LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/10/2019
Start Date:June 28, 2013
End Date:May 26, 2021

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A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib

The primary purpose of the study was to compare the antitumor activity of LDK378 vs.
chemotherapy in patients previously treated with chemotherapy (platinum doublet) and
crizotinib.


Inclusion Criteria:

1. Patient has a histologically or cytologically confirmed diagnosis of non-small cell
lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as assessed by
the FDA approved Abbott FISH Test.

2. Patient has stage IIIB or IV diagnosis and must have received one or two prior
regimens (including platinum- doublet) of cytotoxic chemotherapy for the treatment of
locally advanced or metastatic NSCLC.

3. Patient has at least one measurable lesion as defined by RECIST 1.1. A previously
irradiated site lesion may only be counted as a target lesion if there is clear sign
of progression since the irradiation

4. Patients must have received previous treatment with crizotinib for the treatment of
locally advanced or metastatic NSCLC.

Exclusion Criteria:

1. Patient with known hypersensitivity to any of the excipients of LDK378
(microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and
magnesium stearate)

2. Patient with a history of severe hypersensitivity reaction to pemetrexed or docetaxel
or any known excipients of these drugs.

3. Patient with symptomatic central nervous system (CNS) metastases who is neurologically
unstable or has required increasing doses of steroids within the 2 weeks prior to
screening to manage CNS symptoms.
We found this trial at
18
sites
Boston, Massachusetts 02114
Principal Investigator: Alice Shaw
Phone: 617-724-1223
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Bruxelles,
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Fairfax, Virginia 22031
Principal Investigator: Alexander Spira
Phone: 703-208-3174
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Fairfax, VA
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Fayetteville, Arkansas 72703
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Fayetteville, AR
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Greenwood Village, CO
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1150 North 35th Avenue
Hollywood, Florida 33021
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Hollywood, FL
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Iowa City, IA
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Jacksonville, Florida 32256
Principal Investigator: Safeer Ashraf
Phone: 904-538-3667
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Jacksonville, FL
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Maywood, Illinois 60153
Principal Investigator: Kathy Albain
Phone: 708-327-3222
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Maywood, IL
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Miami, Florida 33136
Principal Investigator: Israel Wiznitzer
Phone: 305-243-4624
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Miami, FL
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Nashville, Tennessee 37203
Principal Investigator: David R. Spigel
Phone: 615-329-7274
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Nashville, TN
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San Francisco, California 94115
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San Francisco, CA
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Seattle, Washington 98104
Principal Investigator: Howard L. (Jack) West
Phone: +1 206 386 2443
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Seattle, WA
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3700 West State Route 89A
Sedona, Arizona 86336
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1350 First Colony Boulevard
Sugar Land, Texas 77479
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Tulsa, OK
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Waco, Texas 76712
Principal Investigator: Carl Chakmakjian
Phone: 254-399-0741
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Waco, TX
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Wenatchee, Washington 98801
Principal Investigator: Mitchell Garrison
Phone: 509-665-5800
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Wenatchee, WA
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