Nimotuzumab in Combination With Radiochemotherapy for Patients With Stage IIIA/IIIB Non-small Cell Lung Cancer
Non-small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring nimotuzumab, non-small cell lung cancer, radiochemotherapy, stage IIIA/IIIB non-small cell lung cancer
Eligibility Criteria
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:
- Previous radiotherapy, chemotherapy or anticancer biotherapy. Participation other clinical trials within 1 month prior to inclusion in the trial.
- with the measureable lesion or lesion could be determined.
- Severe diseases in lung, i.e. emphysema, interstitial pneumonia, bronchial asthma.
- uncontrolled diabetes-random plasma glucose; RPG>11.1mmol/L.(RPG>11.1mmol/L, blood-fasting sugar; BFS; <7.8mmol/L,the patient also be enrolled).
- With other serious internal diseases or uncontrolled infection.
- refractoriness dysentery or enterospasm, intestinal obstruction.
- pregnancy, lactation, fertility but using a prohibited contraceptive method.
- cardiovascular diseases history, congestive heart failure>GradeII, New York Heart Association (NYHA) criteria). With the unstable angina, de novo angina ( happened within 3 month prior to inclusion in the trial) or have myocardial in recently six months.
- With drug addition, I.e. ,drug-taking, drug-taking for long time; type B hepatitis and C hepatitis in active stage, or with AIDS.
- With organ transplantation,or using adrenocortical hormone or immunosuppressive agents for long time.
- With history of serious allergic or allergy.
- Not fit for the clinical trial judged by the investigator.
Sites / Locations
- Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
the tolerance trial of treatment
A
B
nimotuzumab,chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts
nimotuzumab,chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts
chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts