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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
Co-Primary Endpoints:
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 greater than or equal to 4cm, II and IIIA, NSCLC following surgical resection and standard adjuvant therapy.
Secondary Endpoints:
To evaluate the safety profile of nivolumab when given as an adjuvant
therapy
To evaluate and compare disease free and overall survival in patients
with tumors that express PD-L1 in various patterns associated with
nivolumab and standard observation
To evaluate and compare disease free and overall survival in patients
with tumors that have high mutational load associated with nivolumab
and standard observation
To evaluate OS and DFS by stage
To evaluate OS and DFS by each stratification factor
To evaluate the proportion of patients alive and progression free at 1
year, 2 years, and 5 years (OS and DFS rate)
Co-Primary Endpoints:
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 greater than or equal to 4cm, II and IIIA, NSCLC following surgical resection and standard adjuvant therapy.
Secondary Endpoints:
To evaluate the safety profile of nivolumab when given as an adjuvant
therapy
To evaluate and compare disease free and overall survival in patients
with tumors that express PD-L1 in various patterns associated with
nivolumab and standard observation
To evaluate and compare disease free and overall survival in patients
with tumors that have high mutational load associated with nivolumab
and standard observation
To evaluate OS and DFS by stage
To evaluate OS and DFS by each stratification factor
To evaluate the proportion of patients alive and progression free at 1
year, 2 years, and 5 years (OS and DFS rate)
Recruitment Status
Past Studies