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

NCT ID: NCT02364999

Last Updated: 2019-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 719 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-12-31

Brief 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, recurrent or metastatic) non-squamous NSCLC.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bevacizumab-Pfizer

Bevacizumab-Pfizer plus paclitaxel and carboplatin

Group Type: EXPERIMENTAL

Bevacizumab-Pfizer

Intervention Type: DRUG

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.

Paclitaxel

Intervention Type: DRUG

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.

Carboplatin

Intervention Type: DRUG

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.

Bevacizumab-EU

Bevacizumab-EU plus paclitaxel and carboplatin

Group Type: ACTIVE_COMPARATOR

Bevacizumab-EU

Intervention Type: DRUG

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.

Paclitaxel

Intervention Type: DRUG

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.

Carboplatin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Southern Cancer Center, PC

Daphne, Alabama, United States

Southern Cancer Center, PC

Mobile, Alabama, United States

Southern Cancer Center, PC

Mobile, Alabama, United States

Beaver Medical Group, L.P.

Highland, California, United States

Cancer Center of Central Connecticut

New Britain, Connecticut, United States

Cancer Center of Central Connecticut

Southington, Connecticut, United States

Phoebe Putney Memorial Hospital

Albany, Georgia, United States

Swedish Covenant Hospital

Chicago, Illinois, United States

Meritus Center for Clinical Research

Hagerstown, Maryland, United States

Holy Cross Hospital Resource Center

Silver Spring, Maryland, United States

Maryland Oncology & Hematology, PA

Silver Spring, Maryland, United States

Holy Cross Hospital, Hospital Pharmacy

Silver Spring, Maryland, United States

Holy Cross Hospital

Silver Spring, Maryland, United States

Maryland Oncology & Hematology, PA

Wheaton, Maryland, United States

St. Joseph's Regional Medical Center

Paterson, New Jersey, United States

Millennium Oncology

Houston, Texas, United States

Millennium Oncology

Kingwood, Texas, United States

Millennium Oncology

Shenandoah, Texas, United States

Millennium Oncology

The Woodlands, Texas, United States

Epic Pharmacy

Lismore, New South Wales, Australia

The Tweed Hospital

Tweed Heads, New South Wales, Australia

Cardiac Services, John Flynn Private Hospital -

Tugun, Queensland, Australia

South Coast Radiology, John Flynn Private Hospital

Tugun, Queensland, Australia

Austin Health - Olivia Newton - John Cancer & Wellness Centre

Heidelberg, Victoria, Australia

Western Health, Sunshine Hospital

St Albans, Victoria, Australia

Oncoclinic (Clinica de Oncologia e Atendimento de Urgencia Ltda)

Fortaleza, Ceará, Brazil

Hospital Santa Izabel / Santa Casa de Misericordia da Bahia

Salvador, Estado de Bahia, Brazil

COT - Centro Oncologico do Triangulo Ltda

Uberlândia, Minas Gerais, Brazil

Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner

Curitiba, Paraná, Brazil

Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado)

Lajeado, Rio Grande do Sul, Brazil

Oncosinos (Lessa Ferreira Servicos Oncologicos Ltda)

Novo Hamburgo, Rio Grande do Sul, Brazil

Hospital da Cidade de Passo Fundo - HCPF

Passo Fundo, Rio Grande do Sul, Brazil

Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA

Porto Alegre, Rio Grande do Sul, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

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

Joinville, Santa Catarina, Brazil

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

São José do Rio Preto, São Paulo, Brazil

Instituto de Oncologia de Sorocaba - ONCO Clinicas Especializadas SC Ltda

Sorocaba, São Paulo, Brazil

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

Rio de Janeiro, , Brazil

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

São Paulo, , Brazil

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

São Paulo, , Brazil

Complex Oncological Center Shumen EOOD

Shumen, , Bulgaria

Instituto Clinico Oncologico del Sur (ICOS)

Temuco, Región de la Araucanía, Chile

Instituto Clínico Oncológico del Sur (ICOS)

Temuco, Región de la Araucanía, Chile

Centro de Investigaciones Clinicas Vina del Mar Ltda.

Viña del Mar, Región de Valparaíso, Chile

Bradford Hill Centro de Investigaciones Clinicas

Santiago, Santiago Metropolitan, Chile

Centro Internacional de Estudios Clinicos (CIEC)

Santiago, Santiago Metropolitan, Chile

Fresenius Kabi Chile, Therapia i.v.

Santiago, Santiago Metropolitan, Chile

University Hospital Centre "Sestre Milosrdnice"

Zagreb, , Croatia

Nemocnice na Plesi s.r.o

Nová Ves pod Pleší, , Czechia

Nemocnice Novy Jicin a.s

Nový Jičín, , Czechia

Lekarna Agel Novy Jicin

Nový Jičín, , Czechia

Nemocnice Pelhrimov p.o, Radioterapeuticke oddeleni

Pelhřimov, , Czechia

Lekarna Oblastni nemocnice Pribram

Příbram, , Czechia

Centre Hospitalier General De Mont De Marsan

Mont-de-Marsan, , France

Centre Hospitalier Montbeliard

Montbéliard, , France

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

Nantes, , France

Hopital d'instruction des armees Sainte Anne

Toulon, , France

Klinikum Bayreuth GmbH

Bayreuth, , Germany

Evangelische Lungenklinik Berlin

Berlin, , Germany

Viereck-Apotheke

Berlin, , Germany

Vivantes GmbH Apotheke des Humboldt-Klinikums

Berlin, , Germany

Vivantes Klinikum Spandau

Berlin, , Germany

Staedtisches Klinikum Braunschweig gGmbH Apotheke

Braunschweig, , Germany

Staedtisches Klinikum Braunschweig gGmbH Institut fuer Roentgendiagnostik und Nuklearmedizin

Braunschweig, , Germany

Staedtisches Klinikum Braunschweig gGmbH

Braunschweig, , Germany

Fachkrankenhaus Coswig GmbH

Coswig, , Germany

Apotheke Johannstadt Sven Ullrich e.K.

Dresden, , Germany

Klinikum Esslingen GmbH

Esslingen a.N., , Germany

Radiologie Nuklearmedizin Adickesallee

Frankfurt am Main, , Germany

St. Elisabethen - Krankenhaus

Frankfurt am Main, , Germany

Sued-Apotheke

Frankfurt am Main, , Germany

Asklepios Fachkliniken Muenchen Gauting

Gauting, , Germany

Johannes-Apotheke

Gröbenzell, , Germany

Krankenhaus Martha-Maria Halle-Doelau gGmbH - Apotheke

Halle, , Germany

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

Halle, , Germany

Krankenhaus Martha-Maria Halle-Doelau gGmbH

Halle, , Germany

Zytoservice Deutschland GmbH

Hamburg, , Germany

Katholisches Marienkrankenhaus gGmbH

Hamburg, , Germany

Institut fuer Diagnostische und Interventionelle Radiologie

Hanover, , Germany

Medizinische Hochschule Hannover Zentralapotheke

Hanover, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Universitaetsklinikum des Saarlandes - Klinik fuer Diagnostische und Interventionelle Radiologie

Homburg/Saar, , Germany

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

Homburg/Saar, , Germany

Universitaetsklinikum des Saarlandes, Apotheke

Homburg/Saar, , Germany

Vincentius-Diakonissen-Kliniken gAG Karlsruhe

Karlsruhe, , Germany

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

Karlsruhe, , Germany

Vincentius-Diakonissen-Kliniken gAG Zentralapotheke

Karlsruhe, , Germany

Institut Fuer Versorgungsforschung In Der Onkologie

Koblenz, , Germany

Radiologisches Institut Koblenz

Koblenz, , Germany

Sonnenschein Apotheke

Koblenz, , Germany

Hirsch-Apotheke

Leer, , Germany

Onkologie UnterEms

Leer, , Germany

Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz (ZRN Leipzig)

Leipzig, , Germany

Arkana Apotheke OHG

Leipzig, , Germany

POIS Leipzig GbR, Pneumologisch/onkologisch/internistisches Studienzentrum

Leipzig, , Germany

Onkologie Moers GbR

Moers, , Germany

Friedrich-Ebert-Krankenhaus Neumuenster

Neumünster, , Germany

University Hospital of Heraklion

Heraklion, Crete, Greece

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

Athens, , Greece

General Oncology Hospital of Kifissia "Ag. Anargiroi"

Athens, , Greece

University General Hospital Of Patras

Pátrai, , Greece

Euromedica General Clinic of Thessaloniki

Thessaloniki, , Greece

European Inter-Balkan Medical Centre

Thessaloniki, , Greece

Thermi Clinic S.A

Thessaloniki, , Greece

Gen.Hospital "G. Papanikolaou"

Thessaloniki, , Greece

Semmelweis Egyetem Klinikai Pulmonologiai Klinikai Gyogyszertar

Budapest, , Hungary

Semmelweis Egyetem, Pulmonologiai Klinika

Budapest, , Hungary

Csongrad Megyei Mellkasi Betegsegek Szakkorhaza

Deszk, , Hungary

Veszprem Megyei Tudogyogyintezet

Farkasgyepű, , Hungary

Petz Aladar Megyei Oktato Korhaz, Pulmonologiai Osztaly

Győr, , Hungary

Matrai Gyogyintezet Pulmonologiai Osztaly

Mátraháza, , Hungary

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

Szolnok, , Hungary

Tudogyogyintezet Torokbalint

Törökbálint, , Hungary

Zala Megyei Korhaz

Zalaegerszeg, , Hungary

Mahatma Gandhi Cancer Hospital And Research Institute

Visakhapatnam, Andhra Pradesh, India

HealthCare Global Enterprises Limited

Bangalore, Karnataka, India

Shatabdi Super Speciality Hospital

Nashik, Maharashtra, India

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

Pune, Maharashtra, India

Sahyadri Speciality Hospital

Pune, Maharashtra, India

Institute of Respiratory Diseases, SMS Medical College & Hospital

Jaipur, Rajasthan, India

UOC Oncologia

Treviglio, BG, Italy

Oncologia Medica, Fondazione Poliambulanza Instituto Ospedaliero

Brescia, BS, Italy

UO Oncologia Medica

Catania, CT, Italy

Unita di Oncologia Toracica

Meldola, FC, Italy

UOC di Oncologia Medica

Lido di Camaiore, LU, Italy

UOSD Pneumologia Oncologica - Padiglione Flaiani

Roma, RM, Italy

S.C. Oncologia Medica-Presidio Ospedaliero Sondrio

Sondrio, SO, Italy

UOC Oncologia Medica

Legnago, VR, Italy

National Hospital Organization Hirosaki National Hospital

Hirosaki, Aomori, Japan

National Hospital Organization Asahikawa Medical Center

Asahikawa, Hokkaido, Japan

National Hospital Organization Himeji Medical Center

Himeji, Hyōgo, Japan

National Hospital Organization Mito Medical Center

Higashi-ibaraki-gun, Ibaraki, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Kanagawa, Japan

National Hospital Organization Mie Chuo Medical Center

Tsu, Mie-ken, Japan

National Hospital Organization Sendai Medical Center

Sendai, Miyagi, Japan

National Hospital Organization Tokyo National Hospital

Kiyose, Tokyo, Japan

National Hospital Organization Tokyo Medical Center

Meguro-Ku, Tokyo, Japan

National Hospital Organization Disaster Medical Center

Tachikawa, Tokyo, Japan

Saiseikai Fukuoka General Hospital

Fukuoka, , Japan

National Hospital Organization Kochi National Hospital

Kochi, , Japan

Japanese Red Cross Okayama Hospital

Okayama, , Japan

National Hospital Organization Oita Medical Center

Ōita, , Japan

Nilai Medical Centre

Kampung Baharu Nilai, Negeri Sembilan, Malaysia

Mount Miriam Cancer Hospital

Tanjung Bungah, Pulau Pinang, Malaysia

Penang Adventist Hospital

George Town, , Malaysia

Klinisch Chemisch en Hematologisch Laboratorium (KCHL)

Arnhem, , Netherlands

Rijnstate Ziekenhuis

Arnhem, , Netherlands

Ziekenhuis De Gelderse Vallei

Ede, , Netherlands

Elkerliek Ziekenhuis

Helmond, , Netherlands

Cebu Doctors' University Hospital

Cebu City, CEBU, Philippines

Davao Doctors Hospital

Davao City, Davao DEL SUR, Philippines

Wojewodzki Szpital Zespolony w Elblagu

Elblag, , Poland

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

Lodz, , Poland

Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie

Olsztyn, , Poland

Wielkopolskie Centrum Pulmonologii i Torakochirurgii im.Eugenii i Janusza Zeylandow

Poznan, , Poland

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

Rzeszów, , Poland

Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie Szpital Wojewodzki w

Szczecin-Zdunowo, , Poland

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

Torun, , Poland

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

Warsaw, , Poland

Wojskowy Instytut Medyczny, Klinika Onkologii

Warsaw, , Poland

Wojewodzki Szpital Chorob Pluc im. dr Alojzego Pawelca

Wodzisław Śląski, , Poland

SPAD Imaging International S.R.L

Craiova, Dolj, Romania

SC Cardio-Center SRL

Craiova, Dolj, Romania

SC Oncolab SRL, Oncologie

Craiova, JUD DOLJ, Romania

Spitalul Clinic Judetean de Urgenta Targu Mures, Cardiologie

Târgu Mureş, Mureș County, Romania

Spitalul Clinic Judetean Mures, radiologie si imagistica medicala

Târgu Mureş, Mureș County, Romania

Spitalul Clinic Judetean Mures, sectia Clinica de Oncologie Medicala

Târgu Mureş, Mureș County, Romania

S.C. Oncocenter Oncologie Clinica SRL

Timișoara, Timiș County, Romania

Medisprof

Cluj-Napoca, , Romania

Spitalul Clinic Municipal

Cluj-Napoca, , Romania

SC Hiperdia SA

Cluj-Napoca, , Romania

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

Constanța, , Romania

Centrul Medical Pozimed, SC Pozitron Medical Investigation SRL

Constanța, , Romania

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

Craiova, , Romania

SC Radiotherapy Center Cluj SRL

Jud Cluj, , Romania

Hiperdia Timisoara, Cardiologie

Timișoara, , Romania

Hiperdia Timisoara, Radiologie si imagistica medicala

Timișoara, , Romania

Dr's Grineva Private Clinic

Sochi, Krasnodarskiy Kray, Russia

SHI Oncology Dispensary #2 of Health Department of Krasnodar Region

Sochi, Krasnodarskiy Kray, Russia

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

P/o Stepanovskoe, Moscow Oblast, Russia

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

Kislino Steading of Kursk Region, Ryshkovskiy Village Council, Russia

Federal State Budgetary Institution of Healthcare "Clinical Hospital #

Lermontov, Stavropol Kray, Russia

SBHI of Stavropol Region "Pyatigorsk Oncology Dispensary"

Pyatigorsk, Stavropol Kray, Russia

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

Stavropol, Stavropol Kray, Russia

SBHI of Stavropol Region "Essentuki Central City Hospital"

Yessentuki, Stavropol Kray, Russia

S.G. Primushko Republican Clinical Oncology Dispensary

Izhevsk, Udmurt Republic, Russia

SBHI of Vladimir Region "Regional Clinical Oncology Dispensary"

Vladimir, Vladimirskaya Oblast’, Russia

State Budget Healthcare Institution of Arkhangelsk Region

Arkhangelsk, , Russia

Evimed Llc

Chelyabinsk, , Russia

Chelyabinsk Regional Hospital

Chelyabinsk, , Russia

SBHI "Chelyabinsk Regional Clinical Hospital"

Chelyabinsk, , Russia

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

Chelyabinsk, , Russia

Chelyabinsk Regional Clinical Oncology Dispensary

Chelyabinsk, , Russia

MRT-Expert, LLC

Chelyabinsk, , Russia

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

Chelyabinsk, , Russia

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

Krasnodar, , Russia

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

Moscow, , Russia

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

Moscow, , Russia

Privolzhskiy District Medical Center of Federal Biomedical Agency

Nizhny Novgorod, , Russia

SBHI NR Clinical Diagnostic Center

Nizhny Novgorod, , Russia

SBHI of NNR Nizhniy Novgorod Regional Oncology Dispensary

Nizhny Novgorod, , Russia

SBHI of NNR Nizhniy Novgorod Regional Oncology Dispensary

Nizhny Novgorod, , Russia

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

Omsk, , Russia

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

Ryazan, , Russia

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

Saint Petersburg, , Russia

SPb SBHI "City Clinical Oncology Dispensary"

Saint Petersburg, , Russia

Saratov scientific research institute of traumatology and orthopedics

Saratov, , Russia

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

Saratov, , Russia

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

Saratov, , Russia

Limited Liability Company "Common health"

Sochi, , Russia

The Medical Oncology Centre of Rosebank

Johannesburg, Gauteng, South Africa

Amanzimtoti Oncology Centre

eManzimtoti, KwaZulu-Natal, South Africa

Drs Schnetler, Corbett and Partners Inc

Cape Town, Western Cape, South Africa

Dr Lior Sareli Inc

Cape Town, Western Cape, South Africa

Cape Town Oncology Trials (Pty) Ltd

Kraaifontein, Western Cape, South Africa

VHS Medical Center

Seoul, Gangdong-gu, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

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

Seoul, , South Korea

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, Spain

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, Spain

Hospital Universitario Fundacion Alcorcon

Alcorcón, Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Hospital 12 de Octubre

Madrid, , Spain

Hospital Universitario La Paz, Servicio de Oncologia

Madrid, , Spain

Consorcio Hospital Universitario General De Valencia

Valencia, , Spain

Hospital Arnau de Vilanova

Valencia, , Spain

Changhua Christian Hospital

Changhua, , Taiwan

Chulalongkorn University

Patumwan, Bangkok, Thailand

Chiangrai Prachanukroh Hospital

Muang, Changwat Chiang Rai, Thailand

Chula Clinical Research Center

Bangkok, , Thailand

Clinical Research Center, Phramongkutklao Hospital

Bangkok, , Thailand

Medical Oncology Unit, Department of Medicine, Phramongkutklao Hospital

Bangkok, , Thailand

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

Bangkok, , Thailand

Prachachuen Imaging Center Co., Ltd.

Bangkok, , Thailand

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

Phitsanulok, , Thailand

Baskent Universitesi Tip Fakultesi Adana Hastanesi

Adana, , Turkey (Türkiye)

Cukurova Universitesi Tip Fakultesi Balcali Hastanesi

Adana, , Turkey (Türkiye)

Hacettepe Universitesi Tip Fakultesi

Ankara, , Turkey (Türkiye)

Diskapi Yildirim Beyazit Egitim ve Arastirma Hastanesi

Ankara, , Turkey (Türkiye)

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

Ankara, , Turkey (Türkiye)

Yildirim Beyazit Universitesi Tip Fakultesi Ataturk Egitim ve Arastirma Hastanesi

Ankara, , Turkey (Türkiye)

Yedikule Gogus Hastaliklari ve Gogus Cerrahisi

Istanbul, , Turkey (Türkiye)

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

Istanbul, , Turkey (Türkiye)

Istanbul Universitesi Onkoloji Enstitusu

Istanbul, , Turkey (Türkiye)

Iyitem Goruntuleme ve Tani Merkezi

Istanbul, , Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari

Istanbul, , Turkey (Türkiye)

Prof Dr Nuri Tenekeci Tani Merkezi

Istanbul, , Turkey (Türkiye)

Euromed Goruntuleme ve Tani Merkezi

Istanbul, , Turkey (Türkiye)

Ege Universitesi Tip Fakultesi lc Hastaliklari Anabilim Dali

Izmir, , Turkey (Türkiye)

LLC "Medical clinic "INNOVACIA", chemotherapy department

Liutizh, Kyiv Oblast, Ukraine

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

Chernivtsi, , Ukraine

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

Dnipropetrovsk, , Ukraine

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

Kharkiv, , Ukraine

MI 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council'

Kryvyi Rih, , Ukraine

Lviv State Oncologic Regional Treatment and Diagnostic Center

Lviv, , Ukraine

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

Poltava, , Ukraine

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

Sumy, , Ukraine

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

Uzhhorod, , Ukraine

Vinnytsia Regional Clinical Oncology Dispensary

Vinnytsia, , Ukraine

Countries

United States; Australia; Brazil; Bulgaria; Chile; Croatia; Czechia; France; Germany; Greece; Hungary; India; Italy; Japan; Malaysia; Netherlands; Philippines; Poland; Romania; Russia; South Africa; South Korea; Spain; Taiwan; Thailand; Turkey (Türkiye); Ukraine

References

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.

Reference Type: DERIVED

PMID: 31768697 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31338773 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7391003&StudyName=A%20Phase%203%20Randomized%2C%20Double-blind%20Study%20Of%20Pf%2006439535%20Plus%20Paclitaxel-carboplatin%20And%20Bevacizumab%20Plus%20Paclitaxel%20-carboplatin%20For%20The%20First-line%20Treatment%20Of%20Patients%20With%20Advanced%20Non-squamous%20Non-small%20Cell%20Lung%20Cancer.

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

Other Identifiers

2014-003878-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B7391003

Identifier Type: OTHER

Identifier Source: secondary_id

B7391003

Identifier Type: -

Identifier Source: org_study_id