← Back to Search

Checkpoint Inhibitor

SBRT + Pembrolizumab for Lung Cancer

Phase 1
Recruiting
Led By Michael Green, MD
Research Sponsored by VA Ann Arbor Healthcare System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed NSCLC with liver metastases
Adult patients (≥18 years of age)
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 0.5 years after start of study treatment
Awards & highlights

Summary

This trial will test whether giving liver cancer patients both radiation therapy and systemic therapy together is feasible and effective.

Who is the study for?
Adults with metastatic non-small cell lung cancer (NSCLC) and liver metastases can join this trial. They must have good organ function, be able to take immune checkpoint inhibitors, and not be on high-dose steroids. Pregnant or breastfeeding individuals, those with active autoimmune diseases requiring recent treatment, or significant other illnesses are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of liver stereotactic body radiation therapy (SBRT) with Pembrolizumab, an immune checkpoint inhibitor. It aims to see if this combo is feasible for treating NSCLC patients who also have liver metastases.See study design
What are the potential side effects?
Possible side effects include fatigue, skin reactions from radiation, inflammation due to immune response activation by Pembrolizumab which could affect various organs like lungs or intestines, and potential infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung cancer has spread to my liver.
Select...
I am 18 years old or older.
Select...
I can care for myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an active TB, Hepatitis B, or Hepatitis C infection.
Select...
I have not received a live vaccine in the last 30 days.
Select...
I have been diagnosed with advanced liver disease.
Select...
I have an autoimmune disease treated in the last year, not including hormone therapy.
Select...
I am taking more than 10 mg of prednisone or its equivalent daily.
Select...
My liver cancer cannot be treated with targeted radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 0.5 years after start of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 0.5 years after start of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of patients who receive all fractions of radiotherapy as planned
Secondary outcome measures
Overall survival (OS)
Progression-free survival
Proportion of patients who develop grade 3 or higher toxicity
+1 more
Other outcome measures
Proportion of responders with increased frequency of circulating lymphocytes

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

VA Ann Arbor Healthcare SystemLead Sponsor
17 Previous Clinical Trials
13,036 Total Patients Enrolled
LUNGevity FoundationOTHER
7 Previous Clinical Trials
1,634 Total Patients Enrolled
LungevityUNKNOWN

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05430009 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Arm 1
Non-Small Cell Lung Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05430009 — Phase 1
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05430009 — Phase 1
~5 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top