A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Non Small Cell Lung Cancer
  • Age: Between 18 years - 100 years
  • Gender: Male or Female
  • Other Inclusion Criteria:

    1.  Patients must have undergone complete surgical resection of their stage IB, II, or non-squamous IIIA non-small cell lung cancer, with negative margins.

     

    2.  Patients must be positive for translocation or inversion events involving the ALK gene locus

     

    3.  Patients must be registered to the ALCHEMIST-SCREEN trial prior to randomization


You may not be eligible for this study if the following are true:

  • 1.  Patients with uncontrolled intercurrent illnesses, including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance

     

    2.  Patients with known interstitial fibrosis or interstitial lung disease

     

    3.  Patients with prior treatment with crizotinib or another ALK inhibitor

     

    4.  Patients who use medications, herbals, or foods that are known potent CYP3A4 inhibitors or inducers




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