Liver SBRT in Combination With Immune Checkpoint Inhibition in Patients With Metastatic Non-small Cell Lung Cancer

VA Ann Arbor Healthcare System

Status and phase: Enrolling; Phase 1

Conditions: Non-small Cell Lung Cancer; Liver Metastases

Treatments: Drug: Pembrolizumab; Radiation: Liver SBRT

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05430009

1652440

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Arm 1

Experimental group

Description:

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.

Treatment:

Radiation: Liver SBRT

Drug: Pembrolizumab