Recruiting
Phase 1

SBRT & Immune Checkpoint Inhibitors

Sponsor:

VA Ann Arbor Healthcare System

Code:

NCT05430009

Conditions

Liver Metastases

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Liver SBRT

Pembrolizumab

Study Details

Brief 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.

Conditions

Liver Metastases

Non-small Cell Lung Cancer

Study ID

NCT05430009

Start date

Jun 17, 2022

Status verified date

Jul, 2022

Completion date

Jun 15, 2026

Anticipated

Primary completion date

Dec 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Liver SBRT

24-45 Gy delivered in 3-5 fractions to 1-4 lesions.

Pembrolizumab

200 mg every 3 weeks or 400 mg every 6 weeks

Primary outcome measure

  • Percentage of patients who receive all fractions of radiotherapy as planned [ Time Frame: Up to 0.5 years after start of study treatment ]

Central Contacts and Locations

Central contacts

Michael Green, MD

734-845-3914Michael.Green4@va.gov

Shaneta Waddy, MHA

734-845-3914Shaneta.Waddy@va.gov

Locations

Veterans Affairs Ann Arbor Healthcare System

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Michael D Green, MD, PhD

734-845-3914migr@med.umich.edu

More Information

Sponsor

VA Ann Arbor Healthcare System

Last update posted

Aug 1, 2022

Last verified

Jul, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Ann Arbor Healthcare System on 2022-08-01.