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)
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ClinicalTrials.gov Identifier: NCT02201992 |
Recruitment Status :
Recruiting
First Posted : July 28, 2014
Last Update Posted : June 22, 2023
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Tracking Information | ||||
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First Submitted Date ICMJE | July 21, 2014 | |||
First Posted Date ICMJE | July 28, 2014 | |||
Last Update Posted Date | June 22, 2023 | |||
Actual Study Start Date ICMJE | March 23, 2015 | |||
Estimated Primary Completion Date | May 1, 2036 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overall survival (OS) [ Time Frame: The time from randomization to death from any cause, assessed up to 10 years ] Distribution will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate the treatment hazard ratios. The primary comparison will use a logrank test stratified on the randomization stratification factors with a one-sided type I error rate of 5%. Other comparisons of groups will be made using the logrank test and Cox modeling. Estimate will be accompanied by the corresponding 90% confidence intervals.
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Original Primary Outcome Measures ICMJE |
Overall Survival [ Time Frame: The time from randomization to death from any cause, assessed up to 10 years ] Distribution will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate the treatment hazard ratios. The primary comparison will use a logrank test stratified on the randomization stratification factors with a one-sided type I error rate of 5%. Other comparisons of groups will be made using the logrank test and Cox modeling. Estimate will be accompanied by the corresponding 90% confidence intervals.
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | 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) | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. | |||
Detailed Description | PRIMARY OBJECTIVES: I. 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. SECONDARY OBJECTIVES: I. To evaluate and compare disease-free survival (DFS) associated with crizotinib. II. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting. III. To collect tumor tissue and blood specimens for future research. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. ARM B: Patients undergo observation. After completion of study treatment, patients are followed up every 6 months if < 4 or 5 years from study entry, and every 12 months if 5-10 or 6-10 years from study entry. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Recruiting | |||
Estimated Enrollment ICMJE |
168 | |||
Original Estimated Enrollment ICMJE |
378 | |||
Estimated Study Completion Date ICMJE | May 1, 2036 | |||
Estimated Primary Completion Date | May 1, 2036 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | ||||
Listed Location Countries ICMJE | Guam, Puerto Rico, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02201992 | |||
Other Study ID Numbers ICMJE | E4512 NCI-2014-01507 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) s16-02072 E4512 ( Other Identifier: ECOG-ACRIN Cancer Research Group ) E4512 ( Other Identifier: CTEP ) U10CA180820 ( U.S. NIH Grant/Contract ) U10CA180830 ( U.S. NIH Grant/Contract ) U10CA021115 ( U.S. NIH Grant/Contract ) U24CA196172 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ) | |||
Original Responsible Party | Eastern Cooperative Oncology Group | |||
Current Study Sponsor ICMJE | ECOG-ACRIN Cancer Research Group | |||
Original Study Sponsor ICMJE | Eastern Cooperative Oncology Group | |||
Collaborators ICMJE | National Cancer Institute (NCI) | |||
Investigators ICMJE |
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PRS Account | Eastern Cooperative Oncology Group | |||
Verification Date | June 2023 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |