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
VA Ann Arbor Healthcare System
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 pe…
Interventions
- RadiationLiver SBRT
24-45 Gy delivered in 3-5 fractions to 1-4 lesions.
- DrugPembrolizumab
200 mg every 3 weeks or 400 mg every 6 weeks
Location
- Veterans Affairs Ann Arbor Healthcare SystemAnn Arbor, Michigan