NCT05430009 Liver SBRT in Combination With Immune Checkpoint Inhibition in Patients With Metastatic Non-small Cell Lung Cancer
| NCT ID | NCT05430009 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | VA Ann Arbor Healthcare System |
| Condition | Liver Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2022-06-17 |
| Primary Completion | 2025-12-15 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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). * Oth