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 : December 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Other: Clinical Observation Drug: Crizotinib Other: Laboratory Biomarker Analysis||Phase 3|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||378 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||August 18, 2014|
|Estimated Primary Completion Date :||May 1, 2022|
Experimental: Arm A (crizotinib)
Patients receive crizotinib PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Other Names:Other: Laboratory Biomarker Analysis
Active Comparator: Arm B (observation)
Patients undergo observation.
Other: Clinical Observation
Undergo observationOther: Laboratory Biomarker Analysis
- 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.
- Disease free survival (DFS) [ Time Frame: The time from randomization to the earliest event defined as: disease recurrence confirmed by biopsy, any new lung cancer (even in the opposite lung) confirmed by biopsy, or death from any cause at any known point in time, 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. Estimate will be accompanied by the corresponding 90% confidence intervals.
- Toxicity rates, determined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 10 years ]Toxicity rates will be compared using Fisher?s exact tests with a one-sided type I error rate of 5%; multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201992
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|Principal Investigator:||David Gerber||ECOG-ACRIN Cancer Research Group|