Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05691829
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-11
First Post:
2023-01-11
Brief Title:
Immunotherapy With Non-Ablative Radiation in Previously Untreated Patients With Stage IV NSCLC
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Phase II Trial of Immunotherapy With Non-Ablative Radiation in Previously Untreated Patients With Stage IV NSCLC
Status:
ACTIVE_NOT_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:
IRRADIATE-Lung
Brief Summary:
The purpose of this study is to test if low dose radiation which is routinely used in treating patients with lung cancer for symptom control can improve the results from the standard treatment with pembrolizumab and chemotherapy In this study only individuals who have NSCLC that is advanced Stage IV or has come back recurred will be able to participate
Detailed Description:
This is a phase II open-label trial of pembrolizumab sequentially following upfront non-ablative focal therapy to up to five distinct metastatic subsites in de novo stage IV Non-Small Cell Lung Cancer NSCLC The primary goal of this trial is to evaluate the efficacy defined by time to progression or death with upfront non-ablative focal radiation RT to index lesions as a way of enhancing the anti-tumor immune response to pembrolizumab Adult patients with metastatic NSCLC with at least 2 measurable lesions and those Patients with metastatic NSCLC who are previously untreated are eligible for the study if they meet all inclusion criteria and do not satisfy any exclusion criteria Participants will receive standard of care immunotherapy of Pembrolizumab in addition to non-ablative radiation The intervention is the low dose fractionation 4Gy x 5 in the upfront treatment of de novo stage IV NSCLC in up to five distinct subsites of metastatic NSCLC
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