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TerminatedPhase 2NCT06003075
Official study title

Induction Chemo-Nivo in Unresectable Stage III NSCLC

Study summary

The purpose of this study is to determine the response rate, safety, and effectiveness of a combination therapy in patients with lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNivolumab and Chemotherapy and Nivolumab

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 30, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Ralph G Zinner

Study sponsor

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Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Ralph G Zinner
Interventions being studied
Combination Product: Nivolumab and Chemotherapy; Drug: Nivolumab; Procedure: Post Induction Surgery; Radiation: Post Induction XRT
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Early-stage or resectable→Locally advanced→
Treatment approach
Immunotherapy→Chemotherapy→Surgery→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Squamous and non-squamous non-small cell lung cancer that is at baseline, unresectable stage IIIA-IIIC (8th edition AJCC) and not previously treated
  • PD-L1 level needs to be measured with values 0-100% eligible
  • EGFR/ALK/ROS1 Wild Type or unknown genetic alterations in these genes
  • ECOG Performance Status ≤ 1
  • Adequate organ and marrow function
  • Adequate pulmonary reserve (e.g., FVC, FEV1, TLC, FRC, and DLCO) capable of tolerating the proposed lung resection
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
  • 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.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • Clinical risk assessment of cardiac function using the New York Heart Association Functional Classification class 2B or better
  • Ability to understand and the willingness to sign a written informed consent document
Reasons someone may not be able to joinExclusion criteria
  • Patients who have participated in a study with an investigational agent or device within 2 weeks of enrollment
  • Any prior radiotherapy to the lung
  • Any prior treatment for NSCLC
  • Any prior therapy with anti-PD-1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
  • Any history of a severe hypersensitivity reaction to any monoclonal antibody
  • Any history of allergy to the study drug components
  • primary tumors involving the esophagus
  • pancoast tumors
  • Patients cannot have primary tumors which would remain unresectable
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nivolumab or other agents used in study
  • Any active or history of autoimmune disease (including any history of inflammatory bowel disease), or history of syndrome that required systemic steroids or immunosuppressive medications
  • Ongoing requirement for systemic corticosteroids greater than the equivalent of prednisone 10mg
  • previous malignancies
  • history of interstitial lung disease
  • Patients requiring continuous supplemental oxygen
  • Use of any live vaccines against infectious diseases (e.g., influenza, varicella. etc.) within 4 weeks (28 days) of initiation of study therapy
  • Active systemic infection requiring therapy
  • Patients with uncontrolled intercurrent illness
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or lactating women

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of KentuckyLexington, Kentucky

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 30, 2025. Always confirm current availability with the study team.

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