Canakinumab for the Prevention of Lung Cancer, the Can-Prevent-Lung Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Stage IA1 Lung Cancer AJCC v8
- Lung Carcinoma
- Stage IIIB Lung Cancer AJCC v8
- Stage IIIC Lung Cancer AJCC v8
- Stage I Lung Cancer AJCC v8
- Stage IA2 Lung Cancer AJCC v8
- Stage IA3 Lung Cancer AJCC v8
- Stage IB Lung Cancer AJCC v8
- Stage II Lung Cancer AJCC v8
- Stage IIA Lung Cancer AJCC v8
- Stage IIB Lung Cancer AJCC v8
- Stage III Lung Cancer AJCC v8
- Stage IIIA Lung Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 ...
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.
Tracking Information
- NCT #
- NCT04789681
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jianjun Zhang M.D. Anderson Cancer Center
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