Actively Recruiting
Durvalumab and Ablative Radiation in Small Cell Lung Cancer (DARES)
Led by University of Chicago · Updated on 2026-03-04
49
Participants Needed
2
Research Sites
267 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This this study is for individuals who have treatment-naïve extensive-stage small cell lung cancer (small cell lung cancer that wont respond to treatment). Doctors leading this study hope to learn if combining durvalumab, carboplatin and etoposide with hyofractionated ablative radiation therapy (radiation focused on certain parts of the body) will help treat your cancer and improve how long you can live with extensive-stage small cell cancer without it getting worse (progression-free survival). Your participation in this research will last about 48 months. Durvalumab along with chemotherapy has been approved by the Food and Drug Administration (FDA) for the treatment of small cell lung cancer along with chemotherapy. This study is testing the addition of radiation to durvalumab and chemotherapy.
CONDITIONS
Official Title
Durvalumab and Ablative Radiation in Small Cell Lung Cancer (DARES)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent and follow study requirements
- Age over 18 years at study entry
- Diagnosed with small cell lung cancer with metastatic disease
- Suitable to receive platinum-based chemotherapy as first treatment
- Brain metastases must be asymptomatic or stable off steroids and anti-convulsants for at least 2 weeks
- ECOG performance status 0, 1, or 2
- Life expectancy of at least 12 weeks
- Body weight greater than 30 kg
- Adequate organ and marrow function as determined by study doctor
- Willing and able to comply with treatment and scheduled visits
- Measurable disease with at least one lesion suitable for ablative radiation between 0.25 cc and 65 cc
- Female participants of childbearing potential must have negative pregnancy test within 24 hours before first treatment
- Females of childbearing potential must use two birth control methods, be surgically sterile, or abstain from heterosexual activity during study and 120 days after last dose
- Male participants must use adequate contraception from first dose through 120 days after last dose
You will not qualify if you...
- Participation in another investigational study within last 2 weeks
- Concurrent enrollment in another interventional clinical study
- Unresolved grade 2 or higher toxicity from previous cancer therapy except alopecia, vitiligo, and defined lab values
- Concurrent chemotherapy, investigational, biologic, or hormonal cancer therapy outside this trial
- Radiotherapy to more than 30% of bone marrow or wide field radiation within 4 weeks before first dose
- Major surgery within 28 days before first dose (except local palliative surgery)
- History of allogenic organ transplant
- Active or prior autoimmune or inflammatory disorders except certain controlled conditions
- Uncontrolled illness including active infection, heart failure, unstable angina, arrhythmia, interstitial lung disease, serious gastrointestinal conditions, or psychiatric/social issues limiting compliance
- History of other primary malignancies with specific exceptions
- History of leptomeningeal carcinomatosis
- Paraneoplastic syndrome requiring systemic treatment or worsening symptoms
- Brain metastases must be stable and meet specific imaging and symptom criteria
- History of active primary immunodeficiency
- Active infection including tuberculosis, hepatitis B, hepatitis C, or HIV, with some exceptions
- Use of immunosuppressive medication within 14 days before first dose except certain steroids
- Receipt of live vaccine within 30 days before first dose and during study plus 30 days
- Pregnant or breastfeeding females or those unwilling to use effective birth control
- Known allergy or hypersensitivity to study drugs or excipients
- Prior participation or treatment with durvalumab
- Prior chemotherapy, immunotherapy, or thoracic radiation for small cell lung cancer
- Prior exposure to anti-PD1/PD-L1 or anti-CTLA4 therapy
- Prior radiation therapy over 10% of planned trial radiation area
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of Chicago Medicine
Chicago, Illinois, United States, 60637
Actively Recruiting
2
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Active, Not Recruiting
Research Team
C
Cancer Clinical Trials Office
CONTACT
A
Aditya Juloori, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here