Study on Durvalumab and Targeted Radiation Therapy After Chemoradiation for Stage III Non-Small Cell Lung Cancer

Sponsor: Brown University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03589547

Provider View

This clinical trial is exploring whether combining the drug Durvalumab with a focused radiation treatment called SBRT can improve outcomes for patients with Stage III non-small cell lung cancer after they have completed standard chemoradiation therapy.

Patient Parameters

Program Overview

Durvalumab is a medication that helps the immune system fight lung cancer and is already approved for treating this type of cancer. Stereotactic body radiation therapy (SBRT) is a newer form of radiation that delivers higher doses in fewer sessions, targeting the cancer while sparing healthy lung tissue. This study is investigating if using Durvalumab together with SBRT can be more effective in treating Stage III lung cancer. While SBRT is a standard treatment for early-stage lung cancer, its use in Stage III lung cancer is still being studied. The combination of Durvalumab and SBRT is experimental, and this study aims to understand its effects, both positive and negative.

Eligibility Criteria

Inclusion Criteria

  • Have Stage III non-small cell lung cancer (NSCLC).
  • Completed chemoradiation therapy with a specific radiation dose.
  • Ready to start Durvalumab treatment 3 to 7 weeks after finishing chemoradiation.
  • Have a remaining tumor that is suitable for SBRT, with a size less than 120cc.
  • Meet specific blood count and liver function requirements.
  • Have a performance status score of 0 or 1, indicating good overall health.
  • Have a life expectancy of at least 12 weeks.
  • Be 18 years or older.
  • Provide informed consent to participate.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after treatment.
  • Men and women must agree to use effective contraception during and for 6 months after treatment.
  • Have resolved any side effects from previous treatments to a mild level, except for hair loss.
  • Have tissue available from a previous biopsy for study purposes.

Exclusion Criteria

  • Cancer has progressed during or after standard chemoradiation.
  • Have had prior radiation to the chest, except for the recent chemoradiation.
  • Have cancer that has spread to other parts of the body.
  • Have uncontrolled severe illness.
  • Have had chemotherapy within 3 weeks of starting the study treatment.
  • Have had complete surgical removal of the lung cancer.
  • Have severe health conditions like uncontrolled nerve damage, recent heart issues, or severe liver disease.
  • Have a low immune system or are on immunosuppressive therapy, unless stable on low-dose steroids.
  • Have active tuberculosis or a known allergy to Durvalumab.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Have a history of significant lung inflammation or active infection needing IV treatment.
  • Have any condition that could interfere with the study or is not in the patient's best interest.
  • Have psychiatric or substance abuse issues affecting study participation.
  • Are pregnant or breastfeeding.
  • Have had previous treatment with certain immune therapies.
  • Have active Hepatitis B or C infections.

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