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COMPLETED
NCT02839265
PHASE2

FLT3 Ligand Immunotherapy and Stereotactic Radiotherapy for Advanced Non-small Cell Lung Cancer

Sponsor: Montefiore Medical Center

View on ClinicalTrials.gov

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 µg/kg) 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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2016-07

Completion Date

2024-11-22

Last Updated

2026-04-28

Healthy Volunteers

No

Interventions

DRUG

FLT3 Ligand Therapy (CDX-301)

See Arm 1 descriptions

RADIATION

Stereotactic Body Radiotherapy (SBRT)

See Arm 1 descriptions

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States