A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of advanced or recurrent (StageIIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC thatis ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test.Sufficient tumor tissue available to perform ALK IHC is required. Ventana IHCtesting will be performed at the designated central laboratory

• Life expectancy of at least 12 weeks

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2

• No history of receiving systemic treatment for advanced, recurrent (Stage IIIB notamenable for multimodality treatment) or metastatic (Stage IV) NSCLC

• Adequate hematologic function: Platelet count greater than equal to (>=) 100×10^9per liter (/L); absolute neutrophil count (ANC) >=1500 cells per microliter (cells/mcL); hemoglobin>=9.0 grams per deciliter (g/dL)

• Adequate renal function: an estimated glomerular filtration rate (eGFR) calculatedusing the Modification of Diet in Renal Disease (MDRD) formula of >=45 millilitersper minute per 1.73 square meter

• Participants must have recovered from effects of any major surgery or significanttraumatic injury at least 28 days before receiving the first dose of study treatment

• Measurable disease (by Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]) before administration of study treatment

• Previous brain or leptomeningeal metastases are allowed if the participant isasymptomatic (e.g., diagnosed incidentally at study baseline). Asymptomatic centralnervous system (CNS) lesions may be treated at the discretion of the investigator asper local clinical practice. If participant has neurological symptoms or signsbecause of CNS metastasis, the participant must complete whole-brain radiation orgamma knife irradiation treatment. In all cases, radiation treatment must becompleted >=14 days before enrollment and disease must be clinically stable

• For all females of childbearing potential, a negative serum pregnancy test resultmust be obtained within 3 days prior to starting study treatment

• For women who are not postmenopausal (>=12 months of non-therapy-induced amenorrhea)or surgically sterile (absence of ovaries and/or uterus), agreement to remainabstinent or use single or combined contraceptive methods that result in a failurerate of <1% per year during the treatment period and for at least 3 months after thelast dose of study drug. Abstinence is acceptable only if it is in line with thepreferred and usual lifestyle of the participant. Periodic abstinence (e.g.,calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are notacceptable methods of contraception. Examples of contraceptive methods with afailure rate of <1% per year include tubal ligation, male sterilization, hormonalimplants, established, proper use of combined oral or injected hormonalcontraceptives, and certain intrauterine devices. Alternatively, two methods (e.g.,two barrier methods such as a condom and a cervical cap) may be combined to achievea failure rate of <1% per year. Barrier methods must always be supplemented with theuse of a spermicide

• For men, agreement to remain abstinent or use a condom plus an additionalcontraceptive method that together result in a failure rate of <1% per year duringthe treatment period and for at least 3 months after the last dose of study drug.Abstinence is acceptable only if it is in line with the preferred and usuallifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation,symptothermal, or postovulation methods) and withdrawal are not acceptable methodsof contraception

Exclusion Criteria:

• A malignancy within the previous 3 years (other than curatively treated basal cellcarcinoma of the skin, early gastrointestinal (GI) cancer by endoscopic resection,in situ carcinoma of the cervix, or any cured cancer that is considered to have noimpact in progression-free survival (PFS) or overall survival (OS) for the currentNSCLC)

• Any GI disorder that may affect absorption of oral medications, such asmalabsorption syndrome or status post-major bowel resection

• Liver disease characterized by:

• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than (>) 3× the upper limit of normal (ULN; >=5×ULN for participants with concurrent livermetastases) confirmed on two consecutive measurements; or

• Impaired excretory function (e.g., hyperbilirubinemia), synthetic function, or otherconditions of decompensated liver disease such as coagulopathy, hepaticencephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices; or

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

• National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0Grade 3 or higher toxicities because of any previous therapy (e.g., radiotherapy) (excluding alopecia), which have not shown improvement and are strictly consideredto interfere with current study medication

• History of organ transplant

• Co-administration of anti-cancer therapies other than those administered in thisstudy

• Baseline QTc >470 ms or symptomatic bradycardia

• Administration of strong/potent cytochrome P4503A inhibitors or inducers within 14days prior to the receiving the first dose of study treatment and during treatmentwith alectinib or crizotinib

• Administration of agents with potential QT interval prolonging effects within 14days prior to receiving the first dose of study drug

• History of hypersensitivity to any of the additives in the alectinib or crizotinibdrug formulation

• Pregnant or lactating

• Known human immunodeficiency virus (HIV-positivity or acquired immunodeficiencysyndrome (AIDS)-related illness

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

• Any psychological, familial, sociological, or geographical condition thatpotentially hampers compliance with the study protocol requirements or follow-upprocedures; those conditions should be discussed with the participant before studyentry