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: Not yet recruiting
• Trial end date: 2026-06-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Ann Arbor Healthcare System
• Collaborator: Lungevity
• Treatments: Pembrolizumab

Criteria

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 per Appendix.

Exclusion Criteria:

• Liver tumor burden which cannot be targeted with SBRT per treating radiation oncologist

• Presence of uncontrolled intercurrent illness or significant comorbidities precluding participation in a clinical study as determined by investigator

• Diagnosis of underlying parenchymal end stage liver disease (cirrhosis) or biliary disease (primary biliary cirrhosis).

• Other invasive malignancy active within 1 years, excluding in situ cancers

• Presence of psychiatric or substance abuse disorders that would interfere with compliance or safety

• Has a known history of active Bacillus Tuberculosis (TB), Hepatitis B or Hepatitis C infection

• Has received a live (active) vaccine within 30 days of enrollment.

• Active autoimmune disease that has required systemic treatment in the past 1 years aside from hormone replacement therapy (ie. thyroxine, insulin, or physiologic corticosteroid replacement therapy)

• Baseline corticosteroid use (>10 mg prednisone daily or equivalent) at study entry

• Pregnancy or breast feeding