A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer

Inclusion Criteria

• Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Have histologically or cytologically confirmed stage IIIB (locally advanced or recurrent) or stage IV NSCLC.
• Must meet one of the following criteria:
• Have documentation of ALK rearrangement by a positive result from the Vysis ALK Break-Apart fluorescence in situ hybridization (FISH) Probe Kit or the Ventana ALK (D5F3) CDx Assay or Foundation Medicine's FoundationOne CDx.
• Have documented ALK rearrangement by a different test and be able to provide tumor sample to the central laboratory. (Note: central laboratory ALK rearrangement testing results are not required to be obtained before randomization).
• Had PD while on crizotinib, as assessed by the investigator or treating physician except for participants previously participating in the Brigatinib-2002 study (Note: crizotinib does not need to be the last therapy a participant received. The participant may have received chemotherapy as his/her last therapy).
• Treatment with crizotinib for at least 4 weeks before progression except for participants previously participating in the Brigatinib-2002 study.
• Have had no other ALK inhibitor other than crizotinib except for participants previously participating in the Brigatinib-2002 study.
• Have had no more than 2 prior regimens of systemic anticancer therapy (other than crizotinib) in the locally advanced or metastatic setting. Note: a systemic anticancer therapy regimen will be counted if it is administered for at least 1 complete cycle. A new anticancer agent used as maintenance therapy will be counted as a new regimen. Neoadjuvant or adjuvant systemic anticancer therapy will be counted as a prior regimen if disease progression/recurrence occurred within 12 months upon completion of this neoadjuvant or adjuvant therapy. (Systemic therapy followed by maintenance therapy will be considered as one regimen if the maintenance therapy consists of a drug or drugs that were used in the regimen that immediately preceded maintenance).
• Have at least 1 measurable (that is, target) lesion per RECIST v1.1.
• Have recovered from toxicities related to prior anticancer therapy to national cancer institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 grade less than or equal to ( ) 1 are allowed, if deemed irreversible).
• Have adequate organ function, at the time of initial screening, except for participants previously participating in the Brigatinib-2002 study as determined by:
• Total bilirubin =) 30 milliliter per minute (mL/min)/1.73 square meter [m^2], using the modification of diet in renal disease equation.
• Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =75*10^9 per liter [/L].
• Hemoglobin >=9 gram per deciliter (g/dL).
• Absolute neutrophil count >=1.5*10^9 / L.
• Suitable venous access for study-required blood sampling (that is, including pharmacokinetic [PK] and laboratory safety tests).

Exclusion Criteria

• Had participated in the control (crizotinib) arm of Study AP26113-13-301 (ALTA 1L) [NCT02737501].
• Had received crizotinib within 7 days before randomization.
• Have a history or presence at baseline of pulmonary interstitial disease, drug related pneumonitis, or radiation pneumonitis.
• Have uncontrolled hypertension. Participants with hypertension should be under treatment for control of blood pressure upon study entry.
• Had received systemic treatment with strong cytochrome P-450 (CYP) 3A inhibitors, moderate CYP3A inhibitors, strong CYP3A inducers, or moderate CYP3A inducers within 14 days before randomization.
• Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before randomization.
• Have been diagnosed with another primary malignancy other than NSCLC, except for adequately treated nonmelanoma skin cancer or cervical cancer in situ; definitively treated nonmetastatic prostate cancer