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Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)

Phase 2
18 Years
75 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)

Endostar have anti-tumor activity by against vascular endothelial growth factor for initial
treatment. This study was designed to evaluate the safety and efficacy of Endostar Continued
vein-pumping Combining with Gemcitabine-Cisplatin (GP)chemotherapy in patients with
NSCLC,and seeking for more effective injection.

Inclusion Criteria:

1. Histologically or cytologically diagnosed NSCLC;

2. primary treatment,inoperable stage IIIB/IV NSCLC;

3. Age of 18-75years; Gender Not Required;

4. Adequate hematologic, renal, and hepatic function ,Specific index as follows:

liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function:
S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow
Hemopoietic Function: WBC≥4.0×10^9/l, ANC≥2.0×10^9/l platelet count ≥100×10^9/l,
Hb≥100 g/l;

5. ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy;

6. The patients have explicit lung tumor lesions and the lesions were measurable;
(According to the standard of RECIST1.1, they should have at least one of accurately
measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI);

7. No history of serious drug allergy;

8. Informed consent should be obtained before treatment.

Exclusion Criteria:

1. Symptomatic brain metastases with cognitive disorder,bone metastases with

2. Major organ dysfunction and Serious Heart Disease( congestive
heart-failure,incontrollable high-risk arrhythmia,unstable angina, valvular disease,
myocardial infarct and Resistant hypertension,);

3. Serious complications and investigator consider it is unsuited enrolling;

4. Pregnant or lactating women;

5. Allergic to research drug;

6. participating in other experimental trials and receive the treatment in four weeks;

7. The position that is for observing curative effect have a radiotherapy.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival (PFS)

Outcome Time Frame:

two years

Safety Issue:



China: Food and Drug Administration

Study ID:




Start Date:

April 2011

Completion Date:

August 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Endostar
  • advanced Non-small cell lung cancer
  • Continued Pumping into vein
  • Gemcitabine
  • Carboplatin
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms