Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04789681
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2020-12-16
Brief Title:
Canakinumab for the Prevention of Lung Cancer the Can-Prevent-Lung Trial
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Single Arm Phase II Trial Using Canakinumab for the Prevention of Lung Cancer Can-Prevent-Lung
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 benefittoxicities 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 benefittoxicities 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 benefittoxicities 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
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 benefittoxicities 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 benefittoxicities 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 benefittoxicities 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-0674 | OTHER | M D Anderson Cancer Center | None |
| NCI-2020-11724 | REGISTRY | None | None |