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

NCT ID: NCT01393080

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2016-12-31

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nimotuzumab and TP regimen

1. TP Regimen ：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.

Group Type: EXPERIMENTAL

Nimotuzumab and TP regimen

Intervention Type: DRUG

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.

TP Regimen

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

Group Type: PLACEBO_COMPARATOR

TP regimen

Intervention Type: DRUG

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

Interventions

Nimotuzumab 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.

Intervention Type: DRUG

TP regimen

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotech Pharmaceutical Co., Ltd.

OTHER

Sponsor Role: collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daliang Qi, Master

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Locations

Tianjian Medical University Cancer Institue and Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Daliang Qi, MD

Role: CONTACT

xj2880@gmail.com

0086-22-23340123 ext. 3502

Jie Xu, MD

Role: CONTACT

xj2880@tom.com

0086-22-23340123 ext. 3503

Facility Contacts

Daliang Qi, MD

Role: primary

xj2880@gmail.com

+862223340123 ext. 3502

Other Identifiers

BT-IST-NSCLC-053

Identifier Type: -

Identifier Source: org_study_id