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A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab with Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with Stage I/II Non-small Cell Lung Cancer

Protocol No
AZ-D9103C00001-PACIFIC-4
Principal Investigator
Elizabeth Gore
Phase
III
Summary
AstraZeneca AB is doing this research to find out if the medication called Durvalumab will work and be safe for the treatment of patients with Stage I/II NSCLC following SBRT. If you choose to take part in this study, after you complete SBRT you will receive either Durvalumab or placebo (dummy treatment; that looks like the study medication but contains no active ingredient) once a month for up to 24 months. Durvalumab (called Imfinzi) is approved and recommended medicine for stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (which is a more advanced form of the disease you have) in US, Canada, Europe, Japan, Switzerland, India, Brazil and Europe and is still in the process of approval for stage III NSCLC in some other countries. Durvalumab has also been approved by the FDA and the European Medicines Agency (EMA) for the treatment of patients with locally advanced NSCLC after chemoradiation therapy. Durvalumab is still in the development stage for the treatment of an earlier stage of NSCLC and is not approved for treatment of stage I-II NSCLC, except for use in research studies like this. Durvalumab is also approved by some health authorities for advanced bladder cancer.
Description
Durvalumab Following SBRT for the Treatment of Patients with Stage I/II NSCLC
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
Sub Category