Paclitaxel Plus Carboplatin With or Without Endostar in Patients With Advanced Non-small Cell Lung Cancer

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

In this randomized, double-blind, placebo-controlled, multicentre trial, 126 patients between July 5, 2007 and July 30, 2008 were enrolled from 10 centers. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong University and Shanghai Changzheng Hospital. All eligible patients received 1 cycle (21 days) of TC chemotherapy. After chemotherapy, patients evaluated as SD (Stable Disease) or above were randomized to receive endostar plus TC or TC alone for 3 cycles, 21 days as one cycle.

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