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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 6-months post enrollment
Awards & highlights
No Placebo-Only Group
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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-months post enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months post enrollment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The primary study endpoint is 6-month progression-free survival.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver enzymes are not more than 5 times the normal limit.I have been treated with immune checkpoint inhibitors before.I do not have a serious infection worse than a moderate level.I have no other cancers except for certain skin cancers, in situ cervical cancer, or any cancer I've been free of for 3 years.I haven't had major surgery or significant injury in the last 14 days, or minor non-brain surgery in the last 3 days.My kidney function, measured by creatinine and clearance rate, is within the required range.I have a serious wound, ulcer, or bone fracture that won't heal.I cannot use certain immune therapies due to my uncontrolled health conditions.My cancer is advanced or has spread, and the tumor is at least 1 cm big.I have had chemotherapy, radiotherapy, or surgery before.I am not pregnant or nursing, and if capable of childbearing, I have a recent negative pregnancy test and agree to use birth control during and for 3 months after the study.My last chemotherapy or radiation was over 3 weeks ago.I am eligible for immune therapy as per FDA guidelines.I do not have any serious ongoing illnesses, including heart issues, uncontrolled high blood pressure, recent strokes, or severe infections like HIV.I am a candidate for radiation therapy.I am 18 years old or older.I have not had major surgery in the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: Immune Checkpoint Inhibitor + Radiation
Awards:
This trial has 1 awards, including:- 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.