Non-small Cell Lung Cancer Metastatic Clinical Trial
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
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.
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