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

Exclusion Criteria

• •1. Had participated in the control (crizotinib) arm of Study AP26113-13-301 (ALTA 1L) \[NCT02737501\].
• •2. Had received crizotinib within 7 days before randomization.
• •3. Have a history or presence at baseline of pulmonary interstitial disease, drug related pneumonitis, or radiation pneumonitis.
• •4. Have uncontrolled hypertension. Participants with hypertension should be under treatment for control of blood pressure upon study entry.
• •5. 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.
• •6. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before randomization.
• •7. 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; 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.
• •8. Had received chemotherapy or radiation therapy within 14 days before randomization except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.
• •9. Had received antineoplastic monoclonal antibodies within 30 days of randomization.
• •10. Had major surgery within 30 days of randomization. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.
• •11. Have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening (participants with asymptomatic brain metastases or participants who have stable symptoms and did not require an increased dose of corticosteroids to control symptoms within 7 days before randomization will be enrolled). Note: If a participant has worsening neurological symptoms or signs due to CNS metastasis, the participant needs to complete local therapy and be neurologically stable (with no requirement for an increasing dose of corticosteroids or use of anticonvulsants) for 7 days before randomization.
• •12. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed.
• •13. Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to the following:
• •* Myocardial infarction within 6 months before randomization.
• •* Unstable angina within 6 months before randomization.
• •* New York Heart Association Class III or IV heart failure within 6 months before randomization.
• •* History of clinically significant atrial arrhythmia (including clinically significant bradyarrhythmia), as determined by the treating physician.
• •* Any history of clinically significant ventricular arrhythmia.
• •14. Had cerebrovascular accident or transient ischemic attack within 6 months before first dose of study drug.
• •15. Have malabsorption syndrome or other gastrointestinal illness or condition that could affect oral absorption of the study drug.
• •16. Have an ongoing or active infection, including but not limited to, the requirement for intravenous antibiotics.
• •17. Have a known history of human immunodeficiency virus (HIV) infection. Testing is not required in the absence of history.
• •18. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection. Testing is not required in the absence of history.
• •19. Any serious medical condition or psychiatric illness that could, in the investigator's opinion, potentially compromise participant safety or interfere with the completion of treatment according to this protocol.
• •20. Have a known or suspected hypersensitivity to brigatinib or alectinib or their excipients.
• •21. Life-threatening illness unrelated to cancer.
• •22. Female participants who are lactating and breastfeeding.
• •23. Admission or evidence of illicit drug use, drug abuse, or alcohol abuse.