A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/23/2019
Start Date:August 19, 2014
End Date:January 21, 2020

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Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer

This randomized, active controlled, multicenter phase III open-label study is designed to
evaluate the efficacy and safety of alectinib compared with crizotinib treatment in
participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced
non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive
either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally
BID. Participants will receive treatment until disease progression, unacceptable toxicity,
consent withdrawal or death. The study is expected to last approximately 42 months.


Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage
IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is
ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test

- Life expectancy of at least 12 weeks

- Eastern cooperative oncology group performance status (ECOG PS) of 0-2

- Participants with no prior systemic treatment for advanced or recurrent (Stage IIIB
not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC

- Adequate renal, and hematologic function

- Participants must have recovered from effects of any major surgery or significant
traumatic injury at least 28 days before the first dose of study treatment

- Measurable disease by response evaluation criteria in solid tumors (RECIST) version
1.1 (v1.1) prior to the administration of study treatment

- Prior brain or leptomeningeal metastases allowed if asymptomatic (e.g., diagnosed
incidentally at study baseline)

- Negative pregnancy test for all females of child bearing potential

- Use of highly effective contraception as defined by the study protocol

Exclusion Criteria:

- Participants with a previous malignancy within the past 3 years

- Any gastrointestinal (GI) disorder or liver disease

- National cancer institute common terminology criteria for adverse events (NCI CTCAE)
(version 4.0) Grade 3 or higher toxicities due to any prior therapy (e.g.,
radiotherapy) (excluding alopecia)

- History of organ transplant

- Co-administration of anti-cancer therapies other than those administered in this study

- Participants with baseline QTc greater than (>) 470 milliseconds or symptomatic
bradycardia

- Recipient of strong/potent cytochrome P4503A inhibitors or inducers within 14 days
prior to the first dose until the end of study treatment

- Recipient of any drug with potential QT interval prolonging effects within 14 days
prior to the first dose for all participants and while on treatment through the end of
the study for crizotinib-treated participants only

- History of hypersensitivity to any of the additives in the alectinib and crizotinib
drug formulation

- Pregnancy or lactation

- Any clinically significant disease or condition (or history of) that could interfere
with, or for which the treatment might interfere with, the conduct of the study or the
absorption of oral medications or that would, in the opinion of the principal
investigator, pose an unacceptable risk to the participant in this study

- Any psychological, familial, sociological, or geographical condition potentially
hampering compliance with the study protocol requirements and/or follow-up procedures;
those conditions should be discussed with the participant before trial entry
We found this trial at
35
sites
555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Aurora, Colorado 80045
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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801 Ostrum St
Bethlehem, Pennsylvania 18015
(484) 526-4000
St Luke'S Hospital And Health Network St. Luke's University Health Network (SLUHN) is a nonprofit,...
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Massachusetts General Hospital Cancer Center An integral part of one of the world
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330 Brookline Avenue
Boston, Massachusetts 02215
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450 Brookline Avenue
Boston, Massachusetts 02215
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Bronx, New York 10461
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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370 Victoria Street
Darlinghurst, New South Wales 2010
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Deerfield Beach, Florida 33442
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Detroit, Michigan 48201
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Detroit, Michigan 48202
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2151 North Harbor Boulevard
Fullerton, California 92835
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Gilbert, Arizona 85234
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Grand Junction, Colorado 81501
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Hershey, Pennsylvania 17033
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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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3855 Health Sciences Drive
La Jolla, California 92093
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7445 Peak Drive
Las Vegas, Nevada 89128
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701 East 28th Street
Long Beach, California 90806
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Louisville, Kentucky 40207
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Marietta, Georgia 30060
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Northridge, CA
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Orlando, Florida 32804
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3501 Johnson Street
Pembroke Pines, Florida 33028
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Phoenix, Arizona 85054
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5115 Centre Avenue
Pittsburgh, Pennsylvania 15232
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Redondo Beach, California 90277
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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1600 Divisadero Street
San Francisco, California 94115
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