Ignite Creation Date:
2024-05-06 @ 8:50 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02839265
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2016-07-15
Brief Title:
FLT3 Ligand Immunotherapy and Stereotactic Radiotherapy for Advanced Non-small Cell Lung Cancer
Sponsor:
Albert Einstein College of Medicine
Organization:
Albert Einstein College of Medicine
Study Overview
Official Title:
FLT3 Ligand Immunotherapy and Stereotactic Radiotherapy for Advanced Non-small Cell Lung Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
FLT3
Brief Summary:
Based on promising data from our laboratory demonstrating synergy between ablative local radiotherapy and FLT3 ligand immunotherapy in murine NSCLC models investigators are performing a phase II study combining FLT3L immunotherapy and SBRT for patients with advanced NSCLC that has progressed following standard systemic therapy All patients will receive daily subcutaneous injections of CDX-301 75 µgkg for 5 days beginning on the first day of SBRT SBRT will be delivered to a single pulmonary or extrapulmonary lesion The SBRT regimen will depend on the size and location of the target lesion The primary endpoint will be progression-free survival at 4 months defined using immune-related response criteria irRC
Detailed Description:
Primary Objective
To explore the efficacy of combining stereotactic body radiotherapy SBRT with FLT3 ligand immunotherapy for advanced non-small cell lung cancer NSCLC
Secondary Objectives
To establish the feasibility and safety of combining SBRT with FLT3 ligand immunotherapy for advanced NSCLC
To quantify and evaluate potential surrogate outcomes for clinical efficacy of this treatment approach including radiographic responses immunologic responses and circulating tumor cell levels
To explore the efficacy of combining stereotactic body radiotherapy SBRT with FLT3 ligand immunotherapy for advanced non-small cell lung cancer NSCLC
Secondary Objectives
To establish the feasibility and safety of combining SBRT with FLT3 ligand immunotherapy for advanced NSCLC
To quantify and evaluate potential surrogate outcomes for clinical efficacy of this treatment approach including radiographic responses immunologic responses and circulating tumor cell levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None