Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ralph G Zinner
With
Bristol-Myers Squibb
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 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
You may not be if
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
