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Phase II Study of Nimotuzumab Plus Docetaxel in Chemotherapy-refractory/Resistant Patients With Advanced Non-small-cell Lung Cancer

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

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Trial Information

Phase II Study of Nimotuzumab Plus Docetaxel in Chemotherapy-refractory/Resistant Patients With Advanced Non-small-cell Lung Cancer

Nimotuzumab and Docetaxel will be administered to the patient until disease progression or
unacceptable toxicity had occurred.Docetaxel was administered every 3 weeks 75mg/m2;
Nimotuzumab treatment at 200mg per week,at least 12 weeks.The patients'hematology and
biochemistry examination will be monitored weekly, a physical exam and assessment of the
tumor will be performed and every 6 weeks. The patients will be followed up every 3 months
to evaluate the survival.

Inclusion Criteria:

1. Histological/cytological confirmed Non-small cell lung cancer

2. EGFR expression is positive (Immunohistochemistry)

3. Locally advanced or advanced NSCLC patients(Stage IIIb \ IV)

4. Patients must have had progressive disease after only one prior chemotherapy
regimen.This regimen must have been platinum-based.(For the patients who received new
adjuvant chemotherapy or adjuvant chemotherapy, only disease free survival within 9
months will be eligible to enrollment).

5. The last dose of chemotherapy must be finished at least 3 weeks before the study, the
acute toxicity of chemotherapy must be recovery.

6. The patients previously received radiotherapy could be recruited. (bone marrow
influenced by radiotherapy should be less than 25% of the total quantity of general
bone marrow ,and the patients didn't receive the whole pelvis radiation, last
radiotherapy must be finished at least 4 weeks before the enrollment. )

7. Patients with at least one tumor lesion that can accurately be measured by magnetic
resonance imaging, or computed tomography in at least one dimension with longest
diameter to be recorded as ≥ 20 mm using conventional techniques or ≥ 10 mm with
spiral CT.

8. ECOG performance status 0-2.

9. Life expectancy ≥ 12 weeks.

10. Adequate organic function must be according with the following:

- Barrow: Absolute neutrophil count ≥ 1.5×109/L, platelet count ≥ 100×109/L,
Haemoglobin ≥ 90g/L;

- Liver function: BIL ≤ 1.5 x ULN, ALP, AST and ALT≤ 3x ULN or ≤ 5 ULN (Liver

- Renal function: Ccr ≥ 45ml/min;

11. No history of clinically significant or uncontrolled cardiac disease, normal

12. Use of an effective contraceptive method for patients of both genders during study
and after the end of 3 months, female subjects must be non breast feeding period and
serum or urine pregnancy test should be negative.

13. Signed informed consent and submit to the organization of research

Exclusion Criteria:

1. Brain metastasis and with symptom

2. Previously treatment regimen including:Docetaxel, anti EGFR monoclonal
antibody,anti-angiogenesis targeted medicine,small molecule tyrosine kinase

3. Receiving other anti-cancer medicine treatment during the study

4. Uncontrolled pleural effusion、seroperitoneum、pericardial effusion

5. Serious illness or other malignancies diagnosed within the past five years.

6. Patients with any serious active infection

7. The second primary malignant tumor

8. Serious accompanying disease would influenced the study (such as cardiac
disease,Diabetes mellitus etc)

9. Contraindication of hormone therapy

10. Previous definable peripheral neuropathy and with symptom

11. Do not sign informed consent form

Type of Study:


Study Design:

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

Outcome Measure:

Median Survival Time

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Jie Wang

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beijing Cancer Hospital


China: Food and Drug Administration

Study ID:




Start Date:

August 2009

Completion Date:

December 2010

Related Keywords:

  • Advanced Non-Small Cell Lung Cancer
  • Nimotuzumab
  • Docetaxel
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms