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

Inclusion Criteria

• Male and female adult patients at least 18 years of age on day of signing informed consent
• Histologically confirmed non-small cell lung cancer (NSCLC) adenocarcinoma
• Advanced (stage IIIb) disease that is not amenable to curative intent treatment with concurrent chemoradiation and metastatic (stage IV) patients
• Progressed clinically and/or radiographically per RECIST v1.1 after receiving a PD-1 or PD-L1 antagonist for a minimum of 12 weeks
• Measurable disease per RECIST v1.1
• Disease that can be safely accessed via bronchoscopic, thoracoscopic or percutaneous biopsy for multiple core biopsies and participant is willing to provide tissue from newly obtain biopsies on study in a subgroup of patients
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Adequate organ function
• Highly effective birth control
• Able to swallow and absorb oral tablets Key

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