Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)

Inclusion:

1. Histologically or cytologically confirmed diagnosis of stage IIIB (and is not a
candidate for definitive multimodality therapy) or IV ALK-positive NSCLC.

2. Patients may have received one prior treatment regimen with crizotinib (all other ALK
inhibitors are excluded).

3. Patients may have received prior chemotherapy, biologic therapy, or other
investigational agents. ALK inhibitors other than crizotinib are excluded.

4. Patient has a World Health Organization (WHO) performance status 0-2.

Exclusion:

1. Prior treatment with an ALK inhibitor other than crizotinib.

2. History of carcinomatous meningitis.

3. Presence or history of a malignant disease other than an ALK-positive advanced tumor
that has been diagnosed and/or required therapy within the past 3 years.

5. Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6
months) 6. Patient has history of interstitial lung disease or interstitial pneumonitis,
including clinically significant radiation pneumonitis (i.e., affecting activities of daily
living or requiring therapeutic intervention).

7. Patient has other severe, acute, or chronic medical conditions 8. Patient is currently
receiving treatment with warfarin sodium (Coumadin®) or any other coumarin-derivative
anticoagulants.