COVID-19 Vaccine Update: We are now offering WALK-IN vaccinations at our Paramus Vaccination Center and at the Wellness & Walk-In Care Center at the Garden State Plaza for those ages 16 and older who live, work, or go to school in NJ. We are also offering vaccines at both locations, by appointment, to those ages 12-15 years old. Click here for more information and to make an appointment.Read More
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
- 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.
- 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.
- Experimental: Arm A (crizotinib)
- Active Comparator: Arm B (observation)
- 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