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Brief Title: Durvalumab and Stereotactic Radiotherapy for Advanced NSCLC
Official Title: Randomized Phase II Study of Durvalumab (MEDI 4736) and Stereotactic Radiotherapy for Advanced Non-Small Cell Lung Cancer
Study ID: NCT04786093
Brief Summary: This is a randomized Phase II study which is designed to determine the impact of stereotactic radiotherapy and durvalumab on quality-of-life and oncologic outcomes in patients with advanced non-small cell lung cancer. Durvalumab (Imfinzi) and stereotactic radiotherapy, with each fraction of radiotherapy is given every other day on a standard stereotactic ablative radiotherapy (SAbR) schedule or every four weeks on the personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) schedule. Subjects will be followed for a period of 2 years after completion of treatment or until death, whichever occurs first. Specifically, subjects will be followed at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months following treatment. After the 2 year follow up, the patient can continue routine follow up with their physicians, per standard of care. Subjects removed from therapy for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Name: Shahed Badiyan, MD
Affiliation: UT Southwestern Medical Center
Role: PRINCIPAL_INVESTIGATOR