Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer metastatic
Sponsor PeriPharm
Collaborator Personalized Medicine Partnership for Cancer
Start date February 2015
End date June 2019
Trial size 29 participants
Trial identifier NCT02228421, PMPC-03

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
The pharmacoeconomic impact of using personalized medicine for the treatment of ALK+ lung cancer.
time frame: From the date of registration until date of death from any cause, assessed up to 60 months.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Jason Agulnik, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by PeriPharm.