Safety & Efficacy of Consolidative Hypofractionated Radiation Therapy for Boosting Residual Lung Cancer With Durvalumab
NCT04748419 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2026-01-22
Summary
This study is designed to determine if combining consolidative radiation therapy (RT) using a hypofractionated regimen (hfRT) (2 fractions) for boosting the residual primary lung cancer with adjuvant anti-PD-L1 therapy concurrently is safe and will provide better tumor control locoregionally and distantly than either modality alone.
Conditions
- Lung Cancer
- Carcinoma, Non-Small Cell Lung
Interventions
- RADIATION
-
consolidative hypofractionated radiation therapy (hfRT)
Consolidative hfRT will start from 6.5Gy x 2 fractions and dose escalate to 10Gy x 2 fractions in a 3+3 design
- DRUG
-
Durvalumab 50 MG/ML
Durvalumab 10 mg/kg via a 60-minute iv infusion every two weeks ± 3 days for up to 12 months
Sponsors & Collaborators
- collaborator INDUSTRY
-
University of Nebraska
lead OTHER
Principal Investigators
-
Chi Zhang, MD, PhD · University of Nebraska
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-15
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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