MK-3475 and Gemcitabine in Non-Small Cell Lung Cancer (NSCLC)

Prior treatment

• Prior therapy with any anti-PD-1, anti-PD-L1, or anti-CTLA4 antibody.
• Prior therapy with gemcitabine.
• Prior complications from radiation, such as history of radiation pneumonitis or pulmonary edema that, in the opinion of the investigator, may have risk of increasing toxicity with anti-PD1 therapy.

Other illness

• Active autoimmune disease except vitiligo or stable hypothyroidism.
• Active and ongoing steroid use, except for non-systemically absorbed treatments (such as inhaled or topical steroid therapy for asthma, cardiopulmonary disease (COPD), allergic rhinitis).
• Active other malignancy, except for controlled basal cell skin carcinoma.
• HIV positive and/or Hepatitis B or C positive.
• Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in this protocol.

• Women or men with advanced, histologically proven NSCLC.
• Patients must have received at least one but no more than three prior systemic therapies for advanced disease.
• Any toxicity related to prior therapies that, in the opinion of the investigator, would potentially be worsened with anti-PD1 therapy or gemcitabine should be resolved to less than Grade 1.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Women of childbearing potential must have a negative pregnancy test
• Ability to give informed consent and comply with the protocol.
• Anticipated survival minimum 3 months.
• Prior therapy with investigational agents must have been completed at least 3 weeks prior to study enrollment.
• Patients must have normal organ and marrow function as seen on protocol-defined blood test results
• Archived tumor tissue (minimum of 8 slides for paraffin-embedded tumor tissue) available
• Measurable disease by RECIST 1.1 criteria.
• Treated brain metastases will be allowed, provided they are asymptomatic.
• Radiation for symptomatic lesions outside the Central nervous system (CNS) must have been completed at least 2 weeks prior to study enrollment.