Clinical trial NCT02228421: Study to Evaluate Real-world Pharmacoeconomics of Crizotinib in NSCLC Patients
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-small Cell Lung Cancer Metastatic
Lead sponsor: PeriPharm
Sponsor class: OTHER
Collaborators: name: Personalized Medicine Partnership for Cancer
name: Jewish General Hospital
First posted: 2014-08-29
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) found positive for ALK mutation.

Brief 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.


Eligibility 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

Primary outcomes:
measure: The pharmacoeconomic impact of using personalized medicine for the treatment of ALK+ lung cancer.
timeFrame: From the date of registration until date of death from any cause, assessed up to 60 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Rimouski
country: Canada
facility: CSSS de Rimouski-Neigette
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Jason Agulnik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jewish General Hospital
name: Victor Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: