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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)

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

No Placebo-Only Group

All Individual Drugs Already Approved

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.

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.

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active TB, Hepatitis B, or Hepatitis C infection.

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I have not received a live vaccine in the last 30 days.

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I have been diagnosed with advanced liver disease.

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I have an autoimmune disease treated in the last year, not including hormone therapy.

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I am taking more than 10 mg of prednisone or its equivalent daily.

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My liver cancer cannot be treated with targeted radiation.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of patients who receive all fractions of radiotherapy as planned

Secondary study objectives

Overall survival (OS)

Progression-free survival

Proportion of patients who develop grade 3 or higher toxicity

+1 more

Other study objectives

Proportion of responders with increased frequency of circulating lymphocytes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

0 / 9Eligibility criteria met