Nimotuzumab in Combination With Radiochemotherapy for Patients With Stage IIIA/IIIB Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

Nimotuzumab in Combination With Radiochemotherapy for Patients With Stage IIIA/IIIB Non-small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02549261
• Other study ID #: BT-NI-LC-2
• Status: Active, not recruiting
• Phase: N/A
• First received: August 18, 2015
• Last updated: September 11, 2015
• Start date: March 2011
• Est. completion date: December 2015

Study information

• Verified date: September 2015
• Source: Biotech Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 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.

Description:

There is a tolerance trial of Nimotuzumab in Combination With Radiochemotherapy treatment before the randomization,double blind,muti-center sites trial of this treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age from 18 to 70

2. both male and female

3. Subjects with pathologically or cytologically documented stage IIIB or IV NSCLC. Disease must be newly diagnosed.

4. Subjects would refer to the radical radiation therapy, but never have the previous chemotherapy or thoracic radiation therapy.

5. 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%.

6. 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.

7. without pulmonary atelectasis, malignant pleural effusion malignant hydropericardium.

8. with ECOG performance status 0-2,and Life expectancy of more than 3 months.

9. without other malignancy history, except curative carcinoma in situ of cervix and skin basal cell carcinoma.

10. 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.

11. willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

12. both female and male patients must use adequate methods of contraception.

13. Signature of the informed consent

Exclusion Criteria:

1. Previous radiotherapy, chemotherapy or anticancer biotherapy. Participation other clinical trials within 1 month prior to inclusion in the trial.

2. with the measureable lesion or lesion could be determined.

3. Severe diseases in lung, i.e. emphysema, interstitial pneumonia, bronchial asthma.

4. 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).

5. With other serious internal diseases or uncontrolled infection.

6. refractoriness dysentery or enterospasm, intestinal obstruction.

7. pregnancy, lactation, fertility but using a prohibited contraceptive method.

8. 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.

9. With drug addition, I.e. ,drug-taking, drug-taking for long time; type B hepatitis and C hepatitis in active stage, or with AIDS.

10. With organ transplantation,or using adrenocortical hormone or immunosuppressive agents for long time.

11. With history of serious allergic or allergy.

12. Not fit for the clinical trial judged by the investigator.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• nimotuzumab
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).
• Cisplatin
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
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.

Radiation:
• radiotherapy
the tolerance trial of treatment A and B of treatment;95%PTV,60-66Gy/30-33/fraction,6-7weeks.

Locations

Country	Name	City	State
China	Cancer Institute & Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Biotech Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		12months	No
Secondary	Overall survival Time		3 years	No
Secondary	Quality of life		12 months	No
Secondary	Objective response rate		12months	No
Secondary	Disease controlled rate		3 years	No
Secondary	Adverse event rate		1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16weeks	Yes