Clinical trial NCT01154140: 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
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non Squamous Lung Cancer
Keywords: open label
randomized Phase 3
first line treatment
non squamous lung cancer
ALK translocation event positive
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-06-30
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: Progression-Free Survival (PFS) Based on IRR
timeFrame: Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization to death or last date known alive for those not known to have died (up to 72 months)
measure: Overall Survival Probability at Month 12 and 18
timeFrame: Month 12, 18
measure: Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by IRR
timeFrame: Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
measure: Duration of Response (DR) Based on IRR
timeFrame: From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
measure: Time to Tumor Response (TTR) Based on IRR
timeFrame: Randomization to first documentation of objective tumor response (up to 35 months)
measure: Percentage of Participants With Disease Control at Week 12 Based on IRR
timeFrame: Week 12
measure: Time to Progression (TTP) Based on IRR
timeFrame: Randomization to objective progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
measure: Time to Intracranial Progression (IC-TTP) Based on IRR
timeFrame: Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
measure: Time to Extracranial Progression (EC-TTP) Based on IRR
timeFrame: Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
measure: Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to follow up period (up to 72 months)
measure: Percentage of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to follow up period (up to 72 months)
measure: Percentage of Participants With Adverse Events (AEs) According to Maximum Severity
timeFrame: Baseline up to follow up period (up to 72 months)
measure: Plasma Predose Concentration (Ctrough) of Crizotinib and Its Metabolite PF-06260182
timeFrame: Predose at Day 1 of Cycle 2, 3 and 5
measure: Percentage of Participants For Each Anaplastic Lymphoma Kinase (ALK) Gene Fusion Variants
timeFrame: 28 days prior to day 1 of study treatment
measure: Objective Response Rate (ORR) of Anaplastic Lymphoma Kinase (ALK) Variant Groups Based on IRR
timeFrame: Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
measure: Time to Deterioration (TTD) in Chest Pain, Dyspnea or Cough
timeFrame: From randomization of treatment up to deterioration while on study treatment (up to 35 months)
measure: 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)
timeFrame: Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
measure: 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)
timeFrame: Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
measure: 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)
timeFrame: Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
measure: Change From Baseline in General Health Status as Assessed by EuroQol 5D (EQ-5D)- Visual Analog Scale (VAS)
timeFrame: Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
measure: Percentage of Participants With Hospital Admissions-Healthcare Resource Utilization (HCRU)
timeFrame: Baseline up to follow up period (up to 72 months)
measure: 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
timeFrame: Baseline up to follow up period (up to 72 months)
measure: 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
timeFrame: Baseline up to follow up period (up to 72 months)
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation
state: California
city: Beverly Hills
country: United States
facility: Tower Hematology Oncology Medical Group
state: California
city: Fontana
country: United States
facility: CCTAP
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Cancer Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Cancer Center (LLUCC)-Schuman Pavilion
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: CCTAP
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Southern California
state: California
city: San Diego
country: United States
facility: CCTAP
state: California
city: Washington, D.C.
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Washington, D.C.
country: United States
facility: Research Pharmacy, Georgetown University Medical Center
state: District of Columbia
city: Boca Raton
country: United States
facility: Lynn Cancer Institute Center for Hematology Oncology
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Orlando
country: United States
facility: Cancer Institute of Florida
state: Florida
city: Orlando
country: United States
facility: Investigational Drug Services
state: Florida
city: Athens
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Atlanta
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Decatur
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Macon
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Marietta
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Sandy Springs
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Harvey
country: United States
facility: Al Fisher, Pharm D.
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Harvey
country: United States
facility: Monroe Medical Associates
state: Illinois
city: Tinley Park
country: United States
facility: Monroe Medical Associates
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Lois and Eskenazi Hospital
state: Indiana
city: Munster
country: United States
facility: Monroe Medical Association
state: Indiana
city: Munster
country: United States
facility: The Community Hospital
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Biddeford
country: United States
facility: Maine Center for Cancer Medicine
state: Maine
city: Brunswick
country: United States
facility: Maine Center for Cancer Medicine
state: Maine
city: Sanford
country: United States
facility: Maine Center for Cancer Medicine
state: Maine
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine
state: Maine
city: Bingham Farms
country: United States
facility: Kresge Eye Institute
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Kresge Eye Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Karmanos Cancer Institute at Farmington Hills
state: Michigan
city: Creve Coeur
country: United States
facility: Siteman Cancer Center - West County
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Center for Advanced Medicine Infusion Center Pharmacy
state: Missouri
city: Saint Peters
country: United States
facility: Siteman Cancer Center
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Morristown
country: United States
facility: Hematology-Oncology Associates of Northern New Jersey
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Albuquerque
country: United States
facility: UNM Eye Clinic
state: New Mexico
city: Las Cruces
country: United States
facility: Memorial Medical Center
state: New Mexico
city: Lake Success
country: United States
facility: NSLIJ Health System/Monter Cancer Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Beaverton
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Gresham
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Tualatin
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: East Providence
country: United States
facility: Vincent Armenio
state: Rhode Island
city: East Providence
country: United States
facility: Pharma Resource
state: Rhode Island
city: Dickson
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Franklin
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Gallatin
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Hermitage
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Lebanon
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Murfreesboro
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Henry-Joyce Cancer Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Oncology Pharmacy
state: Tennessee
city: Smyrna
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center - Simmons Cancer Center Pharmacy
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern University Hospital - William P. Clements, Jr.
state: Texas
city: Dallas
country: United States
facility: UT Southwestern University Hospital - Zale Lipshy
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Campbelltown
country: Australia
facility: Macarthur Cancer Therapy Centre
state: New South Wales
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Douglas
country: Australia
facility: The Townsville Hospital
state: Queensland
city: Herston
country: Australia
facility: The Royal Brisbane & Womens Hospital
state: Queensland
city: Hyde Park
country: Australia
facility: Parkhaven Medical Center
state: Queensland
city: Adelaide
country: Australia
facility: Department of Medical Oncology
state: South Australia
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre, Department of Haematology and Medical Oncology
state: Victoria
city: Frankston
country: Australia
facility: Peninsula & South Eastern Haematology and Oncology Group
state: Victoria
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen
city: Edegem
country: Belgium
facility: UZ Antwerpen-Pneumologie
state: Antwerp
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi -Site Notre Dame
state: Hainaut
city: Brussels
country: Belgium
facility: Cliniques Universitaires St Luc
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel / Medische Oncologie
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet, Centre des Tumeurs de l'ULB
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent (U.Z. Gent)
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege
city: Roeselare
country: Belgium
facility: Department of Pulmonary Diseases AZ Delta
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer - INCA
state: RJ
city: Ijui
country: Brazil
facility: Associacao Hospital de Caridade de Ijui
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS
state: RS
city: Sao Paulo
country: Brazil
facility: Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP
state: SP
city: Barretos
country: Brazil
facility: Fundacao Pio XII Hospital de Cancer de Barretos
state: São Paulo
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Oshawa
country: Canada
facility: R.S. McLaughlin Durham Regional Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC), Glen Site, Cedars Cancer Centre
state: Quebec
city: Ste-Foy
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Quebec (IUCPQ)
state: Quebec
city: Temuco
country: Chile
facility: Instituto Clinico Oncologico del Sur
state: Cautin
city: Santiago
country: Chile
facility: Instituto Nacional del Cancer
state: RM
city: Independencia
country: Chile
facility: Hospital Clinico Universidad de Chile, Seccion de Oncologia
state: Santiago, Rm
city: Beijing
country: China
facility: 307 Hospital of PLA
state: Beijing
city: Guangzhou
country: China
facility: Oncology Center, Guangdong General Hospital
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center
state: Hubei
city: Nanjing
country: China
facility: No.81 Hospital of the PLA
state: Jiangsu
city: Chengdu
country: China
facility: Oncology Department, West China Hospital of Sichuan University
state: Sichuan
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
city: Shanghai
country: China
facility: Shanghai Chest Hospital/Department of Pulmonary Medicine
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital/Dept. of Oncology
city: Helsinki
country: Finland
facility: Helsingin yliopistollinen keskussairaala, Meilahden kolmiosairaala,Keuhkosairauksien poliklinikka
city: Pori
country: Finland
facility: Satakunnan keskussairaala/Keuhkosairauksien osasto A4
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala
city: Bobigny Cedex
country: France
facility: Hopital Avicenne
city: Caen Cedex
country: France
facility: CHU de Caen
city: Grenoble Cedex
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon Cedex 08
country: France
facility: Centre Leon Berard
city: Marseille Cedex 20
country: France
facility: APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques
city: Montpellier
country: France
facility: Hopital Arnaud de Villeneuve / CHU de Montpellier
city: Paris cedex 20
country: France
facility: Hopital Tenon, Service de Pneumologie
city: Strasbourg
country: France
facility: Nouvel Hopital Civil - HSU - Pôle de Pathologie Thoracique - Service de Pneumologie
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin, Campus Mitte
city: Heidelberg
country: Germany
facility: Thoraxklinik am Universitaetsklinikum Heidelberg
city: Karlsruhe
country: Germany
facility: St.Vincentius-Kliniken Karlsruhe
city: Mainz
country: Germany
facility: UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
city: Moenchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH
city: Oldenburg
country: Germany
facility: Pius-Hospital Oldenburg
city: Wiesbaden
country: Germany
facility: HSK Dr.- Horst-Schmidt-Kliniken GmbH,
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
state: New Territories
city: Kowloon
country: Hong Kong
facility: Department of Clinical Oncology, Queen Elizabeth Hospital
city: Ahmedabad,
country: India
facility: The Gujarat Cancer & Research Institute (M.P Shah Cancer Hospital),
state: Gujarat
city: Mumbai
country: India
facility: Tata Memorial Centre, Tata Memorial Hospital,
state: Maharashtra
city: Dublin
country: Ireland
facility: Aseptic Compounding Unit
city: Dublin
country: Ireland
facility: Department of Medical Oncology
city: Aviano
country: Italy
facility: Struttura Operativa Complessa Oncologia Medica A Centro di Riferimento Oncologico
state: Pordenone
city: Aviano (PN)
country: Italy
facility: Farmacia
city: Bari
country: Italy
facility: Istituto dei tumori Giovanni Paolo II
city: Bologna
country: Italy
facility: Unità Operativa di Oncologia Medica Azienda USL Città di Bologna
city: Catanzaro
country: Italy
facility: Azienda Ospedaliero-Universitaria "Mater Domini"
city: Catanzaro
country: Italy
facility: Unità Operativa di Farmacia - Campus Salvatore venuta
city: Livorno
country: Italy
facility: Ospedale Civile Azienda USL Toscana Nord Ovest
city: Livorno
country: Italy
facility: Unità Operativa Farmacia Ospedaliera PO di Livorno
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Tumori, Struttura Complessa di Medicina Oncologica 1
city: Milano
country: Italy
facility: Farmacia Istituto Europeo di Oncologia IRCCS, U.O. Farmacia
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Milano
country: Italy
facility: Ospedale Niguarda Ca'Granda, Divisione Oncologia Medica Falck
city: Napoli
country: Italy
facility: A.O.R.N. Ospedale Dei Colli - Monaldi
city: Napoli
country: Italy
facility: Farmacia
city: Orbassano (TO)
country: Italy
facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga
city: Orbassano (TO)
country: Italy
facility: S.C. Farmacia Ospedaliera , Azienda Ospedaliero Universitaria San Luigi Gonzaga
city: Parma
country: Italy
facility: Oncologia Medica, Azienda Ospedaliero- Universitaria di Parma
city: Perugia
country: Italy
facility: Farmacia Ospedaliera
city: Perugia
country: Italy
facility: SC Oncologia Medica, Ospedale Santa Maria della Misericordia
city: Reggio Emilia
country: Italy
facility: IRCCS -Arcispedale S. Maria Nuova Tecnologie Avanzate e Modelli Assistenziali in Oncologia
city: Roma
country: Italy
facility: Istituto Regina Elena, Struttura Complessa Oncologia Medica A
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini-Padiglione Flaiani
city: Roma
country: Italy
facility: Farmacia Interna
city: Roma
country: Italy
facility: Unita Operativa, Oncologia Medica, Istituto di Medicina Interna e Geriatria
city: Nagoya
country: Japan
facility: Aichi cancer center central hospital
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
state: Kanagawa
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Okayama-city
country: Japan
facility: Okayama University Hospital
state: Okayama
city: Osakasayama-shi
country: Japan
facility: Kinki University Hospital
state: Osaka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Chuo-Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of JFCR
state: Tokyo
city: Ube-shi
country: Japan
facility: National Hospital Organization Yamaguchi-Ube Medical Center
state: Yamaguchi
city: Fukuoka
country: Japan
facility: National Hospital organization Kyushu Cancer Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital Respiratory Medicine
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan Univ. School of Medicine
city: Luxembourg
country: Luxembourg
facility: Centre Hospitalier de Luxembourg
city: Mexico
country: Mexico
facility: Instituto Nacional de Cancerologia
state: D.f.
city: 's Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
state: NB
city: Amsterdam
country: Netherlands
facility: VUMC
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht / afdeling longziekten en tuberculose
city: Oslo
country: Norway
facility: Oslo universitetssykehus HF - Radiumhospitalet
city: San Isidro
country: Peru
facility: Clinica Anglo Americana/Centro de Investigacion Oncologia CAA
state: Lima
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitario de Coimbra - Hospital Geral
city: Lisboa
country: Portugal
facility: Instituto Português de Oncologia de Lisboa, Prof. Francisco Gentil E.P.E.
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte - Hospital Pulido Valente
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
city: Moscow
country: Russian Federation
facility: Russian Oncological Research Center N.N. Blokhin
city: Saint-Petersburg
country: Russian Federation
facility: City Clinical Oncology Dispensary
city: Saint-Petersburg
country: Russian Federation
facility: First Saint-Petersburg State Medical University n.a. I.P. Pavlov
city: Saint-Petersburg
country: Russian Federation
facility: First Saint-Petersburg State Medical University n.a. I.P.
city: Saint-Petersburg
country: Russian Federation
facility: Russian Scientific Center of Radiology and Surgical Technologies
city: Saint-Petersburg
country: Russian Federation
facility: City Clinical Oncology Dispensary
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Oncology Dispensary
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre
city: Singapore
country: Singapore
facility: Parkway Cancer Centre
city: Singapore
country: Singapore
facility: OncoCare Cancer Centre
city: Johannesburg
country: South Africa
facility: University of Witwatersrand Oncology
state: Gauteng
city: Cape Town
country: South Africa
facility: Rondebosch Oncology Centre, Rondebosch Medical Centre
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
state: Andalucia
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
state: Aragon
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
state: Catalunya
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran Canaria
city: Madrid
country: Spain
facility: Hospital Ramon Y Cajal
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de La Victoria
city: Basel
country: Switzerland
facility: Universitaetsspital Basel
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital (LUKS)
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Medical Foundation, Kaohsiung Branch
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital, Comprehensive Cancer Center
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation, LinKou Branch
city: Dnipropetrovsk
country: Ukraine
facility: City Multiple-Discipline Clinical Hospital #4,
city: Dnipropetrovsk
country: Ukraine
facility: City Multiple-Discipline Clinical Hospital #4
city: Dnipropetrovsk
country: Ukraine
facility: Department of Oncology and Medical Radiology, SI "DMA of MOH, Ukraine
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncologic Center/Department of Chemotherapy
city: Lviv
country: Ukraine
facility: Lviv State Oncologic Regional Treatment and Diagnostic Center
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital, Oncology Centre
state: Cambridgeshire
city: Stevenage
country: United Kingdom
facility: Lister Hospital
state: Hertfordshire
city: Welwyn Garden City
country: United Kingdom
facility: Queen Elizabeth II Hospital
state: Hertfordshire
city: Manchester
country: United Kingdom
facility: Spire Manchester Hospital
state: Lancashire
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital, Mount Vernon Cancer Centre
state: Middlesex
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde Health Board, Beatson West of Scotland Cancer Centre,
state: Scotland
city: Glasgow
country: United Kingdom
facility: Ross Hall Hospital
state: Scotland
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Manchester
country: United Kingdom
facility: The Christie Hospital NHS Foundation Trust, Department of Medical Oncology
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.