Phase I Trial of Feasibility and Safety of Liver SBRT in Combination With Immune Checkpoint Inhibition in Patients With Metastatic Non-small Cell Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

Determine the feasibility of liver stereotactic body radiation therapy (SBRT) given in combination with systemic therapy (immune checkpoint inhibitors) in adult patients with metastatic NSCLC with liver metastases.

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

• Adult patients (≥18 years of age)

• Histologically or cytologically confirmed NSCLC with liver metastases

• Eligible for immune checkpoint inhibitors per treating medical oncologist

• Disease must be measurable per RECIST criteria

• ECOG Performance status of 0 - 2

• Adequate organ function per protocol.

• Allowable prior therapy includes adjuvant durvalumab, prior radiotherapy outside the upper abdomen.

• Patients must be willing and able to sign an informed consent form.

• Participants of childbearing potential willing to undergo pregnancy test and use contraception per Appendix.

Locations
United States
Michigan
Veterans Affairs Ann Arbor Healthcare System
RECRUITING
Ann Arbor
Contact Information
Primary
Michael Green, MD
Michael.Green4@va.gov
734-845-3914
Backup
Shaneta Waddy, MHA
Shaneta.Waddy@va.gov
734-845-3914
Time Frame
Start Date: 2022-06-17
Estimated Completion Date: 2026-06-15
Participants
Target number of participants: 12
Treatments
Experimental: Arm 1
This is an open-label, single-arm, single center clinical trial to evaluate the feasibility of liver SBRT (up to 4 metastases) during the first cycle of physician's choice ICI for NSCLC.
Sponsors
Leads: VA Ann Arbor Healthcare System
Collaborators: LUNGevity Foundation

This content was sourced from clinicaltrials.gov