A non-comparative, randomized phase II study of two different oral schedules of gimatecan (ST1481) as second line therapy for patients with advanced Non Small Cell Lung Cancer (NSCLC)

INTERVENTION: Product Name: gimatecan Product Code: ST1481 Pharmaceutical Form: INN or Proposed INN: gimatecan Current Sponsor code: ST1481 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.1‐ Product Name: gimatecan Product Code: ST1481 Pharmaceutical Form: INN or Proposed INN: gimatecan Current Sponsor code: ST1481 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.1‐ CONDITION: Advanced Non Small Cell Lung Cancer (NSCLC) ; MedDRA version: 6.1 Level: PT Classification code 10026532 PRIMARY OUTCOME: Main Objective: Primary end point(s): Secondary Objective: INCLUSION CRITERIA: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range