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