Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer (nsclc)
Treatments docetaxel, gemcitabine, lurbinectedin (pm01183)
Phase phase 2
Sponsor PharmaMar
Start date October 2013
End date October 2016
Trial size 120 participants
Trial identifier NCT01951157, PM1183-B-004-13

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks
docetaxel
Powder for solution for infusion
(Experimental)
3.2 mg/m2 PM01183, day 1, 1-hour intravenous, every three weeks
lurbinectedin (pm01183)
Powder for concentrate for solution for infusion
(Experimental)
800 mg/m2 gemcitabine / 1.6 mg/m2 PM01183 both on day 1 and day 8, 30-minutes gemcitabine/1-hour PM01183 intravenous, every three weeks
gemcitabine
Powder for solution for infusion
lurbinectedin (pm01183)
Powder for concentrate for solution for infusion

Primary Outcomes

Measure
Progression-free survival rate at four months (PFS4)
time frame: At month four after patient inclusion

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: 12 months after last patient inclusion
Information on quality of life (QoL)
time frame: At screening and every three cycles
Pharmacogenomic (PGx)
time frame: 12 months after last patient inclusion

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title A Randomized-Controlled Three-arm Phase II Study of Lurbinectedin (PM01183) Alone or In Combination With Gemcitabine and a Control Arm With Docetaxel as Second-Line Treatment in Unresectable Non-Small Cell Lung Cancer (NSCLC) Patients
Description A randomized-controlled, three-arm, phase II study of lurbinectedin (PM01183) alone or in combination with gemcitabine and a control arm with docetaxel as second-line treatment in unresectable non-small cell lung cancer (NSCLC)patients to evaluate the antitumor activity as progression-free survival at four months (PFS4) of PM01183 alone or in combination with gemcitabine as using single agent docetaxel as a reference in the control arm as current standard of care and to analyze overall survival (OS), overall survival rate at 1-year (OS12), duration of response (DR), antitumor activity, as response rate (RR), safety and efficacy profiles of PM01183 alone and in combination with gemcitabine, to be preliminary compared with docetaxel, patients' quality of life (QoL), pharmacokinetics (PK) of PM01183, pharmacokinetic/pharmacodynamic (PK/PD)correlation and pharmacogenomics (PGx)to explore potential correlations between clinical outcomes and molecular parameters found in tumor and blood samples
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by PharmaMar.
Location data was received from the National Cancer Institute and was last updated in May 2016.