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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

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


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 Abbott FISH Test.

2. Patient has stage IIIB or IV diagnosis and must have received previous treatment with
crizotinib and one regimen of platinum doublet, 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

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

PFS which is defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.

Outcome Time Frame:

Month 18

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

CLDK378A2303

NCT ID:

NCT01828112

Start Date:

June 2013

Completion Date:

July 2017

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer
  • ALK
  • LDK378
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

St. Francis Hospital and Medical CenterHartford, Connecticut  06105
Columbia University Medical CenterNew York, New York  10032
US Oncology Central MonitoringDallas, Texas  75246
Fox Chase Cancer Center Fox Chase Cancer (2)Philadelphia, Pennsylvania  19111-2497
University of Colorado Univ COAurora, Colorado  80045
Henry Ford Hospital Dept. of Henry Ford HospitalDetroit, Michigan  48202-2689
University of Miami SCMiami, Florida  33136
Aurora Advanced Healthcare SCMilwaukee, Wisconsin  53215
University of Chicago Medical Center SCChicago, Illinois  60546
Memorial Cancer Institute Dept of OncologyPembroke Pines, Florida  33028
Cancer Center of Kansas Dept of CCKWichita, Kansas  67214-3728
Highlands Oncology Group SCFayetteville, Arkansas  72703
University of Iowa Hospitals & Clinics OncologyIowa City, Iowa  52242
Mercy Medical Research Institute SC-1Manchester, Missouri  63021
Mayo Clinic - Arizona SC*see Various Departments*, Arizona  
Bay Area Cancer Research SCConcord, California  94520
City of Hope National Medical Center SC-3Duarte, California  91010-3000
University of California at Los Angeles SC-7Los Angeles, California  90095
The Angeles Clinic and Research Institute SCLos Angeles, California  90025
University of California San Francisco Dept. of UCSFSan Francisco, California  94101
Rocky Mountain Cancer Centers RMCC - LoneTree (Sky Ridge)Greenwood Village, Colorado  
Georgetown University/Lombardi Cancer Center Dept of OncologyWashington, District of Columbia  20007-2197
Loyola University Medical Center /Cardinal Bernardin Cancer SCMaywood, Illinois  60153
Indiana University Health Goshen Center for Cancer SCIndianapolis, Indiana  46202
University of Maryland Medical Center SC -1Baltimore, Maryland  21201
Massachusetts General Hospital SC-8Boston, Massachusetts  02114
University of Michigan Comprehensive Cancer Center Dept of OncAnn Arbor, Michigan  48109-0944
Arena Oncology Associates, PC Clinical Research AllianceLake Success, New York  11042
North Shore University Hospital Dept of OncologyManhasset, New York  10030
University of Rochester MC / James P. Wilmot Cancer Center Rochester M.C. JP Wimot C Ctr.Rochester, New York  14642
Levine Cancer Institute Dept of OncologyCharlotte, North Carolina  28203
Ohio State Comprehensive Cancer Center/James Cancer Hospital SC-3Columbus, Ohio  43210
Providence Cancer Center SCPortland, Oregon  97213
Memorial Hospital of Rhode Island SCPawtucket, Rhode Island  02860
Avera Research Institute SCSioux Falls, South Dakota  57105
Sarah Cannon Research Institute SC-5Nashville, Tennessee  37203
Vanderbilt University Medical Center SC - 7Nashville, Tennessee  37232
Fairfax Northern Virginia Hematology Oncology SC Virginia Cancer SpecialistsFairfax, Virginia  22031
Swedish Cancer Institute SC-1Seattle, Washington  98104
Medical College of Wisconsin SCMilwaukee, Wisconsin  53226