Study on Durvalumab and Radiation Therapy for Treating Extensive-Stage Small Cell Lung Cancer (DARES)

Sponsor: University of Chicago

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05068232

Provider View

This clinical trial is exploring whether adding targeted radiation therapy to the standard treatment of durvalumab and chemotherapy can improve outcomes for patients with extensive-stage small cell lung cancer. The study aims to see if this combination can help control the cancer and extend the time patients live without the disease getting worse.

Patient Parameters

Program Overview

This study is for people with extensive-stage small cell lung cancer that has not been treated before. Researchers want to find out if combining durvalumab, a chemotherapy drug, and focused radiation therapy can help treat this type of cancer and improve how long patients can live without the cancer progressing. The study will last about 48 months. Durvalumab with chemotherapy is already approved by the FDA for treating small cell lung cancer, and this study is testing if adding radiation can make it more effective.

Eligibility Criteria

Inclusion Criteria

  • Able to give informed consent and follow study requirements.
  • Age over 18 years.
  • Diagnosed with small cell lung cancer that has spread.
  • Suitable for platinum-based chemotherapy as the first treatment.
  • Brain metastases must be stable and not require steroids or anti-seizure medication for at least 2 weeks.
  • ECOG performance status of 0, 1, or 2.
  • Life expectancy of at least 12 weeks.
  • Body weight over 30 kg.
  • Normal organ and bone marrow function based on lab tests.
  • Willing to follow the study protocol, including treatments and visits.
  • Have measurable cancer that can be treated with radiation.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use two forms of birth control or abstain from sex during the study and for 120 days after the last dose.
  • Men must agree to use contraception during the study and for 120 days after the last dose.

Exclusion Criteria

  • Participating in another clinical study with an investigational product in the last 2 weeks.
  • Enrolled in another clinical study unless it's observational.
  • Unresolved side effects from previous cancer treatments, except for hair loss and certain lab values.
  • Receiving other cancer treatments not part of this study.
  • Recent major surgery or radiation to a large area.
  • History of organ transplant.
  • Active or past autoimmune or inflammatory disorders, with some exceptions.
  • Uncontrolled illnesses or infections.
  • History of another cancer unless treated and inactive for 5 years.
  • Active primary immunodeficiency.
  • Active infections like tuberculosis, hepatitis B or C, or HIV.
  • Recent use of immunosuppressive medication, with some exceptions.
  • Recent live vaccine.
  • Pregnant or breastfeeding women, or those not using effective birth control.
  • Allergy to study drugs.
  • Previous treatment with durvalumab or similar drugs.
  • Prior chemotherapy, immunotherapy, or radiation for small cell lung cancer.
  • Prior radiation to the area planned for treatment in this study.

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