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Spots Global Cancer Trial Database for Durvalumab and Stereotactic Radiotherapy for Advanced NSCLC

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Texas Southwestern Medical Center, Dallas, Texas, United States

Contact Details

Name: Shahed Badiyan, MD

Affiliation: UT Southwestern Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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