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Checkpoint Inhibitor

Pembrolizumab and Radiation for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By Nathan Pennell, MD, PhD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a performance status of ≤1 ECOG Performance Scale
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first visit to 30 days post treatment, up to 25 months
Awards & highlights

Study Summary

This trial is testing whether adding radiation to a drug regimen can help shrink tumors in people with advanced lung cancer.

Who is the study for?
This trial is for adults with advanced lung cancer who've had prior treatment. They must be able to consent, provide a recent tumor biopsy, have good organ function and performance status (ECOG ≤1), not be on certain medications or treatments recently, and agree to use contraception. Excluded are those with active infections, certain mental health issues, pregnancy/breastfeeding, immune deficiencies or suppressive therapies within 7 days of the first dose.Check my eligibility
What is being tested?
The study tests if adding single fraction non-ablative radiation before pembrolizumab (a drug) improves outcomes in stage IV NSCLC patients compared to pembrolizumab alone. Participants will be randomly assigned to one of these two groups and their tumor growth will be monitored.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation in organs including lungs (pneumonitis), liver problems, skin reactions, hormone gland issues (like thyroid disorders), infusion reactions; fatigue; digestive troubles; appetite changes; joint pain; rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are able to perform daily activities with little or no difficulty.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first visit to disease progression, up to 24 months after beginning treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first visit to disease progression, up to 24 months after beginning 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
Number of Patients With Each Response as Measured by RECIST 1.1
Secondary outcome measures
Duration of Local Control of Disease With SFRT
Median Time of Overall Survival
Median Time of Progression Free Survival
+1 more
Other outcome measures
Changes in PD-L1
Number of Patients With Pneumonitis

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Fraction Radiation Therapy (SFRT) + pembrolizumabExperimental Treatment2 Interventions
200mg Pembrolizumab by IV infusion on day 1 of each 3 week cycle. 8Gy will be given in a single fraction on the first day of treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Single Fraction Radiation Therapy
2017
Completed Phase 2
~20
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
456 Previous Clinical Trials
32,100 Total Patients Enrolled
Nathan Pennell, MD, PhDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center
3 Previous Clinical Trials
122 Total Patients Enrolled

Media Library

Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02658097 — Phase 2
~2 spots leftby Jun 2025
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