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Checkpoint Inhibitor

Chemo-Nivo Combo for Lung Cancer

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response rate after induction

Secondary outcome measures

Change in Toxicity

Change in patient-reported Quality of Life as measured by FACT-TOI

Major pathological response (MPR)

+4 more

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

~4750

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ralph G ZinnerLead Sponsor

Bristol-Myers SquibbIndustry Sponsor

2,641 Previous Clinical Trials

4,130,027 Total Patients Enrolled

Ralph Zinner, MDPrincipal InvestigatorUniversity of Kentucky

2 Previous Clinical Trials

69 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are taking part in this investigation?

"Affirmative, the information found on clinicaltrials.gov asserts that this particular medical trial is presently searching for participants. It was initially posted on September 22nd 2023 and was recently modified on November 2nd 2023; it aims to recruit 37 individuals from a single site."

Answered by AI

Are there any unfilled slots available for those wishing to take part in this experiment?

"According to clinicaltrials.gov, this medical study is actively recruiting participants at present. The trial was first published on September 22nd 2023 and has been amended most recently on November 2nd of the same year."

Answered by AI

Is the therapeutic approach of Combination Chemotherapy, Nivolumab and Surgery recognized by the FDA?

"Combination Chemotherapy and Nivolumab with Surgery has been accorded a safety rating of 2 due to limited evidence from Phase 2 trials that support its security but are insufficient in demonstrating efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Induction Chemo-Nivo in Unresectable Stage III NSCLC

Ralph G Zinner 2023. "Induction Chemo-Nivo in Unresectable Stage III NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06003075.