18F-PD-L1 PET/CT in Nivolumab Treated Patients With NSCLC

Exclusion Criteria

• •1. Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to day 1 (PET imaging). Inhaled or topical steroids, and adrenal replacement steroid \>10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
• •2. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
• •3. Has symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
• •* Note: Subjects with asymptomatic CNS metastases are allowed to enter the study.
• •* Note: Subjects with previously treated brain metastases may participate provided they are clinically stable and not using steroids with \> 10 mg daily prednisone equivalent for at least 7 days prior to trial treatment.
• •4. Has an active autoimmune disease requiring systemic steroid treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids.
• •5. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
• •6. Has an active infection requiring systemic therapy.
• •7. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• •8. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• •9. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 23 weeks after the last dose of trial treatment.
• •10. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
• •11. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
• •12. Has known active Hepatitis B or C.