Ignite Creation Date:
2024-05-06 @ 2:09 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04223596
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2020-01-07
Brief Title:
Clinical Utility of Liquid Biopsy in Brigatinib ALK Patients
Sponsor:
Fundación GECP
Organization:
Fundación GECP
Study Overview
Official Title:
Clinical Utility of Liquid Biopsy as a Tool to Assess the Evolution of Brigatinib Treated Patients With Non-small Cell Lung Cancer With EML4-ALK Translocation an Exploratory Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
CUBIK
Brief Summary:
This is an open-label non-randomised phase II exploratory multi-country and multi-centre clinical trial Chemotherapy-naïve patients with EML4-ALK rearrangement and with locally advanced or metastatic non-small cell lung cancer patients will be selected
Patients enrolled in the study will receive brigatinib 90mg for the first 7 days D 1-7 at cycle 1 and then 180mg daily thereafter for QW4 cycles of duration 28 days 3days
Brigatinib will be administered until progression disease unacceptable toxicity patient or physician decision to discontinue or death
Brigatinib may continue beyond disease progression per RECIST v11 until loss of clinical benefit unacceptable toxicity patient or physician decision to discontinue or death as per SmPC recommendations
Patient accrual is expected to be completed within 15 years excluding a run-in-period of 4-6 months Treatment and follow-up are expected to extend the study duration to a total of 5 years Patients will be followed for 1 year after the end of treatment independently of the cause of end of treatment The study will end once survival follow-up has concluded
The trial will end with the preparation of the final report scheduled for 55 years after the inclusion of the first patient approximately
Patients enrolled in the study will receive brigatinib 90mg for the first 7 days D 1-7 at cycle 1 and then 180mg daily thereafter for QW4 cycles of duration 28 days 3days
Brigatinib will be administered until progression disease unacceptable toxicity patient or physician decision to discontinue or death
Brigatinib may continue beyond disease progression per RECIST v11 until loss of clinical benefit unacceptable toxicity patient or physician decision to discontinue or death as per SmPC recommendations
Patient accrual is expected to be completed within 15 years excluding a run-in-period of 4-6 months Treatment and follow-up are expected to extend the study duration to a total of 5 years Patients will be followed for 1 year after the end of treatment independently of the cause of end of treatment The study will end once survival follow-up has concluded
The trial will end with the preparation of the final report scheduled for 55 years after the inclusion of the first patient approximately
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-002369-36 | EUDRACT_NUMBER | None | None |