Liver SBRT in Combination With Immune Checkpoint Inhibition in Patients With Metastatic Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05430009
• Other study ID #: 1652440
• Status: Recruiting
• Phase: Phase 1
• Start date: June 17, 2022
• Est. completion date: June 15, 2026

Study information

• Verified date: July 2022
• Source: VA Ann Arbor Healthcare System
• Contact: Michael Green, MD
• Phone: 734-845-3914
• Email: Michael.Green4[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 15, 2026
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Liver Metastases
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Radiation:
• Liver SBRT
24-45 Gy delivered in 3-5 fractions to 1-4 lesions.

Drug:
• Pembrolizumab
200 mg every 3 weeks or 400 mg every 6 weeks

Locations

Country	Name	City	State
United States	Veterans Affairs Ann Arbor Healthcare System	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
VA Ann Arbor Healthcare System	Lungevity

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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