A PHASE 2, RANDOMIZED, MULTI-CENTER, OPEN-LABEL STUDY TOEVALUATE THE EFFICACY AND SAFETY OF MAPATUMUMAB ( [HGS1012], AFULLY HUMAN MONOCLONAL ANTIBODY TO TRAIL-R1) IN COMBINATIONWITH CARBOPLATIN AND PACLITAXEL AS FIRST LINE THERAPY INSUBJECTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC)
- Conditions
- Advanced Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 10.1Level: LLTClassification code 10061873Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2007-005153-32-HU
- Lead Sponsor
- Human Genome Sciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 111
1. Histologically or cytologically confirmed Stage IIIB (T4 due to malignant pericardial or pleural effusions as indicated by positive cytology, exudative effusion and LDH > 200IU with effusion/serum LDH ratio 0.6 [Wet IIIB”] or any N3, M0 who are not candidates for standard combined modality therapy) or Stage IV advanced primary non-small cell lung carcinoma.
2. Measurable disease according to RECIST. Measurable lesions must be outside a previous radiotherapy field if they are the sole site of disease unless disease progression has been documented. Pleural/pericardial effusions, ascites or laboratory parameters are not acceptable as the only evidence of disease.
3. Adequate hematologic function and bone marrow reserve:
-Absolute neutrophil count (ANC) = 1.5 x 109/L.
-Platelet (PLT) count = 100 x 109/L without a transfusion within 14 days before randomization.
-Hemoglobin = 9 g/dL without a transfusion or growth factor support within 14 days before randomization.
4. Adequate hepatic and renal function:
-Aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 x upper limit of normal (ULN) in the absence of liver metastases and = 5.0 x ULN in the presence of liver metastases.
-Creatinine clearance = 50 mL/min using the Cockcroft-Gault formula.
-Serum creatinine = 1.5 mg/dL or = 132.6 µmol/L.
5. Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
6. Age 18 years or older.
7. Have the ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the study and follow-up procedures.
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. Any co-morbid condition that in the judgment of the investigator renders the subject at high risk of treatment complication or reduces the probability of assessing clinical effect.
2. Received prior investigational or non-investigational cytotoxic chemotherapy, hormonal therapy, or biological therapy (including but not limited to monoclonal antibodies, small molecules or other immunotherapy) as 1st-line therapy for advanced NSCLC. Chemotherapy administered as a radiosensitizing agent will be allowed provided it was administered at least 4 weeks before randomization and all toxicities are resolved. Adjuvant chemotherapy administered for the treatment of NSCLC will be allowed provided it was completed at least 24 months prior to randomization. Subjects who completed cancer therapy for a cancer other than NSCLC greater than 5 years before randomization and who are documented disease free at the time of randomization will be allowed in study.
3. Need for concomitant anticancer therapy (radiation therapy, chemotherapy,
immunotherapy, radiofrequency ablation) or other investigational agents. Subjects who need palliative radiation therapy within 4 weeks before randomization or during Cycle 1 to lesions identified at baseline that are not designated for follow-up as target lesions are not excluded.
4. Received radiation therapy (with or without chemosensitization), photodynamic therapy or radiofrequency ablation to any lesion identified as a target lesion within 4 weeks before randomization.
5. Major surgery (ie, the opening of a major body cavity, requiring the use of general
anesthesia) within 4 weeks before randomization; minor surgery (except for insertion of vascular access device) within 2 weeks before randomization; or not yet recovered from the effects of such surgery. Invasive percutaneous procedures (eg, thoracentesis) require no washout period prior to randomization if there are no adverse effects of the procedure present.
6. Systemic steroids within 1 week before randomization except steroids used as part of an antiemetic regimen or maintenance-dose steroids for non-cancerous disease.
7. Small cell histology.
8. Any Grade 2 or greater neuropathy.
9. History of severe (Grade 4) hypersensitivity reaction to products containing Cremophor EL (cyclosporine, teniposide).
10. History of any infection requiring hospitalization or systemic anti-infectives within
2 weeks before randomization. Topical anti-infectives and oral antibiotics for standard of care prophylactic indications (for example, but not limited to, subacute bacterial endocarditis during dental procedures) will be permitted.
11. Known symptomatic brain or spinal cord metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids. Asymptomatic brain or spinal cord metastases which are stable and do not require treatment will be allowed.
12. History of other cancers within 5 years before randomization except for basal cell
carcinoma or squamous cell carcinoma of the skin and in situ cancers of the cervix.
13. Known human immunodeficiency virus (HIV) infection.
14. Have a history of, or test positive at screening for Hepatitis B surface antigen, or Hepatitis C antibody.
15. Unstable angina, myocardial infarction, cerebrovascular accident, or = Class III congestive heart failure (CHF) according to the New York Heart Association Classification for CHF (see Appendix 2) within 6 months befo
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