A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC
A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF- 06439535 PLUS PACLITAXEL-CARBOPLATIN AND BEVACIZUMAB PLUS PACLITAXEL -CARBOPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER.
2 other identifiers
interventional
719
27 countries
263
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started Apr 2015
Shorter than P25 for phase_3 nonsmall-cell-lung-cancer
263 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2015
CompletedFirst Posted
Study publicly available on registry
February 18, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedResults Posted
Study results publicly available
June 27, 2018
CompletedFebruary 7, 2019
January 1, 2019
2.1 years
February 10, 2015
May 7, 2018
January 18, 2019
Conditions
Outcome Measures
Primary Outcomes (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.
25 weeks
Secondary Outcomes (8)
Number of Participants With Treatment-Emergent Adverse Events
55 weeks
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
55 weeks
Duration of Response (DOR)
55 weeks
Progression Free Survival Rate at 55 Weeks
55 weeks
Survival Rate at 55 Weeks
55 weeks
- +3 more secondary outcomes
Study Arms (2)
Bevacizumab-Pfizer
EXPERIMENTALBevacizumab-Pfizer plus paclitaxel and carboplatin
Bevacizumab-EU
ACTIVE COMPARATORBevacizumab-EU plus paclitaxel and carboplatin
Interventions
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-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 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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (263)
Southern Cancer Center, PC
Daphne, Alabama, 36526, United States
Southern Cancer Center, PC
Mobile, Alabama, 36607, United States
Southern Cancer Center, PC
Mobile, Alabama, 36608, United States
Beaver Medical Group, L.P.
Highland, California, 92346, United States
Cancer Center of Central Connecticut
New Britain, Connecticut, 06052, United States
Cancer Center of Central Connecticut
Southington, Connecticut, 06489, United States
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701, United States
Swedish Covenant Hospital
Chicago, Illinois, 60625, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742, United States
Holy Cross Hospital Resource Center
Silver Spring, Maryland, 20902, United States
Maryland Oncology & Hematology, PA
Silver Spring, Maryland, 20904, United States
Holy Cross Hospital, Hospital Pharmacy
Silver Spring, Maryland, 20910, United States
Holy Cross Hospital
Silver Spring, Maryland, 20910, United States
Maryland Oncology & Hematology, PA
Wheaton, Maryland, 20902, United States
St. Joseph's Regional Medical Center
Paterson, New Jersey, 07503, United States
Millennium Oncology
Houston, Texas, 77090, United States
Millennium Oncology
Kingwood, Texas, 77339, United States
Millennium Oncology
Shenandoah, Texas, 77384, United States
Millennium Oncology
The Woodlands, Texas, 77380, United States
Epic Pharmacy
Lismore, New South Wales, 2480, Australia
The Tweed Hospital
Tweed Heads, New South Wales, 2485, Australia
Cardiac Services, John Flynn Private Hospital -
Tugun, Queensland, 4224, Australia
South Coast Radiology, John Flynn Private Hospital
Tugun, Queensland, 4224, Australia
Austin Health - Olivia Newton - John Cancer & Wellness Centre
Heidelberg, Victoria, 3084, Australia
Western Health, Sunshine Hospital
St Albans, Victoria, 3021, Australia
Oncoclinic (Clinica de Oncologia e Atendimento de Urgencia Ltda)
Fortaleza, Ceará, 60160230, Brazil
Hospital Santa Izabel / Santa Casa de Misericordia da Bahia
Salvador, Estado de Bahia, 40050-410, Brazil
COT - Centro Oncologico do Triangulo Ltda
Uberlândia, Minas Gerais, 38408-150, Brazil
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060, Brazil
Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado)
Lajeado, Rio Grande do Sul, 95900-000, Brazil
Oncosinos (Lessa Ferreira Servicos Oncologicos Ltda)
Novo Hamburgo, Rio Grande do Sul, 93510-250, Brazil
Hospital da Cidade de Passo Fundo - HCPF
Passo Fundo, Rio Grande do Sul, 99010-260, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre - Hospital Santa Rita
Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Instituto Joinvillense de Hematologia e Oncologia SS Ltda - Clinica de Hematologia e Oncologia
Joinville, Santa Catarina, 89201-260, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto -
São José do Rio Preto, São Paulo, 15090-000, Brazil
Instituto de Oncologia de Sorocaba - ONCO Clinicas Especializadas SC Ltda
Sorocaba, São Paulo, 18035-300, Brazil
Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca
Rio de Janeiro, 22793-080, Brazil
lnstituto do Cancer do Estado de Sao Paulo - Octavio Frias de -
São Paulo, 01246-000, Brazil
Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE/HSPE-FMO
São Paulo, 04039-004, Brazil
Complex Oncological Center Shumen EOOD
Shumen, 9700, Bulgaria
Instituto Clinico Oncologico del Sur (ICOS)
Temuco, Región de la Araucanía, 4810469, Chile
Instituto Clínico Oncológico del Sur (ICOS)
Temuco, Región de la Araucanía, 4810469, Chile
Centro de Investigaciones Clinicas Vina del Mar Ltda.
Viña del Mar, Región de Valparaíso, 2540364, Chile
Bradford Hill Centro de Investigaciones Clinicas
Santiago, Santiago Metropolitan, 8420383, Chile
Centro Internacional de Estudios Clinicos (CIEC)
Santiago, Santiago Metropolitan, 8420383, Chile
Fresenius Kabi Chile, Therapia i.v.
Santiago, Santiago Metropolitan, 8940575, Chile
University Hospital Centre "Sestre Milosrdnice"
Zagreb, 10000, Croatia
Nemocnice na Plesi s.r.o
Nová Ves pod Pleší, 262 04, Czechia
Nemocnice Novy Jicin a.s
Nový Jičín, 741 01, Czechia
Lekarna Agel Novy Jicin
Nový Jičín, 74101, Czechia
Nemocnice Pelhrimov p.o, Radioterapeuticke oddeleni
Pelhřimov, 39338, Czechia
Lekarna Oblastni nemocnice Pribram
Příbram, 26126, Czechia
Centre Hospitalier General De Mont De Marsan
Mont-de-Marsan, 40024, France
Centre Hospitalier Montbeliard
Montbéliard, 25200, France
L'hopital prive du Confluent S.A.S.
Nantes, 44277, France
Hopital d'instruction des armees Sainte Anne
Toulon, 83800, France
Klinikum Bayreuth GmbH
Bayreuth, 95445, Germany
Evangelische Lungenklinik Berlin
Berlin, 13125, Germany
Viereck-Apotheke
Berlin, 13125, Germany
Vivantes GmbH Apotheke des Humboldt-Klinikums
Berlin, 13509, Germany
Vivantes Klinikum Spandau
Berlin, 13585, Germany
Staedtisches Klinikum Braunschweig gGmbH Apotheke
Braunschweig, 38114, Germany
Staedtisches Klinikum Braunschweig gGmbH Institut fuer Roentgendiagnostik und Nuklearmedizin
Braunschweig, 38114, Germany
Staedtisches Klinikum Braunschweig gGmbH
Braunschweig, 38114, Germany
Fachkrankenhaus Coswig GmbH
Coswig, 01640, Germany
Apotheke Johannstadt Sven Ullrich e.K.
Dresden, 01307, Germany
Klinikum Esslingen GmbH
Esslingen a.N., 73730, Germany
Radiologie Nuklearmedizin Adickesallee
Frankfurt am Main, 60322, Germany
St. Elisabethen - Krankenhaus
Frankfurt am Main, 60487, Germany
Sued-Apotheke
Frankfurt am Main, 60596, Germany
Asklepios Fachkliniken Muenchen Gauting
Gauting, 82131, Germany
Johannes-Apotheke
Gröbenzell, 82194, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH - Apotheke
Halle, 06120, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH - Institut fuer Radiologie
Halle, 06120, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle, 06120, Germany
Zytoservice Deutschland GmbH
Hamburg, 22045, Germany
Katholisches Marienkrankenhaus gGmbH
Hamburg, 22087, Germany
Institut fuer Diagnostische und Interventionelle Radiologie
Hanover, 30625, Germany
Medizinische Hochschule Hannover Zentralapotheke
Hanover, 30625, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitaetsklinikum des Saarlandes - Klinik fuer Diagnostische und Interventionelle Radiologie
Homburg/Saar, 66421, Germany
Universitaetsklinikum des Saarlandes - Klinik fuer Innere Medizin V - Pneumologie, Allergologie,
Homburg/Saar, 66421, Germany
Universitaetsklinikum des Saarlandes, Apotheke
Homburg/Saar, 66421, Germany
Vincentius-Diakonissen-Kliniken gAG Karlsruhe
Karlsruhe, 76137, Germany
Vincentius-Diakonissen-Kliniken gAG Klinik fuer Diagnostische und Interventionelle Radiologie
Karlsruhe, 76137, Germany
Vincentius-Diakonissen-Kliniken gAG Zentralapotheke
Karlsruhe, 76137, Germany
Institut Fuer Versorgungsforschung In Der Onkologie
Koblenz, 56068, Germany
Radiologisches Institut Koblenz
Koblenz, 56068, Germany
Sonnenschein Apotheke
Koblenz, 56068, Germany
Hirsch-Apotheke
Leer, 26789, Germany
Onkologie UnterEms
Leer, 26789, Germany
Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz (ZRN Leipzig)
Leipzig, 04103, Germany
Arkana Apotheke OHG
Leipzig, 04315, Germany
POIS Leipzig GbR, Pneumologisch/onkologisch/internistisches Studienzentrum
Leipzig, 04357, Germany
Onkologie Moers GbR
Moers, 47441, Germany
Friedrich-Ebert-Krankenhaus Neumuenster
Neumünster, 24534, Germany
University Hospital of Heraklion
Heraklion, Crete, 71110, Greece
Univ. of Athens Hosp. of Chest Diseases of Athens ''Sotiria''
Athens, 11527, Greece
General Oncology Hospital of Kifissia "Ag. Anargiroi"
Athens, 14564, Greece
University General Hospital Of Patras
Pátrai, 26504, Greece
Euromedica General Clinic of Thessaloniki
Thessaloniki, 54645, Greece
European Inter-Balkan Medical Centre
Thessaloniki, 57001, Greece
Thermi Clinic S.A
Thessaloniki, 57001, Greece
Gen.Hospital "G. Papanikolaou"
Thessaloniki, 57010, Greece
Semmelweis Egyetem Klinikai Pulmonologiai Klinikai Gyogyszertar
Budapest, 1125, Hungary
Semmelweis Egyetem, Pulmonologiai Klinika
Budapest, 1125, Hungary
Csongrad Megyei Mellkasi Betegsegek Szakkorhaza
Deszk, 6772, Hungary
Veszprem Megyei Tudogyogyintezet
Farkasgyepű, 8582, Hungary
Petz Aladar Megyei Oktato Korhaz, Pulmonologiai Osztaly
Győr, 9023, Hungary
Matrai Gyogyintezet Pulmonologiai Osztaly
Mátraháza, 3233, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet, Megyei Onkologiai Kozpont
Szolnok, 5000, Hungary
Tudogyogyintezet Torokbalint
Törökbálint, 2045, Hungary
Zala Megyei Korhaz
Zalaegerszeg, 8900, Hungary
Mahatma Gandhi Cancer Hospital And Research Institute
Visakhapatnam, Andhra Pradesh, 530 017, India
HealthCare Global Enterprises Limited
Bangalore, Karnataka, 560027, India
Shatabdi Super Speciality Hospital
Nashik, Maharashtra, 422005, India
Sahyadri Clinical Research and Development Center (A Unit of Sahayadri hospitals Limited)
Pune, Maharashtra, 411004, India
Sahyadri Speciality Hospital
Pune, Maharashtra, 411004, India
Institute of Respiratory Diseases, SMS Medical College & Hospital
Jaipur, Rajasthan, 302016, India
UOC Oncologia
Treviglio, BG, 24047, Italy
Oncologia Medica, Fondazione Poliambulanza Instituto Ospedaliero
Brescia, BS, 25124, Italy
UO Oncologia Medica
Catania, CT, 95123, Italy
Unita di Oncologia Toracica
Meldola, FC, 47014, Italy
UOC di Oncologia Medica
Lido di Camaiore, LU, 55041, Italy
UOSD Pneumologia Oncologica - Padiglione Flaiani
Roma, RM, 00152, Italy
S.C. Oncologia Medica-Presidio Ospedaliero Sondrio
Sondrio, SO, 23100, Italy
UOC Oncologia Medica
Legnago, VR, 37045, Italy
National Hospital Organization Hirosaki National Hospital
Hirosaki, Aomori, 036-8545, Japan
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, 070-8644, Japan
National Hospital Organization Himeji Medical Center
Himeji, Hyōgo, 670-8520, Japan
National Hospital Organization Mito Medical Center
Higashi-ibaraki-gun, Ibaraki, 311-3193, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa, 236-0051, Japan
National Hospital Organization Mie Chuo Medical Center
Tsu, Mie-ken, 514-1101, Japan
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, 983-8520, Japan
National Hospital Organization Tokyo National Hospital
Kiyose, Tokyo, 204-8585, Japan
National Hospital Organization Tokyo Medical Center
Meguro-Ku, Tokyo, 152-8902, Japan
National Hospital Organization Disaster Medical Center
Tachikawa, Tokyo, 190-0014, Japan
Saiseikai Fukuoka General Hospital
Fukuoka, 810-0001, Japan
National Hospital Organization Kochi National Hospital
Kochi, 780-8077, Japan
Japanese Red Cross Okayama Hospital
Okayama, 700-8607, Japan
National Hospital Organization Oita Medical Center
Ōita, 870-0263, Japan
Nilai Medical Centre
Kampung Baharu Nilai, Negeri Sembilan, 71800, Malaysia
Mount Miriam Cancer Hospital
Tanjung Bungah, Pulau Pinang, 11200, Malaysia
Penang Adventist Hospital
George Town, 10350, Malaysia
Klinisch Chemisch en Hematologisch Laboratorium (KCHL)
Arnhem, 6815 AD, Netherlands
Rijnstate Ziekenhuis
Arnhem, 6815 AD, Netherlands
Ziekenhuis De Gelderse Vallei
Ede, 6716 RP, Netherlands
Elkerliek Ziekenhuis
Helmond, 5707 HA, Netherlands
Cebu Doctors' University Hospital
Cebu City, CEBU, 6000, Philippines
Davao Doctors Hospital
Davao City, Davao DEL SUR, 8000, Philippines
Wojewodzki Szpital Zespolony w Elblagu
Elblag, 82-300, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Kopernika w Lodzi,
Lodz, 93-513, Poland
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie
Olsztyn, 10-357, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im.Eugenii i Janusza Zeylandow
Poznan, 60-569, Poland
MRUKMED. Lekarz Beata Madej Mruk i Partner. Sp. p. Oddzial nr 1 w Rzeszowie
Rzeszów, 35-021, Poland
Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie Szpital Wojewodzki w
Szczecin-Zdunowo, 70-891, Poland
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Obserwacyjno-Zakazny
Torun, 87-100, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
Warsaw, 02-781, Poland
Wojskowy Instytut Medyczny, Klinika Onkologii
Warsaw, 04-141, Poland
Wojewodzki Szpital Chorob Pluc im. dr Alojzego Pawelca
Wodzisław Śląski, 44-300, Poland
SPAD Imaging International S.R.L
Craiova, Dolj, 200352, Romania
SC Cardio-Center SRL
Craiova, Dolj, 200382, Romania
SC Oncolab SRL, Oncologie
Craiova, JUD DOLJ, 200385, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures, Cardiologie
Târgu Mureş, Mureș County, 540136, Romania
Spitalul Clinic Judetean Mures, radiologie si imagistica medicala
Târgu Mureş, Mureș County, 540141, Romania
Spitalul Clinic Judetean Mures, sectia Clinica de Oncologie Medicala
Târgu Mureş, Mureș County, 540141, Romania
S.C. Oncocenter Oncologie Clinica SRL
Timișoara, Timiș County, 300166, Romania
Medisprof
Cluj-Napoca, 400058, Romania
Spitalul Clinic Municipal
Cluj-Napoca, 400139, Romania
SC Hiperdia SA
Cluj-Napoca, 400489, Romania
Spitalul Clinic Judetean de Urgenta "Sf Apostol Andrei" Constanta Clinica Oncologie Medicala
Constanța, 900591, Romania
Centrul Medical Pozimed, SC Pozitron Medical Investigation SRL
Constanța, 900663, Romania
S.C. Centrul de Oncologie Sf. Nectarie S.R.L., Oncologie Medicala
Craiova, 200347, Romania
SC Radiotherapy Center Cluj SRL
Jud Cluj, 407280, Romania
Hiperdia Timisoara, Cardiologie
Timișoara, 300158, Romania
Hiperdia Timisoara, Radiologie si imagistica medicala
Timișoara, 300158, Romania
Dr's Grineva Private Clinic
Sochi, Krasnodarskiy Kray, 354010, Russia
SHI Oncology Dispensary #2 of Health Department of Krasnodar Region
Sochi, Krasnodarskiy Kray, 354057, Russia
"SAHI of Moscow ""Moscow City Oncology Hospital #62 of Health Department of Moscow"""
P/o Stepanovskoe, Moscow Oblast, 143423, Russia
"RBHI ""Kursk Regional Clinical Oncology Dispensary"" of Healthcare Committee of Kursk Region"
Kislino Steading of Kursk Region, Ryshkovskiy Village Council, 305524, Russia
Federal State Budgetary Institution of Healthcare "Clinical Hospital #
Lermontov, Stavropol Kray, 357340, Russia
SBHI of Stavropol Region "Pyatigorsk Oncology Dispensary"
Pyatigorsk, Stavropol Kray, 357502, Russia
Stavropol Krai State Budget Healthcare Institute "Stavropol Regional Oncology Clinic"
Stavropol, Stavropol Kray, 355047, Russia
SBHI of Stavropol Region "Essentuki Central City Hospital"
Yessentuki, Stavropol Kray, 357600, Russia
S.G. Primushko Republican Clinical Oncology Dispensary
Izhevsk, Udmurt Republic, 426067, Russia
SBHI of Vladimir Region "Regional Clinical Oncology Dispensary"
Vladimir, Vladimirskaya Oblast’, 600020, Russia
State Budget Healthcare Institution of Arkhangelsk Region
Arkhangelsk, 163045, Russia
Evimed Llc
Chelyabinsk, 454048, Russia
Chelyabinsk Regional Hospital
Chelyabinsk, 454076, Russia
SBHI "Chelyabinsk Regional Clinical Hospital"
Chelyabinsk, 454076, Russia
"SBHI ""Chelyabinsk Regional Clinical Oncology Dispensary"""
Chelyabinsk, 454087, Russia
Chelyabinsk Regional Clinical Oncology Dispensary
Chelyabinsk, 454087, Russia
MRT-Expert, LLC
Chelyabinsk, 454087, Russia
Road Clinical Hospital on the station Chelyabinsk of OJSC "RZD"
Chelyabinsk, 454092, Russia
SBHI "Regional clinical hospital #2" of MoH of Krasnodar Region
Krasnodar, 350012, Russia
FSBI "N.N.Blokhin Russian Cancer Research Center" RAMS
Moscow, 115478, Russia
P.A.Hertsen Moscow Oncology Research Institute - Branch of the National Medical Radiological
Moscow, 125284, Russia
Privolzhskiy District Medical Center of Federal Biomedical Agency
Nizhny Novgorod, 603001, Russia
SBHI NR Clinical Diagnostic Center
Nizhny Novgorod, 603006, Russia
SBHI of NNR Nizhniy Novgorod Regional Oncology Dispensary
Nizhny Novgorod, 603081, Russia
SBHI of NNR Nizhniy Novgorod Regional Oncology Dispensary
Nizhny Novgorod, 603163, Russia
"Budgetary Healthcare Institution of Omsk Region ""Clinical Oncology Dispensary"""
Omsk, 644013, Russia
SBEI HPE RyazSMU of MoH of Russia based on SBI of Ryazan Region
Ryazan, 390011, Russia
FSBI 'Scientific-Research Oncology Institute n.a. N.N.Petrov' of MoH of RF
Saint Petersburg, 197758, Russia
SPb SBHI "City Clinical Oncology Dispensary"
Saint Petersburg, 198255, Russia
Saratov scientific research institute of traumatology and orthopedics
Saratov, 410002, Russia
NHI Road clinical hospital at the st. Saratov II of OJSC Russian Railways
Saratov, 410004, Russia
Clinical hospital n.a. S.R. Mirotvortseva of SSMU
Saratov, 410054, Russia
Limited Liability Company "Common health"
Sochi, 354003, Russia
The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, 2196, South Africa
Amanzimtoti Oncology Centre
eManzimtoti, KwaZulu-Natal, 4126, South Africa
Drs Schnetler, Corbett and Partners Inc
Cape Town, Western Cape, 7500, South Africa
Dr Lior Sareli Inc
Cape Town, Western Cape, 7560, South Africa
Cape Town Oncology Trials (Pty) Ltd
Kraaifontein, Western Cape, 7570, South Africa
VHS Medical Center
Seoul, Gangdong-gu, 05368, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644, South Korea
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, 06591, South Korea
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, 07198, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, 08208, Spain
Hospital Universitario Fundacion Alcorcon
Alcorcón, Madrid, 28922, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz, Servicio de Oncologia
Madrid, 28046, Spain
Consorcio Hospital Universitario General De Valencia
Valencia, 46014, Spain
Hospital Arnau de Vilanova
Valencia, 46015, Spain
Changhua Christian Hospital
Changhua, 500, Taiwan
Chulalongkorn University
Patumwan, Bangkok, 10330, Thailand
Chiangrai Prachanukroh Hospital
Muang, Changwat Chiang Rai, 57000, Thailand
Chula Clinical Research Center
Bangkok, 10330, Thailand
Clinical Research Center, Phramongkutklao Hospital
Bangkok, 10400, Thailand
Medical Oncology Unit, Department of Medicine, Phramongkutklao Hospital
Bangkok, 10400, Thailand
Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital,
Bangkok, 10700, Thailand
Prachachuen Imaging Center Co., Ltd.
Bangkok, 10900, Thailand
Oncology Unit, Department of Medicine, Faculty of Medicine, Naresuan University
Phitsanulok, 65000, Thailand
Baskent Universitesi Tip Fakultesi Adana Hastanesi
Adana, 01120, Turkey (Türkiye)
Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
Adana, 01330, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi
Ankara, 06230, Turkey (Türkiye)
Diskapi Yildirim Beyazit Egitim ve Arastirma Hastanesi
Ankara, 06330, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
Ankara, 06590, Turkey (Türkiye)
Yildirim Beyazit Universitesi Tip Fakultesi Ataturk Egitim ve Arastirma Hastanesi
Ankara, 06800, Turkey (Türkiye)
Yedikule Gogus Hastaliklari ve Gogus Cerrahisi
Istanbul, 34020, Turkey (Türkiye)
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Istanbul, 34093, Turkey (Türkiye)
Istanbul Universitesi Onkoloji Enstitusu
Istanbul, 34093, Turkey (Türkiye)
Iyitem Goruntuleme ve Tani Merkezi
Istanbul, 34096, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari
Istanbul, 34098, Turkey (Türkiye)
Prof Dr Nuri Tenekeci Tani Merkezi
Istanbul, 34371, Turkey (Türkiye)
Euromed Goruntuleme ve Tani Merkezi
Istanbul, 34724, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi lc Hastaliklari Anabilim Dali
Izmir, 35040, Turkey (Türkiye)
LLC "Medical clinic "INNOVACIA", chemotherapy department
Liutizh, Kyiv Oblast, 07352, Ukraine
"Municipal Institution ""Chernivtsi Regional Clinical Oncology Dispensary"",
Chernivtsi, 58013, Ukraine
MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC', Dep.-nt of Chemotherapy;
Dnipropetrovsk, 49102, Ukraine
Communal Non-Profit Enterprise "Regional Center of Oncology",
Kharkiv, 61070, Ukraine
MI 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council'
Kryvyi Rih, 50048, Ukraine
Lviv State Oncologic Regional Treatment and Diagnostic Center
Lviv, 79031, Ukraine
Poltava Reg. Clinical Oncology Dispensary of PRC, thoracic department, SHEI of Ukr.
Poltava, 36011, Ukraine
"RMI ""Sumy Reg. Clin. Oncology Dispensary"". oncothoracic dep.-nt. Surny State Univ.,
Sumy, 40022, Ukraine
"Central City Clinical Hospital, City Oncology Center, SHEI ""Uzhhorod National University""
Uzhhorod, 88017, Ukraine
Vinnytsia Regional Clinical Oncology Dispensary
Vinnytsia, 21029, Ukraine
Related Publications (2)
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.
PMID: 31768697DERIVEDReinmuth 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.
PMID: 31338773DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2015
First Posted
February 18, 2015
Study Start
April 1, 2015
Primary Completion
May 1, 2017
Study Completion
December 1, 2017
Last Updated
February 7, 2019
Results First Posted
June 27, 2018
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will share
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.