RecruitingPhase 1NCT05430009
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
Sponsor
VA Ann Arbor Healthcare System
Enrollment
12 participants
Start Date
Jun 17, 2022
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria9
- 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 Criteria10
- 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
Interventions
RADIATIONLiver SBRT
24-45 Gy delivered in 3-5 fractions to 1-4 lesions.
DRUGPembrolizumab
200 mg every 3 weeks or 400 mg every 6 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05430009
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