AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 3NCT02364999

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

A Phase 3 study testing Bevacizumab-Pfizer, Bevacizumab-EU and Paclitaxel in people with Non-Small Cell Lung Cancer, run by Pfizer at 263 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Bevacizumab-Pfizer, Bevacizumab-EU and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
719 participants
Where
263 sitesin 27 countries
Study dates
Apr 2015to Dec 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

263 sites in 27 countries.

263 sites in 27 countries

Germany40 sites

  • Klinikum Bayreuth GmbH

    Bayreuth, 95445

  • Evangelische Lungenklinik Berlin

    Berlin, 13125

  • Viereck-Apotheke

    Berlin, 13125

  • Vivantes GmbH Apotheke des Humboldt-Klinikums

    Berlin, 13509

  • Vivantes Klinikum Spandau

    Berlin, 13585

  • Staedtisches Klinikum Braunschweig gGmbH Apotheke

    Braunschweig, 38114

  • Staedtisches Klinikum Braunschweig gGmbH Institut fuer Roentgendiagnostik und Nuklearmedizin

    Braunschweig, 38114

  • Staedtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38114

  • Fachkrankenhaus Coswig GmbH

    Coswig, 01640

  • Apotheke Johannstadt Sven Ullrich e.K.

    Dresden, 01307

  • Klinikum Esslingen GmbH

    Esslingen a.N., 73730

  • Radiologie Nuklearmedizin Adickesallee

    Frankfurt am Main, 60322

  • St. Elisabethen - Krankenhaus

    Frankfurt am Main, 60487

  • Sued-Apotheke

    Frankfurt am Main, 60596

  • Asklepios Fachkliniken Muenchen Gauting

    Gauting, 82131

  • Johannes-Apotheke

    Gröbenzell, 82194

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH - Apotheke

    Halle, 06120

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH - Institut fuer Radiologie

    Halle, 06120

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH

    Halle, 06120

  • Zytoservice Deutschland GmbH

    Hamburg, 22045

  • Katholisches Marienkrankenhaus gGmbH

    Hamburg, 22087

  • Institut fuer Diagnostische und Interventionelle Radiologie

    Hanover, 30625

  • Medizinische Hochschule Hannover Zentralapotheke

    Hanover, 30625

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitaetsklinikum des Saarlandes - Klinik fuer Diagnostische und Interventionelle Radiologie

    Homburg/Saar, 66421

  • Universitaetsklinikum des Saarlandes - Klinik fuer Innere Medizin V - Pneumologie, Allergologie,

    Homburg/Saar, 66421

  • Universitaetsklinikum des Saarlandes, Apotheke

    Homburg/Saar, 66421

  • Vincentius-Diakonissen-Kliniken gAG Karlsruhe

    Karlsruhe, 76137

  • Vincentius-Diakonissen-Kliniken gAG Klinik fuer Diagnostische und Interventionelle Radiologie

    Karlsruhe, 76137

  • Vincentius-Diakonissen-Kliniken gAG Zentralapotheke

    Karlsruhe, 76137

  • Institut Fuer Versorgungsforschung In Der Onkologie

    Koblenz, 56068

  • Radiologisches Institut Koblenz

    Koblenz, 56068

  • Sonnenschein Apotheke

    Koblenz, 56068

  • Hirsch-Apotheke

    Leer, 26789

  • Onkologie UnterEms

    Leer, 26789

  • Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz (ZRN Leipzig)

    Leipzig, 04103

  • Arkana Apotheke OHG

    Leipzig, 04315

  • POIS Leipzig GbR, Pneumologisch/onkologisch/internistisches Studienzentrum

    Leipzig, 04357

  • Onkologie Moers GbR

    Moers, 47441

  • Friedrich-Ebert-Krankenhaus Neumuenster

    Neumünster, 24534

Other trials in Germany

Russia33 sites

  • State Budget Healthcare Institution of Arkhangelsk Region

    Arkhangelsk, 163045

  • Evimed Llc

    Chelyabinsk, 454048

  • Chelyabinsk Regional Hospital

    Chelyabinsk, 454076

  • SBHI "Chelyabinsk Regional Clinical Hospital"

    Chelyabinsk, 454076

  • "SBHI ""Chelyabinsk Regional Clinical Oncology Dispensary"""

    Chelyabinsk, 454087

  • Chelyabinsk Regional Clinical Oncology Dispensary

    Chelyabinsk, 454087

  • MRT-Expert, LLC

    Chelyabinsk, 454087

  • Road Clinical Hospital on the station Chelyabinsk of OJSC "RZD"

    Chelyabinsk, 454092

  • S.G. Primushko Republican Clinical Oncology Dispensary

    Izhevsk, Udmurt Republic, 426067

  • "RBHI ""Kursk Regional Clinical Oncology Dispensary"" of Healthcare Committee of Kursk Region"

    Kislino Steading of Kursk Region, Ryshkovskiy Village Council, 305524

  • SBHI "Regional clinical hospital #2" of MoH of Krasnodar Region

    Krasnodar, 350012

  • Federal State Budgetary Institution of Healthcare "Clinical Hospital #

    Lermontov, Stavropol Kray, 357340

  • FSBI "N.N.Blokhin Russian Cancer Research Center" RAMS

    Moscow, 115478

  • P.A.Hertsen Moscow Oncology Research Institute - Branch of the National Medical Radiological

    Moscow, 125284

  • Privolzhskiy District Medical Center of Federal Biomedical Agency

    Nizhny Novgorod, 603001

  • SBHI NR Clinical Diagnostic Center

    Nizhny Novgorod, 603006

  • SBHI of NNR Nizhniy Novgorod Regional Oncology Dispensary

    Nizhny Novgorod, 603081

  • SBHI of NNR Nizhniy Novgorod Regional Oncology Dispensary

    Nizhny Novgorod, 603163

  • "Budgetary Healthcare Institution of Omsk Region ""Clinical Oncology Dispensary"""

    Omsk, 644013

  • "SAHI of Moscow ""Moscow City Oncology Hospital #62 of Health Department of Moscow"""

    P/o Stepanovskoe, Moscow Oblast, 143423

  • SBHI of Stavropol Region "Pyatigorsk Oncology Dispensary"

    Pyatigorsk, Stavropol Kray, 357502

  • SBEI HPE RyazSMU of MoH of Russia based on SBI of Ryazan Region

    Ryazan, 390011

  • FSBI 'Scientific-Research Oncology Institute n.a. N.N.Petrov' of MoH of RF

    Saint Petersburg, 197758

  • SPb SBHI "City Clinical Oncology Dispensary"

    Saint Petersburg, 198255

  • Saratov scientific research institute of traumatology and orthopedics

    Saratov, 410002

  • NHI Road clinical hospital at the st. Saratov II of OJSC Russian Railways

    Saratov, 410004

  • Clinical hospital n.a. S.R. Mirotvortseva of SSMU

    Saratov, 410054

  • Dr's Grineva Private Clinic

    Sochi, Krasnodarskiy Kray, 354010

  • SHI Oncology Dispensary #2 of Health Department of Krasnodar Region

    Sochi, Krasnodarskiy Kray, 354057

  • Limited Liability Company "Common health"

    Sochi, 354003

  • Stavropol Krai State Budget Healthcare Institute "Stavropol Regional Oncology Clinic"

    Stavropol, Stavropol Kray, 355047

  • SBHI of Vladimir Region "Regional Clinical Oncology Dispensary"

    Vladimir, Vladimirskaya Oblast’, 600020

  • SBHI of Stavropol Region "Essentuki Central City Hospital"

    Yessentuki, Stavropol Kray, 357600

Other trials in Russia

United States19 sites

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

  • Southern Cancer Center, PC

    Daphne, Alabama, 36526

  • Meritus Center for Clinical Research

    Hagerstown, Maryland, 21742

  • Beaver Medical Group, L.P.

    Highland, California, 92346

  • Millennium Oncology

    Houston, Texas, 77090

  • Millennium Oncology

    Kingwood, Texas, 77339

  • Southern Cancer Center, PC

    Mobile, Alabama, 36607

  • Southern Cancer Center, PC

    Mobile, Alabama, 36608

  • Cancer Center of Central Connecticut

    New Britain, Connecticut, 06052

  • St. Joseph's Regional Medical Center

    Paterson, New Jersey, 07503

  • Millennium Oncology

    Shenandoah, Texas, 77384

  • Holy Cross Hospital Resource Center

    Silver Spring, Maryland, 20902

  • Maryland Oncology & Hematology, PA

    Silver Spring, Maryland, 20904

  • Holy Cross Hospital, Hospital Pharmacy

    Silver Spring, Maryland, 20910

  • Holy Cross Hospital

    Silver Spring, Maryland, 20910

  • Cancer Center of Central Connecticut

    Southington, Connecticut, 06489

  • Millennium Oncology

    The Woodlands, Texas, 77380

  • Maryland Oncology & Hematology, PA

    Wheaton, Maryland, 20902

Other trials in United States

Brazil16 sites

  • Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

  • Oncoclinic (Clinica de Oncologia e Atendimento de Urgencia Ltda)

    Fortaleza, Ceará, 60160230

  • Instituto Joinvillense de Hematologia e Oncologia SS Ltda - Clinica de Hematologia e Oncologia

    Joinville, Santa Catarina, 89201-260

  • Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado)

    Lajeado, Rio Grande do Sul, 95900-000

  • Oncosinos (Lessa Ferreira Servicos Oncologicos Ltda)

    Novo Hamburgo, Rio Grande do Sul, 93510-250

  • Hospital da Cidade de Passo Fundo - HCPF

    Passo Fundo, Rio Grande do Sul, 99010-260

  • Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Irmandade da Santa Casa de Misericordia de Porto Alegre - Hospital Santa Rita

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca

    Rio de Janeiro, 22793-080

  • Hospital Santa Izabel / Santa Casa de Misericordia da Bahia

    Salvador, Estado de Bahia, 40050-410

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto -

    São José do Rio Preto, São Paulo, 15090-000

  • lnstituto do Cancer do Estado de Sao Paulo - Octavio Frias de -

    São Paulo, 01246-000

  • Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE/HSPE-FMO

    São Paulo, 04039-004

  • Instituto de Oncologia de Sorocaba - ONCO Clinicas Especializadas SC Ltda

    Sorocaba, São Paulo, 18035-300

  • COT - Centro Oncologico do Triangulo Ltda

    Uberlândia, Minas Gerais, 38408-150

Other trials in Brazil

Romania16 sites

  • Medisprof

    Cluj-Napoca, 400058

  • Spitalul Clinic Municipal

    Cluj-Napoca, 400139

  • SC Hiperdia SA

    Cluj-Napoca, 400489

  • Spitalul Clinic Judetean de Urgenta "Sf Apostol Andrei" Constanta Clinica Oncologie Medicala

    Constanța, 900591

  • Centrul Medical Pozimed, SC Pozitron Medical Investigation SRL

    Constanța, 900663

  • SPAD Imaging International S.R.L

    Craiova, Dolj, 200352

  • SC Cardio-Center SRL

    Craiova, Dolj, 200382

  • SC Oncolab SRL, Oncologie

    Craiova, JUD DOLJ, 200385

  • S.C. Centrul de Oncologie Sf. Nectarie S.R.L., Oncologie Medicala

    Craiova, 200347

  • SC Radiotherapy Center Cluj SRL

    Jud Cluj, 407280

  • Spitalul Clinic Judetean de Urgenta Targu Mures, Cardiologie

    Târgu Mureş, Mureș County, 540136

  • Spitalul Clinic Judetean Mures, radiologie si imagistica medicala

    Târgu Mureş, Mureș County, 540141

  • Spitalul Clinic Judetean Mures, sectia Clinica de Oncologie Medicala

    Târgu Mureş, Mureș County, 540141

  • S.C. Oncocenter Oncologie Clinica SRL

    Timișoara, Timiș County, 300166

  • Hiperdia Timisoara, Cardiologie

    Timișoara, 300158

  • Hiperdia Timisoara, Radiologie si imagistica medicala

    Timișoara, 300158

Other trials in Romania

Japan15 sites

  • National Hospital Organization Asahikawa Medical Center

    Asahikawa, Hokkaido, 070-8644

  • Saiseikai Fukuoka General Hospital

    Fukuoka, 810-0001

  • National Hospital Organization Mito Medical Center

    Higashi-ibaraki-gun, Ibaraki, 311-3193

  • National Hospital Organization Himeji Medical Center

    Himeji, Hyōgo, 670-8520

  • National Hospital Organization Hirosaki National Hospital

    Hirosaki, Aomori, 036-8545

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • National Hospital Organization Tokyo National Hospital

    Kiyose, Tokyo, 204-8585

  • National Hospital Organization Kochi National Hospital

    Kochi, 780-8077

  • National Hospital Organization Tokyo Medical Center

    Meguro-Ku, Tokyo, 152-8902

  • National Hospital Organization Oita Medical Center

    Ōita, 870-0263

  • Japanese Red Cross Okayama Hospital

    Okayama, 700-8607

  • National Hospital Organization Sendai Medical Center

    Sendai, Miyagi, 983-8520

  • National Hospital Organization Disaster Medical Center

    Tachikawa, Tokyo, 190-0014

  • National Hospital Organization Mie Chuo Medical Center

    Tsu, Mie-ken, 514-1101

  • Kanagawa Cardiovascular and Respiratory Center

    Yokohama, Kanagawa, 236-0051

Other trials in Japan

Turkey (Türkiye)14 sites

  • Baskent Universitesi Tip Fakultesi Adana Hastanesi

    Adana, 01120

  • Cukurova Universitesi Tip Fakultesi Balcali Hastanesi

    Adana, 01330

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06230

  • Diskapi Yildirim Beyazit Egitim ve Arastirma Hastanesi

    Ankara, 06330

  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

    Ankara, 06590

  • Yildirim Beyazit Universitesi Tip Fakultesi Ataturk Egitim ve Arastirma Hastanesi

    Ankara, 06800

  • Yedikule Gogus Hastaliklari ve Gogus Cerrahisi

    Istanbul, 34020

  • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

    Istanbul, 34093

  • Istanbul Universitesi Onkoloji Enstitusu

    Istanbul, 34093

  • Iyitem Goruntuleme ve Tani Merkezi

    Istanbul, 34096

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari

    Istanbul, 34098

  • Prof Dr Nuri Tenekeci Tani Merkezi

    Istanbul, 34371

  • Euromed Goruntuleme ve Tani Merkezi

    Istanbul, 34724

  • Ege Universitesi Tip Fakultesi lc Hastaliklari Anabilim Dali

    Izmir, 35040

Other trials in Turkey (Türkiye)

Poland10 sites

  • Wojewodzki Szpital Zespolony w Elblagu

    Elblag, 82-300

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Kopernika w Lodzi,

    Lodz, 93-513

  • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie

    Olsztyn, 10-357

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii im.Eugenii i Janusza Zeylandow

    Poznan, 60-569

  • MRUKMED. Lekarz Beata Madej Mruk i Partner. Sp. p. Oddzial nr 1 w Rzeszowie

    Rzeszów, 35-021

  • Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie Szpital Wojewodzki w

    Szczecin-Zdunowo, 70-891

  • Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Obserwacyjno-Zakazny

    Torun, 87-100

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

    Warsaw, 02-781

  • Wojskowy Instytut Medyczny, Klinika Onkologii

    Warsaw, 04-141

  • Wojewodzki Szpital Chorob Pluc im. dr Alojzego Pawelca

    Wodzisław Śląski, 44-300

Other trials in Poland

Ukraine10 sites

  • "Municipal Institution ""Chernivtsi Regional Clinical Oncology Dispensary"",

    Chernivtsi, 58013

  • MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC', Dep.-nt of Chemotherapy;

    Dnipropetrovsk, 49102

  • Communal Non-Profit Enterprise "Regional Center of Oncology",

    Kharkiv, 61070

  • MI 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council'

    Kryvyi Rih, 50048

  • LLC "Medical clinic "INNOVACIA", chemotherapy department

    Liutizh, Kyiv Oblast, 07352

  • Lviv State Oncologic Regional Treatment and Diagnostic Center

    Lviv, 79031

  • Poltava Reg. Clinical Oncology Dispensary of PRC, thoracic department, SHEI of Ukr.

    Poltava, 36011

  • "RMI ""Sumy Reg. Clin. Oncology Dispensary"". oncothoracic dep.-nt. Surny State Univ.,

    Sumy, 40022

  • "Central City Clinical Hospital, City Oncology Center, SHEI ""Uzhhorod National University""

    Uzhhorod, 88017

  • Vinnytsia Regional Clinical Oncology Dispensary

    Vinnytsia, 21029

Other trials in Ukraine

Hungary9 sites

  • Semmelweis Egyetem Klinikai Pulmonologiai Klinikai Gyogyszertar

    Budapest, 1125

  • Semmelweis Egyetem, Pulmonologiai Klinika

    Budapest, 1125

  • Csongrad Megyei Mellkasi Betegsegek Szakkorhaza

    Deszk, 6772

  • Veszprem Megyei Tudogyogyintezet

    Farkasgyepű, 8582

  • Petz Aladar Megyei Oktato Korhaz, Pulmonologiai Osztaly

    Győr, 9023

  • Matrai Gyogyintezet Pulmonologiai Osztaly

    Mátraháza, 3233

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet, Megyei Onkologiai Kozpont

    Szolnok, 5000

  • Tudogyogyintezet Torokbalint

    Törökbálint, 2045

  • Zala Megyei Korhaz

    Zalaegerszeg, 8900

Other trials in Hungary

Greece8 sites

  • Univ. of Athens Hosp. of Chest Diseases of Athens ''Sotiria''

    Athens, 11527

  • General Oncology Hospital of Kifissia "Ag. Anargiroi"

    Athens, 14564

  • University Hospital of Heraklion

    Heraklion, Crete, 71110

  • University General Hospital Of Patras

    Pátrai, 26504

  • Euromedica General Clinic of Thessaloniki

    Thessaloniki, 54645

  • European Inter-Balkan Medical Centre

    Thessaloniki, 57001

  • Thermi Clinic S.A

    Thessaloniki, 57001

  • Gen.Hospital "G. Papanikolaou"

    Thessaloniki, 57010

Other trials in Greece

Italy8 sites

  • Oncologia Medica, Fondazione Poliambulanza Instituto Ospedaliero

    Brescia, BS, 25124

  • UO Oncologia Medica

    Catania, CT, 95123

  • UOC Oncologia Medica

    Legnago, VR, 37045

  • UOC di Oncologia Medica

    Lido di Camaiore, LU, 55041

  • Unita di Oncologia Toracica

    Meldola, FC, 47014

  • UOSD Pneumologia Oncologica - Padiglione Flaiani

    Roma, RM, 00152

  • S.C. Oncologia Medica-Presidio Ospedaliero Sondrio

    Sondrio, SO, 23100

  • UOC Oncologia

    Treviglio, BG, 24047

Other trials in Italy

Spain8 sites

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón, Madrid, 28922

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz, Servicio de Oncologia

    Madrid, 28046

  • Hospital Son Llatzer

    Palma de Mallorca, Balearic Islands, 07198

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

  • Consorcio Hospital Universitario General De Valencia

    Valencia, 46014

  • Hospital Arnau de Vilanova

    Valencia, 46015

Other trials in Spain

Thailand8 sites

  • Chula Clinical Research Center

    Bangkok, 10330

  • Clinical Research Center, Phramongkutklao Hospital

    Bangkok, 10400

  • Medical Oncology Unit, Department of Medicine, Phramongkutklao Hospital

    Bangkok, 10400

  • Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital,

    Bangkok, 10700

  • Prachachuen Imaging Center Co., Ltd.

    Bangkok, 10900

  • Chiangrai Prachanukroh Hospital

    Muang, Changwat Chiang Rai, 57000

  • Chulalongkorn University

    Patumwan, Bangkok, 10330

  • Oncology Unit, Department of Medicine, Faculty of Medicine, Naresuan University

    Phitsanulok, 65000

Other trials in Thailand

Australia6 sites

  • Austin Health - Olivia Newton - John Cancer & Wellness Centre

    Heidelberg, Victoria, 3084

  • Epic Pharmacy

    Lismore, New South Wales, 2480

  • Western Health, Sunshine Hospital

    St Albans, Victoria, 3021

  • Cardiac Services, John Flynn Private Hospital -

    Tugun, Queensland, 4224

  • South Coast Radiology, John Flynn Private Hospital

    Tugun, Queensland, 4224

  • The Tweed Hospital

    Tweed Heads, New South Wales, 2485

Other trials in Australia

Chile6 sites

  • Bradford Hill Centro de Investigaciones Clinicas

    Santiago, Santiago Metropolitan, 8420383

  • Centro Internacional de Estudios Clinicos (CIEC)

    Santiago, Santiago Metropolitan, 8420383

  • Fresenius Kabi Chile, Therapia i.v.

    Santiago, Santiago Metropolitan, 8940575

  • Instituto Clinico Oncologico del Sur (ICOS)

    Temuco, Araucania, 4810469

  • Instituto Clínico Oncológico del Sur (ICOS)

    Temuco, Araucania, 4810469

  • Centro de Investigaciones Clinicas Vina del Mar Ltda.

    Viña del Mar, Valparaiso, 2540364

Other trials in Chile

India6 sites

  • HealthCare Global Enterprises Limited

    Bangalore, Karnataka, 560027

  • Institute of Respiratory Diseases, SMS Medical College & Hospital

    Jaipur, Rajasthan, 302016

  • Shatabdi Super Speciality Hospital

    Nashik, Maharashtra, 422005

  • Sahyadri Clinical Research and Development Center (A Unit of Sahayadri hospitals Limited)

    Pune, Maharashtra, 411004

  • Sahyadri Speciality Hospital

    Pune, Maharashtra, 411004

  • Mahatma Gandhi Cancer Hospital And Research Institute

    Visakhapatnam, Andhra Pradesh, 530 017

Other trials in India

Czechia5 sites

  • Nemocnice na Plesi s.r.o

    Nová Ves pod Pleší, 262 04

  • Nemocnice Novy Jicin a.s

    Nový Jičín, 741 01

  • Lekarna Agel Novy Jicin

    Nový Jičín, 74101

  • Nemocnice Pelhrimov p.o, Radioterapeuticke oddeleni

    Pelhřimov, 39338

  • Lekarna Oblastni nemocnice Pribram

    Příbram, 26126

Other trials in Czechia

South Africa5 sites

  • Drs Schnetler, Corbett and Partners Inc

    Cape Town, Western Cape, 7500

  • Dr Lior Sareli Inc

    Cape Town, Western Cape, 7560

  • Amanzimtoti Oncology Centre

    eManzimtoti, KwaZulu-Natal, 4126

  • The Medical Oncology Centre of Rosebank

    Johannesburg, Gauteng, 2196

  • Cape Town Oncology Trials (Pty) Ltd

    Kraaifontein, Western Cape, 7570

Other trials in South Africa

South Korea5 sites

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • VHS Medical Center

    Seoul, Gangdong-gu, 05368

  • The Catholic University of Korea, Seoul St.Mary's Hospital

    Seoul, 06591

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

France4 sites

  • Centre Hospitalier General De Mont De Marsan

    Mont-de-Marsan, 40024

  • Centre Hospitalier Montbeliard

    Montbéliard, 25200

  • L'hopital prive du Confluent S.A.S.

    Nantes, 44277

  • Hopital d'instruction des armees Sainte Anne

    Toulon, 83800

Other trials in France

Netherlands4 sites

  • Klinisch Chemisch en Hematologisch Laboratorium (KCHL)

    Arnhem, 6815 AD

  • Rijnstate Ziekenhuis

    Arnhem, 6815 AD

  • Ziekenhuis De Gelderse Vallei

    Ede, 6716 RP

  • Elkerliek Ziekenhuis

    Helmond, 5707 HA

Other trials in Netherlands

Malaysia3 sites

  • Penang Adventist Hospital

    George Town, 10350

  • Nilai Medical Centre

    Kampung Baharu Nilai, Negeri Sembilan, 71800

  • Mount Miriam Cancer Hospital

    Tanjung Bungah, Pulau Pinang, 11200

Other trials in Malaysia

Philippines2 sites

  • Cebu Doctors' University Hospital

    Cebu City, CEBU, 6000

  • Davao Doctors Hospital

    Davao City, Davao DEL SUR, 8000

Other trials in Philippines

Bulgaria1 site

  • Complex Oncological Center Shumen EOOD

    Shumen, 9700

Other trials in Bulgaria

Croatia1 site

  • University Hospital Centre "Sestre Milosrdnice"

    Zagreb, 10000

Other trials in Croatia

Taiwan1 site

  • Changhua Christian Hospital

    Changhua, 500

Other trials in Taiwan

About this study

Official title: 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.

Being tested
Bevacizumab-Pfizer, Bevacizumab-EU, Paclitaxel, Carboplatin
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bevacizumab-PfizerDrug

    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.

  • Bevacizumab-EUDrug

    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.

  • PaclitaxelDrug

    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.

  • CarboplatinDrug

    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.

Study groups in NCT02364999
Study groupRoleWhat they receive
Bevacizumab-PfizerExperimentalBevacizumab-Pfizer plus paclitaxel and carboplatin
Receives: Drug: Bevacizumab-Pfizer; Drug: Paclitaxel; Drug: Carboplatin
Bevacizumab-EUActive comparatorBevacizumab-EU plus paclitaxel and carboplatin
Receives: Drug: Bevacizumab-EU; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 25 weeks

Secondary outcomes (8)

  1. 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.

    Measured: 55 weeks

  2. 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).

    Measured: 55 weeks

  3. 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.

    Measured: 55 weeks

  4. 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.

    Measured: 55 weeks

  5. 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.

    Measured: 55 weeks

  6. Serum Concentration of Bevacizumab up to 1 Year

    Measured: 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

  7. 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.

    Measured: 55 weeks

  8. 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.

    Measured: 55 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionMay 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
719 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02364999
Sponsor's protocol ID
B7391003
Other IDs
2014-003878-16, B7391003, 2014
Status last verified
Jan 2019
First submitted
10 Feb 2015
Last updated
7 Feb 2019
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

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.

    PubMed 31768697

  • 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.

    PubMed 31338773

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab-Pfizer, Bevacizumab-EU and Paclitaxel in people with Non-Small Cell Lung Cancer, run by Pfizer at 263 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 263 sites in Germany, Russia, United States, Brazil, Romania and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) by Week 19 (time frame: 25 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02364999, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.

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