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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Tianjin Medical University Cancer Institute and Hospital
Sponsor:
Collaborator:
Biotech Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01393080
First received: July 11, 2011
Last updated: March 24, 2014
Last verified: February 2013
  Purpose

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.


Condition Intervention
Non-small Cell Lung Cancer
Drug: Nimotuzumab and TP regimen
Drug: TP regimen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 12months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival Time [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Placebo Comparator: TP Regimen
TP Regimen:Paclitaxel Liposome,135mg/m2,d1;Carbopatin(AUC=5) d2, 3 weeks/cycle, for 4 cycles.
Drug: TP regimen
TP Regimen:Paclitaxel Liposome,135mg/m2,d1;Carbopatin(AUC=5) d2, 3 weeks/cycle,for 4 cycles.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393080

Contacts
Contact: Daliang Qi, MD 0086-22-23340123 ext 3502 xj2880@gmail.com
Contact: Jie Xu, MD 0086-22-23340123 ext 3503 xj2880@tom.com

Locations
China, Tianjin
Tianjian Medical University Cancer Institue and Hospital Recruiting
Tianjin, Tianjin, China
Contact: Daliang Qi, MD    +862223340123 ext 3502    xj2880@gmail.com   
Principal Investigator: Daliang Qi, MD         
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Biotech Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Daliang Qi, Master Tianjin Medical University Cancer Institute and Hospital
  More Information

No publications provided

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01393080     History of Changes
Other Study ID Numbers: BT-IST-NSCLC-053
Study First Received: July 11, 2011
Last Updated: March 24, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
nimotuzumab
non-small cell lung cancer
chemotherapy

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014