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

Gender: All
Maximum age: N/A
Minimum age: 18 Years

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.