Expanded Access Study of Alectinib for Patients With ALK-Rearranged Non-Small Cell Lung Cancer After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy

Inclusion Criteria:

- Patients with locally advanced (American Joint Committee on Cancer [AJCC] Stage IIIB)
not amenable to curative therapy or metastatic (AJCC Stage IV) NSCLC

- Life expectancy of at least 12 weeks

- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-3

- Histologically confirmed NSCLC

- Documented ALK rearrangement as assessed by approved fluorescence in situ
hybridization (FISH) test, using the Vysis ALK Break Apart FISH Probe Kit or the
Ventana immunohistochemistry (IHC) test

- After disease progression on or intolerance to prior ALK TKI therapy:

- Patients need to have a minimum washout period of at least 5 half-lives between the
last dose of ALK TKI therapy or other targeted therapies and the first dose of study
treatment

- Patients must have recovered from treatment toxicities to pretreatment levels (for patients who have developed ILD, they must have fully
recovered).

- Patients can either be chemotherapy-naïve or have received at least one line of
platinum-based chemotherapy for locally advanced or metastatic disease

- Recovery from effects of any major surgery or significant traumatic injury at least
28 days before the first dose of study treatment

- Adequate hematological and renal function

- Agreement to use highly effective methods of contraception per protocol definitions

Exclusion Criteria:

- Prior therapy with alectinib

- Patients with symptomatic central nervous system (CNS) metastases who are
neurologically unstable or require increasing doses of steroids within 1 week prior
to Day 1 to manage CNS symptoms:

- Patients with brain or leptomeningeal metastases are allowed

- Symptomatic disease is allowed as long as symptoms are controlled and stable

- Prior treatment with whole brain radiation or gamma knife must have been completed at
least 14 days prior to Day 1 and patients must be clinically stable

- Administration of strong/potent cytochrome P450 3A (CYP3A) inhibitors or inducers,
except for oral corticosteroids up to 20 mg prednisolone equivalent per day, or
agents with potential QT prolonging effects within 14 days prior to first
administration of study drug

- Liver disease characterized by:

- Alanine transaminase (ALT) or aspartate aminotransferase (AST) > 3× upper limit of
normal (ULN) (>/= 5×ULN for patients with concurrent liver metastasis) confirmed on
two consecutive measurements OR

- Impaired excretory function (e.g., hyperbilirubinemia) or synthetic function or other
conditions of decompensated liver disease such as coagulopathy, hepatic
encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices OR

- Acute viral or active autoimmune, alcoholic, or other types of hepatitis

- Any clinically significant concomitant disease or condition that could interfere
with, or for which the treatment might interfere with, the conduct of the study or
the absorption of oral medications or that would, in the opinion of the investigator,
pose an unacceptable risk to the patient in this study

- Active or uncontrolled infectious diseases requiring treatment

- History of organ transplant

- Patients with baseline QTc > 470 ms or patients with symptomatic bradycardia

- Pregnant or lactating, or intending to become pregnant during the study

- History of hypersensitivity to any of the additives in alectinib formulation

- Any psychological, familial, sociological, or geographical condition potentially
hampering compliance with the study protocol requirements and/or follow-up
procedures; those conditions should be discussed with the patient before trial entry

- Serious, uncontrolled infections or current known infection with HIV