Non-small Cell Lung Cancer MetastaticNCT02228421
Study to Evaluate Real-world Pharmacoeconomics of Crizotinib in NSCLC Patients
An observational study of Non-small Cell Lung Cancer Metastatic, run by PeriPharm at 3 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Metastatic
- How many people
- 29 participants
- Where
- 3 sitesCanada
- Study dates
- Feb 2015to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) found positive for ALK mutation.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
CSSS de Rimouski-Neigette
Rimouski, Quebec, J5L 5T1
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
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
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.
Read more
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the date of registration until date of death from any cause, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startFeb 2015
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- PeriPharm
- Sponsor type
- University, hospital or other
- Collaborators
- Personalized Medicine Partnership for Cancer, Jewish General Hospital
- Responsible party
- Sponsor
- Investigators
- Jason Agulnik, MD, Principal investigator, Jewish General HospitalVictor Cohen, MD, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228421
- Sponsor's protocol ID
- PMPC-03
- Status last verified
- Oct 2016
- First submitted
- 27 Aug 2014
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02228421
- Acronym / sponsor ID
- PMPC-03
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 29 participants (actual)
- Lead sponsor
- PeriPharmUniversity, hospital or other
- Collaborators
- Personalized Medicine Partnership for Cancer, Jewish General Hospital
- Study start
- Feb 2015
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 29 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) found positive for ALK mutation.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Agulnik, MD principal investigator
Jewish General Hospital
Victor Cohen, MD principal investigator
Jewish General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer Metastatic, run by PeriPharm at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.