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
Completed · Phase 2
Conditions studied: Non-Small Cell Lung Cancer (NSCLC)
In brief
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
Key facts
- Study ID
- NCT01951157
- Run by
- PharmaMar
- People needed
- 69
- Starts
- 2013-09-11
- Expected to finish
- 2016-11-01
- Last updated by the study team
- 2019-09-24
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — New York, New York, United States
Full record on ClinicalTrials.gov
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