A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Alectinib; Crizotinib
Intervention description: Participants will receive alectinib 600 mg orally (four 150 mg capsules) BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.; Participants will receive crizotinib 250 mg capsules orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Intervention MeSH terms: Crizotinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 303.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, active controlled, multicenter phase III open-label study is designed to
      evaluate the efficacy and safety of alectinib compared with crizotinib treatment in
      participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced
      non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive
      either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally
      BID. Participants will receive treatment until disease progression, unacceptable toxicity,
      withdrawal of consent, or death. The study is expected to last approximately 144 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage
             IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is
             ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test

          -  Life expectancy of at least 12 weeks

          -  Eastern cooperative oncology group performance status (ECOG PS) of 0-2

          -  Participants with no prior systemic treatment for advanced or recurrent (Stage IIIB
             not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC

          -  Adequate renal, and hematologic function

          -  Participants must have recovered from effects of any major surgery or significant
             traumatic injury at least 28 days before the first dose of study treatment

          -  Measurable disease by response evaluation criteria in solid tumors (RECIST) version
             1.1 (v1.1) prior to the administration of study treatment

          -  Prior brain or leptomeningeal metastases allowed if asymptomatic (e.g., diagnosed
             incidentally at study baseline)

          -  Negative pregnancy test for all females of child bearing potential

          -  Use of highly effective contraception as defined by the study protocol

        Exclusion Criteria:

          -  Participants with a previous malignancy within the past 3 years

          -  Any gastrointestinal (GI) disorder or liver disease

          -  National cancer institute common terminology criteria for adverse events (NCI CTCAE)
             (version 4.0) Grade 3 or higher toxicities due to any prior therapy (e.g.,
             radiotherapy) (excluding alopecia)

          -  History of organ transplant

          -  Co-administration of anti-cancer therapies other than those administered in this study

          -  Participants with baseline QTc greater than (>) 470 milliseconds or symptomatic
             bradycardia

          -  Recipient of strong/potent cytochrome P4503A inhibitors or inducers within 14 days
             prior to the first dose until the end of study treatment

          -  Recipient of any drug with potential QT interval prolonging effects within 14 days
             prior to the first dose for all participants and while on treatment through the end of
             the study for crizotinib-treated participants only

          -  History of hypersensitivity to any of the additives in the alectinib and crizotinib
             drug formulation

          -  Pregnancy or lactation

          -  Any clinically significant disease or condition (or history of) that could interfere
             with, or for which the treatment might interfere with, the conduct of the study or the
             absorption of oral medications or that would, in the opinion of the principal
             investigator, pose an unacceptable risk to the participant in this study

          -  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 participant before trial entry