ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants

Inclusion Criteria

• Have histologically or cytologically confirmed stage IIIB (and not a candidate for definitive multimodality therapy) or stage four (IV) NSCLC.
• Must have documented ALK rearrangement.
• Have sufficient tumor tissue available for central analysis.
• Have at least 1 measurable (that is, target) lesion per RECIST v1.1.
• Recovered from toxicities related to prior anticancer therapy to National Cancer Institute (of the United States) (NCI) Common Terminology Criteria for Adverse Events (version 4.0) (CTCAE v 4.0) grade be less than or equal to ( =)18 years old.
• Have adequate organ function, as defined by the study protocol.
• Have Eastern Cooperative Oncology Group (ECOG) performance status <=2.
• Have normal QT interval on screening ECG evaluation, defined as QT interval corrected (Fridericia) (QTcF) of <= 450 millisecond (msec) in males or <=470 msec in females.
• For female participants of childbearing potential, have a negative pregnancy test documented prior to randomization.
• For female and male participants who are fertile, agree to use a highly effective form of contraception, as defined by the study protocol.
• Provide signed and dated informed consent indicating that the participants has been informed of all pertinent aspects of the study, including the potential risks, and is willingly participating.
• Have the willingness and ability to comply with scheduled visit and study procedures.

Exclusion Criteria

• Previously received an investigational antineoplastic agent for NSCLC.
• Previously received any prior tyrosine kinase inhibitor (TKI), including ALK-targeted TKIs.
• Previously received more than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease.
• Received chemotherapy or radiation within 14 days of first dose of study drug, except stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT).
• Received anti-neoplastic monoclonal antibodies within 30 days of the first dose of study drug.
• Had major surgery within 30 days of the first dose of study drug, minor surgical procedures such as catheter placement or minimally invasive biopsies are allowed.
• Have been diagnosed with another primary malignancy other than NSCLC, except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or participants with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.
• Have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days prior to randomization.
• Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed.
• Be pregnant, planning a pregnancy, or breastfeeding.
• Have significant, uncontrolled, or active cardiovascular disease, as defined by the study protocol.
• Have uncontrolled hypertension.
• Have a history or the presence at baseline of pulmonary interstitial disease, drug-related pneumonitis, or radiation pneumonitis.
• Have an ongoing or active infection.
• Have a known history of human immunodeficiency virus (HIV) infection.
• Have a known or suspected hypersensitivity to brigatinib or its excipients and/or crizotinib or its excipients.
• Have malabsorption syndrome or other gastrointestinal (GI) illness or condition.
• Have any condition or illness that, in the opinion of the investigator, would compromise participant's safety or interfere with the evaluation of the study drug.