CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
FLT3 Ligand Therapy (CDX-301) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02839265
NCT02839265Phase 2Completed

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

Montefiore Medical Center·interventional·Posted Jul 20, 2016·Updated Apr 28, 2026

In Brief

A Phase 2 clinical trial evaluating FLT3 Ligand Therapy (CDX-301) and Stereotactic Body Radiotherapy (SBRT) for Non-small Cell Lung Cancer (NSCLC). Completed, enrolled 33 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 20, 2016
Enrollment StartJul 1, 2016
Primary CompletionOct 5, 2022
Study CompletionNov 22, 2024
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 10.0 years ago

Interventions

FLT3 Ligand Therapy (CDX-301)drug

See Arm 1 descriptions

Stereotactic Body Radiotherapy (SBRT)radiation

See Arm 1 descriptions