A Study to Evaluate the Efficacy of Brigatinib (AP26113) in Participants With Anaplastic Lymphoma Kinase (ALK)-Positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib

1. Have histologically or cytologically confirmed locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) that is anaplastic lymphoma kinase (ALK+).

2. Must meet one of the following two criteria:

1. Have documented ALK rearrangement by a positive result from the Vysis® ALK Break-Apart fluorescence in situ hybridization (FISH) Probe Kit; or

2. Have documented ALK positivity by a different test and tissue available for the Vysis® FISH test. Tissue should be derived preferably from a biopsy taken after progression with crizotinib. If such a sample is not available, testing may be performed with archived tumor tissue.

3. Had progressive disease while on crizotinib, as assessed by the investigator or treating physician.

4. Have at least 1 measurable lesion per RECIST v1.1. Note: Previously irradiated lesions may not be used for target lesions, unless there is unambiguous radiological progression after radiotherapy. Brain lesions may not be used as target lesions if they were: 1) previously treated with whole brain radiation therapy (WBRT) within 3 months, or 2) previously treated by stereotactic radiosurgery (SRS) or surgical resection.

5. Recovered from toxicities related to prior anticancer therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, v4.0) grade ≤2.

6. Are a male or female participants ≥18 years old.

7. Have a life expectancy ≥3 months.

8. Have adequate organ and hematologic function, as determined by:

1. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN; ≤5 x ULN is acceptable if liver metastases are present)

2. Total serum bilirubin ≤1.5 x ULN (\<3.0 x ULN for participants with Gilbert syndrome)

3. Serum creatinine ≤1.5 x ULN

4. Serum lipase/amylase ≤1.5 x ULN

5. Absolute neutrophil count (ANC) ≥1500/µL

6. Platelets ≥75000/µL

7. Hemoglobin ≥10 g/dL

9. Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

10. Have normal QT interval on screening electrocardiogram (ECG) evaluation, defined as QT interval corrected (Fridericia) (QTcF) of ≤450 ms in males or ≤470 ms in females.

11. For female participants of childbearing potential, a negative pregnancy test must be documented prior to enrollment.

12. Female and male participants who are fertile must agree to use a highly effective form of contraception with their sexual partners throughout study participation.

13. Must provide a 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.

14. Have the willingness and ability to comply with scheduled visits and study procedures.

What this study is about