RecruitingPhase 1NCT05430009

Liver SBRT in Combination With Immune Checkpoint Inhibition in Patients With Metastatic Non-small Cell Lung Cancer

Phase I Trial of Feasibility and Safety of Liver SBRT in Combination With Immune Checkpoint Inhibition in Patients With Metastatic Non-small Cell Lung Cancer


Sponsor

VA Ann Arbor Healthcare System

Enrollment

12 participants

Start Date

Jun 17, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Determine the feasibility of liver stereotactic body radiation therapy (SBRT) given in combination with systemic therapy (immune checkpoint inhibitors) in adult patients with metastatic NSCLC with liver metastases.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a targeted radiation technique to the liver (called stereotactic body radiation therapy, or SBRT) to standard immunotherapy treatment improves outcomes in people with non-small cell lung cancer (NSCLC) that has spread to the liver. The radiation is thought to potentially stimulate the immune system to attack the cancer more broadly. **You may be eligible if:** - You are at least 18 years old - You have confirmed NSCLC with liver metastases - You are eligible for immune checkpoint inhibitor therapy - Your cancer is measurable on scans (RECIST criteria) - Your general health and organ function are adequate (ECOG 0–2) **You may NOT be eligible if:** - Your liver tumor cannot be targeted safely with radiation - You have cirrhosis or end-stage liver disease - You have another active invasive cancer (diagnosed within the past year) - You have active tuberculosis, hepatitis B, or hepatitis C - You have an autoimmune disease requiring systemic treatment - You received a live vaccine within the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONLiver SBRT

24-45 Gy delivered in 3-5 fractions to 1-4 lesions.

DRUGPembrolizumab

200 mg every 3 weeks or 400 mg every 6 weeks


Locations(1)

Veterans Affairs Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05430009


Related Trials