Clinical trial NCT02364999: A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-02-18
Enrollment: 719
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective Response Rate (ORR) by Week 19
timeFrame: 25 weeks
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events
timeFrame: 55 weeks
measure: Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
timeFrame: 55 weeks
measure: Duration of Response (DOR)
timeFrame: 55 weeks
measure: Progression Free Survival Rate at 55 Weeks
timeFrame: 55 weeks
measure: Survival Rate at 55 Weeks
timeFrame: 55 weeks
measure: Serum Concentration of Bevacizumab up to 1 Year
timeFrame: 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
measure: Number of Participants With Anti-Drug Antibody (ADA)
timeFrame: 55 weeks
measure: Number of Participants With Neutralizing Antibody (NAb)
timeFrame: 55 weeks
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Southern Cancer Center, PC
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center, PC
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center, PC
state: Alabama
city: Highland
country: United States
facility: Beaver Medical Group, L.P.
state: California
city: New Britain
country: United States
facility: Cancer Center of Central Connecticut
state: Connecticut
city: Southington
country: United States
facility: Cancer Center of Central Connecticut
state: Connecticut
city: Albany
country: United States
facility: Phoebe Putney Memorial Hospital
state: Georgia
city: Chicago
country: United States
facility: Swedish Covenant Hospital
state: Illinois
city: Hagerstown
country: United States
facility: Meritus Center for Clinical Research
state: Maryland
city: Silver Spring
country: United States
facility: Holy Cross Hospital Resource Center
state: Maryland
city: Silver Spring
country: United States
facility: Maryland Oncology & Hematology, PA
state: Maryland
city: Silver Spring
country: United States
facility: Holy Cross Hospital, Hospital Pharmacy
state: Maryland
city: Silver Spring
country: United States
facility: Holy Cross Hospital
state: Maryland
city: Wheaton
country: United States
facility: Maryland Oncology & Hematology, PA
state: Maryland
city: Paterson
country: United States
facility: St. Joseph's Regional Medical Center
state: New Jersey
city: Houston
country: United States
facility: Millennium Oncology
state: Texas
city: Kingwood
country: United States
facility: Millennium Oncology
state: Texas
city: Shenandoah
country: United States
facility: Millennium Oncology
state: Texas
city: The Woodlands
country: United States
facility: Millennium Oncology
state: Texas
city: Lismore
country: Australia
facility: Epic Pharmacy
state: New South Wales
city: Tweed Heads
country: Australia
facility: The Tweed Hospital
state: New South Wales
city: Tugun
country: Australia
facility: Cardiac Services, John Flynn Private Hospital -
state: Queensland
city: Tugun
country: Australia
facility: South Coast Radiology, John Flynn Private Hospital
state: Queensland
city: Heidelberg
country: Australia
facility: Austin Health - Olivia Newton - John Cancer & Wellness Centre
state: Victoria
city: St Albans
country: Australia
facility: Western Health, Sunshine Hospital
state: Victoria
city: Salvador
country: Brazil
facility: Hospital Santa Izabel / Santa Casa de Misericordia da Bahia
state: Bahia
city: Fortaleza
country: Brazil
facility: Oncoclinic (Clinica de Oncologia e Atendimento de Urgencia Ltda)
state: Ceara
city: Uberlandia
country: Brazil
facility: COT - Centro Oncologico do Triangulo Ltda
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
state: Parana
city: Lajeado
country: Brazil
facility: Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado)
state: RIO Grande DO SUL
city: Novo Hamburgo
country: Brazil
facility: Oncosinos (Lessa Ferreira Servicos Oncologicos Ltda)
state: RIO Grande DO SUL
city: Passo Fundo
country: Brazil
facility: Hospital da Cidade de Passo Fundo - HCPF
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre - Hospital Santa Rita
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia
state: RIO Grande DO SUL
city: Joinville
country: Brazil
facility: Instituto Joinvillense de Hematologia e Oncologia SS Ltda - Clinica de Hematologia e Oncologia
state: Santa Catarina
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto -
state: SAO Paulo
city: Sorocaba
country: Brazil
facility: Instituto de Oncologia de Sorocaba - ONCO Clinicas Especializadas SC Ltda
state: SAO Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca
city: Sao Paulo
country: Brazil
facility: lnstituto do Cancer do Estado de Sao Paulo - Octavio Frias de -
city: Sao Paulo
country: Brazil
facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE/HSPE-FMO
city: Shumen
country: Bulgaria
facility: Complex Oncological Center Shumen EOOD
city: Temuco
country: Chile
facility: Instituto Clinico Oncologico del Sur (ICOS)
state: Region DE LA Araucania
city: Santiago
country: Chile
facility: Bradford Hill Centro de Investigaciones Clinicas
state: Region Metropolitana
city: Santiago
country: Chile
facility: Centro Internacional de Estudios Clinicos (CIEC)
state: Region Metropolitana
city: Santiago
country: Chile
facility: Fresenius Kabi Chile, Therapia i.v.
state: Region Metropolitana
city: Temuco
country: Chile
facility: Instituto Clínico Oncológico del Sur (ICOS)
state: Región DE LA Araucanía
city: Vina del Mar
country: Chile
facility: Centro de Investigaciones Clinicas Vina del Mar Ltda.
state: V Region
city: Zagreb
country: Croatia
facility: University Hospital Centre "Sestre Milosrdnice"
city: Nova Ves pod Plesi
country: Czechia
facility: Nemocnice na Plesi s.r.o
city: Novy Jicin
country: Czechia
facility: Nemocnice Novy Jicin a.s
city: Novy Jicin
country: Czechia
facility: Lekarna Agel Novy Jicin
city: Pelhrimov
country: Czechia
facility: Nemocnice Pelhrimov p.o, Radioterapeuticke oddeleni
city: Pribram
country: Czechia
facility: Lekarna Oblastni nemocnice Pribram
city: Mont De Marsan Cedex
country: France
facility: Centre Hospitalier General De Mont De Marsan
city: Montbeliard
country: France
facility: Centre Hospitalier Montbeliard
city: Nantes Cedex
country: France
facility: L'hopital prive du Confluent S.A.S.
city: Toulon Cedex 9
country: France
facility: Hopital d'instruction des armees Sainte Anne
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth GmbH
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin
city: Berlin
country: Germany
facility: Viereck-Apotheke
city: Berlin
country: Germany
facility: Vivantes GmbH Apotheke des Humboldt-Klinikums
city: Berlin
country: Germany
facility: Vivantes Klinikum Spandau
city: Braunschweig
country: Germany
facility: Staedtisches Klinikum Braunschweig gGmbH Apotheke
city: Braunschweig
country: Germany
facility: Staedtisches Klinikum Braunschweig gGmbH Institut fuer Roentgendiagnostik und Nuklearmedizin
city: Braunschweig
country: Germany
facility: Staedtisches Klinikum Braunschweig gGmbH
city: Coswig
country: Germany
facility: Fachkrankenhaus Coswig GmbH
city: Dresden
country: Germany
facility: Apotheke Johannstadt Sven Ullrich e.K.
city: Esslingen a.N.
country: Germany
facility: Klinikum Esslingen GmbH
city: Frankfurt am Main
country: Germany
facility: Radiologie Nuklearmedizin Adickesallee
city: Frankfurt am Main
country: Germany
facility: St. Elisabethen - Krankenhaus
city: Frankfurt am Main
country: Germany
facility: Sued-Apotheke
city: Gauting
country: Germany
facility: Asklepios Fachkliniken Muenchen Gauting
city: Groebenzell
country: Germany
facility: Johannes-Apotheke
city: Halle (Saale)
country: Germany
facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH - Apotheke
city: Halle (Saale)
country: Germany
facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH - Institut fuer Radiologie
city: Halle (Saale)
country: Germany
facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH
city: Hamburg
country: Germany
facility: Zytoservice Deutschland GmbH
city: Hamburg
country: Germany
facility: Katholisches Marienkrankenhaus gGmbH
city: Hannover
country: Germany
facility: Institut fuer Diagnostische und Interventionelle Radiologie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover Zentralapotheke
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Homburg/Saar
country: Germany
facility: Universitaetsklinikum des Saarlandes - Klinik fuer Diagnostische und Interventionelle Radiologie
city: Homburg/Saar
country: Germany
facility: Universitaetsklinikum des Saarlandes - Klinik fuer Innere Medizin V - Pneumologie, Allergologie,
city: Homburg/Saar
country: Germany
facility: Universitaetsklinikum des Saarlandes, Apotheke
city: Karlsruhe
country: Germany
facility: Vincentius-Diakonissen-Kliniken gAG Karlsruhe
city: Karlsruhe
country: Germany
facility: Vincentius-Diakonissen-Kliniken gAG Klinik fuer Diagnostische und Interventionelle Radiologie
city: Karlsruhe
country: Germany
facility: Vincentius-Diakonissen-Kliniken gAG Zentralapotheke
city: Koblenz
country: Germany
facility: Institut Fuer Versorgungsforschung In Der Onkologie
city: Koblenz
country: Germany
facility: Radiologisches Institut Koblenz
city: Koblenz
country: Germany
facility: Sonnenschein Apotheke
city: Leer
country: Germany
facility: Hirsch-Apotheke
city: Leer
country: Germany
facility: Onkologie UnterEms
city: Leipzig
country: Germany
facility: Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz (ZRN Leipzig)
city: Leipzig
country: Germany
facility: Arkana Apotheke OHG
city: Leipzig
country: Germany
facility: POIS Leipzig GbR, Pneumologisch/onkologisch/internistisches Studienzentrum
city: Moers
country: Germany
facility: Onkologie Moers GbR
city: Neumuenster
country: Germany
facility: Friedrich-Ebert-Krankenhaus Neumuenster
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
state: Crete
city: Athens
country: Greece
facility: Univ. of Athens Hosp. of Chest Diseases of Athens ''Sotiria''
city: Athens
country: Greece
facility: General Oncology Hospital of Kifissia "Ag. Anargiroi"
city: Patras
country: Greece
facility: University General Hospital Of Patras
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic of Thessaloniki
city: Thessaloniki
country: Greece
facility: European Inter-Balkan Medical Centre
city: Thessaloniki
country: Greece
facility: Thermi Clinic S.A
city: Thessaloniki
country: Greece
facility: Gen.Hospital "G. Papanikolaou"
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Klinikai Pulmonologiai Klinikai Gyogyszertar
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, Pulmonologiai Klinika
city: Deszk
country: Hungary
facility: Csongrad Megyei Mellkasi Betegsegek Szakkorhaza
city: Farkasgyepu
country: Hungary
facility: Veszprem Megyei Tudogyogyintezet
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz, Pulmonologiai Osztaly
city: Matrahaza
country: Hungary
facility: Matrai Gyogyintezet Pulmonologiai Osztaly
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet, Megyei Onkologiai Kozpont
city: Torokbalint
country: Hungary
facility: Tudogyogyintezet Torokbalint
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Korhaz
city: Visakhapatnam
country: India
facility: Mahatma Gandhi Cancer Hospital And Research Institute
state: Andhra Pradesh
city: Bangalore
country: India
facility: HealthCare Global Enterprises Limited
state: Karnataka
city: Nashik
country: India
facility: Shatabdi Super Speciality Hospital
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Clinical Research and Development Center (A Unit of Sahayadri hospitals Limited)
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Speciality Hospital
state: Maharashtra
city: Jaipur
country: India
facility: Institute of Respiratory Diseases, SMS Medical College & Hospital
state: Rajasthan
city: Treviglio
country: Italy
facility: UOC Oncologia
state: BG
city: Brescia
country: Italy
facility: Oncologia Medica, Fondazione Poliambulanza Instituto Ospedaliero
state: BS
city: Catania
country: Italy
facility: UO Oncologia Medica
state: CT
city: Meldola
country: Italy
facility: Unita di Oncologia Toracica
state: FC
city: Lido di Camaiore
country: Italy
facility: UOC di Oncologia Medica
state: LU
city: Roma
country: Italy
facility: UOSD Pneumologia Oncologica - Padiglione Flaiani
state: RM
city: Sondrio
country: Italy
facility: S.C. Oncologia Medica-Presidio Ospedaliero Sondrio
state: SO
city: Legnago
country: Italy
facility: UOC Oncologia Medica
state: VR
city: Hirosaki
country: Japan
facility: National Hospital Organization Hirosaki National Hospital
state: Aomori
city: Asahikawa
country: Japan
facility: National Hospital Organization Asahikawa Medical Center
state: Hokkaido
city: Himeji
country: Japan
facility: National Hospital Organization Himeji Medical Center
state: Hyogo
city: Higashi-ibaraki-gun
country: Japan
facility: National Hospital Organization Mito Medical Center
state: Ibaraki
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
state: Kanagawa
city: Tsu
country: Japan
facility: National Hospital Organization Mie Chuo Medical Center
state: MIE
city: Sendai
country: Japan
facility: National Hospital Organization Sendai Medical Center
state: Miyagi
city: Kiyose
country: Japan
facility: National Hospital Organization Tokyo National Hospital
state: Tokyo
city: Meguro-Ku
country: Japan
facility: National Hospital Organization Tokyo Medical Center
state: Tokyo
city: Tachikawa
country: Japan
facility: National Hospital Organization Disaster Medical Center
state: Tokyo
city: Fukuoka
country: Japan
facility: Saiseikai Fukuoka General Hospital
city: Kochi
country: Japan
facility: National Hospital Organization Kochi National Hospital
city: Oita
country: Japan
facility: National Hospital Organization Oita Medical Center
city: Okayama
country: Japan
facility: Japanese Red Cross Okayama Hospital
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
city: Seoul
country: Korea, Republic of
facility: VHS Medical Center
state: Gangdong-gu
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St.Mary's Hospital
city: Nilai
country: Malaysia
facility: Nilai Medical Centre
state: Negeri Sembilan
city: Tanjung Bungah
country: Malaysia
facility: Mount Miriam Cancer Hospital
state: Penang
city: Penang
country: Malaysia
facility: Penang Adventist Hospital
city: Arnhem
country: Netherlands
facility: Klinisch Chemisch en Hematologisch Laboratorium (KCHL)
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
city: Ede
country: Netherlands
facility: Ziekenhuis De Gelderse Vallei
city: Helmond
country: Netherlands
facility: Elkerliek Ziekenhuis
city: Cebu City
country: Philippines
facility: Cebu Doctors' University Hospital
state: Cebu
city: Davao City
country: Philippines
facility: Davao Doctors Hospital
state: Davao DEL SUR
city: Elblag
country: Poland
facility: Wojewodzki Szpital Zespolony w Elblagu
city: Lodz
country: Poland
facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Kopernika w Lodzi,
city: Olsztyn
country: Poland
facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii im.Eugenii i Janusza Zeylandow
city: Rzeszow
country: Poland
facility: MRUKMED. Lekarz Beata Madej Mruk i Partner. Sp. p. Oddzial nr 1 w Rzeszowie
city: Szczecin-Zdunowo
country: Poland
facility: Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie Szpital Wojewodzki w
city: Torun
country: Poland
facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Obserwacyjno-Zakazny
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny, Klinika Onkologii
city: Wodzislaw-Slaski
country: Poland
facility: Wojewodzki Szpital Chorob Pluc im. dr Alojzego Pawelca
city: Craiova
country: Romania
facility: SPAD Imaging International S.R.L
state: Dolj
city: Craiova
country: Romania
facility: SC Cardio-Center SRL
state: Dolj
city: Craiova
country: Romania
facility: SC Oncolab SRL, Oncologie
state: Jud Dolj
city: Targu-Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Targu Mures, Cardiologie
state: Mures
city: Targu-Mures
country: Romania
facility: Spitalul Clinic Judetean Mures, radiologie si imagistica medicala
state: Mures
city: Targu-Mures
country: Romania
facility: Spitalul Clinic Judetean Mures, sectia Clinica de Oncologie Medicala
state: Mures
city: Timisoara
country: Romania
facility: S.C. Oncocenter Oncologie Clinica SRL
state: Timis
city: Cluj Napoca
country: Romania
facility: Medisprof
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Municipal
city: Cluj-Napoca
country: Romania
facility: SC Hiperdia SA
city: Constanta
country: Romania
facility: Spitalul Clinic Judetean de Urgenta "Sf Apostol Andrei" Constanta Clinica Oncologie Medicala
city: Constanta
country: Romania
facility: Centrul Medical Pozimed, SC Pozitron Medical Investigation SRL
city: Craiova
country: Romania
facility: S.C. Centrul de Oncologie Sf. Nectarie S.R.L., Oncologie Medicala
city: Jud Cluj
country: Romania
facility: SC Radiotherapy Center Cluj SRL
city: Timisoara
country: Romania
facility: Hiperdia Timisoara, Cardiologie
city: Timisoara
country: Romania
facility: Hiperdia Timisoara, Radiologie si imagistica medicala
city: Sochi
country: Russian Federation
facility: Dr's Grineva Private Clinic
state: Krasnodar Region
city: Sochi
country: Russian Federation
facility: SHI Oncology Dispensary #2 of Health Department of Krasnodar Region
state: Krasnodar Region
city: P/o Stepanovskoe
country: Russian Federation
facility: SAHI of Moscow "Moscow City Oncology Hospital #62 of Health Department of Moscow"
state: Moscow Region
city: Kislino Steading Of Kursk Region
country: Russian Federation
facility: RBHI "Kursk Regional Clinical Oncology Dispensary" of Healthcare Committee of Kursk Region
state: Ryshkovskiy Village Council
city: Essentuki
country: Russian Federation
facility: SBHI of Stavropol Region "Essentuki Central City Hospital"
state: Stavropol Region
city: Lermontov
country: Russian Federation
facility: Federal State Budgetary Institution of Healthcare "Clinical Hospital #
state: Stavropol Region
city: Pyatigorsk
country: Russian Federation
facility: SBHI of Stavropol Region "Pyatigorsk Oncology Dispensary"
state: Stavropol Region
city: Stavropol
country: Russian Federation
facility: Stavropol Krai State Budget Healthcare Institute "Stavropol Regional Oncology Clinic"
state: Stavropol Region
city: Izhevsk
country: Russian Federation
facility: S.G. Primushko Republican Clinical Oncology Dispensary
state: Udmurt Republic
city: Vladimir
country: Russian Federation
facility: SBHI of Vladimir Region "Regional Clinical Oncology Dispensary"
state: Vladimir Region
city: Arkhangelsk
country: Russian Federation
facility: State Budget Healthcare Institution of Arkhangelsk Region
city: Chelyabinsk
country: Russian Federation
facility: Evimed Llc
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Hospital
city: Chelyabinsk
country: Russian Federation
facility: SBHI "Chelyabinsk Regional Clinical Hospital"
city: Chelyabinsk
country: Russian Federation
facility: SBHI "Chelyabinsk Regional Clinical Oncology Dispensary"
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncology Dispensary
city: Chelyabinsk
country: Russian Federation
facility: MRT-Expert, LLC
city: Chelyabinsk
country: Russian Federation
facility: Road Clinical Hospital on the station Chelyabinsk of OJSC "RZD"
city: Krasnodar
country: Russian Federation
facility: SBHI "Regional clinical hospital #2" of MoH of Krasnodar Region
city: Moscow
country: Russian Federation
facility: FSBI "N.N.Blokhin Russian Cancer Research Center" RAMS
city: Moscow
country: Russian Federation
facility: P.A.Hertsen Moscow Oncology Research Institute - Branch of the National Medical Radiological
city: Nizhniy Novgorod
country: Russian Federation
facility: Privolzhskiy District Medical Center of Federal Biomedical Agency
city: Nizhniy Novgorod
country: Russian Federation
facility: SBHI NR Clinical Diagnostic Center
city: Nizhniy Novgorod
country: Russian Federation
facility: SBHI of NNR Nizhniy Novgorod Regional Oncology Dispensary
city: Nizhniy Novgorod
country: Russian Federation
facility: SBHI of NNR Nizhniy Novgorod Regional Oncology Dispensary
city: Omsk
country: Russian Federation
facility: Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
city: Ryazan
country: Russian Federation
facility: SBEI HPE RyazSMU of MoH of Russia based on SBI of Ryazan Region
city: Saint Petersburg
country: Russian Federation
facility: SPb SBHI "City Clinical Oncology Dispensary"
city: Saint-Petersburg
country: Russian Federation
facility: FSBI 'Scientific-Research Oncology Institute n.a. N.N.Petrov' of MoH of RF
city: Saratov
country: Russian Federation
facility: Saratov scientific research institute of traumatology and orthopedics
city: Saratov
country: Russian Federation
facility: NHI Road clinical hospital at the st. Saratov II of OJSC Russian Railways
city: Saratov
country: Russian Federation
facility: Clinical hospital n.a. S.R. Mirotvortseva of SSMU
city: Sochi
country: Russian Federation
facility: Limited Liability Company "Common health"
city: Johannesburg
country: South Africa
facility: The Medical Oncology Centre of Rosebank
state: Gauteng
city: Amanzimtoti
country: South Africa
facility: Amanzimtoti Oncology Centre
state: Kwa-zulu Natal
city: Cape Town
country: South Africa
facility: Drs Schnetler, Corbett and Partners Inc
state: Western CAPE
city: Cape Town
country: South Africa
facility: Dr Lior Sareli Inc
state: Western CAPE
city: Kraaifontein
country: South Africa
facility: Cape Town Oncology Trials (Pty) Ltd
state: Western CAPE
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
state: Islas Baleares
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
state: Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz, Servicio de Oncologia
city: Valencia
country: Spain
facility: Consorcio Hospital Universitario General De Valencia
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Patumwan
country: Thailand
facility: Chulalongkorn University
state: Bangkok
city: Muang
country: Thailand
facility: Chiangrai Prachanukroh Hospital
state: Chiang RAI
city: Bangkok
country: Thailand
facility: Chula Clinical Research Center
city: Bangkok
country: Thailand
facility: Clinical Research Center, Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Medical Oncology Unit, Department of Medicine, Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital,
city: Bangkok
country: Thailand
facility: Prachachuen Imaging Center Co., Ltd.
city: Phitsanulok
country: Thailand
facility: Oncology Unit, Department of Medicine, Faculty of Medicine, Naresuan University
city: Adana
country: Turkey
facility: Baskent Universitesi Tip Fakultesi Adana Hastanesi
city: Adana
country: Turkey
facility: Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Egitim ve Arastirma Hastanesi
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
city: Ankara
country: Turkey
facility: Yildirim Beyazit Universitesi Tip Fakultesi Ataturk Egitim ve Arastirma Hastanesi
city: Istanbul
country: Turkey
facility: Yedikule Gogus Hastaliklari ve Gogus Cerrahisi
city: Istanbul
country: Turkey
facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Onkoloji Enstitusu
city: Istanbul
country: Turkey
facility: Iyitem Goruntuleme ve Tani Merkezi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari
city: Istanbul
country: Turkey
facility: Prof Dr Nuri Tenekeci Tani Merkezi
city: Istanbul
country: Turkey
facility: Euromed Goruntuleme ve Tani Merkezi
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi lc Hastaliklari Anabilim Dali
city: Lyutizh
country: Ukraine
facility: LLC "Medical clinic "INNOVACIA", chemotherapy department
state: KYIV Region
city: Chernivtsi
country: Ukraine
facility: "Municipal Institution ""Chernivtsi Regional Clinical Oncology Dispensary"",
city: Dnipropetrovsk
country: Ukraine
facility: MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC', Dep.-nt of Chemotherapy;
city: Kharkiv
country: Ukraine
facility: Communal Non-Profit Enterprise "Regional Center of Oncology",
city: Kryvyi Rih
country: Ukraine
facility: MI 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council'
city: Lviv
country: Ukraine
facility: Lviv State Oncologic Regional Treatment and Diagnostic Center
city: Poltava
country: Ukraine
facility: Poltava Reg. Clinical Oncology Dispensary of PRC, thoracic department, SHEI of Ukr.
city: Sumy
country: Ukraine
facility: "RMI ""Sumy Reg. Clin. Oncology Dispensary"". oncothoracic dep.-nt. Surny State Univ.,
city: Uzhhorod
country: Ukraine
facility: "Central City Clinical Hospital, City Oncology Center, SHEI ""Uzhhorod National University""
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Oncology Dispensary
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.