Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04748419
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2021-02-05
Brief Title:
Safety Efficacy of Consolidative Hypofractionated Radiation Therapy for Boosting Residual Lung Cancer With Durvalumab
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
Phase III Study Assessing Safety Efficacy of Consolidative Hypofractionated Radiation Therapy for Boosting Residual Primary Lung Cancer With Durvalumab After Definitive Chemoradiation Therapy for Stage III Non-small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
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 is designed to determine if combining consolidative radiation therapy RT using a hypofractionated regimen hfRT 2 fractions for boosting the residual primary lung cancer with adjuvant anti-PD-L1 therapy concurrently is safe and will provide better tumor control locoregionally and distantly than either modality alone
Detailed Description:
For safety reasons consolidative hfRT will start from 65Gy x 2 fractions and dose escalate to 10Gy x 2 fractions in a 33 design Consolidative hfRT will be delivered one to two months after finishing definitive chemoradiation therapy dCRT and concurrently with adjuvant anti-PD-L1 therapy using durvalumab in stage III non-small cell lung cancer NSCLC
At the final determined consolidative hfRT dose level a total of thirty-two subjects with pathologically documented stage III NSCLC treated with dCRT will be enrolled for data analyses
Follow-up assessments will occur every 3 months during durvalumab therapy for the first two years then every 4-6 months after 2 years from study registration until confirmed disease progression or death Primary endpoints include the safety of boost hfRT and concurrent anti-PD-L1 therapy adjuvantly following dCRT and the 12-month progression-free survival to compare with historical results
At the final determined consolidative hfRT dose level a total of thirty-two subjects with pathologically documented stage III NSCLC treated with dCRT will be enrolled for data analyses
Follow-up assessments will occur every 3 months during durvalumab therapy for the first two years then every 4-6 months after 2 years from study registration until confirmed disease progression or death Primary endpoints include the safety of boost hfRT and concurrent anti-PD-L1 therapy adjuvantly following dCRT and the 12-month progression-free survival to compare with historical results
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?:
False
Is an FDA AA801 Violation?:
None