Trial Information
Paclitaxel Plus Carboplatin (TC) Versus TC Plus Endostar in Patients With Advanced Non-small Cell Lung Cancer(NSCLC): a Randomized, Double-blind, Placebo-controlled, Multicentre Study
Inclusion Criteria:
- histologically or cytologically confirmed, previously untreated stage IIIB or IV
NSCLC
- age of 18-75 years
- at least one measurable lesion (RECIST)
- patients evaluated as SD or above after 1 cycle (21 days) of TC chemotherapy .
- adequate hematologic, cardiac, renal, and hepatic function
- ECOG PS 0-2
Exclusion Criteria:
- symptomatic brain metastases
- bone metastases with complications
- major organ dysfunction
- bleeding diathesis or coagulopathy
- pregnant or lactating woman
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Progression-free Survival (PFS)
Outcome Time Frame:
every 2 months until disease progression
Safety Issue:
No
Authority:
China: Ethics Committee
Study ID:
XYL014
NCT ID:
NCT00708812
Start Date:
July 2007
Completion Date:
December 2009
Related Keywords:
- Advanced Non-Small Cell Lung Cancer
- Non-small Cell Lung Cancer
- Endostar
- Paclitaxel
- Carboplatin
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms