Study on Grid Radiation Therapy and Immunotherapy for Stage IV Non-Small Cell Lung Cancer

Sponsor: Mayo Clinic

Sponsor score: 60

ClinicalTrials ID:NCT06660407

This clinical trial is exploring the safety and effectiveness of combining grid radiation therapy with standard immunotherapy to treat patients with stage IV non-small cell lung cancer (NSCLC). The study aims to see if this combination can better control the cancer and improve patient outcomes.

Patient Parameters

Parameter	Options

Program Overview

The purpose of this study is to test a new approach for treating stage IV non-small cell lung cancer (NSCLC) by combining grid radiation therapy with standard immunotherapy. Grid radiation therapy delivers high doses of radiation to small areas of the tumor, which may enhance the killing of cancer cells. This method has shown promising results in reducing tumor size and controlling the disease with minimal side effects. By combining it with immunotherapy, which is already a key treatment for stage IV NSCLC, researchers hope to improve survival and quality of life for patients.

Description

The main goal of this study is to assess the safety and any side effects of using grid radiation therapy along with immunotherapy in patients with stage IV NSCLC. Researchers will also evaluate how well the treatment works by measuring the response of tumors that are not directly treated with radiation.

Participants will receive grid radiation therapy on the first day, followed by additional radiation over the next few days if needed. They will also continue with their standard immunotherapy treatment. Throughout the study, patients will have regular CT scans and blood tests to monitor their health and the treatment's effects.

After completing the treatment, patients will have follow-up visits at 30 days, then every 8-12 weeks, and every 3 months for up to 5 years to track their progress and any long-term effects.

Eligibility Criteria

Inclusion Criteria

Must be 18 years or older.
Have a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
Have stage IV non-small cell lung cancer that is not responding to first-line immunotherapy or chemoimmunotherapy.
Have not received stereotactic body radiotherapy (SBRT) within 30 days before joining the study.
Have a tumor outside the brain that is 3 cm or larger and suitable for grid therapy.
If there are brain metastases, they must be stable, not growing, and not require steroids.
May receive radiation to up to 2 other metastatic sites, with at least one tumor that can be measured and is not treated with radiation.
Have adequate blood counts and organ function as determined by specific blood tests.
Women of childbearing potential must have a negative pregnancy test before joining the study.
Must agree to provide blood samples for research purposes.
Must be willing to return for follow-up visits.
Must have a life expectancy of more than 3 months.

Exclusion Criteria

Have other serious illnesses or conditions that could interfere with the study.
Have an active autoimmune disease requiring treatment or a history of severe autoimmune disease.
Have uncontrolled infections or other serious health issues like heart failure or unstable heart conditions.
Have had a heart attack or severe heart failure within the last 6 months.
Are taking other investigational drugs for cancer treatment.
Have had severe allergic reactions to immunotherapy.
Have had serious side effects from previous immunotherapy that led to stopping the treatment.
Have another active cancer within the last 6 months, except for certain types that are not likely to spread.
Have had an organ transplant or have a primary immune deficiency.
Test positive for HIV or active tuberculosis.
Have active hepatitis B or C infections.

Locations

FACILITY	ZIP	CITY	STATE
Mayo Clinic in Rochester	55905	Rochester	Minnesota

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.