Durvalumab and Consolidation SBRT Following Chemoradiation for Locally Advanced Stage III Non-Small Cell Lung
NCT03589547 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2026-04-02
Summary
Durvalumab is a drug that stimulates the immune system to fight lung cancer. Durvalumab is FDA approved to treat lung cancer. Stereotactic body radiation therapy (SBRT) is a newer radiation treatment that gives fewer, but higher doses of radiation than standard radiation.
With SBRT, radiation is focused toward the cancer and away from normal surrounding lung tissue. It is possible that when cancer cells are damaged by SBRT Durvalumab may be more effective in activating the immune system. SBRT is a standard FDA approved treatment for early stage (stage 1) lung cancer and is investigational in patients such as yourself with stage 3 lung cancer. The combination of Durvalumab and SBRT is investigational. This study will investigate the effects, good and bad, of the combination of Durvalumab and SBRT.
Conditions
- Stage III Non-small-cell Lung Cancer
Interventions
- DRUG
-
Durvalumab10mg/kg Q2 weeks (+/- 4 days) for a total of 12 months (maximum of 26 treatments total)
- RADIATION
-
SBRT
SBRT boost will consist of 2 fractions delivered to the primary tumor only, over 1-2 weeks between the first and second treatments with durvalumab. The dose will consist of 20Gy (2 fractions of 10Gy) \*3 fractions are allowed for centrally located tumors
Sponsors & Collaborators
-
Lifespan
collaborator OTHER -
Brown University
lead OTHER
Principal Investigators
-
Hina Khan, MD · Brown University Oncology Research Group (BrUOG) & Lifespan Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-13
- Primary Completion
- 2024-01-31
- Completion
- 2026-02-18
- FDA Drug
- Yes
Countries
- United States
Study Locations
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