A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer

Key Inclusion Criteria:

1. Patients with histologically or cytologically documented squamous or non-squamous
NSCLC who either have stage IIIb or stage IIIc disease who are not candidates for
treatment with definitive concurrent chemo-radiation or have stage IV disease.
Patients must have PD after receiving one prior line of chemotherapy treatment for
advanced NSCLC.

2. Availability of an archival or on-study obtained formalin-fixed, paraffin-embedded
tumor tissue biopsy sample

3. Biopsy evaluable for expression of PD-L1 as determined by a PD-L1 Immunohistochemistry
(IHC) pharma diagnostic test (pharmDx) assay performed by a central laboratory

4. At least 1 radiographically measureable lesion by computed tomography (CT) per RECIST
1.1 criteria

5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

Key Exclusion Criteria:

1. Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime

2. Active or untreated brain metastases or spinal cord compression

3. Patients with tumors tested positive for epidermal growth factor receptor (EGFR) gene
mutations, anaplastic lymphoma kinase (ALK) gene translocations, or C-ros oncogene
receptor tyrosine kinase (ROS1) fusions

4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization

5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing
pneumonia), or active, noninfectious pneumonitis that required immune-suppressive
doses of glucocorticoids to assist with management, or of pneumonitis within the last
5 years

6. Ongoing or recent evidence of significant autoimmune disease that required treatment
with systemic immunosuppressive treatments, which may suggest a risk of immunerelated
treatment-emergent adverse events (irTEAEs)

7. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or
equivalent) within 14 days of randomization

Note: Other protocol defined Inclusion/Exclusion criteria apply.