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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02364999
Recruitment Status : Completed
First Posted : February 18, 2015
Results First Posted : June 27, 2018
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Bevacizumab-Pfizer Drug: Bevacizumab-EU Drug: Paclitaxel Drug: Carboplatin Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 719 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : April 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bevacizumab-Pfizer
Bevacizumab-Pfizer plus paclitaxel and carboplatin
Drug: Bevacizumab-Pfizer
Bevacizumab-Pfizer: 15 mg/kg IV on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles, followed by the assigned blinded bevacizumab monotherapy.

Drug: Paclitaxel
Paclitaxel 200 mg/m2 via IV infusions on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles.

Drug: Carboplatin
carboplatin AUC =6.0 via IV infusions on Day 1 of a 21-day cyclefor each of at least 4 and no more than six (6) 21-day cycles.

Active Comparator: Bevacizumab-EU
Bevacizumab-EU plus paclitaxel and carboplatin
Drug: 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.

Drug: Paclitaxel
Paclitaxel 200 mg/m2 via IV infusions on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles.

Drug: Carboplatin
carboplatin AUC =6.0 via IV infusions on Day 1 of a 21-day cyclefor each of at least 4 and no more than six (6) 21-day cycles.




Primary Outcome Measures :
  1. Objective Response Rate (ORR) by Week 19 [ Time Frame: 25 weeks ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events [ Time Frame: 55 weeks ]
    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.

  2. Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) [ Time Frame: 55 weeks ]
    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).

  3. Duration of Response (DOR) [ Time Frame: 55 weeks ]
    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.

  4. Progression Free Survival Rate at 55 Weeks [ Time Frame: 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.

  5. Survival Rate at 55 Weeks [ Time Frame: 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.

  6. Serum Concentration of Bevacizumab up to 1 Year [ Time Frame: 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) [ Time Frame: 55 weeks ]
    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.

  8. Number of Participants With Neutralizing Antibody (NAb) [ Time Frame: 55 weeks ]
    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.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02364999


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

Documents provided by Pfizer:
Statistical Analysis Plan  [PDF] March 28, 2017
Study Protocol  [PDF] June 10, 2016


Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02364999     History of Changes
Other Study ID Numbers: B7391003
2014-003878-16 ( EudraCT Number )
B7391003 ( Other Identifier: Alias Study Number )
First Posted: February 18, 2015    Key Record Dates
Results First Posted: June 27, 2018
Last Update Posted: February 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors