Arm 1 for Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, MI
Lung Cancer+3 More
Pembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Lung Cancer
  • Hepatic Metastases
  • Non-small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 0.5 years after start of study treatment

Year 3
Overall survival (OS)
Progression-free survival
Proportion of patients with local control
Proportion of responders with increased frequency of circulating lymphocytes
Year 5
Percentage of patients who receive all fractions of radiotherapy as planned
Year 1
Proportion of patients who develop grade 3 or higher toxicity

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Arm 1
1 of 1
Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Arm 1 · No Placebo Group · Phase 1

Arm 1Experimental Group · 2 Interventions: Pembrolizumab, Liver SBRT · Intervention Types: Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2950

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 0.5 years after start of study treatment

Trial Background

Michael Green, Attending Physician, Radiation Oncology
Principal Investigator
VA Ann Arbor Healthcare System
Closest Location: Veterans Affairs Ann Arbor Healthcare System · Ann Arbor, MI
Photo of ann arbor  1Photo of ann arbor  2Photo of ann arbor  3
2017First Recorded Clinical Trial
0 TrialsResearching Lung Cancer
2 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a histologically or cytologically confirmed non-small cell lung cancer with liver metastases.
The patient must have a measurable disease per RECIST criteria.
You have an adult patient (≥18 years of age).
You have received prior radiotherapy to the upper abdomen.
You are willing and able to sign an informed consent form.
You are of childbearing potential.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.