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
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This is an open-label, multicenter, single-arm, expanded access study designed to provide alectinib to participants with ALK-rearranged NSCLC after disease progression on or intolerance to prior ALK tyrosine kinase inhibitor (TKI) therapy. Participants will receive alectinib until disease progression, unacceptable toxicity, withdrawal of consent, patient or physician decision to discontinue treatment, death, alectinib becomes commercially available in the United States following approval of alectinib by the FDA, or the Sponsor decides to close the trial, whichever occurs first (approximately 15 months).
An Open Label, Multicenter, Single-Arm, Expanded Access Study of Alectinib for Patients With ALK-Rearranged Non-Small Cell Lung Cancer After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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)