An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Pf-02341066 Versus Standard Of Care Chemotherapy (Pemetrexed Or Docetaxel) In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus

This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: PF-02341066; Drug: Pemetrexed; Drug: Docetaxel

• Study Type: Interventional
• Enrollment (Actual): 347
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Sydney cancer centre
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital, Department of Medical Oncology
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Department of Medical Oncology
• Brazil
  • BA
    • Salvador, BA, Brazil, 40170-110
      • Núcleo de Oncologia da Bahia
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20231 -050
      • Instituto Nacional de Câncer - INCA
  • RS
    • Ijui, RS, Brazil, 98700-000
      • Associacao Hospital de Caridade de Ijui
    • Porto Alegre, RS, Brazil, 90610-000
      • Hospital São Lucas da PUCRS
    • Porto Alegre, RS, Brazil, 90050-170
      • Irmandade da Santa Casa de Misericordia de Porto Alegre
  • SP
    • Barretos, SP, Brazil, 14784-400
      • Fundacao Pio Xii Hospital de Cancer de Barretos
    • Sao Paulo, SP, Brazil, 01246-000
      • Instituto do Câncer de São Paulo "Octavio Frias de Oliveira" - ICESP
    • Sao Paulo, SP, Brazil, 01509-900
      • Fundacao Antonio Prudente
  • Sao Paulo
    • Jau, Sao Paulo, Brazil, 17210-120
      • Fundacao Hospital Amaral Carvalho
• Bulgaria
  • Plovdiv, Bulgaria, 4004
    • MDOZS Plovdiv EOOD; Parvo vatreshno himioterapevtichno otdelenie
  • Sofia, Bulgaria, 1527
    • UMBAL "Tsaritsa Yoanna - ISUL", Klinika po onkoterapiya
  • Sofia, Bulgaria, 1606
    • MBAL Voennomeditsinska Academia, MMA HAT Sofia
  • Sofia, Bulgaria, 1756
    • Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, Klinika po himioterapiya
  • Varna, Bulgaria, 9002
    • MDOZS "Dr. Marko Markov", Otdelenie po onkoterapiya i paliativni grizhi
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Centre
    • Calgary, Alberta, Canada, T2S 3C3
      • Alberta Health Services, Holy Cross Site
    • Calgary, Alberta, Canada, T2V 2C4
      • Office of Dr. John McWhae
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 8X3
      • Dr. Leon Richard Oncology Centre
    • Moncton, New Brunswick, Canada, E1C 2Z3
      • Dr. Georges-L. Dumont Regional Hospital
  • Ontario
    • Oshawa, Ontario, Canada, L1G 2B9
      • RSM Durham Regional Cancer Centre
    • Oshawa, Ontario, Canada, L1J 8N8
      • Dr. Dana Blakolmer and Associates
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
    • Montreal, Quebec, Canada, H3A 1A1
      • Royal Victoria Hospital
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital
    • Montreal, Quebec, Canada, H3T 1M5
      • St. Mary's Hospital Center
    • Montreal, Quebec, Canada, H2L 4M1
      • Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal (CHUM)
• China
  • Beijing, China, 100071
    • 307 Hospital of PLA
  • Beijing, China, 100021
    • Cancer Institute and Hospital Chinese Academy of Medical Sciences and PUMC
  • Shanghai, China, 200030
    • Shanghai Chest Hospital
  • Shanghai, China, 200030
    • Shanghai Chest Hospital/Department of Pulmonary Medicine
  • Shanghai, China, 200032
    • Zhongshan Hospital Fudan University / Respiratory Department
  • Shanghai, China, 200433
    • Shanghai Pulmonary Hospital/Dept. of Oncology
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
    • Guangzhou, Guangdong, China, 510080
      • Guangdong General Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Nanjing Bayi Hospital
• France
  • Caen Cedex 05, France, 14076
    • Centre Francois Baclesse
  • DIJON Cedex, France, 21079
    • Centre Georges-Francois Leclerc
  • Grenoble Cedex 09, France, 38043
    • Hopital Albert Michallon
  • Marseille Cedex 20, France, 13915
    • Pr Fabrice BARLESI
  • NICE Cedex 2, France, 06189
    • Centre Antoine Lacassagne
  • Paris Cedex 14, France, 75679
    • Groupe Hospitalier Cochin
  • Paris cedex 20, France, 75970
    • Hopital Tenon / Service de Pneumologie
  • St Herblain Cedex, France, 44805
    • Centre Rene Gauducheau / Service d'Oncologie Medicale
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Germany
  • Dresden, Germany, 01307
    • Universitaetsklinik Carl-Gustav-Carus Dresden
  • Essen, Germany, 45122
    • Westdeutsches Tumorzentrum, Universitaetsklinikum Essen, Innere Klinik - Tumorforschung
  • Grosshansdorf, Germany, 22927
    • Krankenhaus Grosshansdorf, Zentrum fuer Pneumologie und Thoraxchirurgie
  • Hamburg, Germany, 22527
    • MVZ Prof. Mathey, Pfrof. Schofer GmbH
  • Heidelberg, Germany, 69126
    • Thoraxklinik am Universitaetsklinikum Heidelberg, Internistische Onkologie der Thoraxtumoren
  • Koeln, Germany, 50937
    • Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin
  • Muenchen, Germany, 80336
    • Klinikum der Universitaet Muenchen, Medizinische Klink - Innenstadt, Pneumologie
  • Oldenburg, Germany, 26121
    • Pius-Hospital Oldenburg
  • Wiesbaden, Germany, 65199
    • HSK Dr.- Horst-Schmidt-Kliniken, Innere Medizin III Haematologie, Onkologie, Palliativmedizin
• Greece
  • Athens, Greece, 11527
    • General Hospital of Chest Diseases of Athens "Sotiria"
  • Crete
    • Heraklion, Crete, Greece, 71110
      • University General Hospital of Heraklion/ Department of Clinical Oncology
  • Thessaloniki
    • Exohi, Thessaloniki, Greece, 57010
      • General Hospital of Thessaloniki Georgios Papanikolaou, Lung Cancer Neoplasia Research Department
• Hong Kong
  • Pokfulam, Hong Kong
    • Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital
  • Shatin, New Territories, Hong Kong
    • Department of Clinical Oncology, Prince of Wales Hospital
  • New Territories
    • Tuen Mun, New Territories, Hong Kong
      • Tuen Mun Hospital, Department of Clinical Oncology
• Hungary
  • Budapest, Hungary, 1121
    • Orszagos Koranyi TBC es Pulmonologiai Intezet, VI. Bronchologia
  • Budapest, Hungary, 1125
    • Semmelweis Egyetem Pulmonologia Intezet
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Orvos- és Egészségtudományi Centrum, Tudogyogyaszati Klinika
  • Farkasgyepu, Hungary, 8582
    • Veszprem Megyei Onkormanyzat Tudogyogyintezete
  • Szekesfehervar, Hungary, 8000
    • Fejer Megyei Szent Gyorgy Korhaz, Pulmonologiai Osztaly
  • Torokbalint, Hungary, 2045
    • Pest Megyei Tudogyogyintezet, III. Osztaly
• Ireland
  • Dublin 8, Ireland
    • Aseptic Compounding Unit
  • Dublin 8, Ireland
    • Department of Medical Oncology
  • Galway, Ireland
    • Department of Medical Oncology
  • Galway, Ireland
    • Merlin Park Imaging Centre
  • Galway, Ireland
    • Pharmacy Aseptic Service Unit
• Italy
  • Avellino, Italy, 83100
    • A.O. di Rilievo Nazionale e di Alta Specialita - S. G. Moscati
  • Firenze, Italy, 50134
    • Azienda Ospedaliero-Universitaria Careggi
  • Genova, Italy, 16132
    • Oncologia Medica A
  • Lido di Camaiore (LU), Italy, 55043
    • Ospedale Versilia, Oncologia Medica
  • Lucca, Italy, 55100
    • Ospedale San Luca
  • Milano, Italy, 20132
    • Dipartimento Oncologia Medica, UO Medicina 1Q A, Unita' Nuovi Farmaci e Terapie Innovative
  • Milano, Italy, 20141
    • Istituto Europeo di Oncologia IRCCS
  • Milano, Italy, 20162
    • Ospedale Niguarda Ca' Granda Dipartimento Oncologico, SC Divisione di Oncologia Medica Falk
  • Monza, Italy, 20052
    • Nuovo Ospedale San Gerardo
  • Orbassano (TO), Italy, 10043
    • Azienda Ospedaliera Universitaria San Luigi Gonzaga
  • Perugia, Italy, 06132
    • SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia
  • Roma, Italy, 00152
    • Unita' Operativa Complessa di Pneumologia Oncologica I, Padiglione Flaiani
  • Torino, Italy, 10126
    • Centro C.O.E.S., A.O. San Giovanni Battista Le Molinette
• Japan
  • Fukuoka, Japan, 811-1395
    • National Kyushu Cancer Center
  • Tokyo, Japan, 135-8550
    • The Cancer Institute Hospital of JFCR
  • Aichi
    • Nagoya, Aichi, Japan, 464-8681
      • Aichi cancer center central hospital
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 003-0804
      • National Hospital Organization Hokkaido Cancer Center
  • Hyogo
    • Akashi, Hyogo, Japan, 673-8558
      • Hyogo Cancer Center
  • Okayama
    • Okayama-city, Okayama, Japan, 700-8558
      • Okayama University Hospital
  • Osaka
    • Osakasayama-shi, Osaka, Japan, 589-8511
      • Kinki University Hospital
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital / Department of Internal Medicine
  • Seoul, Korea, Republic of, 135-710
    • Samsung MedicaCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
      • National Cancer Center, Center for Lung Cancer
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen
• Poland
  • Gdansk, Poland, 80-952
    • Uniwersyteckie Centrum Kliniczne
  • Gdansk, Poland, 80-952
    • Klinika Onkologii i Radioterapii
  • Olsztyn, Poland, 10-357
    • Samodzielny Publiczny Zespol Gruzlicy I Chorob Pluc
  • Otwock, Poland, 05-400
    • Centralna Izba Przyjec Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
  • Otwock, Poland, 05-400
    • Pracownia Tomografii Komputerowej "ALL MEDI" Sp. z o.o.
  • Poznan, Poland, 60-569
    • Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
  • Poznan, Poland, 60-569
    • Zaklad Diagnostyki Obrazowej
  • Warszawa, Poland, 02-676
    • Lux Med. Sp.z o.o
  • NAP
    • Olsztyn, NAP, Poland, 10-344
      • Pracownia Optyczna Bozena Lawrynowicz Optyk Dyplomowany
    • Olsztyn, NAP, Poland, 10-357
      • Centrum Medyczne Ars Medica
    • Olsztyn, NAP, Poland, 10-561
      • Wojewodzki Szpital Specjalistyczny w Olsztynie
• Russian Federation
  • Kazan, Russian Federation, 420029
    • Republican Clinical Oncology Dispensary of the Ministry of Health of Tatarstan Republic
  • Moscow, Russian Federation, 115478
    • State Institution "National Cancer Research Center named after N.N. Blokhin' RAMS"
  • Saint-Peterburg, Russian Federation, 197089
    • Research Institute of Pulmonology
  • Saint-Petersburg, Russian Federation, 197022
    • City Clinical Oncology Dispensary
  • Saint-Petersburg, Russian Federation, 197022
    • Saint-Petersburg State Medical University named after I.P.Pavlov of Roszdrav
  • Sochi, Russian Federation, 354057
    • State Medical Institution "Oncology Center #2" of Healthcare Department of Krasnodar Region
  • St. Petersburg, Russian Federation, 198255
    • City Clinical Oncology Dispensary
• Spain
  • A Coruña, Spain, 15006
    • Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera (Materno-Infantil)
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08035
    • Hospital General Universitari Vall D´Hebron
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Santander, Spain, 39008
    • Hospital Universitario Marques de Valdecilla
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Asturias
    • Oviedo, Asturias, Spain, 33006
      • Hospital Universitario Central de Asturias
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias I Pujol
    • L'hospitalet de Llobregat, Barcelona, Spain, 08907
      • Institut Catala Doncologia - Hospital Duran I Reynals
    • Sabadell, Barcelona, Spain, 08208
      • Consorcio Hospitalario Parc Tauli
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Hospital de Navarra
• Sweden
  • Stockholm, Sweden, 171 76
    • Karolinska Universitetssjukhuset, Onkologiska kliniken
• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital, Department of Internal Medicine
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital, Chest Department
• United Kingdom
  • Cheshire, United Kingdom, SK8 2PX
    • The Alexandra Hospital
  • Eastleigh, United Kingdom, SO53 2DW
    • Nuffield Health Wessex Hospital
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital
  • London, United Kingdom, SE1 9RT
    • Kings College London at Guy's Hospital
  • Manchester, United Kingdom, M20 4BX
    • Christie Hospital NHS Trust, Department of Medical Oncology
  • Oxford, United Kingdom, OX3 7LJ
    • Cancer and Haematology Centre,
  • Southampton, United Kingdom, SO16 6YD
    • Southampton University Hospitals NHS Trust
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Royal Marsden Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Research, Winthrop Rockefeller Cancer Institute
  • California
    • Bakersfield, California, United States, 93309
      • Comprehensive Blood and Cancer Center
    • Beverly Hills, California, United States, 90211-1850
      • Tower Cancer Research Foundation
    • Beverly Hills, California, United States, 90211
      • Tower Hematology Oncology Medical Group
    • La Jolla, California, United States, 92037
      • UCSD Medical Center -La Jolla
    • La Jolla, California, United States, 92093-0698
      • Moores UC San Diego Cancer Center
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • Los Angeles, California, United States, 90095
      • UCLA Hematology Oncology
    • Los Angeles, California, United States, 90095-6984
      • Drug Shipping Address: [IRB# 10-001530] Ronald Reagan UCLA
    • Los Angeles, California, United States, 90095
      • UCLA Ophthalmic Oncology Center
    • Los Angeles, California, United States, 90095
      • University of California-Los Angeles
    • Orange, California, United States, 92868-3298
      • Ship Drug To : Kevin Kong- University of California, Irvine-Pharmacy
    • Orange, California, United States, 92868-3298
      • University of California, Irvine-Medical Center
    • Palo Alto, California, United States, 94305
      • Stanford University-Cancer Center
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
    • Sacramento, California, United States, 95817
      • UC Davis Cancer Center
    • San Diego, California, United States, 92103
      • UCSD Medical Center- Hillcrest
    • Santa Monica, California, United States, 90404
      • Santa Monica-UCLA Medical Center and Orthopaedic Hospital
    • Santa Monica, California, United States, 90404
      • University of California, Los Angeles
    • Santa Rosa, California, United States, 95403
      • Redwood Regional Medical Group, Inc.
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Drug Shipment: University of Colorado Cancer Center, Anschutz Cancer Pavilion
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver (CTRC)
    • Aurora, Colorado, United States, 80045
      • Unviersity of Colorado Hospital, Anschutz Cancer Pavilion
    • Aurora, Colorado, United States, 80045
      • Unviersity of Colorado Hospital, Anschutz Inpatient Pavilion
    • Denver, Colorado, United States, 80205
      • Kaiser Permanente
    • Lafayette, Colorado, United States, 80026
      • Kaiser Permanente
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Smilow Cancer Hospital at Yale New Haven
    • New Haven, Connecticut, United States, 06520
      • Yale Cancer Center
    • New Haven, Connecticut, United States, 06510
      • Drug Shipping for Yale; C/O Thomas Ferencz, RPh, BCOP
    • New Haven, Connecticut, United States, 06519
      • Clinical Trial Office
  • Florida
    • Hollywood, Florida, United States, 33021
      • Memorial Cancer Institute
    • Lake Worth, Florida, United States, 33461
      • Cancer Center of South Florida Foundation, Inc.
    • Pembroke Pines, Florida, United States, 33028
      • Memorial Cancer Institute (West)
    • Tampa, Florida, United States, 33612
      • H Lee Moffitt Cancer Center & Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
    • Atlanta, Georgia, United States, 30322
      • Emory Clinic
    • Atlanta, Georgia, United States, 30322
      • Emory University Clinic
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institution
    • Atlanta, Georgia, United States, 30341
      • Georgia Cancer Specialists-Administrative Annex
    • Decatur, Georgia, United States, 30033
      • Georgia Cancer Specialists - Stemmer
    • Macon, Georgia, United States, 31217
      • Georgia Cancer Specialists-Macon
    • Marietta, Georgia, United States, 30060
      • Georgia Cancer Specialists-Kennestone
    • Sandy Springs, Georgia, United States, 30342
      • Georgia Cancer Specialists
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Cancer Research Center of Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Hawaii Medical Center East
    • Honolulu, Hawaii, United States, 96813
      • OnCare Hawaii, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital (Drug Shipment Only)
    • Harvey, Illinois, United States, 60426
      • Monroe Medical Associates
    • Tinley Park, Illinois, United States, 60477
      • Monroe Medical Associates
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Melvin and Bren Simon Cancer Center
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Hospital
    • Indianapolis, Indiana, United States, 46202
      • Ship drug to: Investigational Drug Services
    • Indianapolis, Indiana, United States, 46202
      • Wishard Memorial Hospital
    • Indianapolis, Indiana, United States, 46290
      • Springmill Medical Clinic
    • Munster, Indiana, United States, 46321
      • The Community Hospital
    • Munster, Indiana, United States, 46321
      • Monroe Medical Associates
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02215
      • Beth Isreal Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachussetts General Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusette General Hospital
    • Boston, Massachusetts, United States, 02215
      • DFCI/Pharmacy (Drug Shipment Only)
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
    • Farmington Hills, Michigan, United States, 48334
      • Lawrence and Idell Weisberg Cancer Treatment Center
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • Siteman Cancer Center- West County
    • St. Louis, Missouri, United States, 63110-1094
      • Barnes-Jewish Hospital
    • St. Louis, Missouri, United States, 63110
      • Washington University, School of Medicine
    • St. Peters, Missouri, United States, 63376
      • Siteman Cancer Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756-0001
      • Dartmouth Hitchcock Medical Center
  • New York
    • Lake Success, New York, United States, 11042
      • NSLIJ Health System/Monter Cancer Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center
    • New York, New York, United States, 10022
      • Memorial Sloan-Kettering Cancer Center: Rockefeller Outpatient Pavilion
    • Oneida, New York, United States, 13421
      • Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians
    • Oswego, New York, United States, 13126
      • Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians
    • Syracuse, New York, United States, 13210-2306
      • SUNY Upstate Medical University
    • Syracuse, New York, United States, 13210
      • Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Investigational Drug Service, Pharmacy Department, UNC Hospitals
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Health Care, NC Cancer Hospital Infusion/lnpatient Pharmacy (CHIP)
    • Chapel Hill, North Carolina, United States, 27599-7600
      • UNC Hospitals
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43205
      • The Ohio State University Hospital East
    • Columbus, Ohio, United States, 43210
      • The Ohio State University James Cancer Hospital and Solove Research Institute
    • Columbus, Ohio, United States, 43221
      • James Care in Kenny
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-0850
      • Penn State Milton S. Hershey Medical Center, Penn State Hershey Cancer Institute
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center-Shadyside
  • Rhode Island
    • East Providence, Rhode Island, United States, 02915
      • Pharma Resource
    • East Providence, Rhode Island, United States, 02914
      • Vincent Armenio, MD
  • Tennessee
    • Dickson, Tennessee, United States, 37055
      • Tennessee Oncology, PLLC
    • Franklin, Tennessee, United States, 37067
      • Tennessee Oncology, PLLC
    • Gallatin, Tennessee, United States, 37066
      • Tennessee Oncology, PLLC
    • Hermitage, Tennessee, United States, 37076
      • Tennessee Oncology, PLLC
    • Lebanon, Tennessee, United States, 37087
      • Tennessee Oncology, PLLC
    • Murfreesboro, Tennessee, United States, 37130
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37205
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37207
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37211
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37203 (Pharmacy)
      • Sarah Cannon Research Institute
    • Nashville, Tennessee, United States, 37232-5536
      • The Vanderbilt Cancer Clinic
    • Nashville, Tennessee, United States, 37232-7610
      • The Vanderbilt Chemo Pharmacy
    • Smyrna, Tennessee, United States, 37167
      • Tennessee Oncology, PLLC
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
    • Seattle, Washington, United States, 98122
      • Investigational Drug Service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• histologically or cytologically proven diagnosis of non-small cell lung cancer
• positive for the ALK fusion gene (test provided by a central laboratory)
• must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug
• tumors must be measurable

Exclusion Criteria:

• prior treatment with PF-02341066
• current treatment in another clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-02341066	Drug: PF-02341066; PF-02341066, 250 mg BID will be administered orally on a continuous schedule
Active Comparator: Pemetrexed or Docetaxel; Investigator selection of either pemetrexed or docetaxel as the active comparator	Drug: Pemetrexed; Pemetrexed, 500 mg/m^2, will be administered by i.v. infusion over 10 minutes on Day 1 of each 21-day cycle; Drug: Docetaxel; Docetaxel, 75 mg/m^2, will be administered by i.v. infusion over 1 hour on Day 1 of each 21-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	PFS: Time in months from randomization to first documentation of objective disease progression as determined by independent radiology review or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria version 1.1 (RECIST v1.1), as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.	Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS: Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4.	Randomization until death (up to 4.5 years)
Overall Survival Probability at Months 6 and 12	Overall survival probability at Month 6 and 12 was defined as the probability of survival at 6 and 12 months respectively, after the randomization of study treatment. The survival probability was estimated using the Kaplan-Meier method.	Month 6, 12
Percentage of Participants With Objective Response (OR)	Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 millimeter [mm] short axis). PR: at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Objective response is based on independent radiology review.	Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
Percentage of Participants With Disease Control at Week 6	Disease control: participants with CR, PR, or stable disease (SD) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Disease control is based on independent radiology review.	Week 6
Percentage of Participants With Disease Control at Week 12	Disease control: participants with CR, PR, or SD according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.	Week 12
Duration of Response (DR)	Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.02. DR was calculated for the subgroup of participants with a confirmed objective tumor response.	Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
Time to Tumor Response (TTR)	Time from date of randomization to first documentation of objective tumor response. TTR was calculated for the subgroup of participants with objective tumor response. Objective tumor response was defined as CR or PR according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.	Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
Plasma Concentration of Crizotinib	Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.	Pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 3, 5
Number of Participants With Categorical Maximum QTcF for Crizotinib	QT interval corrected using Fridericia's formula (QTcF): QT interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles) divided by cube root of RR interval. Maximum QTcF was categorized as less than (<) 450 milliseconds (msec), 450 msec to <480 msec, 480 msec to <500 msec, and more than or equal to (>=) 500 msec. A participant is reported only once under the maximum QTcF interval observed at any of the time-points. Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.	Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2
Plasma Concentration of Soluble c-Met Ectodomain and Hepatocyte Growth Factor Scatter Proteins	Descriptive statistics (absolute value and change from baseline as measured by ratio to baseline) for each best overall response category (CR, PR, SD, PD or combined) have been used to summarize the data from optional soluble c-Met ectodomain assays for crizotinib treated patients.	Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks)
Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough	TTD in pain (pain in chest from European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer [EORTC QLQ-LC13]), dyspnea (from EORTC QLQ-LC13), or cough (from EORTC QLQ-LC13) symptoms was defined as the time from randomization to the earliest time the participant's score showed a 10 point or higher increase from baseline in any of the three symptoms from the instrument. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 range from 0 to 100, greater scores = higher symptom severity.	Baseline up to end of treatment (up to 112 weeks)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)	EORTC QLQ-C30: included global health status/quality of life (QoL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score for Global Qol/functional scales=better level of QoL/functioning or higher score for symptom scale=greater degree of symptoms.	Baseline, Day (D) 1 of each cycle (C) until disease progression, end of treatment (EOT, up to 112 weeks)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer (EORTC QLQ-LC13)	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: 1 'Not at All' to 4 'Very Much'. Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms.	Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)
European Quality of Life - 5 Dimensional (EQ-5D) Visual Analog Scale (VAS)	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.	Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Lin YT, Yu CJ, Yang JC, Shih JY. Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non-Small-Cell Lung Cancer: Analysis and Literature Review. Clin Lung Cancer. 2016 Sep;17(5):e77-e94. doi: 10.1016/j.cllc.2016.03.005. Epub 2016 Mar 30.
• Camidge DR, Kim EE, Usari T, Polli A, Lewis I, Wilner KD. Renal Effects of Crizotinib in Patients With ALK-Positive Advanced NSCLC. J Thorac Oncol. 2019 Jun;14(6):1077-1085. doi: 10.1016/j.jtho.2019.02.015. Epub 2019 Feb 26.
• Wilner KD, Usari T, Polli A, Kim EE. Comparison of cardiovascular effects of crizotinib and chemotherapy in ALK-positive advanced non-small-cell lung cancer. Future Oncol. 2019 Apr;15(10):1097-1103. doi: 10.2217/fon-2018-0869. Epub 2019 Jan 17.
• Yoneda KY, Scranton JR, Cadogan MA, Tassell V, Nadanaciva S, Wilner KD, Stollenwerk NS. Interstitial Lung Disease Associated With Crizotinib in Patients With Advanced Non-Small Cell Lung Cancer: Independent Review of Four PROFILE Trials. Clin Lung Cancer. 2017 Sep;18(5):472-479. doi: 10.1016/j.cllc.2017.03.004. Epub 2017 Mar 14.
• Costa DB, Shaw AT, Ou SH, Solomon BJ, Riely GJ, Ahn MJ, Zhou C, Shreeve SM, Selaru P, Polli A, Schnell P, Wilner KD, Wiltshire R, Camidge DR, Crino L. Clinical Experience With Crizotinib in Patients With Advanced ALK-Rearranged Non-Small-Cell Lung Cancer and Brain Metastases. J Clin Oncol. 2015 Jun 10;33(17):1881-8. doi: 10.1200/JCO.2014.59.0539. Epub 2015 Jan 26.
• Lin YT, Wang YF, Yang JC, Yu CJ, Wu SG, Shih JY, Yang PC. Development of renal cysts after crizotinib treatment in advanced ALK-positive non-small-cell lung cancer. J Thorac Oncol. 2014 Nov;9(11):1720-5. doi: 10.1097/JTO.0000000000000326.
• Shaw AT, Kim DW, Nakagawa K, Seto T, Crino L, Ahn MJ, De Pas T, Besse B, Solomon BJ, Blackhall F, Wu YL, Thomas M, O'Byrne KJ, Moro-Sibilot D, Camidge DR, Mok T, Hirsh V, Riely GJ, Iyer S, Tassell V, Polli A, Wilner KD, Janne PA. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med. 2013 Jun 20;368(25):2385-94. doi: 10.1056/NEJMoa1214886. Epub 2013 Jun 1. Erratum In: N Engl J Med. 2015 Oct 15;373(16):1582.
• Tamiya A, Okamoto I, Miyazaki M, Shimizu S, Kitaichi M, Nakagawa K. Severe acute interstitial lung disease after crizotinib therapy in a patient with EML4-ALK-positive non-small-cell lung cancer. J Clin Oncol. 2013 Jan 1;31(1):e15-7. doi: 10.1200/JCO.2012.43.3730. Epub 2012 Nov 19. No abstract available.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: June 30, 2009
• First Submitted That Met QC Criteria: July 2, 2009
• First Posted (Estimate): July 3, 2009

Study Record Updates

• Last Update Posted (Estimate): January 2, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Lung Neoplasms ALK gene crizotinib
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Protein Kinase Inhibitors; Folic Acid Antagonists; Docetaxel; Pemetrexed; Crizotinib
• Other Study ID Numbers: A8081007; 2009-012595-27 (EudraCT Number)