NCT05068232 · University of Chicago
Durvalumab and Ablative Radiation in Small Cell Lung Cancer (DARES)
What this study 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).
View original scientific description
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).
Interventions
RADIATION
Ablative Radiation
Ablative radiation therapy is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumor or very specific area of the body, while limiting the radiation that affects surrounding organs.
DRUG
Durvalumab
Durvalumab is an immunotherapy drug -- a drug used to help boost your immune response to fight cancer.
DRUG
Etoposide
Etoposide is a chemotherapy drug approved for different kinds of cancer, including small cell lung cancer.
DRUG
Carboplatin
Carboplatin is a chemotherapy drug approved for different kinds of cancer, including small cell lung cancer.
Primary outcome measures
Progression-Free Survival of Participant Until Disease Progression or Death
Time frame: 48 months
The progression-free survival (PFS) of subjects with extensive-stage small cell lung cancer treated with durvalumab, carboplatin and etoposide with hypofractionated ablative radiation therapy. Progression-free survival will be defined as the time from start of treatment until disease progression per Response Evaluation Criteria in Solid Tumors (RECISTv1.1) or death from any cause.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- For inclusion in the study patients must fulfill all of the following criteria: 1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol. 2. Age \> 18 years at time of study entry. 3. Have a histologic/clinically confirmed diagnosis of small cell lung cancer with known metastatic disease. 4. Patient is suitable to receive a platinum-based chemotherapy regimen as first line treatment for extensive stage small cell lung cancer. 5. Brain metastases must be asymptomatic or treated and stable off steroids and anti-convulsant for at least 2 weeks prior to study treatment. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 7. Life expectancy of at least 12 weeks 8. Body weight \>30 kg 9. Adequate normal organ and marrow function as defined by lab values the study doctor will review. 10. Patient is willing and able to comply w
Where
- Chicago, Illinois
- Madison, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 4, 2026 · Source of record for eligibility and locations