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

NCT02839265 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-04-28

Study results available
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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).

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Interventions

DRUG

FLT3 Ligand Therapy (CDX-301)

See Arm 1 descriptions

RADIATION

Stereotactic Body Radiotherapy (SBRT)

See Arm 1 descriptions

Sponsors & Collaborators

  • Celldex Therapeutics

    collaborator INDUSTRY

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Nitin Ohri, MD · Albert Einstein College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2022-10-05
Completion
2024-11-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02839265 on ClinicalTrials.gov