A Phase I/II Study of the ALK Inhibitor CH5424802/RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer

Inclusion Criteria:

- ECOG performance status =< 2

- Confirmed of ALK-positive NSCLC by FDA approved kit

- NSCLC that has failed crizotinib treatment for Phase I and II A

- Measurable disease defined by RECIST 1.1

- Adequate hematologic, hepatic, renal function

Exclusion Criteria:

- Prior therapy with an ALK inhibitor other than crizotinib

- Brain metastases, which are symptomatic and/or requiring treatment

- History of serious cardiac dysfunction

- Clinically significant gastrointestinal abnormality that would affect the absorption
of drug

- Pregnant or a lactating woman