An Open Label, Randomized Study of Neoadjuvant Nivolumab and Chemotherapy, With or Without Sub-ablative Stereotactic Body Radiation Therapy, for Resectable Stage IIA to IIIB Non-small Cell Lung Cancer

Exclusion Criteria

• •1. Participation in another clinical study with an investigational product during the last 3 weeks.
• •2. Active other primary malignancy excepting:
• •* Malignancy treated with curative intent and with no known active disease and of low potential risk for recurrence.
• •* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
• •* Adequately treated carcinoma in situ without evidence of disease eg, cervical cancer in situ, in-situ urinary bladder cancer, treated localized prostate cancer and ductal carcinoma-in situ.
• •3. Current or prior use of immunosuppressive medication within 14 days before the first dose of nivolumab, with the exceptions of intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection), corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid, and steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
• •4. Patients with Grade ≥2 neuropathy.
• •5. Previous receipt of immunotherapy.
• •6. Active or prior documented autoimmune or inflammatory disorders that has required systemic treatment in the past year (including inflammatory bowel disease \[e.g., colitis or Crohn's disease systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). No active diverticulitis within the previous 3 months. The following are exceptions to this criterion:
• •* Patients with vitiligo or alopecia
• •* Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
• •* Any chronic skin condition that does not require systemic therapy
• •* Patients without active disease in the last 5 years may be included but only after consultation with the study physician
• •* Patients with celiac disease controlled by diet alone
• •7. History of allogeneic organ transplant.
• •8. History of hypersensitivity to nivolumab or any excipient.
• •9. Uncontrolled intercurrent illness that would limit compliance with study requirements, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
• •10. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis (TB) testing in line with local practice), active hepatitis B (known positive Hepatitis B virus surface antigen (HBsAg) result), active hepatitis C.
• •11. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of nivolumab monotherapy.
• •12. History of interstitial lung disease, idiopathic pulmonary fibrosis, pneumonitis (including drug induced), or evidence of active pneumonitis on screening chest CT scan.
• •13. Receipt of the last dose of therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, or other investigational agent) for an accepted other malignancy as defined in Section 3.3.2 within 30 days prior to the first dose of study drug for lung cancer.