This phase II trial studies the effects of canakinumab in preventing lung cancer in patients who have high-risk pulmonary nodules. Canakinumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving canakinumab may prevent the development of lung cancer.
PRIMARY OBJECTIVE: I. To determine whether canakinumab increases regression rate of high-risk pulmonary nodules. SECONDARY OBJECTIVES: I. To determine whether canakinumab prolongs lung cancer-free survival. II. To determine whether canakinumab decreases the incidence of lung cancers. III. To assess the safety and tolerability of canakinumab in patients with high-risk indeterminate pulmonary nodules (IPNs). IV. To assess quality of life by patient reported outcomes in patients treated with canakinumab. EXPLORATORY OBJECTIVES: I. To explore the radiographic (including radiomic features) evolution of high-risk IPNs with treatment of canakinumab and to assess their association with risks of lung cancer as well as their association with clinical benefit/toxicities in patients treated with canakinumab. II. To explore the T-cell receptor (TCR) repertoire evolution of patients with high-risk IPNs and assess their association with risks of lung cancer as well as their association with clinical benefit/toxicities in patients treated with canakinumab. III. To explore the evolution of serum soluble factors, such as IFN-gamma and interferon inducible factors (such as CXCL9 and CXCL10), IL-12, TNFalpha, IL-10, TGF-beta, VEGF, IL-6, IL-8, IL-17, IL-18, C-reactive protein etc.) and assess their association with risks of lung cancer as well as their association with clinical benefit/toxicities in patients treated with canakinumab. OUTLINE: Patients receive canakinumab subcutaneously (SC) on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. After completion of study, patients are followed up for 30 days and at 6, 12, and 24 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
50
Given SC
Ancillary studies
M D Anderson Cancer Center
Houston, Texas, United States
RECRUITINGRegression of indeterminate pulmonary nodules (IPNs)
Will assess complete response or partial response by modified Response Evaluation Criteria in Solid Tumors criteria.
Time frame: At 7 months after treatment
Lung cancer-free survival
Will be computed using the Kaplan-Meier method.
Time frame: Up to 24 weeks
Incidence of lung cancers
Time frame: Up to 24 weeks
Incidence of adverse events
Time frame: Up to 24 weeks
Quality of life questionnaires
Assessed using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score ranges (1-4) 1-Not at all, 2-A little, 3-Quite a bit, 4-Very Much
Time frame: Baseline and 24 weeks
Quality of life questionnaires
Assessed using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - the Quality of Life Lung Cancer 29 Module (EORTC QLQ-LC29). Score ranges (1-4) 1-Not at all, 2-A little, 3-Quite a bit, 4-Very Much
Time frame: Baseline and 24 weeks
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