Concurrent Neoadjuvant Chemoradiotherapy Plus Durvalumab (MEDI4736) in Resectable Stage III NSCLC
Status:
Recruiting
Trial end date:
2027-05-01
Target enrollment:
Participant gender:
Summary
Combination treatment of Durvalumab with chemoradiotherapy is ongoing for head/neck cancer,
renal cell carcinoma, melanoma, and non-small cell lung cancer (NCT02318771) and pancreatic
cancer (NCT02305186).Combining Durvalumab with neoadjuvant chemoradiotherapy is a promising
strategy to improve clinical outcome in stage III lung cancer. Using serial biopsied and
surgically resected fresh tissue through the novel/high-throughput RNA sequencing
technologies, we want to identify the change immune signature in tumor microenvironment of
NSCLC patients after Durvalumab treatment. With hypothesis that PD-1 inhibitor as a component
of neoadjuvant chemoradiotherapy followed by surgery could increase complete pathologic
response rate and disease free survival, and overall survival, we suggest adding Durvalumab
to neoadjuvant chemoradiation in stage II/III resectable NSCLC. And with immune marker study
using FACS, whole exome sequencing, or RNAsequencing, we can find the potential predictive
biomarker for anti-PD-L1 blockade. And in this study, we can get "whole" surgical specimen
not biopsy sample after Durvalumab treatment so the analysis for immune marker, tumor
microenvironment, and various tumor infiltrating immune cells and their changes will be
available.