ECOG 4512: 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.

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ECOG 4512: 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.

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
Crizotinib/Placebo
Principal Investigator: Joseph Aisner
Research Nurse: Jennifer Bryan
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions: Rutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@cinj.rutgers.edu.

 

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