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Study to Evaluate Real-world Pharmacoeconomics of Crizotinib in NSCLC Patients

NCT02228421 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2020-03-11

No results posted yet for this study

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.

Conditions

  • Non-small Cell Lung Cancer Metastatic

Sponsors & Collaborators

  • Personalized Medicine Partnership for Cancer

    collaborator OTHER

  • Jewish General Hospital

    collaborator OTHER

  • PeriPharm

    lead OTHER

Principal Investigators

  • Jason Agulnik, MD · Jewish General Hospital

  • Victor Cohen, MD · Jewish General Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02228421 on ClinicalTrials.gov