Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers
Categories (click each to see list of all clinical trials associated with that category): Lung/Thoracic
Current Status: Open to accrual
Phase: III
Principal Investigator: Ganti, Apar
Contact Information:
Shannon Pivovar, RN
402-559-8711
shannon.pivovar@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT02595944#eligibility
Summary
PRIMARY OBJECTIVES:
I. To evaluate whether adjuvant therapy with nivolumab will result in improved overall survival (OS) and/or disease-free survival (DFS) over standard observation in patients with stage IB >= 4 cm, II and IIIA, non-small cell lung cancer (NSCLC) following surgical resection and standard adjuvant therapy.
II. To evaluate whether adjuvant therapy with nivolumab will result in improved disease-free survival (DFS) over standard observation in patients with stage IB >= 4cm, II and IIIA, NSCLC with high PD-L1 expression (>= 50% staining) following surgical resection and standard adjuvant therapy.
III. To evaluate whether adjuvant therapy with nivolumab will result in improved overall survival (OS) over standard observation in patients with stage IB >= 4cm, II and IIIA, NSCLC following surgical resection and standard adjuvant therapy.
SECONDARY OBJECTIVES:
I. To evaluate the safety profile of nivolumab when given as an adjuvant therapy.
II. To evaluate and compare disease free and overall survival in patients with tumors that express programmed cell death ligand (PD-L)1 in various patterns associated with nivolumab and standard observation.
III. To evaluate and compare disease free and overall survival in patients with tumors that have high mutational load associated with nivolumab and standard observation.
IV. To evaluate OS and DFS by stage. V. To evaluate OS and DFS by each stratification factor.