Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04889066
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-06
First Post:
2021-05-11
Brief Title:
Durvalumab MEDI4736 and Radiosurgery fSRT Vs PULSAR for the Treatment of Non-Small Cell Lung Cancer Brain Metastases
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
A Phase II Clinical Trial of Durvalumab MEDI4736 and Fractionated Stereotactic Radiotherapy fSRT Vs Personalized Ultra-Fractionated Stereotactic Adaptive Radiotherapy PULSAR for the Treatment of Brain Metastases from Non-Small Cell Lung Cancer NSCLC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 is a research study to find out if the new anti-cancer drug Durvalumab combined with radiation therapy to the brain will work in treating brain metastases from non-small cell lung cancer NSCLC Focused highly precise radiation therapy to the brain known as stereotactic radiosurgery SRS is a standard of care treatment that is commonly used for patients with metastatic lung cancer to the brain It is standardly used as an alternative to surgery to eradicate the targeted tumours in the brain and prevent them from growing and causing symptoms This study will look at the combination of the novel immunotherapy Durvalumab with two different ways of delivering SRS 1 with each radiation treatment given every other day for 3 treatments with the first dose of Durvalumab fSRT or 2 with each radiation treatment referred to as a pulse given every 4 weeks with each dose of Durvalumab for 3 treatments PULSAR
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?:
None
Is an FDA AA801 Violation?:
None