AzTrials
AzTrials

Non Squamous Lung CancerPhase 3PROFILE 1014NCT01154140

A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung

A Phase 3 study testing treatment in people with Non Squamous Lung Cancer, run by Pfizer at 249 sites in 31 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 study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Squamous Lung Cancer
What is being tested?
treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
343 participants
Where
249 sitesin 31 countries
Study dates
13 Jan 2011to 30 Nov 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

  • Proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung
  • Positive for translocation or inversion events involving the ALK gene locus
  • No prior systemic treatment for locally advanced or metastatic disease; Patients with brain metastases only if treated and neurologically stable with no ongoing requirement for corticosteroids
  • Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome [PRO] measures.
  • 18 years of age or older with the exception of India which has an upper age limit of 65 years old

Who cannot join

  • Current treatment on another therapeutic clinical trial.
  • Prior therapy directly targeting ALK.
  • Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. - - Appropriate treatment with anticoagulants is permitted.
  • Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec.
  • Pregnancy or breastfeeding.
  • Use of drugs or foods that are known potent CYP3A4 inducers/inhibitors Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.
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  • Known HIV infection
  • Known interstitial lung disease or interstitial fibrosis
  • Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study

Trial locations and contacts

249 sites in 31 countries.

249 sites in 31 countries

United States84 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • UNM Eye Clinic

    Albuquerque, New Mexico, 87106

  • Georgia Cancer Specialists

    Athens, Georgia, 30606

  • Georgia Cancer Specialists

    Atlanta, Georgia, 30341

  • OHSU Knight Cancer Institute

    Beaverton, Oregon, 97006

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211-1850

  • Tower Hematology Oncology Medical Group

    Beverly Hills, California, 90211-1850

  • Maine Center for Cancer Medicine

    Biddeford, Maine, 04005

  • Kresge Eye Institute

    Bingham Farms, Michigan, 48025

  • Lynn Cancer Institute Center for Hematology Oncology

    Boca Raton, Florida, 33486

  • Maine Center for Cancer Medicine

    Brunswick, Maine, 04011

  • University of Chicago

    Chicago, Illinois, 60637

  • Siteman Cancer Center

    City of Saint Peters, Missouri, 63376

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri, 63141

  • UT Southwestern Medical Center - Simmons Cancer Center Pharmacy

    Dallas, Texas, 75390-9015

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • UT Southwestern University Hospital - William P. Clements, Jr.

    Dallas, Texas, 75390

  • UT Southwestern University Hospital - Zale Lipshy

    Dallas, Texas, 75390

  • Georgia Cancer Specialists

    Decatur, Georgia, 30033

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Kresge Eye Institute

    Detroit, Michigan, 48201

  • Tennessee Oncology, PLLC

    Dickson, Tennessee, 37055

  • Vincent Armenio

    East Providence, Rhode Island, 02914

  • Pharma Resource

    East Providence, Rhode Island, 02915

  • Karmanos Cancer Institute at Farmington Hills

    Farmington Hills, Michigan, 48334

  • CCTAP

    Fontana, California, 92335

  • Tennessee Oncology, PLLC

    Franklin, Tennessee, 37067

  • Tennessee Oncology, PLLC

    Gallatin, Tennessee, 37066

  • OHSU Knight Cancer Institute

    Gresham, Oregon, 97030

  • Al Fisher, Pharm D.

    Harvey, Illinois, 60426

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Monroe Medical Associates

    Harvey, Illinois, 60426

  • Tennessee Oncology, PLLC

    Hermitage, Tennessee, 37076

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University Hospital

    Indianapolis, Indiana, 46202

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Lois and Eskenazi Hospital

    Indianapolis, Indiana, 46202

  • NSLIJ Health System/Monter Cancer Center

    Lake Success, New York, 11042

  • Memorial Medical Center

    Las Cruces, New Mexico, 88011

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0001

  • Tennessee Oncology, PLLC

    Lebanon, Tennessee, 37087

  • Loma Linda University Cancer Center

    Loma Linda, California, 92350

  • Loma Linda University Cancer Center (LLUCC)-Schuman Pavilion

    Loma Linda, California, 92354

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • CCTAP

    Los Angeles, California, 90027

  • Georgia Cancer Specialists

    Macon, Georgia, 31217

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792-5666

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Georgia Cancer Specialists

    Marietta, Georgia, 30060

  • Hematology-Oncology Associates of Northern New Jersey

    Morristown, New Jersey, 07962

  • Monroe Medical Association

    Munster, Indiana, 46321

  • The Community Hospital

    Munster, Indiana, 46321

  • Tennessee Oncology, PLLC

    Murfreesboro, Tennessee, 37130

  • 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

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232-5536

  • Vanderbilt Oncology Pharmacy

    Nashville, Tennessee, 37232-7610

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Florida Hospital

    Orlando, Florida, 32803

  • Cancer Institute of Florida

    Orlando, Florida, 32804

  • Investigational Drug Services

    Orlando, Florida, 32804

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97210

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97216

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Kaiser Permanente Southern California

    San Diego, California, 92108

  • CCTAP

    San Diego, California, 92120

  • Georgia Cancer Specialists

    Sandy Springs, Georgia, 30342

  • Maine Center for Cancer Medicine

    Sanford, Maine, 04073

  • Maine Center for Cancer Medicine

    Scarborough, Maine, 04074

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Tennessee Oncology, PLLC

    Smyrna, Tennessee, 37167

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110-1094

  • Washington University Center for Advanced Medicine Infusion Center Pharmacy

    St Louis, Missouri, 63110

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Monroe Medical Associates

    Tinley Park, Illinois, 60477

  • OHSU Knight Cancer Institute

    Tualatin, Oregon, 97062

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Research Pharmacy, Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

Italy24 sites

  • Struttura Operativa Complessa Oncologia Medica A Centro di Riferimento Oncologico

    Aviano, Pordenone, 33081

  • Farmacia

    Aviano (PN), 33081

  • Istituto dei tumori Giovanni Paolo II

    Bari, 70124

  • Unità Operativa di Oncologia Medica Azienda USL Città di Bologna

    Bologna, 40100

  • Azienda Ospedaliero-Universitaria "Mater Domini"

    Catanzaro, 88100

  • Unità Operativa di Farmacia - Campus Salvatore venuta

    Catanzaro, 88100

  • Ospedale Civile Azienda USL Toscana Nord Ovest

    Livorno, 57124

  • Unità Operativa Farmacia Ospedaliera PO di Livorno

    Livorno, 57124

  • Fondazione IRCCS Istituto Nazionale Tumori, Struttura Complessa di Medicina Oncologica 1

    Milan, 20133

  • Farmacia Istituto Europeo di Oncologia IRCCS, U.O. Farmacia

    Milan, 20141

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Ospedale Niguarda Ca'Granda, Divisione Oncologia Medica Falck

    Milan, 20162

  • A.O.R.N. Ospedale Dei Colli - Monaldi

    Naples, 80131

  • Farmacia

    Naples, 80131

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga

    Orbassano (TO), 10043

  • S.C. Farmacia Ospedaliera , Azienda Ospedaliero Universitaria San Luigi Gonzaga

    Orbassano (TO), 10043

  • Oncologia Medica, Azienda Ospedaliero- Universitaria di Parma

    Parma, 43126

  • Farmacia Ospedaliera

    Perugia, 06132

  • SC Oncologia Medica, Ospedale Santa Maria della Misericordia

    Perugia, 06132

  • IRCCS -Arcispedale S. Maria Nuova Tecnologie Avanzate e Modelli Assistenziali in Oncologia

    Reggio Emilia, 42123

  • Istituto Regina Elena, Struttura Complessa Oncologia Medica A

    Roma, 00144

  • Azienda Ospedaliera San Camillo Forlanini-Padiglione Flaiani

    Roma, 00152

  • Farmacia Interna

    Roma, 00152

  • Unita Operativa, Oncologia Medica, Istituto di Medicina Interna e Geriatria

    Roma, 00168

Other trials in Italy

Japan15 sites

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558

  • National Cancer Center Hospital

    Chuo-Ku, Tokyo, 104-0045

  • National Hospital organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Kyushu University Hospital Respiratory Medicine

    Fukuoka, 812-8582

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • The Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo, 135-8550

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • 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

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

  • National Hospital Organization Yamaguchi-Ube Medical Center

    Ube-shi, Yamaguchi, 755-0241

  • Kanagawa Cardiovascular and Respiratory Center

    Yokohama, Kanagawa, 236-0051

Other trials in Japan

Australia10 sites

  • Department of Medical Oncology

    Adelaide, South Australia, 5000

  • Macarthur Cancer Therapy Centre

    Campbelltown, New South Wales, 2560

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • The Townsville Hospital

    Douglas, Queensland, 4814

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

    East Melbourne, Victoria, 3002

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria, 3199

  • The Royal Brisbane & Womens Hospital

    Herston, Queensland, 4006

  • Parkhaven Medical Center

    Hyde Park, Queensland, 4812

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

Other trials in Australia

China9 sites

  • 307 Hospital of PLA

    Beijing, Beijing Municipality, 100071

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, 100021

  • Oncology Department, West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Oncology Center, Guangdong General Hospital

    Guangzhou, Guangdong, 510080

  • No.81 Hospital of the PLA

    Nanjing, Jiangsu, 210002

  • Shanghai Chest Hospital/Department of Pulmonary Medicine

    Shanghai, 200030

  • Zhongshan Hospital Fudan University

    Shanghai, 200030

  • Shanghai Pulmonary Hospital/Dept. of Oncology

    Shanghai, 200433

  • Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center

    Wuhan, Hubei, 430023

Other trials in China

France9 sites

  • Hopital Avicenne

    Bobigny, 93009

  • CHU de Caen

    Caen, 14033

  • CHU Grenoble

    Grenoble, 38043

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Leon Berard

    Lyon, 69373

  • APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques

    Marseille, 13915

  • Hopital Arnaud de Villeneuve / CHU de Montpellier

    Montpellier, 34295

  • Hopital Tenon, Service de Pneumologie

    Paris, 75970

  • Nouvel Hopital Civil - HSU - Pôle de Pathologie Thoracique - Service de Pneumologie

    Strasbourg, 67091

Other trials in France

Spain9 sites

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, Catalonia, 08036

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria, 35016

  • Hospital Ramon Y Cajal

    Madrid, 28034

  • Hospital Doce de Octubre

    Madrid, 28041

  • Hospital Universitario Virgen de La Victoria

    Málaga, 29010

  • Hospital Universitario Virgen Macarena

    Seville, Andalusia, 41009

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, Aragon, 50009

Other trials in Spain

United Kingdom9 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

  • Addenbrooke's Hospital, Oncology Centre

    Cambridge, Cambridgeshire, CB2 0QQ

  • NHS Greater Glasgow and Clyde Health Board, Beatson West of Scotland Cancer Centre,

    Glasgow, Scotland, G12 0YN

  • Ross Hall Hospital

    Glasgow, Scotland, G52 3NQ

  • Spire Manchester Hospital

    Manchester, Lancashire, M16 8AJ

  • The Christie Hospital NHS Foundation Trust, Department of Medical Oncology

    Manchester, M20 4BX

  • Mount Vernon Hospital, Mount Vernon Cancer Centre

    Northwood, Middlesex, HA6 2RN

  • Lister Hospital

    Stevenage, Hertfordshire, SG1 4AB

  • Queen Elizabeth II Hospital

    Welwyn Garden City, Hertfordshire, AL7 4HQ

Other trials in United Kingdom

Belgium8 sites

  • Institut Jules Bordet, Centre des Tumeurs de l'ULB

    Brussels, 1000

  • Universitair Ziekenhuis Brussel / Medische Oncologie

    Brussels, 1090

  • Cliniques Universitaires St Luc

    Brussels, 1200

  • Grand Hopital de Charleroi -Site Notre Dame

    Charleroi, Hainaut, 6000

  • UZ Antwerpen-Pneumologie

    Edegem, Antwerp, 2650

  • Universitair Ziekenhuis Gent (U.Z. Gent)

    Ghent, 9000

  • Centre Hospitalier Universitaire de Liege

    Liège, 4000

  • Department of Pulmonary Diseases AZ Delta

    Roeselare, 8800

Other trials in Belgium

Germany8 sites

  • Zentralklinik Bad Berka GmbH

    Bad Berka, 99437

  • Charite - Universitaetsmedizin Berlin, Campus Mitte

    Berlin, 10117

  • Thoraxklinik am Universitaetsklinikum Heidelberg

    Heidelberg, 69126

  • St.Vincentius-Kliniken Karlsruhe

    Karlsruhe, 76137

  • UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, 41063

  • Pius-Hospital Oldenburg

    Oldenburg, 26121

  • HSK Dr.- Horst-Schmidt-Kliniken GmbH,

    Wiesbaden, 65199

Other trials in Germany

Canada7 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B2H 2Y9

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • McGill University Health Centre (MUHC), Glen Site, Cedars Cancer Centre

    Montreal, Quebec, H4A 3J1

  • R.S. McLaughlin Durham Regional Cancer Centre

    Oshawa, Ontario, L1G 2B9

  • Institut universitaire de cardiologie et de pneumologie de Quebec (IUCPQ)

    Ste-Foy, Quebec, G1V 4G5

Other trials in Canada

Russia7 sites

  • Russian Oncological Research Center N.N. Blokhin

    Moscow, 115478

  • City Clinical Oncology Dispensary

    Saint Petersburg, 197022

  • First Saint-Petersburg State Medical University n.a. I.P. Pavlov

    Saint Petersburg, 197022

  • First Saint-Petersburg State Medical University n.a. I.P.

    Saint Petersburg, 197101

  • Russian Scientific Center of Radiology and Surgical Technologies

    Saint Petersburg, 197758

  • City Clinical Oncology Dispensary

    Saint Petersburg, 198255

  • Samara Regional Clinical Oncology Dispensary

    Samara, 443031

Other trials in Russia

Brazil5 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

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Nacional de Cancer - INCA

    Rio de Janeiro, Rio de Janeiro, 20231 -050

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

    São Paulo, São Paulo, 01246-000

Other trials in Brazil

Ukraine5 sites

  • City Multiple-Discipline Clinical Hospital #4,

    Dnipropetrovsk, 49102

  • City Multiple-Discipline Clinical Hospital #4

    Dnipropetrovsk, 49102

  • Department of Oncology and Medical Radiology, SI "DMA of MOH, Ukraine

    Dnipropetrovsk, 49102

  • Kyiv City Clinical Oncologic Center/Department of Chemotherapy

    Kyiv, 03115

  • Lviv State Oncologic Regional Treatment and Diagnostic Center

    Lviv, 79031

Other trials in Ukraine

Portugal4 sites

  • Centro Hospitalar e Universitario de Coimbra - Hospital Geral

    Coimbra, 3041-801

  • Instituto Português de Oncologia de Lisboa, Prof. Francisco Gentil E.P.E.

    Lisbon, 1099-023

  • Centro Hospitalar de Lisboa Norte - Hospital Pulido Valente

    Lisbon, 1769-001

  • Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Singapore4 sites

  • National University Hospital

    Singapore, 119074

  • National Cancer Centre

    Singapore, 169610

  • Parkway Cancer Centre

    Singapore, 228510

  • OncoCare Cancer Centre

    Singapore, 258499

Other trials in Singapore

Taiwan4 sites

  • Chang Gung Medical Foundation, Kaohsiung Branch

    Kaohsiung City, 833

  • China Medical University Hospital

    Taichung, 404

  • Taichung Veterans General Hospital, Comprehensive Cancer Center

    Taichung, 40705

  • Chang Gung Medical Foundation, LinKou Branch

    Taoyuan, 33305

Other trials in Taiwan

Chile3 sites

  • Hospital Clinico Universidad de Chile, Seccion de Oncologia

    Independencia, Santiago, Rm, 8380456

  • Instituto Nacional del Cancer

    Santiago, RM, 8380455

  • Instituto Clinico Oncologico del Sur

    Temuco, Cautin, 4810469

Other trials in Chile

Finland3 sites

  • Helsingin yliopistollinen keskussairaala, Meilahden kolmiosairaala,Keuhkosairauksien poliklinikka

    Helsinki, 00290

  • Satakunnan keskussairaala/Keuhkosairauksien osasto A4

    Pori, 28500

  • Tampereen yliopistollinen sairaala

    Tampere, 33520

Other trials in Finland

Netherlands3 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, North Brabant, 5223 GZ

  • VUMC

    Amsterdam, 1081 HV

  • Academisch Ziekenhuis Maastricht / afdeling longziekten en tuberculose

    Maastricht, 6229 HX

Other trials in Netherlands

South Korea3 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center, Sungkyunkwan Univ. School of Medicine

    Seoul, 06351

Other trials in South Korea

Switzerland3 sites

  • Universitaetsspital Basel

    Basel, CH-4031

  • Luzerner Kantonsspital (LUKS)

    Lucerne, 6000

  • Kantonsspital Winterthur

    Winterthur, CH-8401

Other trials in Switzerland

Hong Kong2 sites

  • Department of Clinical Oncology, Queen Elizabeth Hospital

    Kowloon

  • Prince of Wales Hospital

    Shatin, New Territories

Other trials in Hong Kong

India2 sites

  • The Gujarat Cancer & Research Institute (M.P Shah Cancer Hospital),

    Ahmedabad, Gujarat, 380 016

  • Tata Memorial Centre, Tata Memorial Hospital,

    Mumbai, Maharashtra, 400012

Other trials in India

Ireland2 sites

  • Aseptic Compounding Unit

    Dublin, Dublin 8

  • Department of Medical Oncology

    Dublin, Dublin 8

Other trials in Ireland

South Africa2 sites

  • Rondebosch Oncology Centre, Rondebosch Medical Centre

    Cape Town, 7700

  • University of Witwatersrand Oncology

    Johannesburg, Gauteng, 2193

Other trials in South Africa

Austria1 site

  • Klinikum Wels-Grieskirchen

    Wels, 4600

Other trials in Austria

Luxembourg1 site

  • Centre Hospitalier de Luxembourg

    Luxembourg, 1210

Other trials in Luxembourg

Mexico1 site

  • Instituto Nacional de Cancerologia

    México, D.f., 14080

Other trials in Mexico

Norway1 site

  • Oslo universitetssykehus HF - Radiumhospitalet

    Oslo, 0424

Other trials in Norway

Peru1 site

  • Clinica Anglo Americana/Centro de Investigacion Oncologia CAA

    San Isidro, Lima region, 27

Other trials in Peru

About this study

Official title: Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated Patients With Non-squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus.

This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.

Being tested
treatment
Keywords
open label, randomized Phase 3, first line treatment, non squamous lung cancer, ALK translocation event positive

What participants receive

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

  • treatmentDrug

    crizotinib 250mg orally continuous twice daily dosing

  • treatmentDrug

    pemetrexed 500mg/m2 IV day 1 plus cisplatin 75mg/m2 IV day 1 every 21 days OR pemetrexed 500mg/m2 IV day 1 plus carboplatin AUC 5 or 6 day 1 every 21 days investigator's choice

Study groups in NCT01154140
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: treatment
BActive comparatorNot described
Receives: Drug: treatment

What is being measured

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

  1. Progression-Free Survival (PFS) Based on IRR

    PFS was defined as the time from the date of randomization in study until the date of first documented objective tumor progression (according to RECIST v1.1 as determined by IRR) or death (due to any cause), whichever occurred first. PFS (in months) was calculated as (first event date - randomization date +1)/30.44. Objective progression was defined as a 20 percent (%) increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 millimeter (mm) or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.

    Measured: Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)

Secondary outcomes (23)

  1. Overall Survival (OS)

    OS (in months) was defined as the duration from start of study treatment to date of death due to any cause. OS = (date of death minus the date of randomization of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive.

    Measured: From randomization to death or last date known alive for those not known to have died (up to 72 months)

  2. Overall Survival Probability at Month 12 and 18

    Overall survival probability at Month 12 and 18 was defined as the probability of overall survival at 12 and 18 months respectively, where the OS was defined as the duration from date of randomization to date of death due to any cause. The survival probability was estimated using the Kaplan-Meier method.

    Measured: Month 12, 18

  3. Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by IRR

    ORR was defined as percentage of participants with complete response (CR) or partial response (PR) according to RECIST v1.1 determined by IRR. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as greater than or equal to (>=) 30% decrease taking as reference the baseline sum of lesion dimensions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No clear progression of non-target disease. No new lesions.

    Measured: Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)

  4. Duration of Response (DR) Based on IRR

    DR: time from first documentation of objective tumor response (CR or PR) to first documentation of PD or death due to any cause, whichever occurred first as per RECIST v1.1 determined by IRR. CR: complete disappearance of all target and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions, disappearance of all non-target lesions. PR: >=30% decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions. c) PD: 20 % increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.

    Measured: From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)

  5. Time to Tumor Response (TTR) Based on IRR

    TTR was defined as the time from randomization to first documentation of objective tumor response (CR or PR) according to RECIST v1.1 determined by IRR. CR: complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR: >=30% decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.

    Measured: Randomization to first documentation of objective tumor response (up to 35 months)

  6. Percentage of Participants With Disease Control at Week 12 Based on IRR

    Disease control rate at week 12 is defined as the percent of participants with CR, PR, or stable disease (SD) at week 12 according to RECIST v1.1 determined by IRR. The best response of SD would be assigned if SD criteria was met at least once after randomization at a minimum interval of 6 weeks. CR: complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR: >=30% decrease taking as reference the baseline sum of lesion dimensions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.

    Measured: Week 12

  7. Time to Progression (TTP) Based on IRR

    TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date - randomization date +1)/30.44.

    Measured: Randomization to objective progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)

  8. Time to Intracranial Progression (IC-TTP) Based on IRR

    IC-TTP was defined similarly to TTP, but only considering intracranial disease (excluding extracranial disease) and the progression was determined based on either new brain metastases or progression of existing brain metastases. TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.

    Measured: Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)

  9. Time to Extracranial Progression (EC-TTP) Based on IRR

    EC-TTP was defined similarly to TTP, but only considering extracranial disease (excluding intracranial disease) and the progression was determined based on either new extracranial lesions or progression of existing extracranial lesions. TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.

    Measured: Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)

  10. Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.

    Measured: Baseline up to follow up period (up to 72 months)

  11. Percentage of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.

    Measured: Baseline up to follow up period (up to 72 months)

  12. Percentage of Participants With Adverse Events (AEs) According to Maximum Severity

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death.

    Measured: Baseline up to follow up period (up to 72 months)

  13. Plasma Predose Concentration (Ctrough) of Crizotinib and Its Metabolite PF-06260182

    Ctrough is the concentration prior to study drug administration on Day 1 of Cycle 2 onwards. PF-06260182 is the metabolite of Crizotinib.

    Measured: Predose at Day 1 of Cycle 2, 3 and 5

  14. Percentage of Participants For Each Anaplastic Lymphoma Kinase (ALK) Gene Fusion Variants

    The Response Genetics, Inc. Echinoderm Microtubule Associated Protein Like 4 (EML4) ALK reverse transcriptase polymerase chain reaction (RT PCR) gene fusion test was used for the analysis of tissue samples for the ALK gene fusion variants (either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements [V1, V2, V3a, V3b,V3a/b, V4, V5a, V6, V7]). Percentage of participants who tested positive for ALK gene fusion variants were reported in this outcome measure.

    Measured: 28 days prior to day 1 of study treatment

  15. Objective Response Rate (ORR) of Anaplastic Lymphoma Kinase (ALK) Variant Groups Based on IRR

    The Response Genetics, Inc. EML4 ALK reverse transcriptase polymerase chain reaction (RT PCR) gene fusion test was used for the analysis of tissue samples for the ALK gene fusion variants (either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements [V1, V2, V3a, V3b,V3a/b, V4, V5a, V6, V7]). Percentage of participants with confirmed CR or PR according to RECIST v1.1 determined by IRR, by type of ALK gene fusion variant were reported in this outcome measure. CR: complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR: >=30% decrease decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.

    Measured: Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)

  16. Time to Deterioration (TTD) in Chest Pain, Dyspnea or Cough

    TTD in pain in chest, dyspnea, or cough from the Quality of Life Questionnaire Core 30 (QLQ-LC13) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the 3 symptoms. For those who had not shown deterioration, the data was censored at the last date when the participants completed an assessment (QLQ-LC13) for pain, dyspnea, or cough or at last visit date prior to crossover for participants randomized to chemotherapy who subsequently crossed over to crizotinib. A 10-point or higher change in the score was perceived by participants as clinically significant. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 (European Organization for the Research and Treatment of Cancer) range from 0 to 100, where higher scores indicate greater symptom severity.

    Measured: From randomization of treatment up to deterioration while on study treatment (up to 35 months)

  17. Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)

    EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional and social), global health status/global quality of life scale, 3 symptom scales (fatigue, pain, nausea and vomiting), 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea) and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QoL represents a high QoL (better participant state), and for a symptom scale/item represents a high level of symptoms/problems (worse participant state).

    Measured: Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)

  18. Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)

    EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional and social), global health status/global quality of life scale, 3 symptom scales (fatigue, pain, nausea and vomiting), 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea) and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QoL represents a high QoL (better participant state), and for a symptom scale/item represents a high level of symptoms/problems (worse participant state).

    Measured: Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)

  19. Change From Baseline in Lung Cancer Symptom Scores as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13)

    QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess the specific symptoms (dyspnea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of patients with lung cancer receiving chemotherapy. All multi-item scales and single-item measures range from 0 to 100, where higher score indicates greater degree of symptom severity.

    Measured: Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)

  20. Change From Baseline in General Health Status as Assessed by EuroQol 5D (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. VAS component: participants rated their current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health.

    Measured: Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)

  21. Percentage of Participants With Hospital Admissions-Healthcare Resource Utilization (HCRU)

    Healthcare resource utilization was to be evaluated using the assessment of the following: date and duration of index admission, duration of hospitalization and date of discharge.

    Measured: Baseline up to follow up period (up to 72 months)

  22. Percentage of Participants With Laboratory Test Abnormalities By Maximum Severity: National Cancer Institute Common Terminology Criteria for Adverse Event (Version 4.0) Grade 1 to 4 Hematological Test Abnormalities

    Anemia(grade[g]1:Less than[<] Lower limit of normal[LLN] to 10gram per[/] deciliter[g/dL],g2:<10 to 8g/dL,g3:<8g/dL,g4:lifethreatening);platelet (g1:<LLN to 75*10^3/millimeter[mm]^3,g2:<75*10^3/mm^3 to 50*10^3/mm^3,g3:<50*10^3/mm^3 to 25*10^3/mm^3,g4:<25*10^3/mm^3);lymphopenia(g1:<LLN to 8*10^2/mm^3,g2:<8*10^2 to 5*10^2/mm^3,g3:<5*10^2 to 2*10^2/mm^3,g4:<2*10^2/mm^3);neutrophil (Absolute)(g1:<LLN to 15*10^2/mm^3,g2:<15*10^2 to 10*10^2/mm^3,g3:<10*10^2 to 5*10^2/mm^3,g4:<5*10^2/mm^3);white blood cell count(g1:<LLN to 3*10^3/mm^3,g2:<3*10^3 to 2*10^3/mm^3,g3:<2*10^3 to 1*10^3/mm^3,g4:<1*10^3/mm^3);hemoglobin(g1:increase in hemoglobin level>0 to 2 g/dL above ULN or above baseline if baseline is above ULN,g2:increase in hemoglobin level>2 to 4g/dL above ULN or above baseline if baseline is above ULN,g3:increase in hemoglobin level>4 g/dL above ULN or above baseline if baseline is above ULN). Only categories with atleast 1 participant with abnormality are reported in this outcome measure.

    Measured: Baseline up to follow up period (up to 72 months)

  23. Percentage of Participants With Laboratory Test Abnormalities By Maximum Severity: National Cancer Institute Common Terminology Criteria for Adverse Event (Version 4.0) Grade 1 to 4 Chemistry Test Abnormalities

    ALT/AST (Grade[g]1:>ULN-3*ULN,g2:>3-5*ULN,g3:>5-20*ULN,g4:>20*ULN);Alkaline Phosphatase (g1:>ULN-2.5*ULN,g2:>2.5-5*ULN,g3:>5-20*ULN,g4:>20*ULN);Creatinine (g1:>ULN-1.5*ULN,g2:>1.5-3*ULN,g3:>3-6*ULN,g4:>6*ULN);hyperglycemia (g1:>ULN-160,g2:>160-250,g3:>250-500,g4:>500mg/dL);bilirubin(total) (g1:>ULN-1.5*ULN,g2:>1.5-3*ULN,g3:>3-10*ULN,g4:>10*ULN);hypoglycaemia (g1:<LLN-55,g2:<55-40,g3:<40-30,g4:<30mg/dL);hyperkalemia (g1:>ULN-5.5,g2:>5.5-6,g3:>6-7,g4:>7mmol/L);hypokalemia (g1:<LLN-3,g2:<LLN-3,g3:<3-2.5,g4:<2.5mmol/L);hypermagnesemia (g1:>ULN-3,g3:>3-8,g4:>8mg/dL);hypocalcemia (g1:<LLN-8,g2:<8-7,g3:<7-6,g4:<6mg/dL); hypercalcemia (g1:>ULN-11.5,g2:>11.5-12.5,g3:>12.5-13.5,g4:>13.5mg/dL);hypomagnesemia (g1:<LLN-1.2,g2:<1.2-0.9,g3:<0.9-0.7,g4:<0.7mg/dL);hyponatremia (g1:<LLN-130,g3:<130-120,g4:<120mmol/L);hypoalbuminemia (g1:<LLN-3,g2:<3-2,g3:<2,g4:lifethreatening);hypophosphatemia (g1:<LLN-2.5,g2:<2.5-2,g3:<2-1,g4:<1mg/dL). Participant>=1 abnormality given.

    Measured: Baseline up to follow up period (up to 72 months)

Timeline

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

  1. First posted30 Jun 2010 (estimated)
  2. Study start13 Jan 2011
  3. Primary completion30 Nov 2013
  4. Study completion30 Nov 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
343 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01154140
Sponsor's protocol ID
A8081014
Other IDs
2010-021336-33, XALCORI
Acronym
PROFILE 1014
Status last verified
Sep 2017
First submitted
29 Jun 2010
Last updated
6 Nov 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

  • Solomon BJ, Kim DW, Wu YL, Nakagawa K, Mekhail T, Felip E, Cappuzzo F, Paolini J, Usari T, Tang Y, Wilner KD, Blackhall F, Mok TS. Final Overall Survival Analysis From a Study Comparing First-Line Crizotinib Versus Chemotherapy in ALK-Mutation-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Aug 1;36(22):2251-2258. doi: 10.1200/JCO.2017.77.4794. Epub 2018 May 16.

    PubMed 29768118

  • 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

  • Solomon BJ, Cappuzzo F, Felip E, Blackhall FH, Costa DB, Kim DW, Nakagawa K, Wu YL, Mekhail T, Paolini J, Tursi J, Usari T, Wilner KD, Selaru P, Mok TS. Intracranial Efficacy of Crizotinib Versus Chemotherapy in Patients With Advanced ALK-Positive Non-Small-Cell Lung Cancer: Results From PROFILE 1014. J Clin Oncol. 2016 Aug 20;34(24):2858-65. doi: 10.1200/JCO.2015.63.5888. Epub 2016 Mar 28.

    PubMed 27022118

  • Solomon BJ, Mok T, Kim DW, Wu YL, Nakagawa K, Mekhail T, Felip E, Cappuzzo F, Paolini J, Usari T, Iyer S, Reisman A, Wilner KD, Tursi J, Blackhall F; PROFILE 1014 Investigators. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014 Dec 4;371(23):2167-77. doi: 10.1056/NEJMoa1408440.

    PubMed 25470694

  • Ou SH. Crizotinib: a drug that crystallizes a unique molecular subset of non-small-cell lung cancer. Expert Rev Anticancer Ther. 2012 Feb;12(2):151-62. doi: 10.1586/era.11.186.

    PubMed 22316363

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing treatment in people with Non Squamous Lung Cancer, run by Pfizer at 249 sites in 31 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 5 inclusion and 9 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 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 249 sites in United States, Italy, Japan, Australia, China and 26 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 5 Jan 2015). 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) Based on IRR (time frame: Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)). 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 NCT01154140, which also lists 7 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 6 Nov 2017.

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