Grapiprant (ARY-007) and Pembrolizumab in Patients With Advanced or Metastatic Post-PD-1/L1 NSCLC Adenocarcinoma

Exclusion Criteria

• •Current use of NSAIDs, COX-2 inhibitors
• •Known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), ROS gene alteration
• •No history of smoking (≤100 cigarettes lifetime)
• •History of severe hypersensitivity reactions to a PD-1/L1 antibody
• •Received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment or 5 half-lives, whichever is shorter
• •Received prior radiotherapy within 2 weeks of start of study treatment
• •Has received a live vaccine within 30 days prior to the first dose of study treatment
• •Taking strong CYP3A4 or P-glycoprotein inhibitors or inducers
• •Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
• •Known additional malignancy that is progressing or has required active treatment within the past 3 years (with some permitted exceptions)
• •Known active CNS metastases and/or carcinomatous meningitis
• •Active autoimmune disease that has required systemic treatment in past 2 years
• •History of pneumonitis that required steroids or has current pneumonitis
• •Has an active infection requiring systemic therapy
• •Recent or current GI ulcer, colitis or non-immune colitis
• •Known history of human immunodeficiency virus (HIV) infection, or known active Hepatitis B, or Hepatitis C virus infection
• •Has had an allogeneic tissue/solid organ transplant
• •Clinically significant (i.e.active) cardiovascular disease