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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

Last Updated: 2017-11-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

343 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-13

Study Completion Date

2016-11-30

Brief Summary

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

Detailed Description

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Conditions

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Non Squamous Lung Cancer

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

treatment

Intervention Type DRUG

crizotinib 250mg orally continuous twice daily dosing

B

Group Type ACTIVE_COMPARATOR

treatment

Intervention Type DRUG

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

Interventions

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treatment

crizotinib 250mg orally continuous twice daily dosing

Intervention Type DRUG

treatment

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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University of Washington Medical Center

Seattle, Washington, United States

Site Status

Tower Cancer Research Foundation

Beverly Hills, California, United States

Site Status

Tower Hematology Oncology Medical Group

Beverly Hills, California, United States

Site Status

CCTAP

Fontana, California, United States

Site Status

Loma Linda University Cancer Center

Loma Linda, California, United States

Site Status

Loma Linda University Cancer Center (LLUCC)-Schuman Pavilion

Loma Linda, California, United States

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Loma Linda University Medical Center

Loma Linda, California, United States

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CCTAP

Los Angeles, California, United States

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Kaiser Permanente Southern California

San Diego, California, United States

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CCTAP

San Diego, California, United States

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Georgetown University Hospital

Washington D.C., District of Columbia, United States

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Research Pharmacy, Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

Lynn Cancer Institute Center for Hematology Oncology

Boca Raton, Florida, United States

Site Status

Florida Hospital

Orlando, Florida, United States

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Cancer Institute of Florida

Orlando, Florida, United States

Site Status

Investigational Drug Services

Orlando, Florida, United States

Site Status

Georgia Cancer Specialists

Athens, Georgia, United States

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Georgia Cancer Specialists

Atlanta, Georgia, United States

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Georgia Cancer Specialists

Decatur, Georgia, United States

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Georgia Cancer Specialists

Macon, Georgia, United States

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Georgia Cancer Specialists

Marietta, Georgia, United States

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Georgia Cancer Specialists

Sandy Springs, Georgia, United States

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University of Chicago

Chicago, Illinois, United States

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Al Fisher, Pharm D.

Harvey, Illinois, United States

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Ingalls Memorial Hospital

Harvey, Illinois, United States

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Monroe Medical Associates

Harvey, Illinois, United States

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Monroe Medical Associates

Tinley Park, Illinois, United States

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Indiana University Hospital

Indianapolis, Indiana, United States

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Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

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Lois and Eskenazi Hospital

Indianapolis, Indiana, United States

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Monroe Medical Association

Munster, Indiana, United States

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The Community Hospital

Munster, Indiana, United States

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Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

Maine Center for Cancer Medicine

Biddeford, Maine, United States

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Maine Center for Cancer Medicine

Brunswick, Maine, United States

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Maine Center for Cancer Medicine

Sanford, Maine, United States

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Maine Center for Cancer Medicine

Scarborough, Maine, United States

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Kresge Eye Institute

Bingham Farms, Michigan, United States

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Karmanos Cancer Institute

Detroit, Michigan, United States

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Kresge Eye Institute

Detroit, Michigan, United States

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Karmanos Cancer Institute at Farmington Hills

Farmington Hills, Michigan, United States

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Siteman Cancer Center

City of Saint Peters, Missouri, United States

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Siteman Cancer Center - West County

Creve Coeur, Missouri, United States

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Barnes-Jewish Hospital

St Louis, Missouri, United States

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Washington University Center for Advanced Medicine Infusion Center Pharmacy

St Louis, Missouri, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Hematology-Oncology Associates of Northern New Jersey

Morristown, New Jersey, United States

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University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

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UNM Eye Clinic

Albuquerque, New Mexico, United States

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Memorial Medical Center

Las Cruces, New Mexico, United States

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NSLIJ Health System/Monter Cancer Center

Lake Success, New York, United States

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North Shore University Hospital

Manhasset, New York, United States

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Long Island Jewish Medical Center

New Hyde Park, New York, United States

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SUNY Upstate Medical University

Syracuse, New York, United States

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OHSU Knight Cancer Institute

Beaverton, Oregon, United States

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OHSU Knight Cancer Institute

Gresham, Oregon, United States

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OHSU Knight Cancer Institute

Portland, Oregon, United States

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OHSU Knight Cancer Institute

Portland, Oregon, United States

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Oregon Health and Science University

Portland, Oregon, United States

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OHSU Knight Cancer Institute

Tualatin, Oregon, United States

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Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

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Vincent Armenio

East Providence, Rhode Island, United States

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Pharma Resource

East Providence, Rhode Island, United States

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Tennessee Oncology, PLLC

Dickson, Tennessee, United States

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Tennessee Oncology, PLLC

Franklin, Tennessee, United States

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Tennessee Oncology, PLLC

Gallatin, Tennessee, United States

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Tennessee Oncology, PLLC

Hermitage, Tennessee, United States

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Tennessee Oncology, PLLC

Lebanon, Tennessee, United States

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