Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

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).
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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

12

Study ID:

NCT05430009

Recruitment Status:

Recruiting

Sponsor:

VA Ann Arbor Healthcare System

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There is 1 Location for this study

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Veterans Affairs Ann Arbor Healthcare System
Ann Arbor Michigan, 48109, United States More Info
Michael D Green, MD, PhD
Contact
734-845-3914
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

12

Study ID:

NCT05430009

Recruitment Status:

Recruiting

Sponsor:


VA Ann Arbor Healthcare System

How clear is this clinincal trial information?

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