Combining liver radiation therapy with immune treatment for lung cancer patients
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
This study is testing if combining radiation therapy to the liver with an immune treatment can help adults with lung cancer that has spread to the liver feel better and manage their disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Ann Arbor Healthcare System Federal |
| Drugs / interventions | durvalumab, radiation, prednisone |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05430009 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of administering stereotactic body radiation therapy (SBRT) to the liver in conjunction with immune checkpoint inhibitors, specifically pembrolizumab, for adult patients diagnosed with metastatic non-small cell lung cancer (NSCLC) that has spread to the liver. The trial will assess the safety and effectiveness of this combined approach in managing liver metastases. Eligible participants must have measurable disease and meet specific health criteria, ensuring they can tolerate the treatments involved.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed NSCLC and liver metastases who are eligible for immune checkpoint inhibitors.
Not a fit: Patients with uncontrolled illnesses, significant comorbidities, or advanced liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with metastatic lung cancer that has spread to the liver.
How similar studies have performed: While the combination of SBRT and immune checkpoint inhibitors is a novel approach, similar studies have shown promise in other cancer types, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan
- Veterans Affairs Ann Arbor Healthcare System — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Michael Green, MD — VA Ann Arbor
- Study coordinator: Michael Green, MD
- Email: Michael.Green4@va.gov
- Phone: 734-845-3914
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.