Induction Chemo-Nivo in Unresectable Stage III NSCLC
The purpose of this study is to determine the response rate, safety, and effectiveness of a combination therapy in patients with lung cancer.
Checked against the public recordLast updated Apr 30, 2025 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion 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 Exclusion 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.
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.