NCT05430009
Liver SBRT in Combination With Immune Checkpoint Inhibition in Patients With Metastatic Non-small Cell Lung Cancer
UNKNOWN
PHASE1Ages 18+InterventionalTreatmentVA Ann Arbor Healthcare SystemGovernment-funded
~12 participants
Updated 2022-08-01 on ClinicalTrials.gov
What's tested:Liver SBRTPembrolizumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of patients who receive all fractions of radiotherapy as planned
Measured over Up to 0.5 years after start of study treatment
Conditions
Where it's being run
1 sites across 1 statesMichigan1
Study leadership
- Michael Green, MD · PRINCIPAL_INVESTIGATOR · VA Ann Arbor
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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
What this trial measures
- Percentage of patients who receive all fractions of radiotherapy as plannedUp to 0.5 years after start of study treatment
Feasibility determination. Analyzed with descriptive statistics.