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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Non-Small Cell Lung Carcinoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria
Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II or IIIA NSCLC according to the American Joint Committee on Cancer (AJCC) 7th edition and have had negative surgical margins
Baseline chest computed tomography (CT) must be performed within 1 month (30 days) of randomization to ensure no evidence of disease; if clinically indicated, additional imaging studies must be performed to rule out metastatic disease
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization
Non-squamous tumors must be epidermal growth factor receptor (EGFR) and anaplastic lymphoma receptor tyrosine kinase (ALK) wild-type (results ascertained in centrally as part of ALCHEMIST-SCREEN protocol)
Tumors must have PD-L1 status tested centrally as part of the ALCHEMIST-SCREEN protocol
All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse during the treatment period and for 31 weeks after the last nivolumab infusion
Patients must have adequately recovered from surgery and chemotherapy at the time of randomization
Minimum time between date of surgery and randomization is 4 weeks
Maximum time allowed between surgery and randomization: - 10 months if adjuvant chemotherapy and radiation therapy was administered - 8 months if adjuvant chemotherapy was administered - 3 months if no chemotherapy is administered
Patients must have completed and recovered from any adjuvant chemotherapy 2 or more weeks prior to randomization (6 weeks for mitomycin and nitrosoureas; 4 weeks for post-operative radiation therapy)
Prior to randomization patients with any non-hematologic toxicity from surgery, chemotherapy and radiation therapy must have recovered to grade =
Exclusion Criteria
Pregnant or breast-feeding
Have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
Prior treatment with an immune checkpoint inhibitor (anti-programmed cell death [PD]-1, anti-PD-L1, anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA4] monoclonal antibody)
Have any history of active malignancy within two years from randomization deemed by the investigator to pose a higher risk of recurrence than the lung cancer in question
Have known or suspected autoimmune disease; subjects with type I diabetes mellitus, hypothyroidism requiring hormone replacement, or skin disorders not requiring systemic treatment are permitted to enroll
Have a condition requiring systemic corticosteroids equivalent to > 10 mg prednisone per day or other immunosuppressive medications within 2 weeks of randomization
Have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
Have a known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection that is untreated and/or with a detectable viral load
Have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab

Recruitment Status

Open

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