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

Key Exclusion Criteria:

- Current use of NSAIDs, COX-2 inhibitors

- Known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), ROS
gene alteration, BRAF gene mutation

- 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

- 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, Hepatitis B, or active
Hepatitis C virus infection

- Clinically significant (i.e.active) cardiovascular disease