 - Any approved anti-cancer therapy less than or equal to 21 days including chemotherapy or hormonal therapy before the first study treatment; the following exceptions are allowed: 1 TKIs approved for the treatment of NSCLC must be discontinued greater than 7 days prior to the first study treatment on D1C1 The baseline computed tomography CT scan must be completed after discontinuation of TKIs; 2 Hormone-replacement therapy or oral contraceptives; 3 Anti-emetics, Granulocyte-colony stimulating factor GCS-F, and prophylactic antibiotics according to local standards 