A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients

Inclusion Criteria: * Histologically or cytologically confirmed unresectable NSCLC * Patients must have failed one prior line of CT-based therapy for unresectable disease * Age between 18 and 75 years * Eastern Cooperative Oncology Group (ECOG)performance status (PS) ≤ 1 * Adequate hematological, renal, metabolic and hepatic function * At least three weeks since the last prior therapy, at least four weeks since completion of any prior radiotherapy * Negative pregnancy test for pre-menopausal women Exclusion Criteria: * Concomitant diseases/conditions as unstable angina, myocardial infarction, symptomatic congestive heart failure or asymptomatic with left ventricular ejection fraction (LVEF) ≤ 50%, dyspnea, infection by human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, active uncontrolled infection, pleural or pericardial effusions, myopathy, limitation of the patient's ability to comply with the treatment or to follow-up the protocol, any other major illness * Histological features of neuroendocrine or bronchioalveolar differentiation. * Unknown epidermal growth factor receptor (EGFR)mutation status or previously known EGFR mutated status in patients with adenocarcinoma. * Prior or concurrent invasive malignant disease, unless in complete remission for more than three years. * Significant cancer-related weight loss (≥10%)within four weeks prior to treatment start * Prior treatment with docetaxel-containing therapy * Symptomatic, steroid-requiring or progressive central nervous system (CNS) involvement * Paraneoplastic syndromes