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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
This randomized phase III trial studies how well nivolumab after surgery and chemotherapy work in treating patients with stage IB-IIIA non-small cell lung cancer. Monoclonal antibodies, such as nivolumab, may stimulate the immune system in different ways and kill tumor cells remaining after surgery and standard of care chemotherapy.
2.1 Co-Primary Endpoints: 2.1.1 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.4cm, II and IIIA, NSCLC following surgical resection and standard adjuvant therapy. 2.2 Secondary Endpoints: 2.2.1 To evaluate the safety profile of nivolumab when given as an adjuvant therapy. 2.2.2 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. 2.2.3 To evaluate and compare disease free and overall survival in patients with tumors that have high mutational load associated with nivolumab and standard observation. 2.2.4 To evaluate OS and DFS by stage. 2.2.5 To evaluate OS and DFS by each stratification factor. 2.2.6 To evaluate the proportion of patients alive and progression free at 1 year, 2 years, and 5 years (OS and DFS rate).