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Research and Clinical Trials

Brief Description  
The primary objective of this study is to evaluate the progression-free survival (PFS) in previously untreated patients with Stage IIIB/IV non-small cell lung cancer (NSCLC) treated with IMC-3G3 plus Paclitaxel and Carboplatin (Arm A) versus Paclitaxel and Carboplatin (Arm B) in the first-line metastatic setting. Platelet-derived growth factor receptor alpha (PDGFR?) is expressed in 51% of lung cancers. Preliminary research demonstrated that the PDGF/PDGFR? signaling axis specifically contri
Who may be Eligible  

  1. Histologically or cytologically confirmed NSCLC stage IIIB with effusion or Stage IV.
  2. Measurable disease.
  3. = 18 years old
  4. Patients on full-time anticoagulation must be on a stable dose of anticoagulant, and if on warfarin must have therapeutic INR and have no active bleeding within 14 days of first study drug and have no pathological condition that carries a high risk of b bleeding.
  5. life expectancy of = 3 months
  6. No untreated central nervous system metastases. Patients are eligible if they have clinically stable neurologic function, are off all steroids after cranial radiation therapy, or after surgical resection performed at least 4 weeks prior to study entry
  7. no therapy for Stage IIIB/Stage IV NSCLC outside of the adjuvant setting
  8. no patients with a history of another primary cancer: except the following:
    1. Cervical carcinoma in situ that has been treated and is now considered to be cured
    2. Adequately treated skin cancer that is not melanoma, which was completely removed by surgery
    3. Another cancer treated at least three years ago. All treatment must be complete for at least three years
  9. no uncontrolled bleeding or clotting disorders
  10. no serious non-healing wounds, ulcers, or bone fractures within 28 days prior to study enrollment
  11. no history of gross hemoptysis (bright red blood or more than 1/2teaspoon) within 2 months of randomization
  12. no previous therapy with any agent that targets platelet-derived growth factor (PDGF) or platelet derived growth factor receptor (PDGFR)
  13. no known allergies to any of the treatment components
Speciality/Disorder  
Non-small cell lung cancer (NSCLC)
IRB Number  
05-10-08B
Principal Investigator  
Carrizosa, Daniel

For More Information, Contact  Mary  K, Tipton
Phone:  (704) 355-8289  Fax:  (704) 355-1353  
Email:  mary.tipton@carolinashealthcare.org
Address:1100 South Tryon Street Suite 220 Charlotte, NC 28204
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