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Active Not RecruitingNCT03999710

Determining Whether Durvalumab in Combination With Radiation Therapy Can Prevent the Progression of Non-Small Cell Lung Cancer

Durvalumab With Thoracic Radiation Therapy Without Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer (DART)

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
61 (actual)
Sponsor
Memorial Sloan Kettering Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to see if Durvalumab and radiation therapy can delay the worsening of disease in patients with non-small cell lung cancer normally treated with sequential chemotherapy followed by radiation therapy.

Conditions

Interventions

TypeNameDescription
RADIATIONRadiation TherapyTreatment will consist of 60 Gy in 30 fractions to fields encompassing gross tumor and lymph nodes.
DRUGDurvalumabA dose of 1500mg (for patients \>30kg in weight) will be administered using an IV bag containing 0.9% (w/v) saline or 5% (w/v) dextrose, with a final durvalumab concentration ranging from 1 to 15 mg/mL, and delivered through an IV administration set with a 0.2- or 0.22- μm filter.

Timeline

Start date
2019-07-19
Primary completion
2026-07-01
Completion
2026-07-01
First posted
2019-06-27
Last updated
2025-11-28

Locations

9 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03999710. Inclusion in this directory is not an endorsement.