- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03546894
A Study to Determine Progression-free Survival (PFS) and Evaluate Participant Experience for Participants With Metastatic Anaplastic Lymphoma Kinase-positive (ALK+) Non-Small Cell Lung Cancer (NSCLC) Treated With Anaplastic Lymphoma Kinase (ALK) Inhibitors
An Observational Parallel Group Phase 4 Study to Determine Progression-Free Survival and Evaluate Patient Experience for Patients With Metastatic ALK+ Non-Small Cell Lung Cancer (NSCLC) Treated With ALK Inhibitors
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a prospective and non-interventional study of participants with ALK+NSCLC. The study will seek to determine the real-world differences in the PFS of participants taking brigatinib or any FDA approved ALK inhibitor other than crizotinib in routine clinical practice and will evaluate participant's quality of life, daily function, general condition, and treatment satisfaction.
The study will enroll approximately 160 participants: 80 participants taking brigatinib, and 80 participants taking FDA approved ALK inhibitors other than crizotinib. Participants will be enrolled in one of the 2 cohorts:
- Brigatinib
- Any FDA Approved ALK Inhibitor Other Than Crizotinib
This trial will be conducted in the United States. Upon enrollment into the study, participants will complete a study-specific baseline questionnaire and four validated instrument questionnaires. After that, participants will complete a study-specific monthly questionnaire and four validated instrument questionnaires, which will be made available to participants every 30 days. Participants will be sent automatic e-mail reminders every 30 days when new surveys become available. All participants will receive a notice on completion of their participation in the study at approximately 24 months.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Maynard, Massachusetts, United States, 01754
- EmpiraMed, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Has ALK+ NSCLC.
Has been prescribed:
- Brigatinib at any point in therapy, OR
- Any FDA approved ALK inhibitor at any point in therapy other than crizotinib. Participants who were previously on crizotinib, but are now on another ALK inhibitor are eligible for study participation.
- Has internet access.
- Is willing to answer regular e-surveys and allow for the prescriber or clinic to provide data on the status of the participant's NSCLC.
Exclusion Criteria:
1. Has received any investigational compound within 90 days prior to consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Brigatinib
The dosage and regimen of brigatinib (ALK inhibitors) will be decided by participant's prescribing physician and will not be determined by participation in the study.
|
Brigatinib tablets.
|
Any FDA Approved ALK Inhibitor Other Than Crizotinib
The dosage, regimen of any Food and Drug Administration (FDA) approved ALK inhibitor (at any point in therapy) other than crizotinib will be decided by participant's prescribing physician and will not be determined by participation in the study.
|
Alectinib capsules.
Ceritinib capsules.
Lorlatinib capsules.
FDA approved ALK inhibitors available for treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prescriber-confirmed PFS
Time Frame: Baseline up to disease progression or death due to any cause, whichever comes first (approximately 24 months)
|
PFS is defined as the time from the date of the first administration of ALK inhibitor to the date of the first documentation of disease progression or death due to any cause, whichever comes first.
PFS will be based on prescriber confirmed progression.
Participants that withdraw, drop out, or are lost to follow-up before documentation of the events will be censored at the last date at which the participant was determined to be progression-free.
|
Baseline up to disease progression or death due to any cause, whichever comes first (approximately 24 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life Status Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -Lung Cancer (EORTC QLQ-LC13)
Time Frame: Baseline up to treatment cessation or up to approximately 24 months
|
EORTC QLQ-LC13 contains 13 questions to assess for: dyspnea, and a series of single items including pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.
Score of each item will range from 0 to 100, where 0 indicates no symptoms and 100 indicates worst possible symptoms.
|
Baseline up to treatment cessation or up to approximately 24 months
|
Daily Function Status by M.D. Anderson Symptom Inventory - Lung Cancer (MDASI-LC)
Time Frame: Baseline up to treatment cessation or up to approximately 24 months
|
The MDASI-LC Module includes 22 questions to assess the severity of multiple lung cancer-related symptoms and the impact of these symptoms on daily functioning.
Symptom assessments include: pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness/tingling, coughing, constipation, sore throat, general activity, mood, work, relations with others, walking, and enjoyment of life.
Scores for each item range from 0 to 10, where 0 indicates no symptoms and 10 indicates worst possible symptoms.
|
Baseline up to treatment cessation or up to approximately 24 months
|
General Condition Status Using EuroQol Research Foundation EQ-5D-5L
Time Frame: Baseline up to treatment cessation or up to approximately 24 months
|
The EQ-5D-5L is a standardized non-disease-specific instrument for use as a measure of generic health status.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
|
Baseline up to treatment cessation or up to approximately 24 months
|
Treatment Satisfaction Using the Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Time Frame: Baseline up to treatment cessation or up to approximately 24 months
|
The TSQM-9 contains 9 items assessing the following 3 domains: effectiveness (3 items), convenience (3 items) and global satisfaction (3 items).
|
Baseline up to treatment cessation or up to approximately 24 months
|
Participant-reported PFS
Time Frame: Baseline up to disease progression or death due to any cause, whichever comes first (approximately 24 months)
|
PFS is defined as the time from the date of the first administration of ALK inhibitor to the date of the first documentation of disease progression or death due to any cause, whichever occurs first.
PFS will be based on participant reported progression.
Participants that withdraw, drop out, or are lost to follow-up before documentation of the events will be censored at the last date at which the participant was determined to be progression-free.
|
Baseline up to disease progression or death due to any cause, whichever comes first (approximately 24 months)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Study Director, Takeda
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSCLC-4001
- U1111-1213-1757 (Registry Identifier: WHO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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