This phase 2 clinical trial will test the safety and effectiveness of durvalumab as a first-line therapy for non-small cell lung cancer (NSCLC). The primary outcome will be measured by overall survival and the number of patients with adverse (negative) side effects.
The details
Durvalumab is an immunotherapy for metastatic tumors (cancer that has spread). It uses the body’s own immune system to identify and kill cancer cells. The drug works by inhibiting proteins on immune cells that normally dampen immune responses. Durvalumab is currently approved by the FDA as a second-line therapy.
This trial will determine the safety and effectiveness of durvalumab as a first-line treatment in symptomatic NSCLC patients. The trial will examine the number of individuals with treatment-related adverse side effects up to 33 months and the survival rate up to 42 months. Overall response, time to disease progression, and quality of life will also be measured.
Who are they looking for?
This trial will recruit 50 patients with stage 3b or 4 NSCLC. Patients must not have received prior treatment and must have normal organ and bone marrow function. Participating women cannot be pregnant upon entry.
Patients cannot have received any PD-1 or PD-L1 inhibiting treatment in the past or participated in an investigational study in the past 12 months prior to enrollment. Participants also cannot have active active autoimmune diseases, a history of immunodeficiency, organ transplants, a history of tuberculosis, uncontrolled seizures, or a live vaccination 30 days prior to entry. Patients must be off immunosuppressants 28 days before receiving the first treatment.
How will it work
Patients will receive a dose of durvalumab on day 1 of a 28 day cycle. Treatment will continue for 12 months or until disease progression, side effects, or death occurs.
