Pulmonary sarcomatoid_MEDI4736+Treme

Exclusion Criteria

• •1. A patient with no measurable disease
• •2. chronic systemic steroid therapy or on any other form of immunosuppressive medication
• •3. has received a live-virus vaccination within 30 days of planned treatment start
• •4. history of diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis which are known risks factors for bowel perforation
• •5. active symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
• •6. severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
• •7. active autoimmune disease within the past 2 years (NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment -within the past 2 years- are not excluded) or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
• •8. prior treatment with any other anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or anti CTLA4 agents (including durvalumab and tremelimumab)
• •9. active infection requiring therapy
• •10. history of Human Immunodeficiency Virus (HIV)
• •11. active Hepatitis B or C (inactive healthy carriers of HBV with appropriate prophylactic antiviral agents are allowed)
• •12. symptomatic ascites or pleural effusion
• •13. pneumonitis that has required a course of oral steroids to assist with recovery, or a history of interstitial lung disease
• •14. pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
• •15. History of active tuberculosis
• •16. History of allogeneic organ transplant. Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
• •17. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) ≤ 21 days prior to the first dose of study drug
• •18. History of allogeneic organ transplant
• •19. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
• •20. 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 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period