Advanced Non-small Cell Lung Cancer
Conditions
Keywords
Non-small Cell Lung Cancer, Endostar, Paclitaxel, Carboplatin
Brief summary
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.
Interventions
DRUGEndostar(Recombinant Human Endostatin Injection)
Endostar 7.5mg/m2 on d8-d21 in each 21-day cycle
DRUGpaclitaxel-carboplatin
paclitaxel, 175mg/m2, iv, d1, q3w; carboplatin, AUC 5, iv, d1, q3w
Sponsors
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS) | every 2 months until disease progression |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | the end of each cycle |
| Overall Survival (OS) | 2 years |
Countries
China
Outcome results
None listed