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Protocol No. E4512

Principal Investigator Leal, Ticiana

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title 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 (ALCHEMIST)

Objective The purpose of this research study is to compare any good and bad effects of using the study drug, crizotinib (also known as XALKORI®), after completion of surgery and, in some cases, after chemotherapy and/or radiation therapy for ALK-positive non-small cell lung cancer .The addition of crizotinib may help prevent your cancer from returning, but it could also cause side effects. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.

Treatment The study drug crizotinib is a potent and selective ATP-competitive inhibitor. It is already FDA-approved for use in ALK-positive locally advanced or metastatic (spread to other areas of the body) non-small lung cancer. The use of crizotinib in this study is investigational (not approved by the FDA) because crizotinib will be prescribed for earlier stage disease after the cancer has been surgically removed.

Description A computer will by chance assign you to treatment groups in the research study. You will have an equal (50%) chance of being placed in either group. Group 1 will receive the study drug, crizotinib. Group 2 will be monitored with standard post-operative follow up treatment. Click here for more info

Key Eligibility
  • Patients must have undergone complete surgical resection of their stage IB (≥ 4 cm), II, or non-squamous IIIA NSCLC and have had negative margin
  • N3 disease is not allowed
  • Baseline Chest CT with or without contrast must be performed within 6 months (180 days) prior to randomization to ensure no evidence of disease
  • Positive for translocation or inversion events involving the ALK gene locus
  • Women must not be pregnant or breast-feeding
  • No known interstitial fibrosis or interstitial lung disease
  • No prior treatment with crizotinib or another ALK inhibitor
  • Patients must have completed any prior adjuvant chemotherapy or radiation therapy 2 or more weeks prior to randomization and be adequately recovered at the time of randomization
  • Patients must not have any history of cancer within 5 years from randomization, with the exception of in-situ carcinomas and non-melanoma skin cancer

Applicable Disease Sites Lung

Therapies Involved Cytotoxic Chemotherapy; Not Applicable; Other

Drugs Involved crizotinib; placebo

Status Open

Participating Institutions Aspirus UW Cancer Center (formerly Riverview Hospital); Aspirus Wausau Hospital, Aspirus Regional Cancer Center; Johnson Creek, UW Cancer Center; Langlade Memorial Hospital, Aspirus Regional Cancer Ctr; Swedish American Hospital, Rockford ; UW Hospital and Clinics; UWCCC 1 South Park