Inclusion Criteria:
- Signed written informed consent before any trial related procedure
- Male or female subjects aged greater than or equal to >= 18 years
- Availability of a formalin-fixed, paraffin-embedded block containing tumor tissue or
7 unstained tumor slides suitable for Programmed death-ligand-1 (PD-L1) expression
assessment
- Tumor determined to be evaluable for PD-L1 expression per the evaluation of a central
laboratory
- Subjects with histologically confirmed Stage IIIb/IV or recurrent NSCLC who have
experienced disease progression
- Subjects must have progressed after an acceptable therapy defined as follows:
1. Subjects must have progressed during or after a minimum of 2 cycles of 1 course
of a platinum based combination therapy administered for the treatment of a
metastatic disease. A history of continuation (use of a non platinum agent from
initial combination) or switch (use of a different agent) maintenance therapy is
permitted provided there was no progression after the initial combination. A
switch of agents during treatment for the management of toxicities is also
permitted provided there was no progression after the initial combination OR
2. Subjects must have progressed within 6 months of completion of a platinum-based
adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation
regimen for locally advanced disease
- Subjects with non-squamous cell NSCLC of unknown Epidermal Growth Factor Receptor
(EGFR) mutation status will require testing (local laboratory, or central laboratory
if local testing is not available). For subjects with a tumor that harbors an
activating EGFR mutation, acceptable prior therapy is also defined as a treatment
with an EGFR-targeting tyrosine kinase inhibitor (TKI) given before or after
treatment with a platinum-based combination chemotherapy as defined above. Subjects
with a tumor that harbors an activating EGFR mutation must have failed both the
platinum-based doublet and the EGFR-targeting TKI. Treatment with more than 1 EGFR
targeting TKI is acceptable
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial
entry
- Estimated life expectancy of more than 12 weeks
- Adequate hematological function defined by white blood cells (WBC) count >= 2.5
10^9 per liter (/L) with absolute neutrophil count (ANC) >= 1.5 10^9/L, lymphocyte
count >= 0.5 10^9/L, platelet count >= 100 10^9/L, and hemoglobin >= 9 gram per
deciliter (g/dL) (may have been transfused)
- Adequate hepatic function defined by a total bilirubin level <= 1.0 the upper limit
of normal (ULN) range and aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) levels <= 2.5 ULN for all subjects
- Adequate renal function defined by an estimated creatinine clearance > 30 milliliter
per minute (mL/min) according to the Cockcroft-Gault formula (or local institutional
standard method)
- Other protocol defined criteria could apply
Exclusion Criteria:
- In the United States only, subjects with a squamous cell histology will be excluded
- Systemic anticancer therapy administered after disease progression during or
following a platinum based combination, with the following exception: Subjects whose
disease harbors an activating EGFR mutation who received an EGFR inhibitor after a
minimum of 2 cycles of first-line platinum-based therapy. Subjects who tested
undetermined or wild-type for EGFR but were previously treated with a TKI are not
eligible unless retested and confirmed to be activating EGFR mutation positive
- Subjects with non-squamous cell NSCLC whose disease harbors an anaplastic lymphoma
kinase (ALK) rearrangement will not be eligible for this trial. Subjects of unknown
ALK status will require testing for ALK rearrangement (local laboratory, or central
laboratory if local testing is not available) and must be determined to be ALK
wild-type to be eligible for this trial
- Prior therapy with any antibody/drug targeting T cell coregulatory proteins (immune
checkpoints) such as PD-1, PD L1, or cytotoxic T lymphocyte antigen-4 (CTLA-4).
Prior therapy with a cancer vaccine is acceptable
- Concurrent anticancer treatment
- Major surgery for any reason, except diagnostic biopsy, within 4 weeks of
randomization and/or if the subject has not fully recovered from the surgery within 4
weeks of randomization
- Subjects receiving immunosuppressive agents (such as steroids) for any reason should
be tapered off these drugs before initiation of the trial treatment
- All subjects with brain metastases, except those meeting the following criteria:
1. Brain metastases have been treated locally, and
2. No ongoing neurological symptoms that are related to the brain localization of
the disease
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory
agent:
1. Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid
disease not requiring immunosuppressive treatment are eligible
2. Subjects requiring hormone replacement with corticosteroids are eligible if the
steroids are administered only for the purpose of hormonal replacement and at
doses 10 mg or 10 mg equivalent prednisone per day
3. Administration of steroids through a route known to result in a minimal systemic
exposure are acceptable
- Previous or ongoing administration of systemic steroids for the management of an
acute allergic phenomenon is acceptable as long as it is anticipated that the
administration of steroids will be completed in 14 days, or that the daily dose after
14 days will be <= 10 mg per day of equivalent prednisone
- Other protocol defined criteria could apply
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both