocenter Oncologie Clinica SRL
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • State Budget Healthcare Institution of Arkhangelsk Region
  • Chelyabinsk, Russian Federation, 454087
    • Chelyabinsk Regional Clinical Oncology Dispensary
  • Chelyabinsk, Russian Federation, 454048
    • Evimed LLC
  • Chelyabinsk, Russian Federation, 454076
    • Chelyabinsk Regional Hospital
  • Chelyabinsk, Russian Federation, 454076
    • SBHI "Chelyabinsk Regional Clinical Hospital"
  • Chelyabinsk, Russian Federation, 454087
    • "SBHI ""Chelyabinsk Regional Clinical Oncology Dispensary"""
  • Chelyabinsk, Russian Federation, 454087
    • MRT-Expert, LLC
  • Chelyabinsk, Russian Federation, 454092
    • Road Clinical Hospital on the station Chelyabinsk of OJSC "RZD"
  • Krasnodar, Russian Federation, 350012
    • SBHI "Regional clinical hospital #2" of MoH of Krasnodar Region
  • Moscow, Russian Federation, 115478
    • FSBI "N.N.Blokhin Russian Cancer Research Center" RAMS
  • Moscow, Russian Federation, 125284
    • P.A.Hertsen Moscow Oncology Research Institute - Branch of the National Medical Radiological
  • Nizhniy Novgorod, Russian Federation, 603001
    • Privolzhskiy District Medical Center of Federal Biomedical Agency
  • Nizhniy Novgorod, Russian Federation, 603006
    • SBHI NR Clinical Diagnostic Center
  • Nizhniy Novgorod, Russian Federation, 603081
    • SBHI of NNR Nizhniy Novgorod Regional Oncology Dispensary
  • Nizhniy Novgorod, Russian Federation, 603163
    • SBHI of NNR Nizhniy Novgorod Regional Oncology Dispensary
  • Omsk, Russian Federation, 644013
    • "Budgetary Healthcare Institution of Omsk Region ""Clinical Oncology Dispensary"""
  • Ryazan, Russian Federation, 390011
    • SBEI HPE RyazSMU of MoH of Russia based on SBI of Ryazan Region
  • Saint Petersburg, Russian Federation, 198255
    • SPb SBHI "City Clinical Oncology Dispensary"
  • Saint-Petersburg, Russian Federation, 197758
    • FSBI 'Scientific-Research Oncology Institute n.a. N.N.Petrov' of MoH of RF
  • Saratov, Russian Federation, 410002
    • Saratov scientific research institute of traumatology and orthopedics
  • Saratov, Russian Federation, 410004
    • NHI Road clinical hospital at the st. Saratov II of OJSC Russian Railways
  • Saratov, Russian Federation, 410054
    • Clinical hospital n.a. S.R. Mirotvortseva of SSMU
  • Sochi, Russian Federation, 354003
    • Limited Liability Company "Common health"
  • Krasnodar Region
    • Sochi, Krasnodar Region, Russian Federation, 354010
      • Dr's Grineva Private Clinic
    • Sochi, Krasnodar Region, Russian Federation, 354057
      • SHI Oncology Dispensary #2 of Health Department of Krasnodar Region
  • Moscow Region
    • P/o Stepanovskoe, Moscow Region, Russian Federation, 143423
      • "SAHI of Moscow ""Moscow City Oncology Hospital #62 of Health Department of Moscow"""
  • Ryshkovskiy Village Council
    • Kislino Steading Of Kursk Region, Ryshkovskiy Village Council, Russian Federation, 305524
      • "RBHI ""Kursk Regional Clinical Oncology Dispensary"" of Healthcare Committee of Kursk Region"
  • Stavropol Region
    • Essentuki, Stavropol Region, Russian Federation, 357600
      • SBHI of Stavropol Region "Essentuki Central City Hospital"
    • Lermontov, Stavropol Region, Russian Federation, 357340
      • Federal State Budgetary Institution of Healthcare "Clinical Hospital #
    • Pyatigorsk, Stavropol Region, Russian Federation, 357502
      • SBHI of Stavropol Region "Pyatigorsk Oncology Dispensary"
    • Stavropol, Stavropol Region, Russian Federation, 355047
      • Stavropol Krai State Budget Healthcare Institute "Stavropol Regional Oncology Clinic"
  • Udmurt Republic
    • Izhevsk, Udmurt Republic, Russian Federation, 426067
      • S.G. Primushko Republican Clinical Oncology Dispensary
  • Vladimir Region
    • Vladimir, Vladimir Region, Russian Federation, 600020
      • SBHI of Vladimir Region "Regional Clinical Oncology Dispensary"
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2196
      • The Medical Oncology Centre of Rosebank
  • Kwa-zulu Natal
    • Amanzimtoti, Kwa-zulu Natal, South Africa, 4126
      • Amanzimtoti Oncology Centre
  • Western CAPE
    • Cape Town, Western CAPE, South Africa, 7500
      • Drs Schnetler, Corbett and Partners Inc
    • Cape Town, Western CAPE, South Africa, 7560
      • Dr Lior Sareli Inc
    • Kraaifontein, Western CAPE, South Africa, 7570
      • Cape Town Oncology Trials (Pty) Ltd
• Spain
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain, 28041
    • Hospital 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz, Servicio de Oncología
  • Valencia, Spain, 46015
    • Hospital Arnau de Vilanova
  • Valencia, Spain, 46014
    • Consorcio Hospital Universitario General De Valencia
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporacio Sanitaria Parc Tauli
  • Islas Baleares
    • Palma de Mallorca, Islas Baleares, Spain, 07198
      • Hospital Son Llatzer
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Hospital Universitario Fundacion Alcorcon
• Taiwan
  • Changhua, Taiwan, 500
    • Changhua Christian Hospital
• Thailand
  • Bangkok, Thailand, 10330
    • Chula clinical research center
  • Bangkok, Thailand, 10400
    • Clinical Research Center, Phramongkutklao Hospital
  • Bangkok, Thailand, 10400
    • Medical Oncology Unit, Department of Medicine, Phramongkutklao Hospital
  • Bangkok, Thailand, 10700
    • Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital,
  • Bangkok, Thailand, 10900
    • Prachachuen Imaging Center Co., Ltd.
  • Phitsanulok, Thailand, 65000
    • Oncology Unit, Department of Medicine, Faculty of Medicine, Naresuan University
  • Bangkok
    • Patumwan, Bangkok, Thailand, 10330
      • Chulalongkorn University
  • Chiang RAI
    • Muang, Chiang RAI, Thailand, 57000
      • Chiangrai Prachanukroh Hospital
• Turkey
  • Adana, Turkey, 01330
    • Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
  • Adana, Turkey, 01120
    • Baskent Universitesi Tip Fakultesi Adana Hastanesi
  • Ankara, Turkey, 06230
    • Hacettepe Universitesi Tip Fakultesi
  • Ankara, Turkey, 06590
    • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
  • Ankara, Turkey, 06330
    • Diskapi Yildirim Beyazit Egitim ve Arastirma Hastanesi
  • Ankara, Turkey, 06800
    • Yildirim Beyazit Universitesi Tip Fakultesi Ataturk Egitim ve Arastirma Hastanesi
  • Istanbul, Turkey, 34093
    • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
  • Istanbul, Turkey, 34020
    • Yedikule Gogus Hastaliklari ve Gogus Cerrahisi
  • Istanbul, Turkey, 34093
    • Istanbul Universitesi Onkoloji Enstitusu
  • Istanbul, Turkey, 34096
    • Iyitem Goruntuleme ve Tani Merkezi
  • Istanbul, Turkey, 34098
    • Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari
  • Istanbul, Turkey, 34371
    • Prof Dr Nuri Tenekeci Tani Merkezi
  • Istanbul, Turkey, 34724
    • Euromed Goruntuleme ve Tani Merkezi
  • Izmir, Turkey, 35040
    • Ege Universitesi Tip Fakultesi lc Hastaliklari Anabilim Dali
• Ukraine
  • Chernivtsi, Ukraine, 58013
    • "Municipal Institution ""Chernivtsi Regional Clinical Oncology Dispensary"",
  • Dnipropetrovsk, Ukraine, 49102
    • MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC', Dep.-nt of Chemotherapy;
  • Kharkiv, Ukraine, 61070
    • Communal Non-Profit Enterprise "Regional Center of Oncology",
  • Kryvyi Rih, Ukraine, 50048
    • MI 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council'
  • Lviv, Ukraine, 79031
    • Lviv State Oncologic Regional Treatment and Diagnostic Center
  • Poltava, Ukraine, 36011
    • Poltava Reg. Clinical Oncology Dispensary of PRC, thoracic department, SHEI of Ukr.
  • Sumy, Ukraine, 40022
    • "RMI ""Sumy Reg. Clin. Oncology Dispensary"". oncothoracic dep.-nt. Surny State Univ.,
  • Uzhhorod, Ukraine, 88017
    • "Central City Clinical Hospital, City Oncology Center, SHEI ""Uzhhorod National University""
  • Vinnytsia, Ukraine, 21029
    • Vinnytsia Regional Clinical Oncology Dispensary
  • KYIV Region
    • Lyutizh, KYIV Region, Ukraine, 07352
      • LLC "Medical clinic "INNOVACIA", chemotherapy department
• United States
  • Alabama
    • Daphne, Alabama, United States, 36526
      • Southern Cancer Center, PC
    • Mobile, Alabama, United States, 36608
      • Southern Cancer Center, PC
    • Mobile, Alabama, United States, 36607
      • Southern Cancer Center, PC
  • California
    • Highland, California, United States, 92346
      • Beaver Medical Group, L.P.
  • Connecticut
    • New Britain, Connecticut, United States, 06052
      • Cancer Center of Central Connecticut
    • Southington, Connecticut, United States, 06489
      • Cancer Center of Central Connecticut
  • Georgia
    • Albany, Georgia, United States, 31701
      • Phoebe Putney Memorial Hospital
  • Illinois
    • Chicago, Illinois, United States, 60625
      • Swedish Covenant Hospital
  • Maryland
    • Hagerstown, Maryland, United States, 21742
      • Meritus Center for Clinical Research
    • Silver Spring, Maryland, United States, 20910
      • Holy Cross Hospital
    • Silver Spring, Maryland, United States, 20902
      • Holy Cross Hospital Resource Center
    • Silver Spring, Maryland, United States, 20904
      • Maryland Oncology & Hematology, PA
    • Silver Spring, Maryland, United States, 20910
      • Holy Cross Hospital, Hospital Pharmacy
    • Wheaton, Maryland, United States, 20902
      • Maryland Oncology & Hematology, PA
  • New Jersey
    • Paterson, New Jersey, United States, 07503
      • St. Joseph's Regional Medical Center
  • Texas
    • Houston, Texas, United States, 77090
      • Millennium Oncology
    • Kingwood, Texas, United States, 77339
      • Millennium Oncology
    • Shenandoah, Texas, United States, 77384
      • Millennium Oncology
    • The Woodlands, Texas, United States, 77380
      • Millennium Oncology

Participation Criteria

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:

• Male and female patients age at least 18 years of age, or age of consent in the region.
• Newly diagnosed Stage IIIB or IV non-small cell lung cancer (according to Revised International System for Staging Lung Cancer criteria of 2010) or recurrent non-small cell lung cancer (NSCLC).
• Histologically or cytologically confirmed diagnosis of predominately non-squamous NSCLC.
• Be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous NSCLC.

Exclusion Criteria:

• Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature.
• Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that is likely to bleed.
• Known sensitizing EGFR mutations (for example, deletion 19 or L858R) or EML4-ALK translocation positive mutations.
• Prior systemic therapy for NSCLC; prior neoadjuvant or adjuvant therapy is allowed if surgical resection for primary disease was performed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bevacizumab-Pfizer; Bevacizumab-Pfizer plus paclitaxel and carboplatin	Drug: Bevacizumab-Pfizer; Bevacizumab-Pfizer: 15 mg/kg IV on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles, followed by the assigned blinded bevacizumab monotherapy.; Drug: Paclitaxel; Paclitaxel 200 mg/m2 via IV infusions on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles.; Drug: Carboplatin; carboplatin AUC =6.0 via IV infusions on Day 1 of a 21-day cyclefor each of at least 4 and no more than six (6) 21-day cycles.
Active Comparator: Bevacizumab-EU; Bevacizumab-EU plus paclitaxel and carboplatin	Drug: Paclitaxel; Paclitaxel 200 mg/m2 via IV infusions on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles.; Drug: Carboplatin; carboplatin AUC =6.0 via IV infusions on Day 1 of a 21-day cyclefor each of at least 4 and no more than six (6) 21-day cycles.; Drug: Bevacizumab-EU; bevacizumab-EU: 15 mg/kg IV on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles followed by the assigned blinded bevacizumab monotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) by Week 19	ORR refers to percentage of participants who achieved complete response (CR) or partial response (PR) by Week 19 of the study in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 which was subsequently confirmed by Week 25. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.	25 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events	AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	55 weeks
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)	Laboratory evaluation included hematology (hemoglobin, white blood cells, platelets and absolute neutrophil count), blood chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, serum or plasma creatinine, sodium, potassium, total calcium, magnesium, blood urea nitrogen or urea, and albumin ), coagulation (international normalized ratio for prothrombin time and activated partial thromboplastin time) and urinalysis (dipstick followed by a quantitative urine protein analysis for results of 2+ or greater).	55 weeks
Duration of Response (DOR)	DOR was defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. DOR was based on the Brookmeyer and Crowley method.	55 weeks
Progression Free Survival Rate at 55 Weeks	This outcome measure refers to the possibility of being progression free at 55 weeks since start of study treatment, estimated from the Kaplan-Meier curve using the product-limit method.	55 weeks
Survival Rate at 55 Weeks	This outcome measure refers to the possibility of being alive at 55 weeks since start of study treatment, estimated from the Kaplan-Meier curve using the product-limit method.	55 weeks
Serum Concentration of Bevacizumab up to 1 Year		Pre-dose from Cycle 1 to Cycle 17, 2.5 hours post-dose in Cycle 1, and 1.5 hours post-dose in Cycle 5
Number of Participants With Anti-Drug Antibody (ADA)	ADA assay was performed using a sensitive, specific, and semi-quantitative electrochemiluminescent (ECL) method, which used biotinylated- and ruthenium-labeled PF-06439535 as reagents. Samples with ADA titer greater than or equal to (>=) 2.29 were considered positive.	55 weeks
Number of Participants With Neutralizing Antibody (NAb)	Only samples that were confirmed positive for ADA were further tested for NAb. The NAb analysis was conducted using a single validated quasi-quantitative enzyme-linked immunosorbent assay (ELISA) that utilized PF-06439535 as a reagent. Samples with NAb titer >=1.70 were considered positive.	55 weeks

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Li CSW, Sweeney K, Cronenberger C. Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin(R)) in patients with advanced non-squamous non-small cell lung cancer. Cancer Chemother Pharmacol. 2020 Mar;85(3):487-499. doi: 10.1007/s00280-019-03946-8. Epub 2019 Nov 26.
• Reinmuth N, Bryl M, Bondarenko I, Syrigos K, Vladimirov V, Zereu M, Bair AH, Hilton F, Liau K, Kasahara K. PF-06439535 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (Avastin(R)), Both Plus Paclitaxel and Carboplatin, as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer: A Randomized, Double-Blind Study. BioDrugs. 2019 Oct;33(5):555-570. doi: 10.1007/s40259-019-00363-4.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 10, 2015
• First Posted (Estimate): February 18, 2015

Study Record Updates

• Last Update Posted (Actual): February 7, 2019
• Last Update Submitted That Met QC Criteria: January 18, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Carboplatin; Paclitaxel; Bevacizumab
• Other Study ID Numbers: B7391003 (Other Identifier: Alias Study Number); 2014-003878-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.