RecruitingPhase 2NCT05068232

Durvalumab and Ablative Radiation in Small Cell Lung Cancer (DARES)

A Phase II Trial of Durvalumab and Ablative Radiation in Extensive-Stage Small Cell Lung Cancer (DARES)


Sponsor

University of Chicago

Enrollment

49 participants

Start Date

Aug 19, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (DARES) tests whether adding durvalumab (an immunotherapy) plus targeted radiation to standard chemotherapy improves outcomes for patients with extensive-stage small cell lung cancer — an aggressive form of lung cancer that has spread beyond the chest at the time of diagnosis. **You may be eligible if...** - You are 18 or older with confirmed small cell lung cancer with known metastatic disease - You are suitable to receive platinum-based chemotherapy as your first treatment - You have measurable disease on imaging and are in reasonable health (ECOG 0–2) - Any brain metastases are stable and not causing symptoms **You may NOT be eligible if...** - You have already received treatment for small cell lung cancer - You have active autoimmune disease or other conditions that make immunotherapy unsafe - You have uncontrolled or symptomatic brain metastases - You weigh less than 30 kg Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Medicine

Chicago, Illinois, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05068232


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