drugset / Trial / NCT02839265

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

NCT02839265

NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2016-07
Primary completion
2022-10-05
Completion
2024-11-22

Drugs

EvaluationDrugModalityDoseRoute
Subject CDX-301 Protein / enzyme biologic 75 ug/kg Subcutaneous