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NCT03546894 · ClinicalTrials.gov registry record
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
A clinical trial, sponsored by Takeda.
- Completed
- Registry status
- 111
- Enrollment target
NCT03546894: Completed study, sponsored by Takeda.
NCT03546894 is a clinical trial that has completed, run by Takeda. The registered enrollment target is 111 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03546894 has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- 111 participants
- Enrollment target
Study 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 ALK+NSCLC compared to those participants receiving alectinib, ceritinib, lorlatinib, or other ALK inhibitors that may become available during study treatment.
Primary Outcome
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.
Interventions
- DRUG Lorlatinib
- DRUG Alectinib
- DRUG Ceritinib
- DRUG Brigatinib
- DRUG Any FDA Approved ALK Inhibitors
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2018-07-23 |
| Est. Completion | 2023-02-13 |
What the finished NCT03546894 record still lists
NCT03546894 is an observational study that tracks outcomes without assigning an intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 5 interventions - of which Lorlatinib is the first listed.
NCT03546894 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03546894 about?
NCT03546894 is a clinical study titled "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 primary purpose of this study is to determine the differences in PFS for participants who have been receiving brigatinib as ALK inhibitor therapy for ALK+NSCLC compared to those participants receiving alectinib, ceritinib, lorlatinib, or other ALK inhibitors that may become available during stud...
What is the current status of trial NCT03546894?
This trial is currently completed. The enrollment target is 111 participants. The study started on 2018-07-23. Estimated completion is 2023-02-13.
What interventions are being tested in trial NCT03546894?
The interventions under investigation include: Lorlatinib (DRUG), Alectinib (DRUG), Ceritinib (DRUG), Brigatinib (DRUG), Any FDA Approved ALK Inhibitors (DRUG).
Who is sponsoring clinical trial NCT03546894?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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