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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03546894|
Recruitment Status : Active, not recruiting
First Posted : June 6, 2018
Last Update Posted : March 15, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|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 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 :||Observational|
|Actual Enrollment :||111 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 :||October 31, 2023|
|Estimated Study Completion Date :||November 30, 2023|
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 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.
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 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.
- 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.
- 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.
- 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.
- 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).
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
1. Has received any investigational compound within 90 days prior to consent.
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
|United States, Massachusetts|
|Maynard, Massachusetts, United States, 01754|
|Study Director:||Study Director||Takeda|
|Other Study ID Numbers:||
U1111-1213-1757 ( Registry Identifier: WHO )
|First Posted:||June 6, 2018 Key Record Dates|
|Last Update Posted:||March 15, 2022|
|Last Verified:||February 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Access Criteria:||IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Neoplasms by Histologic Type
Immune System Diseases
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action