RECRUITINGPhase 1INTERVENTIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Adult patients (≥18 years of age)
- diagnosed by tissue sample (biopsy-confirmed) NSCLC with liver metastases
- Eligible for immune checkpoint inhibitors per treating medical oncologist
- Disease must be measurable per RECIST criteria
- You should be able to carry out daily activities with 0 level of ability (ECOG 0) - 2
- your organs (liver, kidneys, etc.) are working well enough based on blood tests per protocol.
- Allowable prior therapy includes adjuvant durvalumab, prior radiotherapy outside the upper abdomen.
- Patients must be willing and able to sign an willing to sign a consent form form.
- Participants of childbearing potential willing to undergo pregnancy test and use contraception per Appendix.
Who Should NOT Join This Trial:
- 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 conditions (where your immune system attacks your own body) 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
RADIATION
Liver SBRT
24-45 Gy delivered in 3-5 fractions to 1-4 lesions.
DRUG
Pembrolizumab
200 mg every 3 weeks or 400 mg every 6 weeks
Locations (1)
Veterans Affairs Ann Arbor Healthcare System
Ann Arbor, Michigan, United States