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Checkpoint Inhibitor

Radiation + Immunotherapy for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By John Villano, MD, PhD
Research Sponsored by John L. Villano, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
AST and ALT with hepatic metastasis ≤ 5 x ULN
Creatinine ≤ 1.5 x ULN and Requires CrCl ≥ 60ml/min (per 24-hour urine collection or calculated according to the Cockcroft-Gault formula)
Must not have
Prior treatment with immune checkpoint inhibitors
Active clinically serious infection > CTCAE Grade 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at specified points--1) prior to each cycle of therapy for 4 cycles (one cycle equals 6 weeks) 2) at disease progression (date first progression post-randomization, assessed up to 3 years) 3) when participant is off-study, assessed up to 3 years
Awards & highlights

Summary

This trial is proposing to treat metastatic non-small cell lung cancer and head/neck squamous cell cancer patients who are already initiating an immune checkpoint inhibitor by delivering a short-course radiation. The objective is to assess six-month progression free survival compared to historical control.

Who is the study for?
Adults with advanced non-small cell lung cancer or head/neck squamous cell carcinoma, who can have radiation therapy and are starting immune checkpoint inhibitors. They must not be pregnant, agree to use contraception, and have no major surgery within 14 days before the trial. No other cancers unless cured over 3 years ago.
What is being tested?
The study tests if a short course of radiation at a single site enhances the effect of FDA-approved immune checkpoint inhibitors like Nivolumab in patients with metastatic lung or head/neck cancer by improving six-month progression free survival rates.
What are the potential side effects?
Possible side effects include typical reactions to radiation such as skin irritation and fatigue, along with those related to immune checkpoint inhibitors: inflammation in organs, infusion reactions, potential for autoimmune conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver enzymes are not more than 5 times the normal limit.
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My kidney function, measured by creatinine and clearance rate, is within the required range.
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My cancer is advanced or has spread, and the tumor is at least 1 cm big.
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I have had chemotherapy, radiotherapy, or surgery before.
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I am a candidate for radiation therapy.
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I am 18 years old or older.
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I have not had major surgery in the last 14 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with immune checkpoint inhibitors before.
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I do not have a serious infection worse than a moderate level.
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I do not have any serious ongoing illnesses, including heart issues, uncontrolled high blood pressure, recent strokes, or severe infections like HIV.
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I have a serious wound, ulcer, or bone fracture that won't heal.
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I cannot use certain immune therapies due to my uncontrolled health conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at specified points--1) prior to each cycle of therapy for 4 cycles (one cycle equals 6 weeks) 2) at disease progression (date first progression post-randomization, assessed up to 3 years) 3) when participant is off-study, assessed up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at specified points--1) prior to each cycle of therapy for 4 cycles (one cycle equals 6 weeks) 2) at disease progression (date first progression post-randomization, assessed up to 3 years) 3) when participant is off-study, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary study endpoint is 6-month progression-free survival.
Secondary outcome measures
Percentage PD-L1+ CD4+ and PD-L1+ CD8+ T-cell expression differences during treatment
Percentage of (programmed death) PD-1+ CD4+ T (helper) cells and PD-1+ CD8+ T (cytotoxic) cells prior to treatment versus with concurrent treatment.
Percentage of CD8+ T-cells that are gamma-interferon positive during treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Immune Checkpoint Inhibitor + RadiationExperimental Treatment2 Interventions
Immune checkpoint inhibitor (Nivolumab OR Pembrolizumab OR Atezolizumab) PLUS Radiation Therapy (Stereotactic Body Radiation Therapy OR fractionated radiation therapy)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Immune checkpoint inhibitor
2017
Completed Phase 1
~142970
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

John L. Villano, MD, PhDLead Sponsor
2 Previous Clinical Trials
17 Total Patients Enrolled
John Villano, MD, PhDPrincipal InvestigatorUniversity of Kentucky
1 Previous Clinical Trials
3 Total Patients Enrolled

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03313804 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Immune Checkpoint Inhibitor + Radiation
Non-Small Cell Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03313804 — Phase 2
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03313804 — Phase 2
~10 spots leftby Sep 2025
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