Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Alectinib; Docetaxel; Pemetrexed
Intervention description: Participants will receive oral alectinib at a dose of 600 mg twice daily, taken with food until disease progression, unacceptable toxicity, withdrawal of consent or death.; Participants will receive docetaxel at a dose of 75 mg/m^2 of body surface area intravenously every 3 weeks, until disease progression, unacceptable toxicity, withdrawal of consent or death.; Participants will receive pemetrexed at a dose of 500 mg/m^2 of body surface area intravenously every 3 weeks, until disease progression, unacceptable toxicity, withdrawal of consent or death.
Intervention MeSH terms: Docetaxel; Pemetrexed
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized active-controlled multicenter Phase III open-label study will evaluate and
      compare between treatment groups the efficacy of alectinib versus chemotherapy in
      participants with ALK-positive advanced NSCLC who were previously treated with chemotherapy
      and crizotinib, as measured by investigator-assessed progression-free survival (PFS) and to
      evaluate and compare between treatment groups the central nervous system (CNS) objective
      response rate (C-ORR) in participants with measurable CNS metastases at baseline, as assessed
      by an Independent Review Committee (IRC).
    

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. ALK positivity must have been determined by a validated fluorescence in
             situ hybridization (FISH) test (recommended probe, Vysis ALK Break-Apart Probe) or a
             validated immunohistochemistry (IHC) test (recommended antibody, clone D5F3)

          -  Participant had received two prior systemic lines of therapy, which must have included
             one line of platinum-based chemotherapy and one line of crizotinib

          -  Prior CNS or leptomeningeal metastases allowed if asymptomatic

          -  Participants with symptomatic CNS metastases for whom radiotherapy is not an option
             will be allowed to participate in this study

          -  Measurable disease by RECIST Version 1.1 prior to the administration of study
             treatment

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

          -  For all females of childbearing potential, a negative pregnancy test must be obtained
             within 3 days before starting study treatment

        Exclusion Criteria:

          -  Participants with a previous malignancy within the past 3 years are excluded (other
             than curatively treated basal cell carcinoma of the skin, early gastrointestinal [GI]
             cancer by endoscopic resection or in situ carcinoma of the cervix)

          -  Participants who have received any previous ALK inhibitor other than crizotinib

          -  Any GI disorder that may affect absorption of oral medications