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

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

ClinicalTrials.gov Identifier: NCT01828112

Novartis Reference Number: CLDK378A2303

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Non-Small Cell Lung Cancer
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
231 participants
Start date 
Jun 28, 2013
Completion date 
Sep 09, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Ceritinib
Ceritinib is the investigational treatment and is referred to as the investigational study drug and was provided as 150 mg hard gelatin capsules for oral use. The dose was 750 mg once daily.
Drug
pemetrexed
Pemetrexed was one of the chemotherapy treatments. Pemetrexed, a reconstituted solution, was intravenously administered over 10 minutes at 500 mg/m2 every 21 days.
Drug
docetaxel
Docetaxel was one of the chemotherapy treatments. Docetaxel, a reconstituted solution, was intravenously administered over 1 hour, at 75 mg/m2 every 21 days.

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patient with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
Patient with a history of severe hypersensitivity reaction to pemetrexed or docetaxel or any known excipients of these drugs.
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.

Study Locations

United States
Highlands Oncology Group
-
Fayetteville, 72703
Arkansas
United States
Memorial Cancer Institute SC
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Hollywood, 33021
Florida
United States
Cancer Specialists of North Florida
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Jacksonville, 32256
Florida
United States
University of Miami SC
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Miami, 33136
Florida
United States
Loyola University Medical Center /Cardinal Bernardin Cancer SC
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Maywood, 60153
Illinois
United States
University of Iowa Hospitals and Clinics Comprehensive Cancer Center
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Iowa City, 52242
Iowa
United States
Massachusetts General Hospital SC-8
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Boston, 02114
Massachusetts
United States
Oklahoma Cancer Specialists and Research Institute SC-2
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Tulsa, 74136
Oklahoma
United States
Sarah Cannon Research Institute SC-5
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Nashville, 37203
Tennessee
United States
Texas Oncology-Sugarland
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Sugar Land, 77479
Texas
United States
Texas Oncology Cancer Care and Research Center
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Waco, 76712
Texas
United States
Virginia Cancer Specialists SC Virginia Cancer Specialists
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Fairfax, 22031
Virginia
United States
Swedish Cancer Institute SC-1
-
Seattle, 98104
Washington
United States
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