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Liver SBRT in Combination With Immune Checkpoint Inhibition in Patients With Metastatic Non-small Cell Lung Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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

NCT05430009•VA Ann Arbor Healthcare System

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (1)

Veterans Affairs Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

Key Dates

Start Date

June 17, 2022

Primary Completion Date

December 15, 2025

Completion Date

June 15, 2026

Last Updated

August 1, 2022

Enrollment

ESTIMATED participants

Conditions

Liver MetastasesNon-small Cell Lung Cancer

Interventions

Liver SBRT

RADIATION

Pembrolizumab

DRUG

Contacts

Michael Green, MD

CONTACT

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

Shaneta Waddy, MHA

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

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