Study ID: EA5142
Nivolumab is a drug that may help the immune system fight cancer cells. The purpose of this study is to see if taking nivolumab after surgery and chemotherapy will improve overall survival and/or disease-free survival in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) compared to having only chemotherapy after surgery.
To participate in this trial, patients must be willing to attend appointments as needed for up to six years. Patients are also required to receive baseline chest CT scan and may be required to receive additional imaging on a follow-up basis.
Adjuvant nivolumab in resected lung cancers (ANVIL): A randomized phase III study of nivolumab after surgical resection and adjuvant chemotherapy in NSCLC
- Registered to study #A151216 prior to randomization
- Baseline chest CT performed within one month (30 days) of randomization
- Completed any prior adjuvant chemotherapy/RT two or more weeks (six or more weeks for mitomycin/ nitrosoureas) prior to randomization and be adequately recovered
- Squamous and non-squamous patients whose tumors are EGFR and ALK wild-type
- Arm I (nivolumab): Patients receive nivolumab (IV over 30 minutes on day one). Course repeats every two weeks for up to one year in the absence of disease progression or unacceptable toxicity
- Arm II (observation): Patients are followed serially with imaging
- Must have undergone complete surgical removal of stage IB (≥4 cm), II or IIIA NSCLC
- Must have adequately recovered from surgery and chemotherapy at the time of trial randomization
- Must have baseline chest CT scan within 30 days of trial randomization to ensure no evidence of disease
Additional criteria may apply.