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Nivolumab After Surgery and Chemotherapy in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer

Status: Recruiting
Phase:
Diagnosis: Lung Cancer
NCT ID: NCT02595944 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 16-723

 

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.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Geoffrey Oxnard, MD, Dana Farber Cancer Institute

Site-responsible Investigators:
Michael Constantine, M.D., Dana Farber Cancer Institute at Milford Hosptial
Daniel Costa, MD, Beth Israel Deaconess Medical Center
Christopher G. Azzoli, MD, Massachusetts General Hospital
Meredith Faggen, MD, Dana Faber Cancer Insitute at South Shore Hospital

Contacts:
Dana-Farber Cancer Institute: Bryan Marion, bryan_marion@dfci.harvard.edu
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

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 - Women must not be pregnant or breast-feeding - 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 NOT 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 - No 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) - 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) - Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =< 2.5 x upper limit normal - Total bilirubin =< 1.5 x upper limit of normal (ULN) (except in subjects with Gilbert syndrome who must have a total bilirubin < 3.0 x ULN) - White blood cell (WBC) >= 2000/uL - Neutrophils >= 1000/uL - Platelets >= 100 x 10^3/uL - Hemoglobin >= 8 g/dL - Serum creatinine =< 2 x ULN - Prior to randomization patients with any non-hematologic toxicity from surgery, chemotherapy and radiation therapy must have recovered to grade =< 1 with the exception of alopecia, ototoxicity and neuropathy - Patients must not 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 - Patients must not be receiving any other investigational anti-cancer agents while on study - Patients must not 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 - Patients must not have a condition requiring systemic corticosteroids equivalent to > 10 mg prednisone per day or other immunosuppressive medications within 2 weeks of randomization - Patients must not have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity - Patients must not 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 - Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab
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