Avelumab in First-line Non-Small Cell Lung Cancer (JAVELIN Lung 100)

Inclusion Criteria:

- Male or female subjects aged greater than or equal to (>=) 18 years

- With Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at
trial entry

- At least 1 measurable tumor lesion

- With histologically confirmed metastatic or recurrent (Stage IV) non-small cell lung
cancer (NSCLC)

- With availability of a recently-obtained, formalin-fixed, paraffin-embedded (FFPE)
tissue sample containing tumor (biopsy from a non-irradiated area preferably within 6
months) or a minimum number of 10 (preferably 25) unstained tumor slides cut within 1
week, and suitable for PD-L1 expression assessment

- Subjects must not have received any treatment for systemic lung cancer, and have an
estimated life expectancy of more than 12 weeks

- Other protocol defined criteria could apply

Exclusion Criteria:

- Subjects whose disease harbors a EGFR mutation, or anaplastic lymphoma kinase (ALK)
rearrangement are not eligible.

- Other exclusion criteria include prior therapy with any antibody or drug targeting T
cell coregulatory proteins, concurrent anticancer treatment, or immunosuppressive
agents

- Known severe hypersensitivity reactions to monoclonal antibodies (Grade >= 3 NCI CTCAE
v 4.03), history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features
of partially controlled asthma), and persisting toxicity related to prior therapy of
Grade > 1 NCI-CTCAE v 4.03.

- Subjects with brain metastases are excluded, except those meeting the following
criteria: brain metastases that have been treated locally and are clinically stable
for at least 2 weeks prior to randomization, subjects must be either off steroids or
on a stable or decreasing dose of <= 10 mg daily prednisone (or equivalent), and do
not have ongoing neurological symptoms that are related to the brain localization of
the disease.

- Other protocol defined criteria could apply