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Trial Summary

Protocol No.E4512
StatusOPEN TO ACCRUAL
Principal InvestigatorJalal, Shadia
ScopeNational
PhasePhase III
Age GroupAdult
TitleA 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
DescriptionThis randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called ALK. Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Tumors with this mutation may respond to treatments that target the mutation, such as crizotinib. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. It is not yet known if crizotinib may be an effective treatment for treating non-small cell lung cancer with an ALK fusion mutation.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II, or IIIA NSCLC per American Joint Committee on Cancer (AJCC) 7th edition and have had negative margins; N3 disease is not allowed
  • Baseline chest computed tomography (CT) must be performed within 3 months (90 days) prior to randomization to ensure no evidence of disease; if clinically indicated additional imaging studies must be performed to rule out metastatic disease
For a full list of participation criteria, please visit ClinicalTrials.gov.
Applicable Disease SitesLung Cancer, Non-Small Cell
Participating InstitutionsIndiana University (IU)
  • Eskenazi Hospital
  • Indiana University Hospital / IU Simon Cancer Center
Roudebush VA Medical Center
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632
    Email: iutrials@iu.edu