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

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab and TP regimen
TP regimen
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring nimotuzumab, non-small cell lung cancer, chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tianjian Medical University Cancer Institue and HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nimotuzumab and TP regimen

TP Regimen

Arm Description

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

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival Time

Full Information

First Posted
July 11, 2011
Last Updated
February 14, 2016
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Biotech Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01393080
Brief Title
Nimotuzumab in Combination With Paclitaxel Liposome and Carboplatin (TP Regimen) for the Advanced NSCLC Patients
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Biotech Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
nimotuzumab, non-small cell lung cancer, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nimotuzumab and TP regimen
Arm Type
Experimental
Arm Description
TP Regimen ：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.
Arm Title
TP Regimen
Arm Type
Placebo Comparator
Arm Description
TP Regimen：Paclitaxel Liposome,135mg/m2,d1;Carbopatin（AUC=5） d2, 3 weeks/cycle, for 4 cycles.
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab and TP regimen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
TP regimen
Intervention Description
TP Regimen：Paclitaxel Liposome,135mg/m2,d1;Carbopatin（AUC=5） d2, 3 weeks/cycle,for 4 cycles.
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
12months
Secondary Outcome Measure Information:
Title
Overall survival Time
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signature of the informed consent form Ages from 18 to 70 years old; both male and female. 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. EGFR mRNA from peripheral bloods is positive by ELISA or the expression of EGFR from tumor tissue is positive by immunohistochemical staining. 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 . With ECOG performance status 0-2; Both female and male patients must use adequate methods of contraception. Exclusion Criteria: Participation other clinical trials within 1 month prior to inclusion in the trial. Previous targeted treatment of TKI or EGFR antibodies prior to inclusion in the trial. Previous paclitaxel liposome and carboplatin (TP) chemotherapy prior to inclusion in the trial. With other serious internal diseases or uncontrolled infection;refractoriness dysentery or enterospasm, intestinal obstruction. 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; With drug addition, I.e. ,drug-taking, drug-taking for long time; type B hepatitis and C hepatitis in active stage, or with AIDS. Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, curative carcinoma of prostate. With history of serious allergic or allergy. Patients with less compliance Pregnancy, lactation, fertility but using a prohibited contraceptive method. Not fit for the clinical trial judged by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daliang Qi, MD
Phone
0086-22-23340123
Ext
3502
Email
xj2880@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Xu, MD
Phone
0086-22-23340123
Ext
3503
Email
xj2880@tom.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daliang Qi, Master
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjian Medical University Cancer Institue and Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daliang Qi, MD
Phone
+862223340123
Ext
3502
Email
xj2880@gmail.com
First Name & Middle Initial & Last Name & Degree
Daliang Qi, MD

12. IPD Sharing Statement

Learn more about this trial

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

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