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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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Advanced Non-small Cell Lung Cancer

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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

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