Enrollment complete
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
NCT No.: NCT02595944
Study Type: INTERVENTIONAL
Phase:
Phase III
Region: Colorado
Acronym:
Official 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
Purpose
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.
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate whether adjuvant therapy with nivolumab will result in improved overall survival (OS) and/or disease-free survival (DFS) over standard observation in patients with stage IB >= 4 cm, II and IIIA, non-small cell lung cancer (NSCLC) following surgical resection and standard adjuvant therapy.
II. To evaluate whether adjuvant therapy with nivolumab will result in improved disease-free survival (DFS) over standard observation in patients with stage IB >= 4cm, II and IIIA, NSCLC with high PD-L1 expression (>= 50% staining) following surgical resection and standard adjuvant therapy.
III. To evaluate whether adjuvant therapy with nivolumab will result in improved overall survival (OS) over standard observation in patients with stage IB >= 4cm, II and IIIA, NSCLC following surgical resection and standard adjuvant therapy.
SECONDARY OBJECTIVES:
I. To evaluate the safety profile of nivolumab when given as an adjuvant therapy.
II. To evaluate and compare disease free and overall survival in patients with tumors that express programmed cell death ligand (PD-L)1 in various patterns associated with nivolumab and standard observation.
III. To evaluate and compare disease free and overall survival in patients with tumors that have high mutational load associated with nivolumab and standard observation.
IV. To evaluate OS and DFS by stage. V. To evaluate OS and DFS by each stratification factor.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
ARM II: Patients are followed serially with imaging for 1 year.
After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 2 years, every 6 months for 2 years, and then every 12 months for 6 years.
Age Limit
18 years & older
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 breastfeeding;
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
Please contact the study coordinator for more inclusion information
|
Exclusion Criteria
|
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-PD-1, anti-PD-L1, anti-CTLA4 monoclonal antibody)
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
|
Keywords and/or Specific Medical Conditions
|
|
|
|
-
Antineoplastic Agents, Immunological
|
|
|
|
|
-
Carcinoma, Non-Small-Cell Lung
|
|
|
|
|
|
|
-
Neoplasms by Histologic Type
|
|
|
-
Neoplasms, Glandular and Epithelial
|
|
|
-
Respiratory Tract Diseases
|
-
Respiratory Tract Neoplasms
|
|
|
|
|
Sponsors
- National Cancer Institute (NCI)
|
|