Study to Evaluate Real-world Pharmacoeconomics of Crizotinib in NSCLC Patients
Conditions
Non-small Cell Lung Cancer Metastatic
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
The Ottawa Hospital
Ottawa, Ontario, Canada
Status: Recruiting
Contact: Kendra Christink - 613-737-7700 - kchristink@toh.on.ca
Princess Margaret Hospital
Toronto, Ontario, Canada
Status: Not yet recruiting
Contact: Devalben Patel - 416-946-4501 - Devalben.Patel@uhn.ca
CSSS de Rimouski-Neigette
Rimouski, Quebec, Canada
Status: Recruiting
Contact: Isabelle Gagnon - (418) 724-3000 - isabelle.gagnon.csssrn@ssss.gouv.qc.ca
Start Date
February 2015
Sponsors
PeriPharm
Source
PeriPharm
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page