A Phase 1 interventional study of Liver SBRT and Pembrolizumab in Liver Metastases and Non-small Cell Lung Cancer, sponsored by VA Ann Arbor Healthcare System. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-01.
Sponsored by VA Ann Arbor Healthcare System · Phase 1, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 12 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →VA Ann Arbor Healthcare System is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Radiation: Liver SBRT · Drug: Pembrolizumab
24-45 Gy delivered in 3-5 fractions to 1-4 lesions.
200 mg every 3 weeks or 400 mg every 6 weeks
Percentage of patients who receive all fractions of radiotherapy as planned
Feasibility determination. Analyzed with descriptive statistics.
Time frame: Up to 0.5 years after start of study treatment
Proportion of patients who develop grade 3 or higher toxicity
Any serious adverse event that occurs within 60 days after treatment with SBRT or after this time frame and is considered related to the study treatment will also be reported. Analyzed with descriptive statistics.
Time frame: Up to 1 year after start of study treatment
Progression-free survival
PFS defined as the time from start of treatment to date of radiological or clinical progression (leading to withdrawal from the study), or death from any cause, whichever comes first. Assessed Per RECIST v1.1; analyzed using Kaplan-Meier curves and descriptive statistics.
Time frame: Time Frame: Up to 3 years after end of study treatment
Overall survival (OS)
OS defined as the time from start of treatment to death. This will be analyzed using Kaplan-Meier curves and descriptive statistics.
Time frame: Time Frame: Up to 3 years after end of study treatment
Proportion of patients with local control
Freedom from local progression (local control) is defined as the lack of progression of the tumors treated by RT, either by tumor size or enhancement. Progression or development of new tumors elsewhere in the liver or outside of the liver would not constitute a local control failure. Tumors which increase in size or demonstrate new or increasing enhancement are considered progression. Analyzed using Kaplan-Meier curves and descriptive statistics.
Time frame: Time Frame: Up to 3 years after end of study treatment
Proportion of responders with increased frequency of circulating lymphocytes
Flow cytometry quantification of circulating biomarkers. Analyzed with paired T-test.
Time frame: Time Frame: Up to 3 years after end of study treatment
Plan to share: No
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VA Ann Arbor Healthcare System