Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer

Key Inclusion Criteria:

1. Men and women ≥20 years of age for Japanese patients

2. Patients with histologically or cytologically documented squamous or non-squamousNSCLC with stage IIIB or IIIC disease who are not candidates for treatment withdefinitive concurrent chemoradiation or patients with stage IV disease if they havenot received prior systemic treatment for recurrent or metastatic NSCLC

3. Availability of an archival (≤5 months) or on-study obtained formalin-fixed,paraffin-embedded tumor tissue sample from a metastatic or recurrent site, which hasnot previously been irradiated

4. Part 1 only: Expression of PD-L1 in <50% of tumor cells determined by a commerciallyavailable assay performed by the central laboratory

5. At least 1 radiographically measurable lesion by computed tomography (CT) ormagnetic resonance imaging (MRI) per RECIST 1.1 criteria. Target lesions may belocated in a previously irradiated field if there is documented (radiographic)disease progression in that site

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

7. Anticipated life expectancy of at least 3 months

Key Exclusion Criteria:

1. Part 1 only: Patients who have never smoked, defined as smoking ≤100 cigarettes in alifetime

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-rosoncogene receptor tyrosine kinase(ROS1) fusions

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

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

6. Ongoing or recent evidence of significant autoimmune disease that required treatmentwith systemic immunosuppressive treatments, which may suggest risk of immune-relatedtreatment-emergent adverse events (irTEAEs)

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply