Non-small Cell Lung Cancer
Conditions
Keywords
nimotuzumab, non-small cell lung cancer, chemotherapy
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.
Interventions
DRUGNimotuzumab and TP regimen
1. TP Regims：Paclitaxel Liposome,135mg/m2,d1;Carbopatin（AUC=5） d2, 3 weeks/cycle, for 4 cycles. 2. Nimotuzumab: 200mg/w, weekly, for 6 weeks; Consolidation treatment， 200mg every 2 weeks, until the end of 4 cycles of chemotherapy or the disease progression.
DRUGTP regimen
TP Regimen：Paclitaxel Liposome,135mg/m2,d1;Carbopatin（AUC=5） d2, 3 weeks/cycle,for 4 cycles.
Sponsors
Biotech Pharmaceutical Co., Ltd.
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | 12months |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Time | 3 years |
Countries
China
Contacts
Primary ContactDaliang Qi, MD
Backup ContactJie Xu, MD
Outcome results
None listed