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Protocol No. EA5142

Principal Investigator Leal, Ticiana

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title 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

Objective The purpose of this study is to find if adding the study drug, nivolumab (also known as OPDIVO®), will limit lung cancer from growing back in patients with early stage non-small cell lung cancer.

Treatment Nivolumab is a drug that may turn on the body's immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab may help prevent your cancer from returning, but it could also cause side effects. This research study will allow researchers to find out whether this different treatment is better, the same, or worse. The use of nivolumab in this study is investigational (not approved by the FDA) in your type of cancer. The study drug, nivolumab, is already FDA-approved for use in non-small cell lung cancer that has previously been treated with chemotherapy. The use of nivolumab in this study is investigational (not approved by the FDA) in your type of cancer.

Description A computer will by chance assign you to the groups in the research study. This is called randomization. You will have an equal (50%) chance of being placed in either group. You and your doctor will be informed of your group. Group 1 will get the study drug, nivolumab. Nivolumab is administered by an intravenous (IV) infusion over 30 minutes once every two weeks. Treatment will continue for a maximum of 1 year or 26 doses of nivolumab or until you have side effects, your cancer returns, or you decide to stop. Group 2 will be monitored with standard post-operative follow-up treatment.

Key Eligibility
  • Patients must have undergone complete surgical resection of their stage IB (≥4 cm), II or IIIA NSCLC and have had negative surgical margins
  • Baseline chest CT must be performed within 1 month (30 days) of randomization to ensure no evidence of disease
  • Non-squamous tumors must be EGFR and ALK wild-type
  • Tumors must have PD-L1 status tested
  • Women must not be pregnant or breast-feeding
  • Patients must have adequately recovered from surgery and chemotherapy at the time of randomization
  • Patients must not be receiving any other investigational anti-cancer agents while on study
  • Patients must not have known or suspected autoimmune disease
  • Patients must not have known interstitial lung disease that is symptomatic
  • Patients must not have a known history of HIV, hepatitis B, or hepatitis C infection that is untreated and/or with a detectable viral load

Applicable Disease Sites Lung

Therapies Involved Immunotherapy

Drugs Involved BMS-936558 (Nivolumab); Nivolumab; Opdivo (Nivolumab)

Status Open

Participating Institutions Aspirus UW Cancer Center (formerly Riverview Hospital); Aspirus Wausau Hospital, Aspirus Regional Cancer Center; Johnson Creek, UW Cancer Center; Langlade Memorial Hospital, Aspirus Regional Cancer Ctr; Swedish American Hospital, Rockford ; UW Hospital and Clinics; UWCCC 1 South Park; VA Hospital, Madison, WI