AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 3NCT00932893

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

A Phase 3 study testing PF-02341066, Pemetrexed and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer at 264 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
PF-02341066, Pemetrexed and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
347 participants
Where
264 sitesin 22 countries
Study dates
Sep 2009to Jan 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

264 sites in 22 countries.

264 sites in 22 countries

United States119 sites

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory Clinic

    Atlanta, Georgia, 30322

  • Emory University Clinic

    Atlanta, Georgia, 30322

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Winship Cancer Institution

    Atlanta, Georgia, 30322

  • Georgia Cancer Specialists-Administrative Annex

    Atlanta, Georgia, 30341

  • Drug Shipment: University of Colorado Cancer Center, Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • University of Colorado Denver (CTRC)

    Aurora, Colorado, 80045

  • Unviersity of Colorado Hospital, Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Unviersity of Colorado Hospital, Anschutz Inpatient Pavilion

    Aurora, Colorado, 80045

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21231

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211-1850

  • Tower Hematology Oncology Medical Group

    Beverly Hills, California, 90211

  • Massachusette General Hospital

    Boston, Massachusetts, 02114

  • Massachussetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Isreal Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • DFCI/Pharmacy (Drug Shipment Only)

    Boston, Massachusetts, 02215

  • Investigational Drug Service, Pharmacy Department, UNC Hospitals

    Chapel Hill, North Carolina, 27514

  • UNC Health Care, NC Cancer Hospital Infusion/lnpatient Pharmacy (CHIP)

    Chapel Hill, North Carolina, 27514

  • UNC Hospitals

    Chapel Hill, North Carolina, 27599-7600

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Siteman Cancer Center

    City of Saint Peters, Missouri, 63376

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University Hospital East

    Columbus, Ohio, 43205

  • The Ohio State University James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43210

  • James Care in Kenny

    Columbus, Ohio, 43221

  • Siteman Cancer Center- West County

    Creve Coeur, Missouri, 63141

  • Georgia Cancer Specialists - Stemmer

    Decatur, Georgia, 30033

  • Kaiser Permanente

    Denver, Colorado, 80205

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Tennessee Oncology, PLLC

    Dickson, Tennessee, 37055

  • Vincent Armenio, MD

    East Providence, Rhode Island, 02914

  • Pharma Resource

    East Providence, Rhode Island, 02915

  • Lawrence and Idell Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • Tennessee Oncology, PLLC

    Franklin, Tennessee, 37067

  • Tennessee Oncology, PLLC

    Gallatin, Tennessee, 37066

  • Ingalls Memorial Hospital (Drug Shipment Only)

    Harvey, Illinois, 60426

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Monroe Medical Associates

    Harvey, Illinois, 60426

  • Tennessee Oncology, PLLC

    Hermitage, Tennessee, 37076

  • Penn State Milton S. Hershey Medical Center, Penn State Hershey Cancer Institute

    Hershey, Pennsylvania, 17033-0850

  • Memorial Cancer Institute

    Hollywood, Florida, 33021

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Hawaii Medical Center East

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Inc.

    Honolulu, Hawaii, 96813

  • The University of Texas

    Houston, Texas, 77030

  • Indiana University Hospital

    Indianapolis, Indiana, 46202

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Ship Drug to: Investigational Drug Services

    Indianapolis, Indiana, 46202

  • Wishard Memorial Hospital

    Indianapolis, Indiana, 46202

  • Springmill Medical Clinic

    Indianapolis, Indiana, 46290

  • UCSD Medical Center -La Jolla

    La Jolla, California, 92037

  • Moores UC San Diego Cancer Center

    La Jolla, California, 92093-0698

  • Kaiser Permanente

    Lafayette, Colorado, 80026

  • NSLIJ Health System/Monter Cancer Center

    Lake Success, New York, 11042

  • Cancer Center of South Florida Foundation, Inc.

    Lake Worth, Florida, 33461

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0001

  • Tennessee Oncology, PLLC

    Lebanon, Tennessee, 37087

  • University of Arkansas for Medical Research, Winthrop Rockefeller Cancer Institute

    Little Rock, Arkansas, 72205

  • Drug Shipping Address: [IRB# 10-001530] Ronald Reagan UCLA

    Los Angeles, California, 90095-6984

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • UCLA Hematology Oncology

    Los Angeles, California, 90095

  • UCLA Ophthalmic Oncology Center

    Los Angeles, California, 90095

  • University of California-Los Angeles

    Los Angeles, California, 90095

  • Georgia Cancer Specialists-Macon

    Macon, Georgia, 31217

  • Georgia Cancer Specialists-Kennestone

    Marietta, Georgia, 30060

  • Monroe Medical Associates

    Munster, Indiana, 46321

  • The Community Hospital

    Munster, Indiana, 46321

  • Tennessee Oncology, PLLC

    Murfreesboro, Tennessee, 37130

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203 (Pharmacy)

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37205

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37207

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37211

  • The Vanderbilt Cancer Clinic

    Nashville, Tennessee, 37232-5536

  • The Vanderbilt Chemo Pharmacy

    Nashville, Tennessee, 37232-7610

  • Drug Shipping for Yale; C/O Thomas Ferencz, RPh, BCOP

    New Haven, Connecticut, 06510

  • Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut, 06510

  • Clinical Trial Office

    New Haven, Connecticut, 06519

  • Yale Cancer Center

    New Haven, Connecticut, 06520

  • Memorial Sloan-Kettering Cancer Center: Rockefeller Outpatient Pavilion

    New York, New York, 10022

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians

    Oneida, New York, 13421

  • Ship Drug To : Kevin Kong- University of California, Irvine-Pharmacy

    Orange, California, 92868-3298

  • University of California, Irvine-Medical Center

    Orange, California, 92868-3298

  • Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians

    Oswego, New York, 13126

  • Stanford University-Cancer Center

    Palo Alto, California, 94305

  • Memorial Cancer Institute (West)

    Pembroke Pines, Florida, 33028

  • Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh Medical Center-Shadyside

    Pittsburgh, Pennsylvania, 15232

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • UC Davis Cancer Center

    Sacramento, California, 95817

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • UCSD Medical Center- Hillcrest

    San Diego, California, 92103

  • Georgia Cancer Specialists

    Sandy Springs, Georgia, 30342

  • Santa Monica-UCLA Medical Center and Orthopaedic Hospital

    Santa Monica, California, 90404

  • University of California, Los Angeles

    Santa Monica, California, 90404

  • Redwood Regional Medical Group, Inc.

    Santa Rosa, California, 95403

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Investigational Drug Service

    Seattle, Washington, 98122

  • Swedish Medical Center

    Seattle, Washington, 98122

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Tennessee Oncology, PLLC

    Smyrna, Tennessee, 37167

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110-1094

  • Washington University, School of Medicine

    St Louis, Missouri, 63110

  • SUNY Upstate Medical University

    Syracuse, New York, 13210-2306

  • Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians

    Syracuse, New York, 13210

  • H Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

  • Monroe Medical Associates

    Tinley Park, Illinois, 60477

Other trials in United States

Canada14 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Alberta Health Services, Holy Cross Site

    Calgary, Alberta, T2S 3C3

  • Office of Dr. John McWhae

    Calgary, Alberta, T2V 2C4

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Dr. Georges-L. Dumont Regional Hospital

    Moncton, New Brunswick, E1C 2Z3

  • Dr. Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

  • Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2L 4M1

  • Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • St. Mary's Hospital Center

    Montreal, Quebec, H3T 1M5

  • RSM Durham Regional Cancer Centre

    Oshawa, Ontario, L1G 2B9

  • Dr. Dana Blakolmer and Associates

    Oshawa, Ontario, L1J 8N8

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Italy13 sites

  • A.O. di Rilievo Nazionale e di Alta Specialita - S. G. Moscati

    Avellino, 83100

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134

  • Oncologia Medica A

    Genova, 16132

  • Ospedale Versilia, Oncologia Medica

    Lido Di Camaiore (LU), 55043

  • Ospedale San Luca

    Lucca, 55100

  • Dipartimento Oncologia Medica, UO Medicina 1Q A, Unita' Nuovi Farmaci e Terapie Innovative

    Milan, 20132

  • Istituto Europeo di Oncologia IRCCS

    Milan, 20141

  • Ospedale Niguarda Ca' Granda Dipartimento Oncologico, SC Divisione di Oncologia Medica Falk

    Milan, 20162

  • Nuovo Ospedale San Gerardo

    Monza, 20052

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga

    Orbassano (TO), 10043

  • SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia

    Perugia, 06132

  • Unita' Operativa Complessa di Pneumologia Oncologica I, Padiglione Flaiani

    Roma, 00152

  • Centro C.O.E.S., A.O. San Giovanni Battista Le Molinette

    Torino, 10126

Other trials in Italy

Poland11 sites

  • Klinika Onkologii i Radioterapii

    Gdansk, 80-952

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Pracownia Optyczna Bozena Lawrynowicz Optyk Dyplomowany

    Olsztyn, NAP, 10-344

  • Centrum Medyczne Ars Medica

    Olsztyn, NAP, 10-357

  • Wojewodzki Szpital Specjalistyczny w Olsztynie

    Olsztyn, NAP, 10-561

  • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

    Olsztyn, 10-357

  • Pracownia Tomografii Komputerowej "ALL MEDI" Sp. z o.o.

    Otwock, Poland, 05-400

  • Centralna Izba Przyjec Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

    Otwock, 05-400

  • Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii

    Poznan, 60-569

  • Zaklad Diagnostyki Obrazowej

    Poznan, 60-569

  • Lux Med. Sp.z o.o

    Warsaw, 02-676

Other trials in Poland

Spain11 sites

  • Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera (Materno-Infantil)

    A Coruña, A Coruña, 15006

  • Hospital Universitari Germans Trias I Pujol

    Badalona, Barcelona, 08916

  • Hospital Del Mar

    Barcelona, Barcelona, 08003

  • Hospital General Universitari Vall D´Hebron

    Barcelona, Barcelona, 08035

  • Institut Catala Doncologia - Hospital Duran I Reynals

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33006

  • Hospital de Navarra

    Pamplona, Navarre, 31008

  • Consorcio Hospitalario Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen Del Rocio

    Seville, Sevilla, 41013

Other trials in Spain

Japan10 sites

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • National Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Aichi cancer center central hospital

    Nagoya, Aichi-ken, 464-8681

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

  • Kinki University Hospital

    Osakasayama-shi, Osaka, 589-8511

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

Other trials in Japan

Brazil9 sites

  • Fundacao Pio XII Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Associacao Hospital de Caridade de Ijui

    Ijuí, Rio Grande do Sul, 98700-000

  • Fundacao Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-120

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Nacional de Câncer - INCA

    Rio de Janeiro, Rio de Janeiro, 20231 -050

  • Nucleo de Oncologia da Bahia

    Salvador, Estado de Bahia, 40170-110

  • Instituto do Câncer de São Paulo "Octavio Frias de Oliveira" - ICESP

    São Paulo, São Paulo, 01246-000

  • Fundacao Antonio Prudente

    São Paulo, São Paulo, 01509-900

Other trials in Brazil

China9 sites

  • Cancer Institute and Hospital Chinese Academy of Medical Sciences and PUMC

    Beijing, 100021

  • 307 Hospital of PLA

    Beijing, 100071

  • SUN Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080

  • Nanjing Bayi Hospital

    Nanjing, Jiangsu, 210002

  • Shanghai Chest Hospital/Department of Pulmonary Medicine

    Shanghai, 200030

  • Shanghai Chest Hospital

    Shanghai, 200030

  • Zhongshan Hospital Fudan University / Respiratory Department

    Shanghai, 200032

  • Shanghai Pulmonary Hospital/Dept. of Oncology

    Shanghai, 200433

Other trials in China

France9 sites

  • Centre Francois Baclesse

    Caen, 14076

  • Centre Georges-François Leclerc

    Dijon, 21079

  • Hopital Albert Michallon

    Grenoble, 38043

  • Pr Fabrice BARLESI

    Marseille, 13915

  • Centre Antoine Lacassagne

    Nice, 06189

  • Groupe Hospitalier Cochin

    Paris, 75679

  • Hopital Tenon / Service de Pneumologie

    Paris, 75970

  • Centre Rene Gauducheau / Service d'Oncologie Medicale

    Saint-Herblain, 44805

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany9 sites

  • Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin

    Cologne, 50937

  • Universitaetsklinik Carl-Gustav-Carus Dresden

    Dresden, 01307

  • Westdeutsches Tumorzentrum, Universitaetsklinikum Essen, Innere Klinik - Tumorforschung

    Essen, 45122

  • Krankenhaus Grosshansdorf, Zentrum fuer Pneumologie und Thoraxchirurgie

    Großhansdorf, 22927

  • MVZ Prof. Mathey, Pfrof. Schofer GmbH

    Hamburg, 22527

  • Thoraxklinik am Universitaetsklinikum Heidelberg, Internistische Onkologie der Thoraxtumoren

    Heidelberg, 69126

  • Klinikum der Universitaet Muenchen, Medizinische Klink - Innenstadt, Pneumologie

    München, 80336

  • Pius-Hospital Oldenburg

    Oldenburg, 26121

  • HSK Dr.- Horst-Schmidt-Kliniken, Innere Medizin III Haematologie, Onkologie, Palliativmedizin

    Wiesbaden, 65199

Other trials in Germany

United Kingdom9 sites

  • The Alexandra Hospital

    Cheshire, SK8 2PX

  • Nuffield Health Wessex Hospital

    Eastleigh, SO53 2DW

  • Royal Free Hospital

    London, NW3 2QG

  • Kings College London at Guy's Hospital

    London, SE1 9RT

  • Royal Marsden Hospital

    London, SW3 6JJ

  • Christie Hospital NHS Trust, Department of Medical Oncology

    Manchester, M20 4BX

  • Cancer and Haematology Centre,

    Oxford, OX3 7LJ

  • Southampton University Hospitals NHS Trust

    Southampton, SO16 6YD

  • Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Russia7 sites

  • Republican Clinical Oncology Dispensary of the Ministry of Health of Tatarstan Republic

    Kazan', 420029

  • State Institution "National Cancer Research Center named after N.N. Blokhin' RAMS"

    Moscow, 115478

  • City Clinical Oncology Dispensary

    Saint Petersburg, 197022

  • Saint-Petersburg State Medical University named after I.P.Pavlov of Roszdrav

    Saint Petersburg, 197022

  • City Clinical Oncology Dispensary

    Saint Petersburg, 198255

  • Research Institute of Pulmonology

    Saint-Peterburg, 197089

  • State Medical Institution "Oncology Center #2" of Healthcare Department of Krasnodar Region

    Sochi, 354057

Other trials in Russia

Hungary6 sites

  • Orszagos Koranyi TBC és Pulmonologiai Intezet, VI. Bronchologia

    Budapest, 1121

  • Semmelweis Egyetem Pulmonologia Intezet

    Budapest, 1125

  • Debreceni Egyetem Orvos- és Egészségtudományi Centrum, Tudogyogyaszati Klinika

    Debrecen, 4032

  • Veszprem Megyei Onkormanyzat Tudogyogyintezete

    Farkasgyepű, 8582

  • Fejer Megyei Szent Gyorgy Korhaz, Pulmonologiai Osztaly

    Székesfehérvár, 8000

  • Pest Megyei Tudogyogyintezet, III. Osztaly

    Törökbálint, 2045

Other trials in Hungary

Bulgaria5 sites

  • MDOZS Plovdiv EOOD; Parvo vatreshno himioterapevtichno otdelenie

    Plovdiv, 4004

  • UMBAL "Tsaritsa Yoanna - ISUL", Klinika po onkoterapiya

    Sofia, Bulgaria, 1527

  • Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, Klinika po himioterapiya

    Sofia, Bulgaria, 1756

  • MBAL Voennomeditsinska Academia, MMA HAT Sofia

    Sofia, 1606

  • MDOZS "Dr. Marko Markov", Otdelenie po onkoterapiya i paliativni grizhi

    Varna, 9002

Other trials in Bulgaria

Ireland5 sites

  • Aseptic Compounding Unit

    Dublin

  • Department of Medical Oncology

    Dublin

  • Department of Medical Oncology

    Galway

  • Merlin Park Imaging Centre

    Galway

  • Pharmacy Aseptic Service Unit

    Galway

Other trials in Ireland

Australia4 sites

  • Royal Adelaide Hospital, Department of Medical Oncology

    Adelaide, South Australia, 5000

  • Sydney Cancer Centre

    Camperdown, New South Wales, 2050

  • Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology

    East Melbourne, Victoria, 3002

  • Department of Medical Oncology

    Nedlands, Western Australia, 6009

Other trials in Australia

Greece3 sites

  • General Hospital of Chest Diseases of Athens "Sotiria"

    Athens, 11527

  • General Hospital of Thessaloniki Georgios Papanikolaou, Lung Cancer Neoplasia Research Department

    Eksochi, Thessaloniki, 57010

  • University General Hospital of Heraklion/ Department of Clinical Oncology

    Heraklion, Crete, 71110

Other trials in Greece

Hong Kong3 sites

  • Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital

    Pokfulam

  • Department of Clinical Oncology, Prince of Wales Hospital

    Shatin, New Territories

  • Tuen Mun Hospital, Department of Clinical Oncology

    Tuenmen, New Territories

Other trials in Hong Kong

South Korea3 sites

  • National Cancer Center, Center for Lung Cancer

    Goyang-si, Gyeonggi-do, 410-769

  • Seoul National University Hospital / Department of Internal Medicine

    Seoul, 110-744

  • Samsung MedicaCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine

    Seoul, 135-710

Other trials in South Korea

Taiwan3 sites

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital, Department of Internal Medicine

    Taipei, 100

  • Taipei Veterans General Hospital, Chest Department

    Taipei, 112

Other trials in Taiwan

Netherlands1 site

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

Other trials in Netherlands

Sweden1 site

  • Karolinska Universitetssjukhuset, Onkologiska kliniken

    Stockholm, 171 76

Other trials in Sweden

About this study

Official title: 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.

Being tested
PF-02341066, Pemetrexed, Docetaxel
Keywords
Lung Neoplasms ALK gene crizotinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-02341066Drug

    PF-02341066, 250 mg BID will be administered orally on a continuous schedule

  • PemetrexedDrug

    Pemetrexed, 500 mg/m^2, will be administered by i.v. infusion over 10 minutes on Day 1 of each 21-day cycle

  • DocetaxelDrug

    Docetaxel, 75 mg/m^2, will be administered by i.v. infusion over 1 hour on Day 1 of each 21-day cycle

Study groups in NCT00932893
Study groupRoleWhat they receive
PF-02341066ExperimentalNot described
Receives: Drug: PF-02341066
Pemetrexed or DocetaxelActive comparatorInvestigator selection of either pemetrexed or docetaxel as the active comparator
Receives: Drug: Pemetrexed; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (14)

  1. 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.

    Measured: Randomization until death (up to 4.5 years)

  2. 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.

    Measured: Month 6, 12

  3. 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.

    Measured: Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)

  4. 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.

    Measured: Week 6

  5. 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.

    Measured: Week 12

  6. 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.

    Measured: Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)

  7. 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.

    Measured: Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)

  8. Plasma Concentration of Crizotinib

    Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.

    Measured: Pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 3, 5

  9. 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.

    Measured: Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2

  10. 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.

    Measured: 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)

  11. 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.

    Measured: Baseline up to end of treatment (up to 112 weeks)

  12. 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.

    Measured: Baseline, Day (D) 1 of each cycle (C) until disease progression, end of treatment (EOT, up to 112 weeks)

  13. 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.

    Measured: Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)

  14. 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.

    Measured: Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionMar 2012
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
347 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00932893
Sponsor's protocol ID
A8081007
Other IDs
2009-012595-27, 2009
Status last verified
Oct 2016
First submitted
30 Jun 2009
Last updated
2 Jan 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30822515

  • 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.

    PubMed 30652510

  • 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.

    PubMed 28373069

  • 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.

    PubMed 27130468

  • 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.

    PubMed 25624436

  • 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.

    PubMed 25436806

  • 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.

    PubMed 23724913

  • 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.

    PubMed 23169500

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PF-02341066, Pemetrexed and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer at 264 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 264 sites in United States, Canada, Italy, Poland, Spain and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00932893, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2017.

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