Phase I/II study to assess the safety and efficacy of consolidative hypofractionated radiation therapy (hfRT) for boosting the residual primary lung cancer in combination with Durvalumab after definitive chemoradiation therapy for stage III non-small cell lung cancer (NSCLC)
Categories (click each to see list of all clinical trials associated with that category): Thoracic (ONC)
Current Status: Open
Phase: I/II (Cancer Control)
Principal Investigator: Zhang, Chi
Contact Information:
Amberley Proctor
+1 402-836-9171
amberley.proctor@unmc.edu
Eligibility: https://www.clinicaltrials.gov/study/NCT04748419?term=NCT04748419&rank=1
Summary
Primary Objectives
1. To evaluate the safety of combining hfRT and durvalumab
2. To evaluate 12-month PFS when combining hfRT with adjuvant anti-PD-L1 therapy
Secondary Objectives
1. To evaluate 18-month PFS when combining hfRT with adjuvant anti-PD-L1 therapy
2. To evaluate 12-month Overall survival (OS) when combining hfRT with adjuvant anti-PD-L1 therapy
3. To evaluate the rate of local control (LC), locoregional control (LRC), DM, TTDM
4. To assess symptoms and health- related quality of life in patients treated with Durvalumab plus hfRT using EORTC QLQ- C30 v3 and LC13 module
Exploratory Objectives
1. To evaluate the effects of combined treatment on tumor microenvironment
2. To evaluate the systemic effects of combined therapy by testing circulating tumor RNA/DNA, and cytokine levels.
3. To explore potential biomarkers in
residual biological samples (e.g., tumor, plasma and/or serum), which may influence the progression of cancer (and associated clinical characteristics) and/or prospectively identify patients likely to respond to Durvalumab/hfRT treatment
4. To evaluate the potential difference in pattern and treatment response and the potential relationship between acute radiation pneumonitis (aRP) during dCRT and shortly after hfRT.