5407W-13: Novartis LDK378 NSCLC

CRC 13049: 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

Type of Study
Cancer (Oncology) - Lung
Swedish Cancer Institute
Short Description

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

Open to Enrollment
Principal Investigator
Howard (Jack) West, M.D.
Eligibility Notes
  • 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.
  • 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.
  • Must have 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
  • No known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
  • No history of severe hypersensitivity reaction to pemetrexed or docetaxel or any known excipients of these drugs.
  • No 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
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
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