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A Double Blind , Randomized, Multicenter Study of Second Line Treatment of Endostar(rh Recombined Endostatin)With Single Docetaxel In NSCLC Patients

Phase 4
18 Years
75 Years
Open (Enrolling)
Advanced NSCLC, Recurrent NSCLC

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Trial Information

A Double Blind , Randomized, Multicenter Study of Second Line Treatment of Endostar(rh Recombined Endostatin)With Single Docetaxel In NSCLC Patients

The combinative therapy of Endostar, Vinorelbine and cisplatin has been shown to increase
response rate and survival in patients (pts) with advanced NSCLC and is sFDA-approved for
this indication. However, there are limited data on the safety and efficacy of Endostar in
combination with other widely used chemotherapy doublets for NSCLC. Clinical data proved
that Endostar was a wild spectrum and safe antiangiogenesis factor which could suppress
almost 65 kinds of tumor mass in animal models and affect about 12 percent human genome. In
this clinical trial, there will be 160 patients enrollment, giving Docetaxel (75mg/m2,iv,
d1, every 3 weeks) plus Endostar(7.5mg/m2/day, iv, d1-d14, every 3 weeks) or Docetaxel with
placebo. We'll evaluate the efficacy and safety of the Docetaxel plus Endostar treatment to
NSCLC and hope to provide a promising regimen to advanced lung cancer patients.

Inclusion Criteria:

1. Age 18-75 years old, males or females;

2. Patients with NSCLC confirmed by histopathology or cytology who need second-line
chemotherapy, including progressive disease cases during or in 3 months posterior to
end of first-line chemotherapy( at least 4 cycles done) and cases with intolerant
adverse effects in first-line chemotherapy( at least 4 cycles done); neo-adjuvant
chemotherapy and targeted therapy(EFGR-TKIs) not to be served as first-line
chemotherapy; 3 months of clearance needed for neo-adjuvant chemotherapy and 1 month
for targeted and first-line chemotherapy;

3. Local advanced and metastatic cases with tumor foci that can be evaluated by CT, MRI
or PET-CT; at least one diameter ≥ 1 cm (including metastatic lymph nodes) confirmed
by CT scan or ≥ 1 cm by spin CT or PET-CT );

4. No contraindication for chemotherapy, with normal peripheral hemogram, renal and
hepatic function: Peripheral hemogram: WBC≥4.0×109/L,PLT≥80×109/L,Hgb≥90g/L; Renal
function: serum BUN and creatinine ≤1.0×UNL; Hepatic function: transaminase≤1.5×UNL,

5. Karnofsky performance scale≥60 or ECOG performance scale≤ 2; expected survival time≥3

6. No allergic history to biological agents and taxane agents;

7. Patients are voluntary to participate and sign the informed contents.

Exclusion Criteria:

1. Pregnant or breast-feeding females; or females who have reproductive ability but do
not take contraception method;

2. With severe acute infection uncontrolled; purulent or chronic infection with wounds
difficult to recover;

3. With history of severe heart diseases, including congestive heart failure,
uncontrolled arrhythmia with high risk, unstable angina pectoris, myocardial
infarction, severe cardiac valvular diseases and refractory hypertension;

4. Patients with uncontrolled neurological, mental disease or psychosis, patients with
poor compliance that cannot coordinate the therapy or describe the treatment

5. Uncontrolled brain metastasis patients with obvious manifestations of intracranial
hypertension or neurological and mental disorders;

6. Uncontrolled diabetes and contraindication to corticoid agents;

7. Obvious hemorrhage tendency;

8. Allergic to any drug in the trial;

9. Patients with a second tumor;

10. Patients participating in other clinical trials;

11. Patients treated by Endostar or Docetaxel (excluding neo-chemotherapy) included
combination chemotherapy previously;

12. Foci to be evaluated for response in trial treated by radiation in 6 months.

13. Other conditions that are regarded for exclusion by the trialists.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival time,survival rate for 1 year

Outcome Time Frame:

two years (2010.10)

Safety Issue:


Principal Investigator

Kai LI, professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Hospital of Tianjin Medical University


China: Food and Drug Administration

Study ID:




Start Date:

October 2008

Completion Date:

October 2010

Related Keywords:

  • Advanced NSCLC
  • Recurrent NSCLC
  • Endostar
  • Docetaxel
  • Combined therapy
  • second-line chemotherapy
  • Carcinoma, Non-Small-Cell Lung