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The Study of Nimotuzumab in Combination With Paclitaxel Liposome and Carboplatin (TP Regimen) for Patient With the Advanced Non-small Cell Lung Cancer( NSCLC)

18 Years
70 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

The Study of Nimotuzumab in Combination With Paclitaxel Liposome and Carboplatin (TP Regimen) for Patient With the Advanced Non-small Cell Lung Cancer( NSCLC)

This is a randomized, muti-center sites trial of Nimotuzumab combination with Paclitaxel
Liposome and Carboplatin (TP regimen) treatment.

Inclusion Criteria:

1. Signature of the informed consent form

2. Ages from 18 to 70 years old; both male and female.

3. Pathologically and/or cytologically ① the patients of ⅢB~Ⅳstage NSCLC; ② the patients
of IIIA stage NSCLC could not receive the operation or could not operate. ③ the
patients of IIIA stage NSCLC are recurrent postoperation.

4. EGFR mRNA from peripheral bloods is positive by ELISA or the expression of EGFR from
tumor tissue is positive by immunohistochemical staining.

5. Functions of major organs( haemogram,heart,liver,kidney)are basically normal, White
blood count ≥3.5 x 109/L with neutrophils ≥1.5 x 109/L, platelet count≥100 x 109/L,
and hemoglobin ≥90g/L.

Total bilirubin ≤1.5 times upper limit of normal (ULN) range; alkaline
phosphatase(ALP)≤ 2.5 times ULN, Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times
ULN, serum creatinine ≤ 1.2 times ULN .

6. With ECOG performance status 0-2;

7. Both female and male patients must use adequate methods of contraception.

Exclusion Criteria:

1. Participation other clinical trials within 1 month prior to inclusion in the trial.

2. Previous targeted treatment of TKI or EGFR antibodies prior to inclusion in the

3. Previous paclitaxel liposome and carboplatin (TP) chemotherapy prior to inclusion in
the trial.

4. With other serious internal diseases or uncontrolled infection;refractoriness
dysentery or enterospasm, intestinal obstruction.

5. Cardiovascular diseases history (1)Uncontrollable hypertension, unstable angina,
heart infarction, or congestive heart failure and arrhythmia ( happened within 12
month prior to inclusion in the trial) (2)Ischemia checked by ECG, or clinical
diagnostic Heart valve disease (3)The patients of Grade II(CTC AE 3.0) of arrhythmia,
myocardial ischemia, troponin T abnormality, hypertension or left ventricular
ejection fraction <50%,could not include in the TP+ nimotuzumab test group;

6. With drug addition, I.e. ,drug-taking, drug-taking for long time; type B hepatitis
and C hepatitis in active stage, or with AIDS.

7. Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma
in situ, curative carcinoma of prostate.

8. With history of serious allergic or allergy.

9. Patients with less compliance

10. Pregnancy, lactation, fertility but using a prohibited contraceptive method.

11. Not fit for the clinical trial judged by the investigator.

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

Outcome Time Frame:


Safety Issue:


Principal Investigator

Daliang Qi, Master

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tianjin Medical University Cancer Institute and Hospital


China: Food and Drug Administration

Study ID:




Start Date:

March 2011

Completion Date:

December 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • nimotuzumab
  • non-small cell lung cancer
  • chemotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms