Expanded Access Study of Alectinib for Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy

This is an expanded access trial for Non-Small Cell Lung Cancer Read More

Inclusion Criteria:

• Participants with locally advanced (American Joint Committee on Cancer [AJCC] Stage IIIB) not amenable to curative therapy or metastatic (AJCC Stage IV) NSCLC
• Life expectancy of at least 12 weeks
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-3
• Histologically confirmed NSCLC
• Documented ALK rearrangement as assessed by approved fluorescence in situ hybridization (FISH) test, using the Vysis ALK Break Apart FISH Probe Kit or the Ventana immunohistochemistry (IHC) test
• After disease progression on or intolerance to prior ALK TKI therapy: 1) participants need to have a minimum washout period of at least 5 half-lives between the last dose of ALK TKI therapy or other targeted therapies and the first dose of study treatment; 2) participants must have recovered from treatment toxicities to less than or equal to (</=) Grade 1 or to their pretreatment levels (for participants who have developed interstitial lung disease [ILD], they must have fully recovered); 3) participants can either be chemotherapy-naïve or have received at least one line of platinum-based chemotherapy for locally advanced or metastatic disease
• Recovery from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment
• Adequate hematological and renal function
• Agreement to use highly effective methods of contraception per protocol definitions

Exclusion Criteria:

• Prior therapy with alectinib
• Participants with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids within 1 week prior to Day 1 to manage CNS symptoms
• Administration of strong/potent cytochrome P450 3A (CYP3A) inhibitors or inducers, or agents with potential QT prolonging effects within 14 days prior to first administration of study drug
• Participants with liver disease
• Any clinically significant concomitant disease or condition that could interfere with the conduct of the study
• Active or uncontrolled infectious diseases requiring treatment
• History of organ transplant
• Participants with baseline QTc > 470 milliseconds (ms) or participants with symptomatic bradycardia
• Pregnant or lactating, or intending to become pregnant during the study
• History of hypersensitivity to any of the additives in alectinib formulation
• Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the participants before trial entry
• Serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV)