Ignite Creation Date:
2024-05-06 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05033691
Status:
RECRUITING
Last Update Posted:
2021-09-05
First Post:
2021-07-04
Brief Title:
A Study to Evaluate the Efficacy of Osimertinib With Early Intervention SRS Treatment Compared to the Continuation of Osimertinib Alone in Patients With EGFR Mutated NSCLC and Asymptomatic Brain Metastases
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
A Multi-center Open-label Randomized Two-arm Study to Evaluate the Efficacy of Osimertinib With Early Intervention SRS Treatment Compared to the Continuation of Osimertinib Alone in Patients With EGFR Mutated NSCLC and Asymptomatic Brain Metastases
Status:
RECRUITING
Status Verified Date:
2021-08
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:
This study involves patients with EGFR-mutated NSCLC and asymptomatic brain metastases This is an open-label randomized study comparing the continuation of Osimertinib treatment alone to Osimertinib treatment combined with early intervention stereotactic radiosurgery SRS The current first line of care for EGFR-mutated NSCLC is administration of Osimertinib a small molecule that penetrates the blood brain barrier BBB well and controls majority but not all of the brain metastases We hypothesize that relatively early intervention with SRS to brain metastases that are still visualized by MRI 2 months-post initiation of Osimertinib treatment LUNG- will improve long term brain control cognitive abilities and potentially overall survival Patients with EGFR-mutated NSCLC and asymptomatic brain metastases will be treated with Osimertinib for 2 months Brain MRI scans will be collected pre-Osimertinib and 2 months after treatment start Patients with asymptomatic brain metastases present after 2 months of Osimertinib will be randomized into one of two study arms Arm A patients will be treated with SRS while continuing Osimertinib while arm B patients will continue with Osimertinib alone Patients will be assessed based on brain and whole body progression by RECIST Patients will also be assessed for CNS-PFS and body-PFS cognitive function Quality of life and overall survival status via routine follow-up tests
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None