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UnknownPhase 1NCT05430009
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLiver SBRT and Pembrolizumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 1, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Unknown

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?VA Ann Arbor Healthcare System

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
VA Ann Arbor Healthcare System
Interventions being studied
Radiation: Liver SBRT; Drug: Pembrolizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Treatment approach
Immunotherapy→Radiation therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Veterans Affairs Ann Arbor Healthcare SystemAnn Arbor, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 1, 2022. Always confirm current availability with the study team.

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