This phase 2 clinical trial will test the effectiveness of FLT3 ligand immunotherapy in combination with stereotactic body radiotherapy (SBRT) in advanced non-small cell lung cancer (NSCLC). The main outcome of this trial will be measured as the time to disease progression. This study is being conducted in New York City.
The details
In advanced NSCLC, cancer has spread to other parts of the body. FLT3 ligand immunotherapy uses the body’s own immune system to fight this disease. It is a signaling molecule that works by binding to immune cells and activating them. This activation triggers the immune system to attack tumor cells and kill them all throughout the body. SBRT uses high-energy radiation to kill cancer cells by damaging their DNA.
The trial will examine whether the combination of FLT3 ligand immunotherapy and SBRT is effective for treating advanced NSCLC. The primary outcome will be measured by the time following treatment before the disease progresses.
Who are they looking for?
This trial is recruiting 29 patients with stage 3 or 4 NSCLC. Patients must have had have at least one type of chemotherapy treatment prior to enrollment. Patients cannot have had chemotherapy, biotherapy, immunotherapy, radiotherapy, or taken corticosteroids for 21 days prior to participation.
Participants cannot have other uncontrolled illnesses, including congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness that could interfere with taking part in the study. Any central nervous system metastases should not have been treated within 60 days of the study. Participants should not have any type of autoimmune illness (where the immune system attacks healthy tissue). Female participants must not be pregnant.
How will it work
Patients will be treated with SBRT to a single tumor site as well as FLT3 immunotherapy. For the first 5 days, the participants will receive daily under-the-skin injections of FLT3 immunotherapy along with the SBRT treatment.
Patients who do not show negative effects or progression of the disease will receive additional cycles of treatment every 2-4 months. The therapy will be stopped if the patient experiences treatment-related negative effects or disease progression.
Progression-free survival will be measured after 4 months.
