Ignite Creation Date:
2024-05-06 @ 7:21 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05987644
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-07-26
Brief Title:
Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements
Sponsor:
Joshua Palmer
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
DURABLE Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and rEarrangements
Status:
RECRUITING
Status Verified Date:
2024-10
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:
DURABLE
Brief Summary:
This study will consist of a Phase 1b and Phase 2 portion The Phase 1b portion will enroll first followed by the Phase 2 portion Each cycle of treatment 28 days
Subjects will receive alectinib twice daily Those in the Phase 1b portion will receive alectinib alone Those in Phase 2 Arm A will receive alectinib alone Those in Phase 2 Arm B will receive SRS alectinib
A maximum of 25 cycles 2 years of alectinib may be administered on study
Subjects will receive alectinib twice daily Those in the Phase 1b portion will receive alectinib alone Those in Phase 2 Arm A will receive alectinib alone Those in Phase 2 Arm B will receive SRS alectinib
A maximum of 25 cycles 2 years of alectinib may be administered on study
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None