Study on Split-Course Radiation Therapy with Pembrolizumab and Optional Chemotherapy for Stage IV Lung Cancer

Sponsor: Vanderbilt-Ingram Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT05501665

This clinical trial is exploring a new approach to treating stage IV lung cancer by combining split-course radiation therapy with immunotherapy, and possibly chemotherapy, to see if it is safe and effective.

Patient Parameters

Parameter	Options

Program Overview

This study is testing a new treatment method for stage IV lung cancer, which involves using a type of radiation therapy that can be adjusted based on how the cancer responds. This is combined with immunotherapy, which helps the immune system fight cancer, and may also include chemotherapy, which targets cancer cells. The goal is to see if this combination is more effective than using these treatments separately.

Description

The main goals of this study are to determine if the combination of split-course radiation therapy and immunotherapy, with or without chemotherapy, is safe and effective for treating stage IV lung cancer. Researchers will also look at how well this treatment approach can slow down the cancer and improve survival rates.

Patients will be assigned to one of several treatment groups based on their specific type of lung cancer and other factors. Each group will receive a combination of radiation therapy and standard treatments like immunotherapy and chemotherapy. The study will monitor how well the cancer responds to the treatment and any side effects that occur.

Participants will undergo various tests, including PET/CT scans, blood tests, and possibly MRI, to track their progress throughout the study. After completing the treatment, patients will have follow-up visits to monitor their health and the long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

Must be 18 years or older.
Have a confirmed diagnosis of stage IV or locally advanced non-small cell lung cancer that cannot be treated with standard chemoradiation.
Have available tumor material for testing.
Be in good overall health with an ECOG performance status of 0-2.
Have adequate organ function to receive treatment.
If there are brain metastases, they must be manageable with surgery or radiosurgery before starting treatment.
Women must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential.
Eligible for immunotherapy-based treatments as determined by the study doctor.
Able to provide written informed consent.

Exclusion Criteria

Have a type of lung cancer with mixed small cell histology.
Be a candidate for other specific treatments based on genetic mutations.
Have brain metastases requiring whole brain radiotherapy.
Have symptomatic fluid buildup in the abdomen or around the lungs.
Have had major surgery within 4 weeks before starting the study.
Have a history of organ transplant requiring immunosuppression.
Have significant infections or uncontrolled illnesses.
Have had a different cancer within the last 3 years, except for certain skin or in situ cancers.
Have received more than one cycle of immune checkpoint inhibitors for the current cancer.
Have had prior radiotherapy that would interfere with the study treatment.
Be using immunosuppressive medications, except for certain low-dose steroids.
Have an active autoimmune disease requiring treatment in the past year.
Have received a live vaccine within 30 days before starting the study.
Be taking prohibited medications.
Have a known severe allergy to the study treatment.
Be enrolled in another clinical trial, unless it is observational or in the follow-up phase.
Have any condition that would prevent participation in the study, as determined by the investigator.

Locations

FACILITY	ZIP	CITY	STATE
Vanderbilt University/Ingram Cancer Center	37232	Nashville	Tennessee

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