Single Arm Phase II Trial Using Canakinumab for the Prevention of Lung Cancer (Can-Prevent-Lung)
M.D. Anderson Cancer Center
Summary
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.
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 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) ev…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * The participant (or legally authorized representative if applicable) provides written informed consent for the trial * Participants are eligible to be included in the study if one of the following criteria applies: * Patients with no history of lung cancer, who have persistent IPNs (on two computed tomography \[CT\] scans at least 3 months apart with no evidence of shrinkage or regression) detected by low dose computed tomography \[LDCT\]-guided lung cancer screening or imaging studies for other reasons (incidentalomas) with 10-30% cancer probability by Brock Universi…
Interventions
- DrugCanakinumab
Given SC
- OtherQuality-of-Life Assessment
Ancillary studies
Location
- M D Anderson Cancer CenterHouston, Texas