Sentences with phrase «within central laboratories»

Not exact matches

Inclusion Criteria: • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 • Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC)(Stage IIIb or greater) • Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 • Known PD - L1 tumor status as determined by an immunohistochemistry (IHC) assay performed by the central laboratory on tissue obtained at Screening • A woman of childbearing potential must have a negative highly sensitive serum (beta - human chorionic gonadotropin [beta - hCG]-RRB- at Screening within 14 days prior to study drug administration Inclusion Criteria for Crossover: • Participants must have been randomized to Arm A of the study and had radiographic disease progression according to RECIST 1.1 • Participants must have a mandatory biopsy at the time of disease progression according to RECIST 1.1 prior to crossing over.