Clinical trial · Interventional
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
NCT05430009CI-TRIAL-00060001unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Metastases | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liver SBRT | Radiation | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- This is an open-label, single-arm, single center clinical trial to evaluate the feasibility of liver SBRT (up to 4 metastases) during the first cycle of physician's choice ICI for NSCLC.
- interventionNames
- Radiation: Liver SBRT
- Drug: Pembrolizumab
Primary outcomes (1)
- measure
- Percentage of patients who receive all fractions of radiotherapy as planned
- timeFrame
- Up to 0.5 years after start of study treatment
- description
- Feasibility determination. Analyzed with descriptive statistics.
Secondary outcomes (4)
- measure
- Proportion of patients who develop grade 3 or higher toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.