Nimotuzumab in Combination With Paclitaxel Liposome and Carboplatin (TP Regimen) for the Advanced NSCLC Patients

Non-small Cell Lung Cancer Clinical Trial

— NSCLC  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01393080
• Other study ID #: BT-IST-NSCLC-053
• Status: Recruiting
• Phase: N/A
• First received: July 11, 2011
• Last updated: February 14, 2016
• Start date: March 2011
• Est. completion date: December 2016

Study information

• Verified date: February 2013
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Daliang Qi, MD
• Phone: 0086-22-23340123
• Email: xj2880[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 ? the patients of ?B~?stage NSCLC; ? the patients of IIIA stage NSCLC could not receive the operation or could not operate. ? 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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Nimotuzumab and TP regimen
TP Regims:Paclitaxel Liposome,135mg/m2,d1;Carbopatin(AUC=5) d2, 3 weeks/cycle, for 4 cycles. 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.
• TP regimen
TP Regimen:Paclitaxel Liposome,135mg/m2,d1;Carbopatin(AUC=5) d2, 3 weeks/cycle,for 4 cycles.

Locations

Country	Name	City	State
China	Tianjian Medical University Cancer Institue and Hospital	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital	Biotech Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		12months	No
Secondary	Overall survival Time		3 years	No