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Brief Title: Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)
Official Title: Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)
Study ID: NCT04585477
Brief Summary: In this study circulating tumor DNA (ctDNA) blood testing is used to detect the residual blood cancer. If residual cancer using this blood test is detected there may be at higher risk of having the cancer return. The study is going to test whether or not the number of circulating cancer cells detected in the blood can be reduced by administration durvalumab after the standard treatment if you are tested positive for the residual cancer.
Detailed Description: Primary Objective: The primary objective of this study is to measure the change in ctDNA from trial enrollment to after 2 cycles of adjuvant durvalumab in subjects with stage I to III NSCLC who had positive ctDNA following definitive treatment with surgery or radiation and completion of adjuvant standard of care chemotherapy. Secondary Objectives 1. To compare disease free survival (DFS) 2. To compare overall survival (OS) 3. To evaluate the frequency and severity of toxicity 4. To evaluate the severity of toxicity
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Stanford University, Stanford, California, United States
Name: Joel W Neal, MD,PhD
Affiliation: Stanford Universiy
Role: PRINCIPAL_INVESTIGATOR