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

Non-Small Cell Lung Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364999
• Other study ID #: B7391003
• Secondary ID: 2014-003878-16B7
• Status: Completed
• Phase: Phase 3
• Start date: April 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 719
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

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.
• 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.
• 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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Bulgaria,  Chile,  Croatia,  Czechia,  France,  Germany,  Greece,  Hungary,  India,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Netherlands,  Philippines,  Poland,  Romania,  Russian Federation,  South Africa,  Spain,  Taiwan,  Thailand,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR) by Week 19	ORR refers to percentage of participants who achieved complete response (CR) or partial response (PR) by Week 19 of the study in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 which was subsequently confirmed by Week 25. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.	25 weeks
Secondary	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.	55 weeks
Secondary	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).	55 weeks
Secondary	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.	55 weeks
Secondary	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.	55 weeks
Secondary	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.	55 weeks
Secondary	Serum Concentration of Bevacizumab up to 1 Year		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
Secondary	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.	55 weeks
Secondary	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.	55 weeks

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