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

NCT ID: NCT02549261

Last Updated: 2015-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2015-12-31

Brief 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.

Detailed 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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

the tolerance trial of treatment

nimotuzumab,chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts

Group Type: EXPERIMENTAL

nimotuzumab

Intervention Type: 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).

Cisplatin

Intervention Type: 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

Intervention Type: 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

Intervention Type: RADIATION

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

A

nimotuzumab,chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts

Group Type: EXPERIMENTAL

nimotuzumab

Intervention Type: 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).

Cisplatin

Intervention Type: 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

Intervention Type: 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

Intervention Type: RADIATION

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

B

chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts

Group Type: PLACEBO_COMPARATOR

Cisplatin

Intervention Type: 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

Intervention Type: 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

Intervention Type: RADIATION

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

Interventions

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).

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

radiotherapy

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

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotech Pharmaceutical Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lvhua Wang, profressor

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Institute & Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

BT-NI-LC-2

Identifier Type: -

Identifier Source: org_study_id