MK-3475 in Combination With Docetaxel vs Docetaxel Alone in Non-Small Cell Lung Cancer Patients

Inclusion Criteria

• Signed written informed consent
• Patients should be signed and dated form of written informed consent approved by the IRB / IEC in accordance with regulatory and institutional guidelines. This must be obtained before performing any procedure related to the protocol that are not part of the normal care of the patient.
• Patients must be willing and able to comply with scheduled visits , treatment program , laboratory testing including filling of questionnaires the results reported by the patient and other study requirements .
• Target Population
• Subjects with locally advanced NSCLC of squamous cell and non-squamous cell (adenocarcinoma and big cells) histological or cytologically documented , those who submit Stage IIIB / IV or recurrent disease after receiving radiation treatment or surgical resection
• Men and women ≥ 18 years of age.
• Performance status Eastern Cooperative Oncology Group ( ECOG ) ≤ 1.
• Subjects must have measurable disease by CT or MRI according to RECIST 1.1 criteria Radiographic Evaluation of Tumor on in the span of 28 days before randomization.
• The target lesions may be located on a previously irradiated field exists if documented progression of disease (radiographic) in that site. Subjects progression or recurrence of the disease must have experienced during or after prior chemotherapy regimen containing platinum in metastatic disease.

This includes individuals who meet the following criteria:

• Subjects who received pemetrexed, bevacizumab or erlotinib as maintenance therapy (non-progressors double platinum-based chemotherapy) and progressed are eligible However, patients who received a wild EGFR tyrosine kinase inhibitor after failure of prior platinum-based therapy were excluded.
• Eligible patients who received double- platinum -based chemotherapy in adjuvant or neo adjuvant (after surgery and / or radiation) and developed recurrent or metastatic disease within 6 months after treatment ends
• Eligible individuals with recurrent disease > 6 months after adjuvant chemotherapy or neoadjuvant platinum-based , who also subsequently progressed during or after one platinum-based doublet regimen to treat recurrences
• Subjects with a known mutation of EGFR and received EGFR TKI (erlotinib , gefitinib or experimental) and double platinum-based chemotherapy ( regardless of the order of administration).
• subjects with known ALK translocation double receiving platinum-based chemotherapy and ALK inhibitor ( crizotinib or experimental )
• patients who have received >30Gy to the chest should have waited at least 6 months from completing radiation to starting pembrolizumab.
• must be available a blood sample, for evaluation of biomarkers. Samples must be received by the central laboratory before randomization.
• All baseline laboratory requirements will be evaluated , and must be obtained -14 days of randomization. The screening laboratory values must meet the following criteria:

i) WBC ≥ 2000/μL ii) iNeutrophils ≥ 1500/μL iii) Platelets ≥ 100 x 10 ³ / uL iv) Hemoglobin ≥ 9.0 g / dL v) Serum creatinine ≤ 1.5 x ULN or creatinine clearance > 40 mL / min (using the Cockcroft / Gault ) Women : CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg / dL Males: CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg / dL vi) ≤ 1.5 X ULN AST vii) ≤ 1.5 X ULN ALT viii) Total bilirubin ≤ 1.5x ULN (except for subjects with Gilbert 's Syndrome who must have total bilirubin 18 years of age on day of signing informed consent.

• Have measurable disease based on RECIST 1.1.
• Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion.
• Have a performance status of 0 or 1 on the ECOG Performance Scale.
• Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 10 days of treatment initiation.

Exclusion Criteria

The subject mus