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
NCT number | NCT02228421 |
Other study ID # | PMPC-03 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | February 2015 |
Est. completion date | March 2020 |
Verified date | October 2016 |
Source | PeriPharm |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 29 |
Est. completion date | March 2020 |
Est. primary completion date | March 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with histologically confirmed locally advanced or metastatic NSCLC - Presence of the ALK-fusion oncogene (ALK+) as determined using a validated testing platform - Planned first or second-line treatment with crizotinib - Signed and dated IRB-approved informed consent document - Ability to read and understand English or French - 18 years of age or older |
Country | Name | City | State |
---|---|---|---|
Canada | The Ottawa Hospital | Ottawa | Ontario |
Canada | CSSS de Rimouski-Neigette | Rimouski | Quebec |
Canada | Princess Margaret Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
PeriPharm | Jewish General Hospital, Personalized Medicine Partnership for Cancer |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The pharmacoeconomic impact of using personalized medicine for the treatment of ALK+ lung cancer. | 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. | From the date of registration until date of death from any cause, assessed up to 60 months. |
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