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



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2011
End Date:August 2016

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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.


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
We found this trial at
89
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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550 University Boulevard
Indianapolis, Indiana 46202
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Albuquerque, New Mexico 87106
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Athens, Georgia 30606
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Atlanta, Georgia 30341
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Beaverton, Oregon 97006
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Beverly Hills, California 90211
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Biddeford, Maine 04005
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Bingham Farms, Michigan 48205
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Campbelltown, New South Wales 2560
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Creve Coeur, Missouri 63141
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Decatur, Georgia 30033
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Detroit, Michigan 48201
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Dickson, Tennessee 37055
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East Providence, Rhode Island 02915
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Farmington Hills, Michigan 48334
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Fontana, California 92335
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Franklin, Tennessee 37067
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Gresham, Oregon 97030
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Harvey, Illinois 60426
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Harvey, Illinois 60426
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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Hermitage, Tennessee 37076
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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Indianapolis, Indiana 46202
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Lake Success, New York 11042
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Las Cruces, New Mexico 88011
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Lebanon, Tennessee 37087
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
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Loma Linda, California 92350
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Los Angeles, California 90034
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Macon, Georgia 31217
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
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Marietta, Georgia 30060
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Munster, Indiana 46321
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Murfreesboro, Tennessee 37130
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
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Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
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Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Nashville, Tennessee 37232
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
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270-05 76th Ave
New Hyde Park, New York 11040
(718) 470-7480
Long Island Jewish Medical Center Serving North Shore LIJ Health System employees and their families....
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New Orleans, Louisiana 70121
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
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Orlando, Florida 32804
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Philadelphia, Pennsylvania 19111
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3181 S.W. Sam Jackson Park Road
Portland, Oregon 97239
503 494-7999
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3181 S.W. Sam Jackson Park Road
Portland, Oregon 97239
503 494-7999
OHSU Knight Cancer Institute OHSU Knight Cancer Institute is known worldwide for our contributions to...
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San Diego, California 92120
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Sanford, Maine 04073
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Smyrna, Tennessee 37167
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1 Barnes Jewish Hospital Plaza
St. Louis, Missouri 63110
(314) 747-3000
Barnes Jewish Hospital Barnes-Jewish Hospital at Washington University Medical Center is the largest hospital in...
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St. Peters, Missouri 63376
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750 East Adams Street
Syracuse, New York 13210
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Tinley Park, Illinois 60477
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Tualatin, Oregon 97062
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
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