A Phase II Trial of Durvalumab and Ablative Radiation in Extensive-Stage Small Cell Lung Cancer (DARES)
University of Chicago
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- RadiationAblative 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.
- DrugDurvalumab
Durvalumab is an immunotherapy drug -- a drug used to help boost your immune response to fight cancer.
- DrugEtoposide
Etoposide is a chemotherapy drug approved for different kinds of cancer, including small cell lung cancer.
- DrugCarboplatin
Carboplatin is a chemotherapy drug approved for different kinds of cancer, including small cell lung cancer.
Locations (2)
- University of Chicago MedicineChicago, Illinois
- University of Wisconsin Carbone Cancer CenterMadison, Wisconsin