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ECOG 4512: A Randomized Phase III Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein.

Primary objective:
To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) over placebo for patients with stage IB ? 4cm, II and IIIA, ALK-positive NSCLC following surgical resection.

Secondary objectives:
1. To evaluate and compare disease-free survival (DFS) associated with crizotinib and placebo
2. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting
3. To collect tumor tissue and blood specimens for future research.

Protocol Number: 031502
Phase: Phase III
Applicable Disease Sites: Lung
Drugs Involved: Crizotinib
Principal Investigator: Joseph Aisner M.D.
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions:
  • RWJBarnabas Health
    • Community Medical Center
    • Monmouth Medical Center
    • Newark Beth Israel Medical Center
    • Robert Wood Johnson University Hospital, Hamilton
    • Robert Wood Johnson University Hospital, Somerset
    • Saint Barnabas Medical Center, Livingston
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.