Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer metastatic
Phase phase 4
Targets ALK, c-MET, ROS1
Sponsor Jewish General Hospital
Collaborator Pfizer
Start date January 2014
End date April 2017
Trial size 29 participants
Trial identifier NCT02041468, Q-CROC-05

Summary

This is a phase IV multicenter trial to evaluate the mechanisms of resistance and 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.

The study will address two anticipated issues surrounding personalized medicine and treatment with crizotinib:

- it will enable real-life Heath Economics and Outcome Research (HEOR)

- it will validate and/or identify new blood-based or tissue-based biomarkers of resistance to crizotinib.

At least 30 patients will be recruited in Quebec and Ontario for the PE study. Patients will be asked to complete quality-of-life questionnaires at regular intervals in a real-life setting of treatment with crizotinib.

Approximately 25 patients will be recruited to the biomarker sub-study in Quebec to understand resistance mechanisms of crizotinib. In these patients, a biopsy from any accessible metastatic lesion will be obtained when the patient is no longer responding to treatment, as well as blood sampling during regular treatment visits.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients from Quebec and Ontario (first or second line treatment)
Patients from Quebec only (first or second line treatment)

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.

Secondary Outcomes

Measure
Type of resistance mechanisms identified in crizotinib-resistant tumors
time frame: At progression of disease, an expected average of 24 months.
Change in blood-based biomarkers of response to crizotinib.
time frame: From the date of registration until the date of treatment discontinuation, an expected average of 24 months.
Number of participants with adverse events related to the biopsy procedure.
time frame: Up to 4 years.

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 - Measurable disease according to RECIST v. 1.1 - Planned or ongoing 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 Exclusion Criteria: - Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease. - Unwilling to provide consent for genetic studies of the tumor, whole blood, or plasma specimens.

Additional Information

Official title A Phase IV Multicenter Trial to Evaluate the Resistance Mechanisms and 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
Description This is a phase IV multicenter trial to evaluate the mechanisms of resistance and 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. Despite the benefits of crizotinib, some patients do not respond to treatment and most patients will eventually develop resistance. To date, it is unclear why some rare patients do not respond to treatment and the resistance mechanisms of crizotinib have not been fully elucidated. The study will address two anticipated issues surrounding personalized medicine and treatment with crizotinib: - it will enable real-life Heath Economics and Outcome Research (HEOR) - it will validate and/or identify new blood-based or tissue-based biomarkers of resistance to crizotinib. At least 30 patients will be recruited in Quebec and Ontario for the PE study. Patients will be asked to complete quality-of-life questionnaires at regular intervals in a real-life setting of treatment with crizotinib. Approximately 25 patients will be recruited to the biomarker sub-study in Quebec to understand resistance mechanisms of crizotinib. In these patients, a biopsy from any accessible metastatic lesion will be obtained when the patient is no longer responding to treatment, as well as blood sampling during regular treatment visits.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Jewish General Hospital.