Actively Recruiting
Liver SBRT in Combination With Immune Checkpoint Inhibition in Patients With Metastatic Non-small Cell Lung Cancer
Led by VA Ann Arbor Healthcare System · Updated on 2022-08-01
12
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
V
VA Ann Arbor Healthcare System
Lead Sponsor
L
LUNGevity Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Liver SBRT in Combination With Immune Checkpoint Inhibition in Patients With Metastatic Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Histologically or cytologically confirmed non-small cell lung cancer with liver metastases
- Eligible for immune checkpoint inhibitors as determined by treating medical oncologist
- Disease measurable according to RECIST criteria
- ECOG Performance status between 0 and 2
- Adequate organ function per protocol requirements
- Prior therapy allowed includes adjuvant durvalumab and prior radiotherapy outside upper abdomen
- Willing and able to sign an informed consent form
- Participants of childbearing potential must agree to pregnancy testing and use contraception as specified
You will not qualify if you...
- Liver tumor burden not suitable for SBRT targeting as determined by radiation oncologist
- Uncontrolled illnesses or significant comorbidities that prevent study participation
- Diagnosis of end stage liver disease (cirrhosis) or primary biliary cirrhosis
- Active invasive malignancy within past year excluding in situ cancers
- Psychiatric or substance abuse disorders that interfere with safety or compliance
- Known active infection with Bacillus Tuberculosis, Hepatitis B, or Hepatitis C
- Receipt of live vaccine within 30 days before enrollment
- Active autoimmune disease requiring systemic treatment within past year except hormone replacement therapy
- Use of baseline corticosteroids greater than 10 mg prednisone daily or equivalent
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Veterans Affairs Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
M
Michael Green, MD
CONTACT
S
Shaneta Waddy, MHA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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