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

Non-small Cell Lung Cancer Metastatic Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02228421
• Other study ID #: PMPC-03
• Status: Terminated
• Start date: February 2015
• Est. completion date: March 2020

Study information

• Verified date: October 2016
• Source: PeriPharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Metastatic

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	CSSS de Rimouski-Neigette	Rimouski	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
PeriPharm	Jewish General Hospital, Personalized Medicine Partnership for Cancer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.