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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 0.5 years after start of study treatment
Awards & highlights
Study 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 belowSelect...
My lung cancer has spread to my liver.
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I am 18 years old or older.
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I can care for myself and am up and about more than 50% of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 0.5 years after start of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 0.5 years after start of study treatment
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 moreOther outcome measures
Proportion of responders with increased frequency of circulating lymphocytes
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
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%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung cancer has spread to my liver.I am 18 years old or older.I have an active TB, Hepatitis B, or Hepatitis C infection.I have not received a live vaccine in the last 30 days.I have not had any other cancer besides in situ cancers in the last year.I have been diagnosed with advanced liver disease.I can care for myself and am up and about more than 50% of my waking hours.I have an autoimmune disease treated in the last year, not including hormone therapy.My doctor has approved me for immune therapy.I've had durvalumab or radiation therapy not targeting my upper abdomen before.I am taking more than 10 mg of prednisone or its equivalent daily.My liver cancer cannot be treated with targeted radiation.My organs are functioning well.You have mental health or drug problems that could make it hard to follow the study rules or be safe.Your disease can be measured using specific guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are actively engaged in the clinical trial?
"Correct. Per clinicaltrials.gov, this research project is currently searching for participants; the trial was first introduced on June 17th 2022 and recently revised on July 27th 2022. 12 patients must be recruited from a single location to participate in the study."
Answered by AI
To what degree do the risks of Liver SBRT outweigh its potential benefits?
"The safety of liver SBRT has been calculated as a 1 due to its Phase 1 status. This means there is minimal data available for evaluating the efficacy and security of this intervention."
Answered by AI
Is there still availability for participants in this experiment?
"Affirmative. Data hosted on clinicaltrials.gov demonstrates that recruitment for this trial is ongoing, with the first post having been made on June 17th 2022 and being last updated on July 27th 2022. This research project seeks to enrol a total of 12 patients at one site."
Answered by AI
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