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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
Objective
Primary Objective:
- To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) for patients with stage IB >= 4 cm, II and IIIA, ALK-positive non-small cell lung cancer (NSCLC) following surgical resection.
Secondary Objectives:
- To evaluate and compare disease-free survival (DFS) associated with crizotinib.
- To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting.
- To collect tumor tissue and blood specimens for future research.
Study Arms
- Experimental: Arm A (crizotinib)
- Active Comparator: Arm B (observation)
Eligibility
- Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II, or non-squamous IIIA NSCLC
- Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization
- Positive for translocation or inversion events involving the ALK gene locus (e.g. resulting in echinoderm microtubule associated protein like 4 [EML4]-ALK fusion)
- Patients must NOT have uncontrolled intercurrent illness 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 with study requirements
- No known interstitial fibrosis or interstitial lung disease
- No prior treatment with crizotinib or another ALK inhibitor
- No ongoing cardiac dysrhythmias of grade >= 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, uncontrolled atrial fibrillation (any grade), or corrected QT (QTc) interval > 470 msec
- No use of medications, herbals, or foods that are known potent cytochrome P450, subfamily 3A, polypeptide 4 (CYP3A4) inhibitors or inducers, included but not limited to those outlined
- Patients must be adequately recovered from surgery at the time of randomization
NCT ID
NCT02201992
