Clinical Trial TitleDurvalumab vs placebo following stereotactic body radiation therapy in early stage unresected non-small cell lung cancer patients.
National Clinical Trial Number:NCT03833154
Clinical Trial Protocol Description:
The purpose of this study is to find out if a drug called durvalumab will work and be safe for the treatment of patients with stage I/II non-small cell lung cancer (NSCLC) following stereotactic body radiation therapy. Stereotactic body radiation therapy (SBRT), also known as stereotactic ablative radiotherapy, is a treatment for cancer that gives very high doses of radiation, using several beams of different strengths aimed at different angles to precisely target a tumor.
Qualifying participants will receive either durvalumab or a placebo once a month for up to 24 months after completing SBRT. Participants will be randomly assigned to either group (50/50 chance, like the flip of a coin). The study drug or placebo will be given intravenously for about 1 hour. Participants will need to return to the clinic every 4 weeks to receive the treatment. During study visits, participants may have the following procedures: have blood and other radiographic tests (CT/MRI), discuss side effects and general health, review current medications, undergo a physical exam, have an ECG (electrocardiogram, a test to measure the pattern of your heart beats).
The study is expected to last about 6 years.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are at least 18 years of age.
- Are stage I to II with clinical stage I/II lymph node-negative (T1 to T3N0M0).
- Have completed SBRT as definitive treatment prior to enrollment in the study.
You will be excluded from the study if any of the following criteria apply to you:
- Have active or prior documented autoimmune or inflammatory disorders.
- Have prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2 antibodies.
- Have a history of active primary immunodeficiency or infection.
This is a partial list of inclusion and exclusion criteria.