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

Primary Purpose

Non-Small Cell Lung Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Bevacizumab-Pfizer

Bevacizumab-EU

Paclitaxel

Carboplatin

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Southern Cancer Center, PC
Southern Cancer Center, PC
Southern Cancer Center, PC
Beaver Medical Group, L.P.
Cancer Center of Central Connecticut
Cancer Center of Central Connecticut
Phoebe Putney Memorial Hospital
Swedish Covenant Hospital
Meritus Center for Clinical Research
Holy Cross Hospital Resource Center
Maryland Oncology & Hematology, PA
Holy Cross Hospital, Hospital Pharmacy
Holy Cross Hospital
Maryland Oncology & Hematology, PA
St. Joseph's Regional Medical Center
Millennium Oncology
Millennium Oncology
Millennium Oncology
Millennium Oncology
Epic Pharmacy
The Tweed Hospital
Cardiac Services, John Flynn Private Hospital -
South Coast Radiology, John Flynn Private Hospital
Austin Health - Olivia Newton - John Cancer & Wellness Centre
Western Health, Sunshine Hospital
Hospital Santa Izabel / Santa Casa de Misericordia da Bahia
Oncoclinic (Clinica de Oncologia e Atendimento de Urgencia Ltda)
COT - Centro Oncologico do Triangulo Ltda
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado)
Oncosinos (Lessa Ferreira Servicos Oncologicos Ltda)
Hospital da Cidade de Passo Fundo - HCPF
Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA
Irmandade da Santa Casa de Misericordia de Porto Alegre - Hospital Santa Rita
Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia
Instituto Joinvillense de Hematologia e Oncologia SS Ltda - Clinica de Hematologia e Oncologia
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto -
Instituto de Oncologia de Sorocaba - ONCO Clinicas Especializadas SC Ltda
Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca
lnstituto do Cancer do Estado de Sao Paulo - Octavio Frias de -
Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE/HSPE-FMO
Complex Oncological Center Shumen EOOD
Instituto Clinico Oncologico del Sur (ICOS)
Bradford Hill Centro de Investigaciones Clinicas
Centro Internacional de Estudios Clinicos (CIEC)
Fresenius Kabi Chile, Therapia i.v.
Instituto Clínico Oncológico del Sur (ICOS)
Centro de Investigaciones Clinicas Vina del Mar Ltda.
University Hospital Centre "Sestre Milosrdnice"
Nemocnice na Plesi s.r.o
Nemocnice Novy Jicin a.s
Lekarna Agel Novy Jicin
Nemocnice Pelhrimov p.o, Radioterapeuticke oddeleni
Lekarna Oblastni nemocnice Pribram
Centre Hospitalier General De Mont De Marsan
Centre Hospitalier Montbeliard
L'hopital prive du Confluent S.A.S.
Hopital d'instruction des armees Sainte Anne
Klinikum Bayreuth GmbH
Evangelische Lungenklinik Berlin
Viereck-Apotheke
Vivantes GmbH Apotheke des Humboldt-Klinikums
Vivantes Klinikum Spandau
Staedtisches Klinikum Braunschweig gGmbH Apotheke
Staedtisches Klinikum Braunschweig gGmbH Institut fuer Roentgendiagnostik und Nuklearmedizin
Staedtisches Klinikum Braunschweig gGmbH
Fachkrankenhaus Coswig GmbH
Apotheke Johannstadt Sven Ullrich e.K.
Klinikum Esslingen GmbH
Radiologie Nuklearmedizin Adickesallee
St. Elisabethen - Krankenhaus
Sued-Apotheke
Asklepios Fachkliniken Muenchen Gauting
Johannes-Apotheke
Krankenhaus Martha-Maria Halle-Doelau gGmbH - Apotheke
Krankenhaus Martha-Maria Halle-Doelau gGmbH - Institut fuer Radiologie
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Zytoservice Deutschland GmbH
Katholisches Marienkrankenhaus gGmbH
Institut fuer Diagnostische und Interventionelle Radiologie
Medizinische Hochschule Hannover Zentralapotheke
Medizinische Hochschule Hannover
Universitaetsklinikum des Saarlandes - Klinik fuer Diagnostische und Interventionelle Radiologie
Universitaetsklinikum des Saarlandes - Klinik fuer Innere Medizin V - Pneumologie, Allergologie,
Universitaetsklinikum des Saarlandes, Apotheke
Vincentius-Diakonissen-Kliniken gAG Karlsruhe
Vincentius-Diakonissen-Kliniken gAG Klinik fuer Diagnostische und Interventionelle Radiologie
Vincentius-Diakonissen-Kliniken gAG Zentralapotheke
Institut Fuer Versorgungsforschung In Der Onkologie
Radiologisches Institut Koblenz
Sonnenschein Apotheke
Hirsch-Apotheke
Onkologie UnterEms
Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz (ZRN Leipzig)
Arkana Apotheke OHG
POIS Leipzig GbR, Pneumologisch/onkologisch/internistisches Studienzentrum
Onkologie Moers GbR
Friedrich-Ebert-Krankenhaus Neumuenster
University Hospital of Heraklion
Univ. of Athens Hosp. of Chest Diseases of Athens ''Sotiria''
General Oncology Hospital of Kifissia "Ag. Anargiroi"
University General Hospital Of Patras
Euromedica General Clinic of Thessaloniki
European Inter-Balkan Medical Centre
Thermi Clinic S.A
Gen.Hospital "G. Papanikolaou"
Semmelweis Egyetem Klinikai Pulmonologiai Klinikai Gyogyszertar
Semmelweis Egyetem, Pulmonologiai Klinika
Csongrad Megyei Mellkasi Betegsegek Szakkorhaza
Veszprem Megyei Tudogyogyintezet
Petz Aladar Megyei Oktato Korhaz, Pulmonologiai Osztaly
Matrai Gyogyintezet Pulmonologiai Osztaly
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet, Megyei Onkologiai Kozpont
Tudogyogyintezet Torokbalint
Zala Megyei Korhaz
Mahatma Gandhi Cancer Hospital And Research Institute
HealthCare Global Enterprises Limited
Shatabdi Super Speciality Hospital
Sahyadri Clinical Research and Development Center (A Unit of Sahayadri hospitals Limited)
Sahyadri Speciality Hospital
Institute of Respiratory Diseases, SMS Medical College & Hospital
UOC Oncologia
Oncologia Medica, Fondazione Poliambulanza Instituto Ospedaliero
UO Oncologia Medica
Unita di Oncologia Toracica
UOC di Oncologia Medica
UOSD Pneumologia Oncologica - Padiglione Flaiani
S.C. Oncologia Medica-Presidio Ospedaliero Sondrio
UOC Oncologia Medica
National Hospital Organization Hirosaki National Hospital
National Hospital Organization Asahikawa Medical Center
National Hospital Organization Himeji Medical Center
National Hospital Organization Mito Medical Center
Kanazawa University Hospital
Kanagawa Cardiovascular and Respiratory Center
National Hospital Organization Mie Chuo Medical Center
National Hospital Organization Sendai Medical Center
National Hospital Organization Tokyo National Hospital
National Hospital Organization Tokyo Medical Center
National Hospital Organization Disaster Medical Center
Saiseikai Fukuoka General Hospital
National Hospital Organization Kochi National Hospital
National Hospital Organization Oita Medical Center
Japanese Red Cross Okayama Hospital
Chungbuk National University Hospital
VHS Medical Center
Seoul National University Bundang Hospital
Ajou University Hospital
The Catholic University of Korea, Seoul St.Mary's Hospital
Nilai Medical Centre
Mount Miriam Cancer Hospital
Penang Adventist Hospital
Klinisch Chemisch en Hematologisch Laboratorium (KCHL)
Rijnstate Ziekenhuis
Ziekenhuis De Gelderse Vallei
Elkerliek Ziekenhuis
Cebu Doctors' University Hospital
Davao Doctors Hospital
Wojewodzki Szpital Zespolony w Elblagu
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Kopernika w Lodzi,
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im.Eugenii i Janusza Zeylandow
MRUKMED. Lekarz Beata Madej Mruk i Partner. Sp. p. Oddzial nr 1 w Rzeszowie
Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie Szpital Wojewodzki w
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Obserwacyjno-Zakazny
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
Wojskowy Instytut Medyczny, Klinika Onkologii
Wojewodzki Szpital Chorob Pluc im. dr Alojzego Pawelca
SPAD Imaging International S.R.L
SC Cardio-Center SRL
SC Oncolab SRL, Oncologie
Spitalul Clinic Judetean de Urgenta Targu Mures, Cardiologie
Spitalul Clinic Judetean Mures, radiologie si imagistica medicala
Spitalul Clinic Judetean Mures, sectia Clinica de Oncologie Medicala
S.C. Oncocenter Oncologie Clinica SRL
Medisprof
Spitalul Clinic Municipal
SC Hiperdia SA
Spitalul Clinic Judetean de Urgenta "Sf Apostol Andrei" Constanta Clinica Oncologie Medicala
Centrul Medical Pozimed, SC Pozitron Medical Investigation SRL
S.C. Centrul de Oncologie Sf. Nectarie S.R.L., Oncologie Medicala
SC Radiotherapy Center Cluj SRL
Hiperdia Timisoara, Cardiologie
Hiperdia Timisoara, Radiologie si imagistica medicala
Dr's Grineva Private Clinic
SHI Oncology Dispensary #2 of Health Department of Krasnodar Region
"SAHI of Moscow ""Moscow City Oncology Hospital #62 of Health Department of Moscow"""
"RBHI ""Kursk Regional Clinical Oncology Dispensary"" of Healthcare Committee of Kursk Region"
SBHI of Stavropol Region "Essentuki Central City Hospital"
Federal State Budgetary Institution of Healthcare "Clinical Hospital #
SBHI of Stavropol Region "Pyatigorsk Oncology Dispensary"
Stavropol Krai State Budget Healthcare Institute "Stavropol Regional Oncology Clinic"
S.G. Primushko Republican Clinical Oncology Dispensary
SBHI of Vladimir Region "Regional Clinical Oncology Dispensary"
State Budget Healthcare Institution of Arkhangelsk Region
Evimed Llc
Chelyabinsk Regional Hospital
SBHI "Chelyabinsk Regional Clinical Hospital"
"SBHI ""Chelyabinsk Regional Clinical Oncology Dispensary"""
Chelyabinsk Regional Clinical Oncology Dispensary
MRT-Expert, LLC
Road Clinical Hospital on the station Chelyabinsk of OJSC "RZD"
SBHI "Regional clinical hospital #2" of MoH of Krasnodar Region
FSBI "N.N.Blokhin Russian Cancer Research Center" RAMS
P.A.Hertsen Moscow Oncology Research Institute - Branch of the National Medical Radiological
Privolzhskiy District Medical Center of Federal Biomedical Agency
SBHI NR Clinical Diagnostic Center
SBHI of NNR Nizhniy Novgorod Regional Oncology Dispensary
SBHI of NNR Nizhniy Novgorod Regional Oncology Dispensary
"Budgetary Healthcare Institution of Omsk Region ""Clinical Oncology Dispensary"""
SBEI HPE RyazSMU of MoH of Russia based on SBI of Ryazan Region
SPb SBHI "City Clinical Oncology Dispensary"
FSBI 'Scientific-Research Oncology Institute n.a. N.N.Petrov' of MoH of RF
Saratov scientific research institute of traumatology and orthopedics
NHI Road clinical hospital at the st. Saratov II of OJSC Russian Railways
Clinical hospital n.a. S.R. Mirotvortseva of SSMU
Limited Liability Company "Common health"
The Medical Oncology Centre of Rosebank
Amanzimtoti Oncology Centre
Drs Schnetler, Corbett and Partners Inc
Dr Lior Sareli Inc
Cape Town Oncology Trials (Pty) Ltd
Corporacio Sanitaria Parc Tauli
Hospital Son Llatzer
Hospital Universitario Fundacion Alcorcon
Hospital Universitario Fundacion Jimenez Diaz
Hospital 12 de Octubre
Hospital Universitario La Paz, Servicio de Oncologia
Consorcio Hospital Universitario General De Valencia
Hospital Arnau de Vilanova
Changhua Christian Hospital
Chulalongkorn University
Chiangrai Prachanukroh Hospital
Chula Clinical Research Center
Clinical Research Center, Phramongkutklao Hospital
Medical Oncology Unit, Department of Medicine, Phramongkutklao Hospital
Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital,
Prachachuen Imaging Center Co., Ltd.
Oncology Unit, Department of Medicine, Faculty of Medicine, Naresuan University
Baskent Universitesi Tip Fakultesi Adana Hastanesi
Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
Hacettepe Universitesi Tip Fakultesi
Diskapi Yildirim Beyazit Egitim ve Arastirma Hastanesi
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
Yildirim Beyazit Universitesi Tip Fakultesi Ataturk Egitim ve Arastirma Hastanesi
Yedikule Gogus Hastaliklari ve Gogus Cerrahisi
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Istanbul Universitesi Onkoloji Enstitusu
Iyitem Goruntuleme ve Tani Merkezi
Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari
Prof Dr Nuri Tenekeci Tani Merkezi
Euromed Goruntuleme ve Tani Merkezi
Ege Universitesi Tip Fakultesi lc Hastaliklari Anabilim Dali
LLC "Medical clinic "INNOVACIA", chemotherapy department
"Municipal Institution ""Chernivtsi Regional Clinical Oncology Dispensary"",
MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC', Dep.-nt of Chemotherapy;
Communal Non-Profit Enterprise "Regional Center of Oncology",
MI 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council'
Lviv State Oncologic Regional Treatment and Diagnostic Center
Poltava Reg. Clinical Oncology Dispensary of PRC, thoracic department, SHEI of Ukr.
"RMI ""Sumy Reg. Clin. Oncology Dispensary"". oncothoracic dep.-nt. Surny State Univ.,
"Central City Clinical Hospital, City Oncology Center, SHEI ""Uzhhorod National University""
Vinnytsia Regional Clinical Oncology Dispensary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bevacizumab-Pfizer

Bevacizumab-EU

Arm Description

Bevacizumab-Pfizer plus paclitaxel and carboplatin

Bevacizumab-EU plus paclitaxel and carboplatin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events

AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)

Laboratory evaluation included hematology (hemoglobin, white blood cells, platelets and absolute neutrophil count), blood chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, serum or plasma creatinine, sodium, potassium, total calcium, magnesium, blood urea nitrogen or urea, and albumin ), coagulation (international normalized ratio for prothrombin time and activated partial thromboplastin time) and urinalysis (dipstick followed by a quantitative urine protein analysis for results of 2+ or greater).

Duration of Response (DOR)

DOR was defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. DOR was based on the Brookmeyer and Crowley method.

Progression Free Survival Rate at 55 Weeks

This outcome measure refers to the possibility of being progression free at 55 weeks since start of study treatment, estimated from the Kaplan-Meier curve using the product-limit method.

Survival Rate at 55 Weeks

This outcome measure refers to the possibility of being alive at 55 weeks since start of study treatment, estimated from the Kaplan-Meier curve using the product-limit method.

Serum Concentration of Bevacizumab up to 1 Year

Number of Participants With Anti-Drug Antibody (ADA)

ADA assay was performed using a sensitive, specific, and semi-quantitative electrochemiluminescent (ECL) method, which used biotinylated- and ruthenium-labeled PF-06439535 as reagents. Samples with ADA titer greater than or equal to (>=) 2.29 were considered positive.

Number of Participants With Neutralizing Antibody (NAb)

Only samples that were confirmed positive for ADA were further tested for NAb. The NAb analysis was conducted using a single validated quasi-quantitative enzyme-linked immunosorbent assay (ELISA) that utilized PF-06439535 as a reagent. Samples with NAb titer >=1.70 were considered positive.

Full Information

NCT ID

NCT02364999

First Posted

February 10, 2015

Last Updated

January 18, 2019

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02364999

Brief Title

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

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

April 2015 (Actual)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

719 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bevacizumab-Pfizer

Arm Type

Experimental

Arm Description

Bevacizumab-Pfizer plus paclitaxel and carboplatin

Arm Title

Bevacizumab-EU

Arm Type

Active Comparator

Arm Description

Bevacizumab-EU plus paclitaxel and carboplatin

Intervention Type

Drug

Intervention Name(s)

Bevacizumab-Pfizer

Intervention Description

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

Intervention Name(s)

Bevacizumab-EU

Intervention Description

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

Intervention Name(s)

Paclitaxel

Intervention Description

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

Intervention Name(s)

Carboplatin

Intervention Description

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 Measure Information:

Title

Objective Response Rate (ORR) by Week 19

Description

Time Frame

25 weeks

Secondary Outcome Measure Information:

Title

Number of Participants With Treatment-Emergent Adverse Events

Description

Time Frame

55 weeks

Title

Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)

Description

Time Frame

55 weeks

Title

Duration of Response (DOR)

Description

Time Frame

55 weeks

Title

Progression Free Survival Rate at 55 Weeks

Description

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.

Time Frame

55 weeks

Title

Survival Rate at 55 Weeks

Description

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.

Time Frame

55 weeks

Title

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

Title

Number of Participants With Anti-Drug Antibody (ADA)

Description

Time Frame

55 weeks

Title

Number of Participants With Neutralizing Antibody (NAb)

Description

Time Frame

55 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Southern Cancer Center, PC

City

Daphne

State/Province

Alabama

ZIP/Postal Code

36526

Country

United States

Facility Name

Southern Cancer Center, PC

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36607

Country

United States

Facility Name

Southern Cancer Center, PC

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Beaver Medical Group, L.P.

City

Highland

State/Province

California

ZIP/Postal Code

92346

Country

United States

Facility Name

Cancer Center of Central Connecticut

City

New Britain

State/Province

Connecticut

ZIP/Postal Code

06052

Country

United States

Facility Name

Cancer Center of Central Connecticut

City

Southington

State/Province

Connecticut

ZIP/Postal Code

06489

Country

United States

Facility Name

Phoebe Putney Memorial Hospital

City

Albany

State/Province

Georgia

ZIP/Postal Code

31701

Country

United States

Facility Name

Swedish Covenant Hospital

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60625

Country

United States

Facility Name

Meritus Center for Clinical Research

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21742

Country

United States

Facility Name

Holy Cross Hospital Resource Center

City

Silver Spring

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

Maryland Oncology & Hematology, PA

City

Silver Spring

State/Province

Maryland

ZIP/Postal Code

20904

Country

United States

Facility Name

Holy Cross Hospital, Hospital Pharmacy

City

Silver Spring

State/Province

Maryland

ZIP/Postal Code

20910

Country

United States

Facility Name

Holy Cross Hospital

City

Silver Spring

State/Province

Maryland

ZIP/Postal Code

20910

Country

United States

Facility Name

Maryland Oncology & Hematology, PA

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

St. Joseph's Regional Medical Center

City

Paterson

State/Province

New Jersey

ZIP/Postal Code

07503

Country

United States

Facility Name

Millennium Oncology

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Millennium Oncology

City

Kingwood

State/Province

Texas

ZIP/Postal Code

77339

Country

United States

Facility Name

Millennium Oncology

City

Shenandoah

State/Province

Texas

ZIP/Postal Code

77384

Country

United States

Facility Name

Millennium Oncology

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77380

Country

United States

Facility Name

Epic Pharmacy

City

Lismore

State/Province

New South Wales

ZIP/Postal Code

2480

Country

Australia

Facility Name

The Tweed Hospital

City

Tweed Heads

State/Province

New South Wales

ZIP/Postal Code

2485

Country

Australia

Facility Name

Cardiac Services, John Flynn Private Hospital -

City

Tugun

State/Province

Queensland

ZIP/Postal Code

4224

Country

Australia

Facility Name

South Coast Radiology, John Flynn Private Hospital

City

Tugun

State/Province

Queensland

ZIP/Postal Code

4224

Country

Australia

Facility Name

Austin Health - Olivia Newton - John Cancer & Wellness Centre

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Western Health, Sunshine Hospital

City

St Albans

State/Province

Victoria

ZIP/Postal Code

3021

Country

Australia

Facility Name

Hospital Santa Izabel / Santa Casa de Misericordia da Bahia

City

Salvador

State/Province

Bahia

ZIP/Postal Code

40050-410

Country

Brazil

Facility Name

Oncoclinic (Clinica de Oncologia e Atendimento de Urgencia Ltda)

City

Fortaleza

State/Province

Ceara

ZIP/Postal Code

60160230

Country

Brazil

Facility Name

COT - Centro Oncologico do Triangulo Ltda

City

Uberlandia

State/Province

Minas Gerais

ZIP/Postal Code

38408-150

Country

Brazil

Facility Name

Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner

City

Curitiba

State/Province

Parana

ZIP/Postal Code

81520-060

Country

Brazil

Facility Name

Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado)

City

Lajeado

State/Province

RIO Grande DO SUL

ZIP/Postal Code

95900-000

Country

Brazil

Facility Name

Oncosinos (Lessa Ferreira Servicos Oncologicos Ltda)

City

Novo Hamburgo

State/Province

RIO Grande DO SUL

ZIP/Postal Code

93510-250

Country

Brazil

Facility Name

Hospital da Cidade de Passo Fundo - HCPF

City

Passo Fundo

State/Province

RIO Grande DO SUL

ZIP/Postal Code

99010-260

Country

Brazil

Facility Name

Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA

City

Porto Alegre

State/Province

RIO Grande DO SUL

ZIP/Postal Code

90020-090

Country

Brazil

Facility Name

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

City

Porto Alegre

State/Province

RIO Grande DO SUL

ZIP/Postal Code

90050-170

Country

Brazil

Facility Name

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

City

Porto Alegre

State/Province

RIO Grande DO SUL

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

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

City

Joinville

State/Province

Santa Catarina

ZIP/Postal Code

89201-260

Country

Brazil

Facility Name

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

City

Sao Jose do Rio Preto

State/Province

SAO Paulo

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

Instituto de Oncologia de Sorocaba - ONCO Clinicas Especializadas SC Ltda

City

Sorocaba

State/Province

SAO Paulo

ZIP/Postal Code

18035-300

Country

Brazil

Facility Name

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

City

Rio de Janeiro

ZIP/Postal Code

22793-080

Country

Brazil

Facility Name

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

City

Sao Paulo

ZIP/Postal Code

01246-000

Country

Brazil

Facility Name

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

City

Sao Paulo

ZIP/Postal Code

04039-004

Country

Brazil

Facility Name

Complex Oncological Center Shumen EOOD

City

Shumen

ZIP/Postal Code

9700

Country

Bulgaria

Facility Name

Instituto Clinico Oncologico del Sur (ICOS)

City

Temuco

State/Province

Region DE LA Araucania

ZIP/Postal Code

4810469

Country

Chile

Facility Name

Bradford Hill Centro de Investigaciones Clinicas

City

Santiago

State/Province

Region Metropolitana

ZIP/Postal Code

8420383

Country

Chile

Facility Name

Centro Internacional de Estudios Clinicos (CIEC)

City

Santiago

State/Province

Region Metropolitana

ZIP/Postal Code

8420383

Country

Chile

Facility Name

Fresenius Kabi Chile, Therapia i.v.

City

Santiago

State/Province

Region Metropolitana

ZIP/Postal Code

8940575

Country

Chile

Facility Name

Instituto Clínico Oncológico del Sur (ICOS)

City

Temuco

State/Province

Región DE LA Araucanía

ZIP/Postal Code

4810469

Country

Chile

Facility Name

Centro de Investigaciones Clinicas Vina del Mar Ltda.

City

Vina del Mar

State/Province

V Region

ZIP/Postal Code

2540364

Country

Chile

Facility Name

University Hospital Centre "Sestre Milosrdnice"

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Nemocnice na Plesi s.r.o

City

Nova Ves pod Plesi

ZIP/Postal Code

262 04

Country

Czechia

Facility Name

Nemocnice Novy Jicin a.s

City

Novy Jicin

ZIP/Postal Code

741 01

Country

Czechia

Facility Name

Lekarna Agel Novy Jicin

City

Novy Jicin

ZIP/Postal Code

74101

Country

Czechia

Facility Name

Nemocnice Pelhrimov p.o, Radioterapeuticke oddeleni

City

Pelhrimov

ZIP/Postal Code

39338

Country

Czechia

Facility Name

Lekarna Oblastni nemocnice Pribram

City

Pribram

ZIP/Postal Code

26126

Country

Czechia

Facility Name

Centre Hospitalier General De Mont De Marsan

City

Mont De Marsan Cedex

ZIP/Postal Code

40024

Country

France

Facility Name

Centre Hospitalier Montbeliard

City

Montbeliard

ZIP/Postal Code

25200

Country

France

Facility Name

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

City

Nantes Cedex

ZIP/Postal Code

44277

Country

France

Facility Name

Hopital d'instruction des armees Sainte Anne

City

Toulon Cedex 9

ZIP/Postal Code

83800

Country

France

Facility Name

Klinikum Bayreuth GmbH

City

Bayreuth

ZIP/Postal Code

95445

Country

Germany

Facility Name

Evangelische Lungenklinik Berlin

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Viereck-Apotheke

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Vivantes GmbH Apotheke des Humboldt-Klinikums

City

Berlin

ZIP/Postal Code

13509

Country

Germany

Facility Name

Vivantes Klinikum Spandau

City

Berlin

ZIP/Postal Code

13585

Country

Germany

Facility Name

Staedtisches Klinikum Braunschweig gGmbH Apotheke

City

Braunschweig

ZIP/Postal Code

38114

Country

Germany

Facility Name

Staedtisches Klinikum Braunschweig gGmbH Institut fuer Roentgendiagnostik und Nuklearmedizin

City

Braunschweig

ZIP/Postal Code

38114

Country

Germany

Facility Name

Staedtisches Klinikum Braunschweig gGmbH

City

Braunschweig

ZIP/Postal Code

38114

Country

Germany

Facility Name

Fachkrankenhaus Coswig GmbH

City

Coswig

ZIP/Postal Code

01640

Country

Germany

Facility Name

Apotheke Johannstadt Sven Ullrich e.K.

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Klinikum Esslingen GmbH

City

Esslingen a.N.

ZIP/Postal Code

73730

Country

Germany

Facility Name

Radiologie Nuklearmedizin Adickesallee

City

Frankfurt am Main

ZIP/Postal Code

60322

Country

Germany

Facility Name

St. Elisabethen - Krankenhaus

City

Frankfurt am Main

ZIP/Postal Code

60487

Country

Germany

Facility Name

Sued-Apotheke

City

Frankfurt am Main

ZIP/Postal Code

60596

Country

Germany

Facility Name

Asklepios Fachkliniken Muenchen Gauting

City

Gauting

ZIP/Postal Code

82131

Country

Germany

Facility Name

Johannes-Apotheke

City

Groebenzell

ZIP/Postal Code

82194

Country

Germany

Facility Name

Krankenhaus Martha-Maria Halle-Doelau gGmbH - Apotheke

City

Halle (Saale)

ZIP/Postal Code

06120

Country

Germany

Facility Name

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

City

Halle (Saale)

ZIP/Postal Code

06120

Country

Germany

Facility Name

Krankenhaus Martha-Maria Halle-Doelau gGmbH

City

Halle (Saale)

ZIP/Postal Code

06120

Country

Germany

Facility Name

Zytoservice Deutschland GmbH

City

Hamburg

ZIP/Postal Code

22045

Country

Germany

Facility Name

Katholisches Marienkrankenhaus gGmbH

City

Hamburg

ZIP/Postal Code

22087

Country

Germany

Facility Name

Institut fuer Diagnostische und Interventionelle Radiologie

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Medizinische Hochschule Hannover Zentralapotheke

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Medizinische Hochschule Hannover

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Universitaetsklinikum des Saarlandes - Klinik fuer Diagnostische und Interventionelle Radiologie

City

Homburg/Saar

ZIP/Postal Code

66421

Country

Germany

Facility Name

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

City

Homburg/Saar

ZIP/Postal Code

66421

Country

Germany

Facility Name

Universitaetsklinikum des Saarlandes, Apotheke

City

Homburg/Saar

ZIP/Postal Code

66421

Country

Germany

Facility Name

Vincentius-Diakonissen-Kliniken gAG Karlsruhe

City

Karlsruhe

ZIP/Postal Code

76137

Country

Germany

Facility Name

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

City

Karlsruhe

ZIP/Postal Code

76137

Country

Germany

Facility Name

Vincentius-Diakonissen-Kliniken gAG Zentralapotheke

City

Karlsruhe

ZIP/Postal Code

76137

Country

Germany

Facility Name

Institut Fuer Versorgungsforschung In Der Onkologie

City

Koblenz

ZIP/Postal Code

56068

Country

Germany

Facility Name

Radiologisches Institut Koblenz

City

Koblenz

ZIP/Postal Code

56068

Country

Germany

Facility Name

Sonnenschein Apotheke

City

Koblenz

ZIP/Postal Code

56068

Country

Germany

Facility Name

Hirsch-Apotheke

City

Leer

ZIP/Postal Code

26789

Country

Germany

Facility Name

Onkologie UnterEms

City

Leer

ZIP/Postal Code

26789

Country

Germany

Facility Name

Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz (ZRN Leipzig)

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Arkana Apotheke OHG

City

Leipzig

ZIP/Postal Code

04315

Country

Germany

Facility Name

POIS Leipzig GbR, Pneumologisch/onkologisch/internistisches Studienzentrum

City

Leipzig

ZIP/Postal Code

04357

Country

Germany

Facility Name

Onkologie Moers GbR

City

Moers

ZIP/Postal Code

47441

Country

Germany

Facility Name

Friedrich-Ebert-Krankenhaus Neumuenster

City

Neumuenster

ZIP/Postal Code

24534

Country

Germany

Facility Name

University Hospital of Heraklion

City

Heraklion

State/Province

Crete

ZIP/Postal Code

71110

Country

Greece

Facility Name

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

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

General Oncology Hospital of Kifissia "Ag. Anargiroi"

City

Athens

ZIP/Postal Code

14564

Country

Greece

Facility Name

University General Hospital Of Patras

City

Patras

ZIP/Postal Code

26504

Country

Greece

Facility Name

Euromedica General Clinic of Thessaloniki

City

Thessaloniki

ZIP/Postal Code

54645

Country

Greece

Facility Name

European Inter-Balkan Medical Centre

City

Thessaloniki

ZIP/Postal Code

57001

Country

Greece

Facility Name

Thermi Clinic S.A

City

Thessaloniki

ZIP/Postal Code

57001

Country

Greece

Facility Name

Gen.Hospital "G. Papanikolaou"

City

Thessaloniki

ZIP/Postal Code

57010

Country

Greece

Facility Name

Semmelweis Egyetem Klinikai Pulmonologiai Klinikai Gyogyszertar

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Facility Name

Semmelweis Egyetem, Pulmonologiai Klinika

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Facility Name

Csongrad Megyei Mellkasi Betegsegek Szakkorhaza

City

Deszk

ZIP/Postal Code

6772

Country

Hungary

Facility Name

Veszprem Megyei Tudogyogyintezet

City

Farkasgyepu

ZIP/Postal Code

8582

Country

Hungary

Facility Name

Petz Aladar Megyei Oktato Korhaz, Pulmonologiai Osztaly

City

Gyor

ZIP/Postal Code

9023

Country

Hungary

Facility Name

Matrai Gyogyintezet Pulmonologiai Osztaly

City

Matrahaza

ZIP/Postal Code

3233

Country

Hungary

Facility Name

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

City

Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Tudogyogyintezet Torokbalint

City

Torokbalint

ZIP/Postal Code

2045

Country

Hungary

Facility Name

Zala Megyei Korhaz

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Mahatma Gandhi Cancer Hospital And Research Institute

City

Visakhapatnam

State/Province

Andhra Pradesh

ZIP/Postal Code

530 017

Country

India

Facility Name

HealthCare Global Enterprises Limited

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560027

Country

India

Facility Name

Shatabdi Super Speciality Hospital

City

Nashik

State/Province

Maharashtra

ZIP/Postal Code

422005

Country

India

Facility Name

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

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411004

Country

India

Facility Name

Sahyadri Speciality Hospital

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411004

Country

India

Facility Name

Institute of Respiratory Diseases, SMS Medical College & Hospital

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302016

Country

India

Facility Name

UOC Oncologia

City

Treviglio

State/Province

ZIP/Postal Code

24047

Country

Italy

Facility Name

Oncologia Medica, Fondazione Poliambulanza Instituto Ospedaliero

City

Brescia

State/Province

ZIP/Postal Code

25124

Country

Italy

Facility Name

UO Oncologia Medica

City

Catania

State/Province

ZIP/Postal Code

95123

Country

Italy

Facility Name

Unita di Oncologia Toracica

City

Meldola

State/Province

ZIP/Postal Code

47014

Country

Italy

Facility Name

UOC di Oncologia Medica

City

Lido di Camaiore

State/Province

ZIP/Postal Code

55041

Country

Italy

Facility Name

UOSD Pneumologia Oncologica - Padiglione Flaiani

City

Roma

State/Province

ZIP/Postal Code

00152

Country

Italy

Facility Name

S.C. Oncologia Medica-Presidio Ospedaliero Sondrio

City

Sondrio

State/Province

ZIP/Postal Code

23100

Country

Italy

Facility Name

UOC Oncologia Medica

City

Legnago

State/Province

ZIP/Postal Code

37045

Country

Italy

Facility Name

National Hospital Organization Hirosaki National Hospital

City

Hirosaki

State/Province

Aomori

ZIP/Postal Code

036-8545

Country

Japan

Facility Name

National Hospital Organization Asahikawa Medical Center

City

Asahikawa

State/Province

Hokkaido

ZIP/Postal Code

070-8644

Country

Japan

Facility Name

National Hospital Organization Himeji Medical Center

City

Himeji

State/Province

Hyogo

ZIP/Postal Code

670-8520

Country

Japan

Facility Name

National Hospital Organization Mito Medical Center

City

Higashi-ibaraki-gun

State/Province

Ibaraki

ZIP/Postal Code

311-3193

Country

Japan

Facility Name

Kanazawa University Hospital

City

Kanazawa

State/Province

Ishikawa

ZIP/Postal Code

920-8641

Country

Japan

Facility Name

Kanagawa Cardiovascular and Respiratory Center

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

236-0051

Country

Japan

Facility Name

National Hospital Organization Mie Chuo Medical Center

City

Tsu

State/Province

MIE

ZIP/Postal Code

514-1101

Country

Japan

Facility Name

National Hospital Organization Sendai Medical Center

City

Sendai

State/Province

Miyagi

ZIP/Postal Code

983-8520

Country

Japan

Facility Name

National Hospital Organization Tokyo National Hospital

City

Kiyose

State/Province

Tokyo

ZIP/Postal Code

204-8585

Country

Japan

Facility Name

National Hospital Organization Tokyo Medical Center

City

Meguro-Ku

State/Province

Tokyo

ZIP/Postal Code

152-8902

Country

Japan

Facility Name

National Hospital Organization Disaster Medical Center

City

Tachikawa

State/Province

Tokyo

ZIP/Postal Code

190-0014

Country

Japan

Facility Name

Saiseikai Fukuoka General Hospital

City

Fukuoka

ZIP/Postal Code

810-0001

Country

Japan

Facility Name

National Hospital Organization Kochi National Hospital

City

Kochi

ZIP/Postal Code

780-8077

Country

Japan

Facility Name

National Hospital Organization Oita Medical Center

City

Oita

ZIP/Postal Code

870-0263

Country

Japan

Facility Name

Japanese Red Cross Okayama Hospital

City

Okayama

ZIP/Postal Code

700-8607

Country

Japan

Facility Name

Chungbuk National University Hospital

City

Cheongju-si

State/Province

Chungcheongbuk-do

ZIP/Postal Code

28644

Country

Korea, Republic of

Facility Name

VHS Medical Center

City

Seoul

State/Province

Gangdong-gu

ZIP/Postal Code

05368

Country

Korea, Republic of

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Ajou University Hospital

City

Suwon

State/Province

Gyeonggi-do

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

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

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Nilai Medical Centre

City

Nilai

State/Province

Negeri Sembilan

ZIP/Postal Code

71800

Country

Malaysia

Facility Name

Mount Miriam Cancer Hospital

City

Tanjung Bungah

State/Province

Penang

ZIP/Postal Code

11200

Country

Malaysia

Facility Name

Penang Adventist Hospital

City

Penang

ZIP/Postal Code

10350

Country

Malaysia

Facility Name

Klinisch Chemisch en Hematologisch Laboratorium (KCHL)

City

Arnhem

ZIP/Postal Code

6815 AD

Country

Netherlands

Facility Name

Rijnstate Ziekenhuis

City

Arnhem

ZIP/Postal Code

6815 AD

Country

Netherlands

Facility Name

Ziekenhuis De Gelderse Vallei

City

Ede

ZIP/Postal Code

6716 RP

Country

Netherlands

Facility Name

Elkerliek Ziekenhuis

City

Helmond

ZIP/Postal Code

5707 HA

Country

Netherlands

Facility Name

Cebu Doctors' University Hospital

City

Cebu City

State/Province

Cebu

ZIP/Postal Code

6000

Country

Philippines

Facility Name

Davao Doctors Hospital

City

Davao City

State/Province

Davao DEL SUR

ZIP/Postal Code

8000

Country

Philippines

Facility Name

Wojewodzki Szpital Zespolony w Elblagu

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

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

City

Lodz

ZIP/Postal Code

93-513

Country

Poland

Facility Name

Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie

City

Olsztyn

ZIP/Postal Code

10-357

Country

Poland

Facility Name

Wielkopolskie Centrum Pulmonologii i Torakochirurgii im.Eugenii i Janusza Zeylandow

City

Poznan

ZIP/Postal Code

60-569

Country

Poland

Facility Name

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

City

Rzeszow

ZIP/Postal Code

35-021

Country

Poland

Facility Name

Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie Szpital Wojewodzki w

City

Szczecin-Zdunowo

ZIP/Postal Code

70-891

Country

Poland

Facility Name

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

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Wojskowy Instytut Medyczny, Klinika Onkologii

City

Warszawa

ZIP/Postal Code

04-141

Country

Poland

Facility Name

Wojewodzki Szpital Chorob Pluc im. dr Alojzego Pawelca

City

Wodzislaw-Slaski

ZIP/Postal Code

44-300

Country

Poland

Facility Name

SPAD Imaging International S.R.L

City

Craiova

State/Province

Dolj

ZIP/Postal Code

200352

Country

Romania

Facility Name

SC Cardio-Center SRL

City

Craiova

State/Province

Dolj

ZIP/Postal Code

200382

Country

Romania

Facility Name

SC Oncolab SRL, Oncologie

City

Craiova

State/Province

Jud Dolj

ZIP/Postal Code

200385

Country

Romania

Facility Name

Spitalul Clinic Judetean de Urgenta Targu Mures, Cardiologie

City

Targu-Mures

State/Province

Mures

ZIP/Postal Code

540136

Country

Romania

Facility Name

Spitalul Clinic Judetean Mures, radiologie si imagistica medicala

City

Targu-Mures

State/Province

Mures

ZIP/Postal Code

540141

Country

Romania

Facility Name

Spitalul Clinic Judetean Mures, sectia Clinica de Oncologie Medicala

City

Targu-Mures

State/Province

Mures

ZIP/Postal Code

540141

Country

Romania

Facility Name

S.C. Oncocenter Oncologie Clinica SRL

City

Timisoara

State/Province

Timis

ZIP/Postal Code

300166

Country

Romania

Facility Name

Medisprof

City

Cluj Napoca

ZIP/Postal Code

400058

Country

Romania

Facility Name

Spitalul Clinic Municipal

City

Cluj-Napoca

ZIP/Postal Code

400139

Country

Romania

Facility Name

SC Hiperdia SA

City

Cluj-Napoca

ZIP/Postal Code

400489

Country

Romania

Facility Name

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

City

Constanta

ZIP/Postal Code

900591

Country

Romania

Facility Name

Centrul Medical Pozimed, SC Pozitron Medical Investigation SRL

City

Constanta

ZIP/Postal Code

900663

Country

Romania

Facility Name

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

City

Craiova

ZIP/Postal Code

200347

Country

Romania

Facility Name

SC Radiotherapy Center Cluj SRL

City

Jud Cluj

ZIP/Postal Code

407280

Country

Romania

Facility Name

Hiperdia Timisoara, Cardiologie

City

Timisoara

ZIP/Postal Code

300158

Country

Romania

Facility Name

Hiperdia Timisoara, Radiologie si imagistica medicala

City

Timisoara

ZIP/Postal Code

300158

Country

Romania

Facility Name

Dr's Grineva Private Clinic

City

Sochi

State/Province

Krasnodar Region

ZIP/Postal Code

354010

Country

Russian Federation

Facility Name

SHI Oncology Dispensary #2 of Health Department of Krasnodar Region

City

Sochi

State/Province

Krasnodar Region

ZIP/Postal Code

354057

Country

Russian Federation

Facility Name

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

City

P/o Stepanovskoe

State/Province

Moscow Region

ZIP/Postal Code

143423

Country

Russian Federation

Facility Name

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

City

Kislino Steading Of Kursk Region

State/Province

Ryshkovskiy Village Council

ZIP/Postal Code

305524

Country

Russian Federation

Facility Name

SBHI of Stavropol Region "Essentuki Central City Hospital"

City

Essentuki

State/Province

Stavropol Region

ZIP/Postal Code

357600

Country

Russian Federation

Facility Name

Federal State Budgetary Institution of Healthcare "Clinical Hospital #

City

Lermontov

State/Province

Stavropol Region

ZIP/Postal Code

357340

Country

Russian Federation

Facility Name

SBHI of Stavropol Region "Pyatigorsk Oncology Dispensary"

City

Pyatigorsk

State/Province

Stavropol Region

ZIP/Postal Code

357502

Country

Russian Federation

Facility Name

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

City

Stavropol

State/Province

Stavropol Region

ZIP/Postal Code

355047

Country

Russian Federation

Facility Name

S.G. Primushko Republican Clinical Oncology Dispensary

City

Izhevsk

State/Province

Udmurt Republic

ZIP/Postal Code

426067

Country

Russian Federation

Facility Name

SBHI of Vladimir Region "Regional Clinical Oncology Dispensary"

City

Vladimir

State/Province

Vladimir Region

ZIP/Postal Code

600020

Country

Russian Federation

Facility Name

State Budget Healthcare Institution of Arkhangelsk Region

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

Evimed Llc

City

Chelyabinsk

ZIP/Postal Code

454048

Country

Russian Federation

Facility Name

Chelyabinsk Regional Hospital

City

Chelyabinsk

ZIP/Postal Code

454076

Country

Russian Federation

Facility Name

SBHI "Chelyabinsk Regional Clinical Hospital"

City

Chelyabinsk

ZIP/Postal Code

454076

Country

Russian Federation

Facility Name

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

City

Chelyabinsk

ZIP/Postal Code

454087

Country

Russian Federation

Facility Name

Chelyabinsk Regional Clinical Oncology Dispensary

City

Chelyabinsk

ZIP/Postal Code

454087

Country

Russian Federation

Facility Name

MRT-Expert, LLC

City

Chelyabinsk

ZIP/Postal Code

454087

Country

Russian Federation

Facility Name

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

City

Chelyabinsk

ZIP/Postal Code

454092

Country

Russian Federation

Facility Name

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

City

Krasnodar

ZIP/Postal Code

350012

Country

Russian Federation

Facility Name

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

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

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

City

Moscow

ZIP/Postal Code

125284

Country

Russian Federation

Facility Name

Privolzhskiy District Medical Center of Federal Biomedical Agency

City

Nizhniy Novgorod

ZIP/Postal Code

603001

Country

Russian Federation

Facility Name

SBHI NR Clinical Diagnostic Center

City

Nizhniy Novgorod

ZIP/Postal Code

603006

Country

Russian Federation

Facility Name

SBHI of NNR Nizhniy Novgorod Regional Oncology Dispensary

City

Nizhniy Novgorod

ZIP/Postal Code

603081

Country

Russian Federation

Facility Name

SBHI of NNR Nizhniy Novgorod Regional Oncology Dispensary

City

Nizhniy Novgorod

ZIP/Postal Code

603163

Country

Russian Federation

Facility Name

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

City

Omsk

ZIP/Postal Code

644013

Country

Russian Federation

Facility Name

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

City

Ryazan

ZIP/Postal Code

390011

Country

Russian Federation

Facility Name

SPb SBHI "City Clinical Oncology Dispensary"

City

Saint Petersburg

ZIP/Postal Code

198255

Country

Russian Federation

Facility Name

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

City

Saint-Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Saratov scientific research institute of traumatology and orthopedics

City

Saratov

ZIP/Postal Code

410002

Country

Russian Federation

Facility Name

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

City

Saratov

ZIP/Postal Code

410004

Country

Russian Federation

Facility Name

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

City

Saratov

ZIP/Postal Code

410054

Country

Russian Federation

Facility Name

Limited Liability Company "Common health"

City

Sochi

ZIP/Postal Code

354003

Country

Russian Federation

Facility Name

The Medical Oncology Centre of Rosebank

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Amanzimtoti Oncology Centre

City

Amanzimtoti

State/Province

Kwa-zulu Natal

ZIP/Postal Code

4126

Country

South Africa

Facility Name

Drs Schnetler, Corbett and Partners Inc

City

Cape Town

State/Province

Western CAPE

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Dr Lior Sareli Inc

City

Cape Town

State/Province

Western CAPE

ZIP/Postal Code

7560

Country

South Africa

Facility Name

Cape Town Oncology Trials (Pty) Ltd

City

Kraaifontein

State/Province

Western CAPE

ZIP/Postal Code

7570

Country

South Africa

Facility Name

Corporacio Sanitaria Parc Tauli

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Hospital Son Llatzer

City

Palma de Mallorca

State/Province

Islas Baleares

ZIP/Postal Code

07198

Country

Spain

Facility Name

Hospital Universitario Fundacion Alcorcon

City

Alcorcon

State/Province

Madrid

ZIP/Postal Code

28922

Country

Spain

Facility Name

Hospital Universitario Fundacion Jimenez Diaz

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital 12 de Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hospital Universitario La Paz, Servicio de Oncologia

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Consorcio Hospital Universitario General De Valencia

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Hospital Arnau de Vilanova

City

Valencia

ZIP/Postal Code

46015

Country

Spain

Facility Name

Changhua Christian Hospital

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

Chulalongkorn University

City

Patumwan

State/Province

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Chiangrai Prachanukroh Hospital

City

Muang

State/Province

Chiang RAI

ZIP/Postal Code

57000

Country

Thailand

Facility Name

Chula Clinical Research Center

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Clinical Research Center, Phramongkutklao Hospital

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Medical Oncology Unit, Department of Medicine, Phramongkutklao Hospital

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

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

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Prachachuen Imaging Center Co., Ltd.

City

Bangkok

ZIP/Postal Code

10900

Country

Thailand

Facility Name

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

City

Phitsanulok

ZIP/Postal Code

65000

Country

Thailand

Facility Name

Baskent Universitesi Tip Fakultesi Adana Hastanesi

City

Adana

ZIP/Postal Code

01120

Country

Turkey

Facility Name

Cukurova Universitesi Tip Fakultesi Balcali Hastanesi

City

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

Hacettepe Universitesi Tip Fakultesi

City

Ankara

ZIP/Postal Code

06230

Country

Turkey

Facility Name

Diskapi Yildirim Beyazit Egitim ve Arastirma Hastanesi

City

Ankara

ZIP/Postal Code

06330

Country

Turkey

Facility Name

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

City

Ankara

ZIP/Postal Code

06590

Country

Turkey

Facility Name

Yildirim Beyazit Universitesi Tip Fakultesi Ataturk Egitim ve Arastirma Hastanesi

City

Ankara

ZIP/Postal Code

06800

Country

Turkey

Facility Name

Yedikule Gogus Hastaliklari ve Gogus Cerrahisi

City

Istanbul

ZIP/Postal Code

34020

Country

Turkey

Facility Name

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Istanbul Universitesi Onkoloji Enstitusu

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Iyitem Goruntuleme ve Tani Merkezi

City

Istanbul

ZIP/Postal Code

34096

Country

Turkey

Facility Name

Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Prof Dr Nuri Tenekeci Tani Merkezi

City

Istanbul

ZIP/Postal Code

34371

Country

Turkey

Facility Name

Euromed Goruntuleme ve Tani Merkezi

City

Istanbul

ZIP/Postal Code

34724

Country

Turkey

Facility Name

Ege Universitesi Tip Fakultesi lc Hastaliklari Anabilim Dali

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

Facility Name

LLC "Medical clinic "INNOVACIA", chemotherapy department

City

Lyutizh

State/Province

KYIV Region

ZIP/Postal Code

07352

Country

Ukraine

Facility Name

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

City

Chernivtsi

ZIP/Postal Code

58013

Country

Ukraine

Facility Name

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

City

Dnipropetrovsk

ZIP/Postal Code

49102

Country

Ukraine

Facility Name

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

City

Kharkiv

ZIP/Postal Code

61070

Country

Ukraine

Facility Name

MI 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council'

City

Kryvyi Rih

ZIP/Postal Code

50048

Country

Ukraine

Facility Name

Lviv State Oncologic Regional Treatment and Diagnostic Center

City

Lviv

ZIP/Postal Code

79031

Country

Ukraine

Facility Name

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

City

Poltava

ZIP/Postal Code

36011

Country

Ukraine

Facility Name

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

City

Sumy

ZIP/Postal Code

40022

Country

Ukraine

Facility Name

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

City

Uzhhorod

ZIP/Postal Code

88017

Country

Ukraine

Facility Name

Vinnytsia Regional Clinical Oncology Dispensary

City

Vinnytsia

ZIP/Postal Code

21029

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

31768697

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.

Results Reference

derived

PubMed Identifier

31338773

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.

Results Reference

derived

Links:

URL

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.

Description

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

Learn more about this trial

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

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