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

Key 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