Small Cell Lung Cancer (SCLC) Clinical Trials

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PRIME-LRT: PRomoting IMmunotherapy Efficacy With Low-Dose Liver RT

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years.

• ECOG performance status ≤2 (or Karnofsky ≥60%, see Appendix A).

• Patients must have adequate organ and marrow function to receive standard of care immunotherapy and/or chemoimmunotherapy as per the treating medical oncologist.

• 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.

• Biopsy proven Non-Small Cell Lung Cancer (NSCLC) or Melanoma.

• Radiographic evidence of liver metastases.

• 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.

• 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.

• Patients must have insurance authorization to proceed with radiotherapy prior to initiation of radiation treatment on study

Locations
United States
Ohio
University of Cincinnati Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
UCCC Clinical Trials Office
cancer@uchealth.com
513-584-7698
Backup
Jordan Kharofa, MD
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2029-12-15
Participants
Target number of participants: 21
Treatments
Experimental: LD-LRT
Low-dose radiation to the liver the week prior to Cycles 1, 2 and 3 of systemic treatment.
Sponsors
Leads: Jordan Kharofa

This content was sourced from clinicaltrials.gov