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

Part of paid clinical trials in New York, New York.

Sponsor
PharmaMar
Study ID
NCT01951157
Phase
PHASE2
Status
Completed

Conditions

  • Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel — DRUG
    Powder for solution for infusion
  • Gemcitabine — DRUG
    Powder for solution for infusion
  • Lurbinectedin (PM01183) — DRUG
    Powder for concentrate for solution for infusion

Study Details

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 Dates

Start date
Sep 11, 2013
Status verified
Sep 2019
Primary completion
Nov 30, 2016
Completion
Nov 30, 2016

Study Design

Enrollment
69 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: A - docetaxel
    75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks
  • Experimental: B - lurbinectedin (PM01183)
    3.2 mg/m2 PM01183, day 1, 1-hour intravenous, every three weeks
  • Experimental: C - gemcitabine + lurbinectedin (PM01183)
    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

Primary Outcome Measure

Progression-free Survival Rate at Four Months (PFS4) [ Time Frame: At month four after patient inclusion ]

Locations (1)

FacilityCityStateZIPSite coordinators
-New YorkNew York--

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