Actively Recruiting
Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer
Led by Wake Forest University Health Sciences · Updated on 2026-03-23
28
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study aims to determine what effects (good and bad) Durvalumab has on participants and their cancer with a "quick start" of Durvalumab within 14 days of finishing chemotherapy and radiation. The study will also determine the logistic barriers to the quick start of Durvalumab.
CONDITIONS
Official Title
Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have Stage II or Stage III nonsmall cell lung cancer confirmed by biopsy and clinical assessment based on the AJCC Cancer Staging Manual, 8th Edition (2017).
- Cancer must be unresectable or patient medically inoperable as determined by the investigator.
- Patient must have definitive radiation therapy planned to start within 28 days, currently being given, or completed within the last 14 days.
- Patient must have had platinum-based chemotherapy planned to start within 28 days, currently being given, or completed within the last 14 days, with at least two cycles administered before or during radiation therapy.
- Consolidation with Durvalumab is planned after radiation and chemotherapy.
- Participant is 18 years of age or older.
- ECOG performance status must be between 0 and 2.
- Life expectancy must be greater than three months.
- Patients who could become pregnant or whose partners could become pregnant must use contraception during treatment.
- Ability to understand and provide informed consent or have a legally authorized representative do so.
You will not qualify if you...
- Uncontrolled respiratory symptoms interfering with daily activities, including cough, shortness of breath, fever, chest pain, or increased oxygen needs.
- Presence of EGFR mutation sensitive to first-line tyrosine kinase inhibitors (Ex19del or L858R), unless testing is inconclusive with low suspicion.
- Prior treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1, or PD-L1.
- Active autoimmune disease requiring systemic immunosuppression at enrollment.
- History of autoimmune pneumonitis needing high-dose steroids (prednisone >20 mg/day for more than one week).
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting study compliance.
- Pregnancy or breastfeeding.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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