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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
Not Enrolling
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:


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:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




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



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