A Randomized, Double-Blind, Phase 2, Dose-Ranging Study to Evaluate the Safety and Efficacy of Veliparib and Whole Brain Radiation Therapy Versus Placebo and Whole Brain Radiation Therapy in Subjects With Brain Metastases From Non-Small Cell Lung Cancer

Inclusion Criteria:

- Subject must be greater than or equal to 18 years of age

- Subject must have cytologically or histologically confirmed non-small cell lung
cancer

- Subject must have brain metastases demonstrated on a MRI brain scan

- Subject must be eligible for WBRT

Exclusion Criteria:

- Subject is diagnosed with brain metastases greater than 28 days prior to treatment

- Subject received any prior form of cranial radiation and/or neurosurgery for their
brain metastases

- Subject's last dose of anti-cancer therapy or investigational therapy was less than
or equal to 7 days prior to treatment

- Subject has a Karnofsky Performance Score of less than 70

- Subject has significant dyspnea requiring supplemental oxygen therapy

- Subject has liver metastases (restaging is not required for known liver metastases)

- Subject has more than 2 sites (organ systems) of metastases from non-small cell lung
cancer with the exception of intra-cranial sites of metastases from non-small cell
lung cancer, thoracic sites of metastases from non-small cell lung cancer and bone
metastases

- Subject has leptomeningeal metastases or subarachnoid spread of tumor

- Subject has unresolved or unstable, serious toxicity from prior administration of
another investigational drug and/or prior anti-cancer treatment

- Subject has a known seizure disorder that is uncontrolled, or has seizures occurring
greater than or equal to 3 times a week over the past month. Subjects presenting with
symptoms of seizures from the brain metastases are eligible; however he/she should
receive adequate anti-seizure medication prior to study treatment

- Subject is pregnant or lactating

- Subject has previously been treated with a poly-(ADP-ribose)-polymerase inhibitor as
an investigational agent

- Subject has clinically significant and uncontrolled major medical condition(s)

- Subject has a history of another active cancer within the past 5 years except:
cervical cancer in situ, in situ carcinoma of the bladder, basal or squamous cell
carcinoma of the skin or other cancer in situ that is considered cured