Study of the Effects of an Experimental Drug in Combination with Chemoradiotherapy to Treat Lung Cancer

What we are studying

You have been diagnosed with Stage III Non-Small Cell Lung Cancer. Your doctor will have confirmed this by a pathologist looking at a tissue sample and scans that were taken to assess your disease. In lung cancer, current therapy does not always cure the cancer. This study will test whether an investigational drug, Veliparib, can improve current therapy.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Inclusion criteria:
    • Adequate bone marrow
  • Adequate kidney function
  • Adequate liver function
  • Adequate lung function
  • Willingness to sign/date informed consent form
  • Appropriately sized tumor to follow progression via imaging Exclusion criteria:
    • Pregnant/Breast feeding
  • Subjects who recently underwent chemotherapy or radiotherapy for current lung cancer (NSCLC)
  • Subjects previously treated with drugs similar to Veliparib (PARP inhibitors)
  • Subjects with known sensitivity to carboplatin/paclitaxel
  • Subjects who had major surgery 4 weeks prior to study enrollment
  • Subjects who are unable to swallow medication
  • Subjects who had a seizure within 12 months prior to study enrollment
  • Subjects with peripheral nerve damage

What is involved

  • Subject consent
  • Collection of medical history
  • 1 PET Scan
  • 1 MRI of brain
  • 8 physical exams with vital signs
  • 3 12-lead ECGs
  • 8 performance status assessments
  • 1 serum pregnancy test
  • 1 urine pregnancy test
  • 7 blood draws for chemistry/hematology assessment
  • 3 urine samples for urinalysis
  • 4 CT scans with contrast for tumor assessment
  • 4 quality of life questionnaires
  • Adverse event assessments at each visit
  • Study randomization for treatment type
  • Experimental drug dispensing and oral administration
  • 8 Paclitaxel/Carboplatin chemotherapy treatments
  • Radiation treatment (5 of every 7 day cycle) for 7 weeks
  • 4 blood draws for pharmacokinetic assessments.



Contact Information

Study Coordinator
Sharon Averill
Principal Investigator
Jeff Petty

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.