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

NCT ID: NCT05430009

Last Updated: 2022-08-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-17
• Study Completion Date: 2026-06-15

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Liver SBRT

Intervention Type: RADIATION

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

Pembrolizumab

Intervention Type: DRUG

200 mg every 3 weeks or 400 mg every 6 weeks

Interventions

Liver SBRT

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

Intervention Type: RADIATION

Pembrolizumab

200 mg every 3 weeks or 400 mg every 6 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LUNGevity Foundation

OTHER

Sponsor Role: collaborator

VA Ann Arbor Healthcare System

FED

Sponsor Role: lead

Responsible Party

Michael Green

Attending Physician, Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Green, MD

Role: PRINCIPAL_INVESTIGATOR

VA Ann Arbor

Locations

Veterans Affairs Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael Green, MD

Role: CONTACT

Michael.Green4@va.gov

734-845-3914

Shaneta Waddy, MHA

Role: CONTACT

Shaneta.Waddy@va.gov

734-845-3914

Facility Contacts

Michael D Green, MD, PhD

Role: primary

migr@med.umich.edu

734-845-3914

Other Identifiers

1652440

Identifier Type: -

Identifier Source: org_study_id