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.
This research study is led by Dr. John McCann.
Contact: Katie Colbeck, 413-794-9875
July 28, 2014
Cancer - Lung
D'Amour Center for Cancer Care, 3350 Main Street, Springfield, MA 01199
- Baseline chest computed tomography (CT) with or without contrast must be performed within 6 months (180 days) prior to randomization to ensure no evidence of disease; if clinically indicated additional imaging studies must be performed to rule out metastatic disease
- All females of childbearing potential must have a blood or urine pregnancy test within 72 hours prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Women of childbearing potential and sexually active males must be strongly advised to practice abstinence or use an accepted and effective method of contraception
- Patients must be adequately recovered from surgery at the time of randomization
- The minimum time requirement between date of surgery and randomization must be at least 4 weeks (28 days)
- Known interstitial fibrosis or interstitial lung disease
- Prior treatment with crizotinib or another ALK inhibitor
- History of locally advanced or metastatic cancer requiring systemic therapy within 5 years from randomization, with the exception of in-situ carcinomas and non-melanoma skin cancer; patients must have no previous primary lung cancer diagnosed concurrently or within the past 2 years
- Patients with 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
- Women who are pregnant or breast-feeding
Interventional (Clinical Trial)