Study to Evaluate Real-world Pharmacoeconomics of Crizotinib in NSCLC Patients
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|ClinicalTrials.gov Identifier: NCT02228421|
Recruitment Status : Active, not recruiting
First Posted : August 29, 2014
Last Update Posted : October 6, 2016
This is a phase IV multicenter trial to evaluate the pharmacoeconomic (PE) impact of crizotinib and its companion diagnostic test used in a real-life setting in advanced ALK-positive non-small cell lung cancer (NSCLC) patients.
NSCLC represent 80% of all new cases of lung cancer. One molecular subtype of NSCLC is the ALK-positive subtype. The anaplastic lymphoma kinase (ALK) is a transmembrane receptor tyrosine kinase. Activation of ALK occurs through the formation of gene fusions and in NSCLC, the gene fusion partner for ALK is primarily EML4. The resulting fusion protein is capable of activating the ALK kinase domain, leading to cell growth. The estimated prevalence for ALK rearrangements in NSCLC is 3-5%, and is more commonly found amongst patients with adenocarcinoma histology, in never smokers and in those who are known to be wild type for EGFR and KRAS.
Crizotinib is a potent inhibitor of ALK and is approved for the treatment of advanced ALK+ NSCLC patients. This is an example of personalized medicine, where patients are selected for treatment based upon a molecular assay, and are provided a specific therapy (crizotinib) for their disease. The pharmacoeconomic impact of using genetic information in early treatment decisions in NSCLC has not been determined.
The study will enable real-life Heath Economics and Outcome Research (HEOR).
Approximately 90 patients will be recruited. Patients will be asked to complete quality-of-life questionnaires at regular intervals in a real-life setting of treatment with crizotinib.
|Condition or disease|
|Non-small Cell Lung Cancer Metastatic|
|Study Type :||Observational|
|Actual Enrollment :||29 participants|
|Official Title:||A Phase IV Multicenter Trial to Evaluate Real-world Pharmacoeconomics of Crizotinib and Its Companion Diagnostic Test in Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC) Patients|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||June 2019|
- The pharmacoeconomic impact of using personalized medicine for the treatment of ALK+ lung cancer. [ Time Frame: From the date of registration until date of death from any cause, assessed up to 60 months. ]Pharmacoeconomic impact (cost-effectiveness and cost utility) will be evaluated by questionnaires completed by the patient and caregiver. These include quality of life, health resource utilization, work productivity and activity impairment, and health questionnaires.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228421
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1H 8L6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|CSSS de Rimouski-Neigette|
|Rimouski, Quebec, Canada, J5L 5T1|
|Principal Investigator:||Jason Agulnik, MD||Jewish General Hospital|
|Principal Investigator:||Victor Cohen, MD||Jewish General Hospital|