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
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|ClinicalTrials.gov Identifier: NCT03546894|
Recruitment Status : Recruiting
First Posted : June 5, 2018
Last Update Posted : July 31, 2019
|Condition or disease||Intervention/treatment|
|Anaplastic Lymphoma Kinase-positive Carcinoma Non-small-cell Lung||Drug: Brigatinib Drug: Alectinib Drug: Ceritinib Drug: Lorlatinib Drug: Any FDA Approved ALK Inhibitors|
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:
- Any FDA Approved ALK Inhibitor
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 36 months.
|Study Type :||Observational|
|Estimated Enrollment :||160 participants|
|Official Title:||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|
|Actual Study Start Date :||July 23, 2018|
|Estimated Primary Completion Date :||April 30, 2022|
|Estimated Study Completion Date :||May 30, 2022|
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.
Any FDA Approved ALK Inhibitor
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.
Drug: Any FDA Approved ALK Inhibitors
FDA approved ALK inhibitors available for treatment.
- Prescriber-confirmed PFS [ Time Frame: Baseline up to disease progression or death due to any cause, whichever comes first (approximately 36 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.
- 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 36 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.
- Daily Function Status by M.D. Anderson Symptom Inventory - Lung Cancer (MDASI-LC) [ Time Frame: Baseline up to treatment cessation or up to approximately 36 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.
- General Condition Status Using EuroQol Research Foundation EQ-5D-5L [ Time Frame: Baseline up to treatment cessation or up to approximately 36 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.
- Treatment Satisfaction Using the Treatment Satisfaction Questionnaire for Medication (TSQM-9) [ Time Frame: Baseline up to treatment cessation or up to approximately 36 months ]The TSQM-9 contains 9 items assessing the following 3 domains: effectiveness (3 items), convenience (3 items) and global satisfaction (3 items).
- Participant-reported PFS [ Time Frame: Baseline up to disease progression or death due to any cause, whichever comes first (approximately 36 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546894
|Contact: Takeda Study Registration Call Centerfirstname.lastname@example.org|
|United States, Massachusetts|
|Maynard, Massachusetts, United States, 01754|
|Study Director:||Medical Director||Millennium Pharmaceuticals, Inc.|