A Randomised, Open-Label Phase 3 Trial Comparing Amrubicin Versus Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy
Phase 3
20 Years
74 Years
20 Years
74 Years
Open (Enrolling)
Both
Lung Cancer
Both
Lung Cancer
Trial Information
A Randomised, Open-Label Phase 3 Trial Comparing Amrubicin Versus Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy
Inclusion Criteria:
- Histological or cytological diagnosis of non-small cell lung cancer (NSCLC)
- 1 or 2 prior chemotherapy regimen including 1 platinum-based chemotherapy
- 20 or older but younger than 75 years of age
Exclusion Criteria:
- Symptomatic brain metastasis
- Interstitial pneumonia or pulmonary fibrosis
- Abnormal cardiac function or myocardial infraction within 6 months before study
enrollment
- Active infection
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label
Outcome Measure:
Progression free survival
Outcome Time Frame:
Until death
Safety Issue:
No
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
D0702035
NCT ID:
NCT01207011
Start Date:
October 2010
Completion Date:
Related Keywords:
- Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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