- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01393080
Nimotuzumab in Combination With Paclitaxel Liposome and Carboplatin (TP Regimen) for the Advanced NSCLC Patients (NSCLC)
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Daliang Qi, MD
- Phone Number: 3502 0086-22-23340123
- Email: xj2880@gmail.com
Study Contact Backup
- Name: Jie Xu, MD
- Phone Number: 3503 0086-22-23340123
- Email: xj2880@tom.com
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China
- Recruiting
- Tianjian Medical University Cancer Institue and Hospital
-
Contact:
- Daliang Qi, MD
- Phone Number: 3502 +862223340123
- Email: xj2880@gmail.com
-
Principal Investigator:
- Daliang Qi, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nimotuzumab and TP regimen
|
|
Placebo Comparator: TP Regimen
TP Regimen:Paclitaxel Liposome,135mg/m2,d1;Carbopatin(AUC=5) d2, 3 weeks/cycle, for 4 cycles.
|
TP Regimen:Paclitaxel Liposome,135mg/m2,d1;Carbopatin(AUC=5) d2, 3 weeks/cycle,for 4 cycles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival
Time Frame: 12months
|
12months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival Time
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Daliang Qi, Master, Tianjin Medical University Cancer Institute and Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Paclitaxel
- Cisplatin
- Nimotuzumab
Other Study ID Numbers
- BT-IST-NSCLC-053
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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