A Randomized, Open-label, Multi-center Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF receptor Antibody, in Combination with Chemo-Radiation in Stage IIIA-IIIB Non Small Cell Lung Cancer Patients - Zalutumumab in Combination with Chemo-Radiation in NSCLC

Genmab A/S0 个研究点目标入组 276 人开始时间: 2007年1月29日最近更新: 2012年3月19日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Genmab A/S
入组人数: 276

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Histological or cytological diagnosis of NSCLC in one of the following subtypes: Squamous cell carcinoma, basaloid carcinoma, adenocarcinoma, adenosquamous carcinoma, large cell carcinoma, large cell neuroendocrine carcinoma, giant cell carcinoma, sarcomatoid carcinoma and non small cell carcinoma NOS
•2. Any stage III NSCLC based on CT scan, due to invasion or involvement of mediastinal structures or lymph nodes. In the latter case, proof of nodal status involvement should be confirmed either by cytology or histology, or by appropriate PET imaging (for definition of nodal status, see section 20.2, Definition of Terms)
•3. Performance status 0 or 1 (Zubrod or WHO Scale)
•4. Age = 18 years
•5. Following receipt of verbal and written information about the trial, the patient has provided signed informed consent before any trial related activity is carried out
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Evidence of metastases (based on whole body PET scan and CT scan or MRI of brain), either in a separate lobe of the lung, or extra thoracic
•2. Malignant pleural effusion defined as any significant pleural effusion that has been proven cytologically positive. Non-malignant pleural effusions need to be negative on at least 2 punctures with cytological examination and/or thoracoscopy.
•3. Eligible patients should have tumor volumes that are unlikely to result in a high risk of radiation pneumonitis, and high-risk will be defined as the need to use fields that are likely to result in a V20 of greater than 35%. If a patient who has been included is subsequently found to have a V20 of > 35%, this patient will remain eligible unless the V20 is in excess of 38%. The volume of normal lung which is included in the GTV is not included in the V20 calculation.
•4. Estimated life expectancy of less than 3 months
•5. Unwillingness and inability to attend the required follow-up
•6. Bone marrow reserve: white blood cell count (WBC) < 3.0 x 10^9/L, neutrophils < 1.5 x 10^9/L, platelets < 100 x 10^9/L, hemoglobin < 10 g/dL
•7. Renal function: creatinine clearance calculated by the Cockcroft and Gault equation < 50
•8. Liver function: bilirubin > 1.5 x normal. ALT, alkaline phosphatase and AST > 2.5 x normal
•9. Impaired respiratory function as indicated by a forced expiratory volume in 1 second (FEV1) of less than, or equal to, 40% of predicted normal values OR a diffusion capacity for carbon monoxide (DLCO) of less than, or equal to, 50% of predicted normal values (based on measurement of both parameters)
•10. Evidence of malignancy in the past 2 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other in situ cancers
•11. History of interstitial pneumonitis
•12. Severe COPD requiring = 3 hospitalizations over the past year
•13. Peripheral neuropathy > grade 1
•14. Unintended weight loss of = 15% in the 3 months prior to enrolment
•15. Chronic or current infectious disease such as, but not limited to, chronic renal infection, sinusitis, tuberculosis, and chronic chest infection with bronchiectasis
•16. Severe ongoing infection requiring intravenous antibiotic or antifungal therapy
•17. Serious concomitant systemic disorder incompatible with the trial
•18. Known HIV positive
•19. Known hepatitis B or hepatitis C
•20. Prior chemotherapy for lung cancer
•21. Prior radiotherapy to the chest
•22. Prior surgery with curative intent for lung cancer
•23. Previous exposure to EGFr monoclonal antibodies and/or small molecule inhibitors of EGFr
•24. Use of any anti-cancer or investigational agent in the 4 weeks immediately prior to screening
•25. Current participation in any other interventional clinical trial
•26. Breast feeding women or women with a positive pregnancy test at Visit 1
•27. Male not willing to use adequate contraception during and for 12 months after last dose of zalutumumab or woman of childbearing potential not willing to use adequate contraception such as hormonal birth control or intrauterine device, during trial and 12 months after last dose of zalutumumab. For patients in the USA the use of a double barrier method is also considered adequate.

研究者

发起方

Genmab A/S

相似试验

进行中（未招募）

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A Randomized, Open-label, Multi-center Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF receptor Antibody, in Combination with Chemo-Radiation in Stage IIIA-IIIB Non Small Cell Lung Cancer Patients - Zalutumumab in Combination with Chemo-Radiation in NSCLCStage IIIA-IIIB Non Small Cell Lung CancerMedDRA version: 8.1Level: LLTClassification code 10029519Term: Non-small cell lung cancer stage III

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