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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
VA Ann Arbor Healthcare System
Study ID
NCT05430009
Phase
PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liver SBRT — RADIATION
    24-45 Gy delivered in 3-5 fractions to 1-4 lesions.
  • Pembrolizumab — DRUG
    200 mg every 3 weeks or 400 mg every 6 weeks

Study Details

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.

Key Dates

Start date
Jun 17, 2022
Status verified
Jul 2022
Primary completion
Dec 15, 2025
Completion
Jun 15, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    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.

Primary Outcome Measure

Percentage of patients who receive all fractions of radiotherapy as planned [ Time Frame: Up to 0.5 years after start of study treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Veterans Affairs Ann Arbor Healthcare SystemAnn ArborMichigan48109
Michael D Green, MD, PhD
734-845-3914

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