Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| LUNGevity Foundation | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver SBRT | Radiation | 24-45 Gy delivered in 3-5 fractions to 1-4 lesions. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who receive all fractions of radiotherapy as planned | Feasibility determination. Analyzed with descriptive statistics. | Up to 0.5 years after start of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1 year after start of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of responders with increased frequency of circulating lymphocytes | Flow cytometry quantification of circulating biomarkers. Analyzed with paired T-test. | Time Frame: Up to 3 years after end of study treatment |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Green, MD | Contact | 734-845-3914 | Michael.Green4@va.gov | |
| Shaneta Waddy, MHA | Contact | 734-845-3914 | Shaneta.Waddy@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Michael Green, MD | VA Ann Arbor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Ann Arbor Healthcare System | Recruiting | Ann Arbor | Michigan | 48109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pembrolizumab |
| Drug |
200 mg every 3 weeks or 400 mg every 6 weeks |
|
| 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: 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: 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: Up to 3 years after end of study treatment |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |