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

NCT02228421 | Terminated

• 1 other identifier: PMPC-03
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 3

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.

Conditions

Non-small Cell Lung Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) found positive for ALK mutation.

You may qualify if:

• 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
• years of age or older

Sponsors & Collaborators

• PeriPharm: lead
• Personalized Medicine Partnership for Cancer: collaborator
• Jewish General Hospital: collaborator

Study Sites (3)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CSSS de Rimouski-Neigette

Rimouski, Quebec, J5L 5T1, Canada

Location

Study Officials

• Jason Agulnik, MD

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

• Victor Cohen, MD

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: August 29, 2014
• Study Start: February 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 11, 2020

Record last verified: 2016-10

Locations

CA (3)