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Clinical Trial Summary

The proposed study will evaluate the safety and feasibility of preoperative administration nivolumab in patients with high-risk resectable NSCLC, and will facilitate a comprehensive exploratory characterization of the tumor immune milieu and circulating immune cells and soluble factors in these patients. Data obtained in this study will provide valuable information for planning further prospective clinical trials of anti-PD-1 or anti-PD-L1 in NSCLC, both in the peri-operative and advanced disease setting.


Clinical Trial Description

The proposed study will evaluate the safety and feasibility of preoperative administration nivolumab in patients with high-risk resectable NSCLC, and will facilitate a comprehensive exploratory characterization of the tumor immune milieu and circulating immune cells and soluble factors in these patients. Data obtained in this study will provide valuable information for planning further prospective clinical trials of anti-PD-1 or anti-PD-L1 in NSCLC, both in the peri-operative and advanced disease setting. Ultimately, it is highly desirable to discover prospective biomarkers of response and toxicity to allow patients with NSCLC who are most likely to derive benefit to receive anti-PD-1 or anti-PD-L1 treatment, and conversely to minimize the risk of toxicity and ineffective treatment for patients who are unlikely to benefit. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03732664
Study type Interventional
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact
Status Completed
Phase Phase 1
Start date October 1, 2018
Completion date March 23, 2023