Recruiting

LD-LRT

Sponsor:

Jordan Kharofa

Code:

NCT07225036

Conditions

Low-Dose Liver Radiation (LD-LRT)

Non Small Cell Lung Cancer

Melanoma

Liver Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LD-LRT

Study Details

Brief summary:

The purpose of this study is to see if adding Low-Dose Liver Radiation (LD-LRT) improves progression free survival (PFS). This study is for patients with either melanoma or non-small cell lung cancer (NSCLC), with liver metastases, and receiving immunotherapy.

Conditions

Low-Dose Liver Radiation (LD-LRT)

Non Small Cell Lung Cancer

Melanoma

Liver Metastases

Study ID

NCT07225036

Start date

Dec 15, 2025

Status verified date

Feb, 2026

Completion date

Dec 15, 2029

Anticipated

Primary completion date

Jun 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥18 years.
2. ECOG performance status ≤2 (or Karnofsky ≥60%, see Appendix A).
3. Patients must have adequate organ and marrow function to receive standard of care immunotherapy and/or chemoimmunotherapy as per the treating medical oncologist.
4. Must be planning to, and able to, undergo active treatment with PD-L1 or PD-1 checkpoint immunotherapy given per standard care throughout the duration of the RT intervention per their treating physician.

• Note: Patients may receive other SOC CTLA 4 inhibitors or other SOC chemotherapy/immunotherapy in combination with a SOC PD-L1 or PD-1 checkpoint inhibitor and remain eligible.
5. Biopsy proven Non-Small Cell Lung Cancer (NSCLC) or Melanoma.
6. Radiographic evidence of liver metastases.
7. Women of child-bearing potential and men must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
8. Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
9. Patients must have insurance authorization to proceed with radiotherapy prior to initiation of radiation treatment on study

Exclusion Criteria:

1. Patients with prior immunotherapy use in the adjuvant setting for NSCLC or Melanoma are eligible unless the adjuvant immunotherapy was delivered within 6 months of enrollment.
2. Patients with NSCLC are ineligible for enrollment in cohort 1 if the presence of the following driver mutations are noted: EGFR, ALK, ROS1, RET.
3. Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous, in the opinion of the Investigator.
4. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen in the opinion of the Investigator.
5. Pregnant women are excluded from this study considering the use of ionizing radiation.

Study Design

Enrollment

21 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LD-LRT

Low-dose radiation to the liver the week prior to Cycles 1, 2 and 3 of systemic treatment.

Interventions

LD-LRT

Low-dose radiation to the liver the week prior to Cycles 1, 2 and 3 of standard of care immunotherapy treatment.

Primary outcome measure

  • Progression free survival (PFS) measured by 6-month PFS for each cohort compared separately to historical trials with an effect size goal of 25% improvement in 6-month PFS [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

UCCC Clinical Trials Office

513-584-7698cancer@uchealth.com

Locations

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Principal Investigator:

Jordan Kharofa, MD

More Information

Sponsor

Jordan Kharofa

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jordan Kharofa on 2026-02-27.