Lung Cancer E4512

April 27, 2017

Sponsor: ECOG-ACRIN Cancer Research Group

Number: E4512

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase III trial (Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely) that studies how well Crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.

Who’s eligible:

  • Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II, or non-squamous IIIA (Click here for lung cancer staging definitions) NSCLC (non-small cell lung cancer) per American Joint Committee on Cancer (AJCC) 7th edition and have had negative margins. N3 disease is not allowed; N# is the amount of lymph nodes that are involved. There must be a 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. Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization.
  • Positive for translocation (movement) or inversion (reversal) events involving the ALK gene locus/positing on the gene in the patient’s DNA (e.g. resulting in echinoderm microtubule associated protein like 4 [EML4]-ALK fusion) as determined by the Vysis Break Point fluorescence in situ hybridization (FISH) assay (testing). FISH testing provides researchers with a way to visualize and map he genetic material in an individual’s cells. Defined by an increase in the distance between 5' and 3' ALK probes or the loss of the 5' probe; this must have been performed:
    • By a local Clinical Laboratory Improvement Amendments (CLIA) certified laboratory: report must indicate the results as well as the CLIA number of the laboratory which performed the assay; tissue must be available for submission for central, retrospective confirmation of the ALK fusion status via ALCHEMIST-SCREEN (ALLIANCE A151216) OR
    • Patient registered to and the ALK fusion status performed centrally on the ALCHEMIST-SCREEN (ALLIANCE A151216)
  • This study is for patients age 18 and older

Available at: The Hospital of Central Connecticut, Hartford Hospital, Backus Hospital- Eastern Connecticut Hematology and Oncology.

Cancer Clinical Research Office