KEYNOTE-407: This phase III trial is testing carboplatin and paclitaxel (or nab-paclitaxel) alone and in combination with pembrolizumab for the treatment of Non-Small Cell (NSC) Lung Cancer, in adults, that has spread to other parts of the bodyA Randomized, Double-Blind, Phase III Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in First Line Metastatic Squamous Non-small Cell Lung Cancer Subjects

Exclusion

• Has non-squamous histology NSCLC.
• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to administration of pembrolizumab.
• Before the first dose of study drug: a) Has received prior systemic cytotoxic chemotherapy for metastatic disease; b) Has received other targeted or biological antineoplastic therapy (e.g., erlotinib, crizotinib, cetuximab) for metastatic disease; c) Has had major surgery (<3 weeks prior to first dose).
• Received radiation therapy to the lung that is > 30 Gy within 6 months of the first dose of study drug.
• Completed palliative radiotherapy within 7 days of the first dose of study drug.
• Is expected to require any other form of antineoplastic therapy while on study.
• Has received a live-virus vaccination within 30 days of planned treatment start.
• Has a known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has pre-existing peripheral neuropathy that is ≥ Grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria.
• Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody.
• Has a known sensitivity to any component of carboplatin or paclitaxel or nab-paclitaxel.
• Has active autoimmune disease that has required systemic treatment in past 2 years.
• Is on chronic systemic steroids.
• Had prior treatment with any other anti-programmed cell death 1 (anti-PD-1), or programmed cell death ligand 1 (PD-L1) or PD-L2 agent or an antibody or a small molecule targeting other immuno-regulatory receptors or mechanisms.
• Has participated in any other pembrolizumab trial and has been treated with pembrolizumab.
• Has an active infection requiring therapy.
• Has known history of Human Immunodeficiency Virus (HIV).
• Has known active Hepatitis B or C. Active Hepatitis B.
• Is, at the time of providing documented informed consent, a regular user (including "recreational use") of any illicit drugs or has a recent history (within the last year) of substance abuse (including alcohol).
• Has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.