Neoadjuvant Compound 121564 Plus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer

Exclusion Criteria

• •1. Subject deemed unfit for surgery (by pulmonary or cardiac assessment).
• •2. Subject with known autoimmune disease that has required systemic therapy in the last 2 years.
• •3. Prior organ transplantation including allogenic stem-cell transplantation.
• •4. Clinically significant (i.e. active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
• •5. Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade \> 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
• •6. Subject on immunosuppressive therapy or corticosteroids within 14 days prior to starting study drugs.
• •7. Subject with interstitial lung disease that is symptomatic or history of pneumonitis that required oral or systemic glucocorticoids to manage.
• •8. Subject must have recovered from the effects of major surgery or significant trauma at least 14 days prior to therapy.
• •9. Subject with previous malignancies are excluded unless complete remission was achieved at least 2 years prior to therapy.
• •10. Other active malignancy requiring concurrent intervention.
• •11. Subject with active infection requiring systemic therapy.
• •12. Subject with known history of testing positive for human immunodeficiency virus (HIV) or known to have acquired immunodeficiency syndrome (AIDS).
• •13. Subject has known active hepatitis B or C.
• •14. Vaccination within 4 weeks of the first dose of Compound 121564 and while on trials is prohibited except for administration of inactivated vaccines.
• •15. Subject is pregnant or breastfeeding.
• •16. Subject has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• •17. Subject previously had a severe hypersensitivity reaction to any of the study drugs.
• •18. Subject is currently participating and receiving study therapy from another clinical trial.
• •19. Subject had prior treatment with any other anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms.
• •20. Patient who is not willing to sign the consent form.
• •21. Legal incapacity or limited legal capacity patients receiving other oncology specific medication not authorized in the protocol.