Viewing Study NCT03546894



Ignite Creation Date: 2024-05-06 @ 11:32 AM
Last Modification Date: 2024-10-26 @ 12:47 PM
Study NCT ID: NCT03546894
Status: COMPLETED
Last Update Posted: 2024-07-15
First Post: 2018-05-23

Brief Title: 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
Sponsor: Takeda
Organization: Takeda

Study Overview

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
Status: COMPLETED
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The primary purpose of this study is to determine the differences in PFS for participants who have been receiving brigatinib as ALK inhibitor therapy for ALKNSCLC compared to those participants receiving alectinib ceritinib lorlatinib or other ALK inhibitors that may become available during study treatment
Detailed Description: This is a prospective and non-interventional study of participants with ALKNSCLC 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 participants 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
U1111-1213-1757 REGISTRY WHO None