Clinical trial NCT01393080: Nimotuzumab in Combination With Paclitaxel Liposome and Carboplatin (TP Regimen) for the Advanced NSCLC Patients
Official title: The Study of Nimotuzumab in Combination With Paclitaxel Liposome and Carboplatin (TP Regimen) for Patient With the Advanced Non-small Cell Lung Cancer( NSCLC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-small Cell Lung Cancer
Keywords: nimotuzumab
non-small cell lung cancer
chemotherapy
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: Biotech Pharmaceutical Co., Ltd.
First posted: 2011-07-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adults with head and neck cancer. This study assesses the efficacy and safety of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with NSCLC. This is a randomized, muti-center sites trial of this treatment.

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

Eligibility criteria: 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 trial.
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.

Primary outcomes:
measure: Progression-free survival
timeFrame: 12months
Secondary outcomes:
measure: Overall survival Time
timeFrame: 3 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjian Medical University Cancer Institue and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Daliang Qi, Master
role: PRINCIPAL_INVESTIGATOR
References: