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Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 168 to confirmed 166
    • Study sites: 1619 to 1618
    v16
  2. Re-verified, no change to tracked fieldsv15
  3. Start date: Aug 18, 2014 to Mar 23, 2015v14
  4. Study sites: 1604 to 1619v13
  5. Study sites: 1498 to 1604v12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary completion date: May 1, 2022 to May 1, 2036
    • Study completion date: May 1, 2036
    v11
  2. Study sites: 1431 to 1498v10
  3. Study sites: 1289 to 1431v9
  4. Re-verified, no change to tracked fieldsv8
  5. Enrollment target: 378 to 168v7
  6. Primary endpoint revisedv6 Show 7 more changesShow less
    • Study sites: 1039 to 1289
    • Primary completion date: May 2022 to May 1, 2022
    • Study completion date: May 2027 to not stated
    • Interventions: Crizotinib (Drug), Laboratory Biomarker Analysis (Other), Placebo (Other) to Clinical Observation (Other), Crizotinib (Drug), Laboratory Biomarker Analysis (Other)
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints revised (2)
    • Study description shortened, about 8 words
  7. Study completion date: May 2027
    • Start date: Aug 2014 to Aug 18, 2014
    • Site details revised at 6 of 1039 sites
    v5
  8. Lead sponsor: Eastern Cooperative Oncology Group to ECOG-ACRIN Cancer Research Groupv4 Show 4 more changesShow less
    • Study sites: 1 to 1039
    • Interventions: crizotinib (Drug), laboratory biomarker analysis (Other), placebo (Other) to Crizotinib (Drug), Laboratory Biomarker Analysis (Other), Placebo (Other)
    • Eligibility criteria expanded, about 15 words
    • Study description shortened, about 17 words
  9. Re-verified, no change to tracked fieldsv3
  10. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary endpoint revised
    • Start date: Oct 2014 to Aug 2014
    • Interventions: crizotinib (Drug), laboratory biomarker analysis (Other), placebo (Drug) to crizotinib (Drug), laboratory biomarker analysis (Other), placebo (Other)
    • Secondary endpoints revised (2)
    • Site details revised
    • Study title expanded, about 4 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This randomized phase III trial studies how well crizotinib works 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.
Trial Details
NCT Number NCT02201992
Lead Sponsor ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 ALK Gene Rearrangement, ALK Gene Translocation, ALK Positive, Stage IB Non-Small Cell Lung Carcinoma AJCC v7, Stage II Non-Small Cell Lung Cancer AJCC v7, Stage IIA Non-Small Cell Lung Carcinoma AJCC v7, Stage IIB Non-Small Cell Lung Carcinoma AJCC v7, Stage IIIA Non-Small Cell Lung Cancer AJCC v7
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 166 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov