Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
