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

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.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: nimotuzumab; Drug: Cisplatin; Drug: Etoposide; Radiation: radiotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Cancer Institute & Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the tolerance trial of treatment; nimotuzumab,chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts	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).; 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.; 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.; Radiation: radiotherapy; the tolerance trial of treatment A and B of treatment;95％PTV,60-66Gy/30-33/fraction,6-7weeks.
Experimental: A; nimotuzumab,chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts	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).; 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.; 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.; Radiation: radiotherapy; the tolerance trial of treatment A and B of treatment;95％PTV,60-66Gy/30-33/fraction,6-7weeks.
Placebo Comparator: B; chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts	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.; 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.; Radiation: radiotherapy; the tolerance trial of treatment A and B of treatment;95％PTV,60-66Gy/30-33/fraction,6-7weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival	12months

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life	12 months
Overall survival Time	3 years
Objective response rate	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

Collaborators and Investigators

• Sponsor: Biotech Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Lvhua Wang, profressor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: August 18, 2015
• First Submitted That Met QC Criteria: September 11, 2015
• First Posted (Estimate): September 15, 2015

Study Record Updates

• Last Update Posted (Estimate): September 15, 2015
• Last Update Submitted That Met QC Criteria: September 11, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; radiochemotherapy; nimotuzumab; stage IIIA/IIIB non-small cell lung cancer
• 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; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Etoposide; Cisplatin; Nimotuzumab
• Other Study ID Numbers: BT-NI-LC-2