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

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

A clinical study of lurbinectedin(PM01183) alone or in combination with gemcitabine in comparison to docetaxel for the treatment of unresectable non-small cell lung cancer (NSCLC)patients

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaMar
• Treatments: Docetaxel; Gemcitabine

Criteria

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