Clinical trial NCT01951157: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Lead sponsor: PharmaMar
Sponsor class: INDUSTRY
First posted: 2013-09-26
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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

Eligibility 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

Primary outcomes:
measure: Progression-free Survival Rate at Four Months (PFS4)
timeFrame: At month four after patient inclusion
Secondary outcomes:
measure: Progression-free Survival
timeFrame: Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years
measure: Progression-free Survival Rate at Six Months (PFS6)
timeFrame: At month six after patient inclusion
measure: Overall Response Rate
timeFrame: Time from the date of randomization until 30±7 days after the last treatment infusion, assessed up to 3 years
measure: Objective Response Per RECIST v.1.1
timeFrame: Time from the date of randomization until 30±7 days after the last treatment infusion, assessed up to 3 years
measure: Duration of Response
timeFrame: The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years
measure: Overall Survival (OS)
timeFrame: From the date of first infusion to the date of death or last contact, up to 12 months after last patient inclusion
measure: Information on Quality of Life (QoL)
timeFrame: Baseline, Cycle 3 (~9 weeks), Cycle 6 (~18 weeks) and Cycle 9 (~27 weeks)
Other outcomes:
Locations:
city: New York
country: United States
state: New York
Study officials:
References: