RecruitingPhase 1Phase 2NCT05501665

Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer

SiCARIO (Split Course Adaptive Radioimmunotherapy) for the Treatment of Oligometastatic Non-Small Cell Lung Cancer (NSCLC) Using Biologically-Adaptive Radiotherapy - A Phase I/II Study


Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

25 participants

Start Date

May 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I/II trial tests the safety and efficacy of split-course adaptive radiation therapy in combination with immunotherapy with or without chemotherapy for the treatment of patients with stage IV lung cancer or lung cancer that that has spread to nearby tissue or lymph nodes (locally advanced). Radiation therapy is a standard cancer treatment that uses high energy rays to kill cancer cells and shrink tumors. Split-course adaptive radiation therapy uses patient disease response to alter the intensity of the radiation therapy. Immunotherapy with monoclonal antibodies such as pembrolizumab, ipilimumab, cemiplimab, atezolizumab or nivolumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs like carboplatin, pemetrexed, and paclitaxel work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving split-course adaptive radiation therapy with standard treatments like immunotherapy and chemotherapy may be more effective at treating stage IV or locally advanced lung cancer than giving them alone.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new radiotherapy approach combined with the immunotherapy drug pembrolizumab (with or without chemotherapy) for patients with advanced or inoperable stage IV non-small cell lung cancer. The radiation is given in a split-course — two separate sessions — to allow the immune system to respond between treatments. **You may be eligible if...** - You are 18 or older with confirmed stage IV or locally advanced non-small cell lung cancer - You have measurable disease and sufficient tumor tissue for PD-L1 testing - Your general health is acceptable (ECOG 0–2) - Brain metastases, if present, can be managed with surgery or radiation **You may NOT be eligible if...** - You have serious uncontrolled autoimmune disease - Your organ function is not adequate for treatment - You have other conditions that make immunotherapy unsafe 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

PROCEDUREBiospecimen Collection

Correlative studies

DRUGCarboplatin

Given carboplatin

PROCEDUREComputed Tomography

Undergo PET/CT

OTHERFludeoxyglucose F-18

Given IV

DRUGNab-paclitaxel

Given nab-paclitaxel

BIOLOGICALPembrolizumab

Given pembrolizumab

DRUGPemetrexed

Given pemetrexed

PROCEDUREPositron Emission Tomography

Undergo PET/CT

RADIATIONRadiation Therapy

Undergo radiation therapy

OTHER[18-F] (fluoropropyl)-L-glutamate (FSPG) PET scan

Undergo PET scan

BIOLOGICALIpilimumab

Given Ipilimumab

BIOLOGICALNivolumab

Given Nivolumab

BIOLOGICALCemiplimab

Given Cemiplimab

BIOLOGICALAtezolizumab

Given Atezolizumab


Locations(1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

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

Visit

NCT05501665


Related Trials