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Checkpoint Inhibitor

Chemo-Nivo Combo for Lung Cancer

Phase 2
Waitlist Available
Led By Ralph Zinner, MD
Research Sponsored by Ralph G Zinner
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Must not have
Pancoast tumors
Any prior treatment for NSCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how well a combo of therapies works against lung cancer, and how safe and effective it is.

Who is the study for?
This trial is for adults with stage IIIA-IIIC non-small cell lung cancer that hasn't been treated before. They must not have certain genetic alterations, should be able to sign consent, have good organ function and no severe hepatitis or HIV. People can't join if they've had allergic reactions to similar drugs, other cancers that could affect the trial's outcome, require oxygen therapy, or are pregnant.
What is being tested?
The study tests how well patients respond to a combination of Nivolumab (an immunotherapy drug) and chemotherapy followed by either radiation therapy (XRT) or surgery. The goal is to see if this treatment improves outcomes in lung cancer patients who cannot have their tumors surgically removed at diagnosis.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs like the lungs or liver, infusion-related symptoms such as fever or chills, fatigue from chemotherapy, potential complications from surgery or radiation therapy like infection and healing issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My hepatitis B virus load is undetectable with treatment.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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My cancer does not have known changes in EGFR, ALK, or ROS1 genes.
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My lungs are strong enough for surgery.
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My lung cancer is at an advanced stage and hasn't been treated yet.
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My heart function is classified as NYHA class 2B or better.
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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is located at the top part of my lung.
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I have received treatment for non-small cell lung cancer before.
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I need to take more than 10mg of prednisone or its equivalent daily.
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I have not received treatments targeting immune checkpoints.
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My cancer originates in the esophagus.
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I have never had an autoimmune disease or needed steroids for a long-term condition.
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I am currently being treated for an infection.
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My primary tumor can be surgically removed.
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I need to use extra oxygen all the time.
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I have a history of lung scarring or fibrosis.
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I have had radiation therapy to my lung before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Response rate after induction
Secondary study objectives
Change in Toxicity
Change in patient-reported Quality of Life as measured by FACT-TOI
Major pathological response (MPR)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Combination Chemotherapy and Nivolumab and SurgeryExperimental Treatment4 Interventions
Patients with lung cancer receiving combination therapy with surgery
Group II: Combination Chemotherapy and Nivolumab and RadiationExperimental Treatment3 Interventions
Patients with lung cancer receiving combination therapy with radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5220

Find a Location

Who is running the clinical trial?

Ralph G ZinnerLead Sponsor
Bristol-Myers SquibbIndustry Sponsor
2,681 Previous Clinical Trials
4,124,983 Total Patients Enrolled
Ralph Zinner, MDPrincipal InvestigatorUniversity of Kentucky
2 Previous Clinical Trials
69 Total Patients Enrolled
~1 spots leftby Nov 2025
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