RECRUITING

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

Conditions

Liver Metastases Non-small Cell Lung Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-06-17

Study Completion:2026-06-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05430009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Michael Green, MD

CONTACT

734-845-3914

Michael.Green4@va.gov

Shaneta Waddy, MHA

CONTACT

734-845-3914

Shaneta.Waddy@va.gov

Principal Investigator

Michael Green, MD

PRINCIPAL_INVESTIGATOR

VA Ann Arbor

Study Locations (Sites)

Veterans Affairs Ann Arbor Healthcare System

Ann Arbor, Michigan, 48109

United States

Collaborators and Investigators

Sponsor: VA Ann Arbor Healthcare System

Michael Green, MD, PRINCIPAL_INVESTIGATOR, VA Ann Arbor

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-17

Study Completion Date2026-06-15

Study Record Updates

Study Start Date2022-06-17

Study Completion Date2026-06-15

Terms related to this study

Additional Relevant MeSH Terms

Liver Metastases
Non-small Cell Lung Cancer