Clinical trial NCT05430009: Liver SBRT in Combination With Immune Checkpoint Inhibition in Patients With Metastatic Non-small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Liver Metastases
Non-small Cell Lung Cancer
Lead sponsor: VA Ann Arbor Healthcare System
Sponsor class: FED
Collaborators: name: LUNGevity Foundation
First posted: 2022-06-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Percentage of patients who receive all fractions of radiotherapy as planned
timeFrame: Up to 0.5 years after start of study treatment
Secondary outcomes:
measure: Proportion of patients who develop grade 3 or higher toxicity
timeFrame: Up to 1 year after start of study treatment
measure: Progression-free survival
timeFrame: Time Frame: Up to 3 years after end of study treatment
measure: Overall survival (OS)
timeFrame: Time Frame: Up to 3 years after end of study treatment
measure: Proportion of patients with local control
timeFrame: Time Frame: Up to 3 years after end of study treatment
Other outcomes:
measure: Proportion of responders with increased frequency of circulating lymphocytes
timeFrame: Time Frame: Up to 3 years after end of study treatment
Locations:
city: Ann Arbor
country: United States
facility: Veterans Affairs Ann Arbor Healthcare System
state: Michigan
Study officials:
affiliation: VA Ann Arbor
name: Michael Green, MD
role: PRINCIPAL_INVESTIGATOR
References: