NCT02504489_predicted_inclusion.txt

INCLUSION CRITERIA :  
  
 Males and females ≥ 18 years of age 
 ECOG performance status ≤ 2.  
 Histopathologically or cytologically confirmed non - squamous or squamous NSCLC . 
 Disease progression during or after treatment with one or two treatment regimen ( s ) Treatment regimens can be chemotherapy , targeted therapy , biological therapy , or immunotherapy for advanced ( Stage IIIB ) or metastatic disease ( Stage IV ) . Modification of a regimen to manage toxicity with a different drug does not constitute a new regimen . Maintenance therapy following platinum - based chemotherapy is not considered as a separate regimen . Adjuvant or neoadjuvant chemotherapy and / or chemo - radiation for early stage disease do not count as prior systemic therapy . Prior radiation therapy is not exclusionary . Prior immunotherapy with a PD - 1 / PD - L 1 inhibitor is not exclusionary . Prior treatment for advanced or metastatic disease must have included a platinum - based regimen . ( Treatment of early stage disease [ Stage IIIA or earlier ] with a platinum - containing therapy does not count ) . 
 Patients with active brain metastasis or leptomeningeal involvement with brain metastases who are asymptomatic , and whose lesions by imaging are at least stable and without interim development of new lesions for at least 4 weeks may be enrolled . Patients who require continued therapy with steroid medication for management for their brain metastases are eligible; dosing must be stable for at least 4 weeks prior to randomization; 
 Patients must have at least one measurable lung lesion of ≥ 10 mm by CT or MRI per RECIST 1.1 criteria . Radiographic tumor assessment is to be performed within 28 days prior to randomization; 
 All patients with non - squamous NSCLC must have been tested for 19 deletion and exon 21 L 858R substitution mutation . Only patients without EGFR sensitizing mutations are eligible , and they must have progressed on platinum - based chemotherapy . Patients with known ALK - rearrangements should be treated with an appropriate tyrosine kinase inhibitor ( TKI ) before entering the study . The TKI regimen would count as a line of treatment . 
 All adverse events of any prior systemic therapy , surgery , or radiotherapy , must have resolved to CTCAE ( v 4.03 ) Grade ≤ 2 , except for neurological adverse events that must have resolved to Grade ≤ 1 ; 
  
 The following laboratory results from the central laboratory within 14 days prior to Cycle 1 Day 1 study drug administration . 
  
 Hemoglobin ≥ 9 g / dL independent of transfusion or growth factor support; 
 Absolute neutrophil count ≥ 1.5 x 109 / L independent of growth factor support; 
 Platelet count ≥ 100 x 109 / L independent of transfusion or growth factor support; 
 Serum total bilirubin ≤ ULN , unless the patient has a diagnosis of Gilbert's disease in which case serum bilirubin ≤ 3.0 times ULN; 
 AST and ALT ≤ 2.5 x ULN ( ≤ 1.5 x ULN if alkaline phosphatase is > 2.5 x ULN ) ; 
 Serum creatinine ≤ 1.5 x ULN; 
 Life expectancy more than 12 weeks; 
  
 Female patients of childbearing potential have a negative pregnancy test at baseline . Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months . However , women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy , anti - estrogens , or ovarian suppression . 
  
 Women of childbearing potential ( i .e . , menstruating women ) must have a negative urine pregnancy test ( positive urine tests are to be confirmed by serum test ) documented within the 24 - hour period prior to the first dose of study drug . 
 Sexually active women of childbearing potential enrolled in the study must agree to use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of study drug . Effective birth control includes ( a ) intrauterine device ( IUD ) plus one barrier method; ( b ) on stable doses of hormonal contraception for at least 3 months ( e .g . , oral , injectable , implant , transdermal ) plus one barrier method; ( c ) 2 barrier methods . Effective barrier methods are male or female condoms , diaphragms , and spermicides ( creams or gels that contain a chemical to kill sperm ) ; or ( d ) a vasectomized partner . 
 For male patients who are sexually active and who are partners of premenopausal women : agreement to use two forms of contraception as in criterion 11 b above during the treatment period and for at least 3 months after the last dose of study drug . 
 Signed informed consent .