Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)

Inclusion Criteria:

Histologically or cytologically confirmed lung cancer (Stage IIIb/IV nonsmall-cell lung cancer or extensive stage small-cell lung cancer [SCLC])
Measurable tumor lesion (as long as it is not located in a previously irradiated area) as defined by modified World Health Organization criteria
Eastern Cooperative Oncology Group performance status of ≤1 at study entry
Accessible for treatment and follow-up

Exclusion Criteria:

Brain metastases
Malignant pleural effusion
Autoimmune disease
Motor neuropathy of autoimmune origin
SCLC-related paraneoplastic syndromes
Any concurrent malignancy other than nonmelanoma skin cancer; carcinoma in situ of the cervix or breast; or prostate cancer treated with systemic therapy (participants with a previous malignancy but without evidence of disease for 5 years were allowed to enter the study)

Prior systemic therapy for lung cancer. Prior radiation therapy or locoregional surgeries performed later than at least 3 weeks prior to randomization date were allowed.

Grade 2 peripheral neuropathy (motor or sensory)
Known HIV or hepatitis B or C infection
Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or noncancer-related illnesses). However, use of corticosteroids was allowed if used as premedication for paclitaxel infusion or for treating immune-related adverse events or adrenal insufficiencies.
Inadequate hematologic function defined by an absolute neutrophil count <1,500/mm^3, a platelet count <100,000/mm^3, or hemoglobin level <9 g/dL.
Inadequate hepatic function defined by a total bilirubin level >2.0 times the upper limit of normal (ULN), or ≥2.5 times the ULN if liver metastases are present, aspartate aminotransferase and alanine aminotransferase levels ≥2.5 times the ULN or ≥5 times the ULN if liver metastases are present.
Inadequate renal function defined by a serum creatinine level ≥2.5 times the ULN
Inadequate creatinine clearance defined as less than 50 mL/min.