PBF-1129 in Patients With NSCLC

Inclusion Criteria: * Histological or cytological diagnosis of metastatic squamous or non-squamous NSCLC. * Life expectancy greater or equal to 3 months, as determined by the investigator -Patients must have progressed on the standard therapy, including platinum based - chemotherapy. Patients with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations must have progressed on standard treatment options including EGFR, ALK, or ROS-1-directed therapies. * No limits to the prior lines of treatment * ECOG performance status of 0/1 * Measurable Disease by RECIST v1.1 * Age greater than 18 years. * Adequate bone marrow, renal and hepatic function: * Absolute neutrophil count (ANC) ≥ 1500 /µL * White blood cell count (WBC) t ≥ 2.5 x 109/L (2500/µL) * Lymphocyte count ≥ 0.5 x 109/L (500/µL) * Platelet count ≥ 100 x 109/L (100,000/µL) without transfusion * Hemoglobin ≥ (9.0 g/dL) - patients may be transfused to meet this criterion. * Aspartate aminotransferase AST, alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 x upper limit of normal (ULN) * Serum bilirubin ≤ 1.5 x ULN, with the exception of patients with known Gilbert disease: serum bilirubin level ≤ 3 x ULN * Creatinine clearance \>60 mL/min (calculated using the Cockcroft-Gault formula) or by 24-hours urine collection * Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations * Subject is willing and able to comply with the protocol for the duration of the study Exclusion Criteria: * Participation in another clinical study with an investigational product during the last 4 weeks or 5 half-lives prior to starting on treatment. * Symptomatic and/or untreated or actively progressing central nervous system (CNS) metastases or leptomeningeal disease. Patients with a history of treated CNS metastases are eligible, provided that all of the following criteria are met: * The patient has not received stereotactic radiotherapy within 7 days prior to initiation of study treatment or whole-brain radiotherapy within 14 days prior to initiation of study treatment. * The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anti-convulsant therapy at a stable dose is permitted. * Serious uncontrolled medical disorder or active infection that would impair the patient's ability to receive study treatment. * Concurrent use of other anticancer approved or investigational agents is not allowed. * Autoimmune disorder * Prior malignancy in past 2 years or as identified in Section 7.2 of this protocol * Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. * Patients receiving systemic steroids ≥ 10mg/day of prednisone or the equivalent * Smoking (cigarettes, cigars or pipes) must be discontinued at least 7 days prior to initiating study drug administration; smoking cessation products (transdermal nicotine patches or chewing gum may be used. * Pregnancy or breastfeeding, or intention of becoming pregnant during the study. Female subjects must either be of non-reproductive potential or have a negative serum pregnancy test result within 14 days prior to initiation of study treatment