Induction Chemo-Nivo in Unresectable Stage III NSCLC

• Status: Recruiting
• Trial end date: 2027-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ralph G Zinner
• Collaborator: Bristol-Myers Squibb
• Treatments: Nivolumab

Criteria

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