Non-small Cell Lung Cancer Metastatic Clinical Trial
Official title:
A Phase IV Multicenter Trial to Evaluate the Resistance Mechanisms and 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 mechanisms of resistance and
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.
The study will address two anticipated issues surrounding personalized medicine and treatment
with crizotinib:
- it will enable real-life Heath Economics and Outcome Research (HEOR)
- it will validate and/or identify new blood-based or tissue-based biomarkers of
resistance to crizotinib.
At least 30 patients will be recruited in Quebec and Ontario for the PE study. Patients will
be asked to complete quality-of-life questionnaires at regular intervals in a real-life
setting of treatment with crizotinib.
Approximately 25 patients will be recruited to the biomarker sub-study in Quebec to
understand resistance mechanisms of crizotinib. In these patients, a biopsy from any
accessible metastatic lesion will be obtained when the patient is no longer responding to
treatment, as well as blood sampling during regular treatment visits.
This is a phase IV multicenter trial to evaluate the mechanisms of resistance and
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. Despite the benefits of crizotinib, some patients
do not respond to treatment and most patients will eventually develop resistance. To date, it
is unclear why some rare patients do not respond to treatment and the resistance mechanisms
of crizotinib have not been fully elucidated.
The study will address two anticipated issues surrounding personalized medicine and treatment
with crizotinib:
- it will enable real-life Heath Economics and Outcome Research (HEOR)
- it will validate and/or identify new blood-based or tissue-based biomarkers of
resistance to crizotinib.
At least 30 patients will be recruited in Quebec and Ontario for the PE study. Patients will
be asked to complete quality-of-life questionnaires at regular intervals in a real-life
setting of treatment with crizotinib.
Approximately 25 patients will be recruited to the biomarker sub-study in Quebec to
understand resistance mechanisms of crizotinib. In these patients, a biopsy from any
accessible metastatic lesion will be obtained when the patient is no longer responding to
treatment, as well as blood sampling during regular treatment visits.
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