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Lung
General Information
Study Name:
Nivolumab After Surgery and Chemotherapy in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer (An ALCHEMIST Treatment Trial) (ANVIL)
Age Group:
Adult
Protocol Number:
NCT02595944
Background Information:
This phase III ALCHEMIST 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.
Offered at:
Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital
Eligibility Information
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 not be positive for epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R mutation and anaplastic lymphoma receptor tyrosine kinase (ALK) rearrangement (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
Additional eligibility in protocol
Ineligibility Information
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; inhaled, intra-articular, and epidural steroids are permissible
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.
Additional ineligibility in protocol
Contact Information
Contact Name:
Perry Montgomery, RN
Contact Phone:
571-472-0625
Contact Email:
perry.montgomery@inova.org
Additional information can be found at
https://clinicaltrials.gov/ct2/show/NCT02595944