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
- Conditions
- Stage IIIA-IIIB Non Small Cell Lung CancerMedDRA version: 8.1Level: LLTClassification code 10029519Term: Non-small cell lung cancer stage III
- Registration Number
- EUCTR2006-004945-40-DE
- Lead Sponsor
- Genmab A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 276
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method