NCT04789681

Canakinumab for the Prevention of Lung Cancer, the Can-Prevent-Lung Trial

Single Arm Phase II Trial Using Canakinumab for the Prevention of Lung Cancer (Can-Prevent-Lung)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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) 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.

Conditions

• Lung Carcinoma
• Stage I Lung Cancer AJCC v8
• Stage IA1 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
• Stage IIIB Lung Cancer AJCC v8
• Stage IIIC Lung Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Canakinumab	Given SC
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2021-07-20
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2021-03-09
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study