Status:
TERMINATED
Induction Chemo-Nivo in Unresectable Stage III NSCLC
Lead Sponsor:
Ralph G Zinner
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Lung Cancer, Nonsmall Cell
Lung Cancer Stage III
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the response rate, safety, and effectiveness of a combination therapy in patients with lung cancer.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2024
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT06003075
Start Date
December 13 2023
End Date
July 5 2024
Last Update
April 30 2025
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40506