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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 adult with head and neck cancer. The study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with chemoradiotherapy in patients with NSCLC .There is a tolerance trial of Nimotuzumab in Combination With Radiochemotherapy treatment before the randomization,double blind,muti-center sites trial of this treatment.
There is a tolerance trial of Nimotuzumab in Combination With Radiochemotherapy treatment before the randomization,double blind,muti-center sites trial of this treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the tolerance trial of treatment | Experimental | nimotuzumab,chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts |
|
| A | Experimental | nimotuzumab,chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts |
|
| B | Placebo Comparator | chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nimotuzumab | Drug | the nimotuzumab treatment: 200mg/w weekly, for 16 weeks. A treatment:nimotuzumab for 3 levels (100mg/w, 200mg/w, 400mg/w, weekly, for 16 weeks). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 12months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival Time | 3 years | |
| Quality of life | 12 months | |
| Objective response rate |
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Inclusion Criteria:
Age from 18 to 70
both male and female
Subjects with pathologically or cytologically documented stage IIIB or IV NSCLC. Disease must be newly diagnosed.
Subjects would refer to the radical radiation therapy, but never have the previous chemotherapy or thoracic radiation therapy.
V20<30%, means that the percentage of the volume of lung which received the radiation<20Gy accounts the whole volume of lung is less than 30%.
Presence of at least 1 uni-dimensionally measurable index lesion,with the longest diameter ≥ 20 mm using conventional computer tomography(CT)/magnetic resonance imaging(MRI)scan or ≥ 10 mm using spiral computed tomography scan.
without pulmonary atelectasis, malignant pleural effusion malignant hydropericardium.
with ECOG performance status 0-2,and Life expectancy of more than 3 months.
without other malignancy history, except curative carcinoma in situ of cervix and skin basal cell carcinoma.
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 .
pulmonary function, FEV1≥1L, and >40% normal value.
willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
both female and male patients must use adequate methods of contraception.
Signature of the informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lvhua Wang, profressor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute & Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D002945 | Cisplatin |
| D005047 | Etoposide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Cisplatin | Drug | Concurrent Chemotherapy,50mg/m2 (d1,d8),4 weeks/cycle, for 2 cycles. the consolidation chemotherapy: Cisplatin: 50mg/m2 (d1,d8)4 weeks/cycle, for 2 cycles. |
|
| Etoposide | Drug | Concurrent Chemotherapy, Cisplatin: Etoposide: 50mg/m2 (d1-5),4 weeks/cycle, for 2 cycles. the consolidation chemotherapy:Etoposide: 50mg/m2 (d1-5),4 weeks/cycle, for 2 cycles. |
|
| radiotherapy | Radiation | the tolerance trial of treatment A and B of treatment;95%PTV,60-66Gy/30-33/fraction,6-7weeks. |
|
| 12months |
| Disease controlled rate | 3 years |
| Adverse event rate | 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16weeks |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011034 |
| Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013812 | Therapeutics |